Media Mentions
2012
“PE’s Healing Touch Faces Test in Hospital Buys”
Law360, February 8, 2012
Ira Coleman discussed reasons why not-for-profit hospitals are turning more to private equity investors. He cited the “proverbial perfect storm” of capital demands increasing dramatically "at the same time reimbursement is decreasing." Mr. Coleman added that, “the regulatory regime is so draconian, a minor slip has major consequences that can easily derail a health care venture.”
“IRS Broadly Describes Tax Exemption Requirements for Health Care Co-Ops”
BNA Health Care Daily Report, February 7, 2012
Michael Fine said that, in offering its first tax guidance on health insurance cooperatives under health care reform, the IRS decision to allow the Centers for Medicare and Medicaid Services to evaluate co-op qualification involves “letting some of the other federal agencies lead here and then relying on those federal agencies to establish the rules that are really driving the show.” Nevertheless, Mr. Fine added, for the IRS to clarify how qualifying co-ops can apply for tax exemption “is what we are waiting for.”
“Eye Toward Patient Safety, Labor-Savings Fuels Growth”
Boston Business Journal, February 3, 2012
Stephen Bernstein said that medical device makers have “huge opportunities … to enhance and grow technologies” in the field of medical automation, because “the need for speed and reduced expense is growing ever more important.”
Stephen W. Bernstein, Health, Life Sciences - Medical Products & Technology
“Get Ready for FCPA Enforcement to Target R&D, Trials, Experts Say”
Clinical Trials Advisor, February 2, 2012
Glenn Engelmann noted that drug makers must better understand the distinct corruption risks in R&D departments, which typically are more open and collaborative than commercial departments. Such risks have increased in light of the Justice Department’s increased emphasis on sales and marketing activities in enforcing the Foreign Corrupt Practices Act.
Glenn Engelmann, Foreign Corrupt Practices Act (FCPA) and International Anticorruption, Health
“Building Connections on the Care Continuum”
Health Data Management, February 2012
Bernadette Broccolo said that many state privacy laws will make it difficult for accountable care organizations (ACOs) to share electronic health records and other patient information. “A key to the ACO will be the ability to aggregate, share and analyze data,” Ms. Broccolo stated. “The legal and I.T. issues are intertwined. The legal requirements are complex.”
Bernadette M. Broccolo, Accountable Care Organization Resource Center, Health
“GCs Laud Securities, M&A Attys. with Top Client Skills”
Law360, February 1, 2012
Paul Lawrence and Michael Peregrine were among 84 securities, M&A and transactional lawyers throughout the country recognized as “Client Service All-Stars” by BTI Consulting. The recognition reflected a survey of corporate in-house counsel who singled out the lawyers for superior client focus, business understanding, value, legal skills and results.
Paul F. Lawrence, Michael W. Peregrine, Health
“Firm Life”
Chicago Lawyer, February 1, 2012
Erin Arnold, Kevin Miller, Brett Johnson and Maureen O’Brien, Amol Parikh and Adam Sherman were cited as the six McDermott Chicago office lawyers among 29 recently named to the Firm’s partnership.
Erin Arnold, Brett R. Johnson, Kevin L. Miller, Maureen O'Brien, Amol Parikh, Adam Sherman, Airport & Aviation, Employee Benefits, Health, Intellectual Property, IP Litigation, Private Client, Trial
“R&D, Trials to See More FCPA Enforcement, Experts Say”
Washington Drug Letter, January 30, 2012
Glenn Engelmann cautioned that, while research and development departments of drug companies typically view compliance with anti-corruption statutes like FCPA as a marketing concern, companies need to train their scientists to beware of ethical conflicts when engaging with academic, industry or healthcare peers – especially if those peers work at facilities that are government controlled.
Glenn Engelmann, Foreign Corrupt Practices Act (FCPA) and International Anticorruption, Health
“510(k) Guidance Footnote May Signal Greater FDA Oversight of Preclinical Testing”
The Gray Sheet, January 23, 2012
James Cohen pointed out that that a footnote in a new FDA draft guidance contains “the suggestion” that all nonclinical laboratory studies for medical device safety include a statement of compliance with the agency’s Good Laboratory Practices, which “is not now contained” in the 501(k) regulation.
“AHA Wants Medicare Measures Tied to Payroll Tax-Cut Legislation”
Modern Healthcare, January 22, 2012
Eric Zimmerman said that if Congress does not renew two programs that benefit Medicare-dependent hospitals and low-volume hospitals, the Medicare reimbursements for these generally smaller health care providers “could be pretty severely affected.”
Eric Zimmerman, Health, Health Care Law Reform
“Hospital Wage Index Formula Fix Delayed”
PoliticoPro, January 20, 2012
Eric Zimmerman, calling revision of Medicare’s index of hospital labor cost differences a “thorny problem without easy solutions,” noted that a reimbursement increase from the budget-neutral index for hospitals in high wage areas means “some of the hospitals win but many of the hospitals also lose.” He added that if Congress does not approve some financial help for the losers, “there are going to be a lot of disgruntled hospitals.”
Eric Zimmerman, Health, Health Care Law Reform
“Movers & Shakers”
The Deal Pipeline, January 19, 2012
Warren Rosborough and Mary Samsa were noted as new partners joining McDermott. Mr. Rosborough, formerly a trial lawyer in the Justice Department Antitrust Division, focuses on antitrust and compliance matters in the Washington office. Ms. Samsa is a member of the Health Advisory Practice in the Chicago office, and most recently was a shareholder at other major law firms.
Warren Rosborough, Mary K. Samsa, Antitrust & Competition, Health
“Nevada Cancer Institute Sale OK’d”
The Deal Pipeline, January 13, 2012
James Kapp III, Gary Gertler and Esther Chang represented the successful stalking horse bidder in the $18 million bankruptcy sale of Nevada Cancer Institute’s oncology treatment business, which has been approved by federal bankruptcy court in Nevada.
Esther Chang, Gary B. Gertler, James W. Kapp III, Corporate, Health
“Medicare Physician Pay Fix Extension to Dominate Congressional Action in 2012”
BNA Health Law Resource Center, January 13, 2012
Eric Zimmerman said that Medicare spending could again be targeted by Congressional budget reduction efforts. He noted that the failure of the joint committee on deficit reduction could mandate Medicare spending cuts of two percent or more, adding that because the mandated cuts would not take effect until 2013, Congress has time to alter them. Mr. Zimmerman also saw controversy over startup of the Independent Payment Advisory Board, saying “up to this point the IPAB has only been an idea,” but in 2012 “the administrative machinery that will enable the IPAB to operate” must be established, likely with controversy in Congress.
Eric Zimmerman, Health, Health Care Law Reform
“Supreme Court Ruling, Exchanges Top Issues for Health Insurers in 2012”
Bloomberg BNA Health Insurance Report, January 11, 2012
Eric Zimmerman cautioned health care stakeholders, “don’t expect much legislative change” to the Affordable Care Act in 2012 because the political situation in Washington, D.C., remains the same. “House Republicans may continue efforts to pick away at the law, and may approve some measures to repeal or scale back the law,” he said, “but those efforts are not likely to be enacted so long as Democrats control the Senate.”
Eric Zimmerman, Health, Health Care Law Reform
Supreme Court Ruling, Exchanges Top Issues for Health Insurers in 2012
Bloomberg BNA Health Insurance Report, January 11, 2012
The rule that HHS will issue in 2012 on the EHB package affects not only ‘‘qualified health plans’’ offered through the state insurance exchanges, but also all ‘‘nongrandfathered’’ individual and small group plans that did not exist before PPACA was enacted, Anne Hance, a partner in the health industry advisory practice group of McDermott Will & Emery LLP, told Bloomberg BNA. ‘‘It becomes a very critical benchmark,’’ Hance said. ‘‘For plans it’s a strategic issue,’’ since some benefits that are not defined as ‘‘essential’’ are popular, and health plans will have to consider what to offer in the context of the rule, she said.
“Catholic Health Initiatives Pursues New Deal After Governor Blocks Three-Hospital Merger”
BNA Health Law Resource Center, January 9, 2012
Michael Peregrine assessed the rejection by Kentucky’s Governor and Attorney General (AG) of a state-owned hospital’s participation in a Catholic health system merger by saying that, although there were “a number of credible legal reasons to say ‘no,’” the real impact of the decision goes beyond this transaction. “This just as easily could have involved an AG’s review of a transaction involving any nonprofit hospital,” he noted, meaning “there will be a broader spillover effect.”
“Regulatory Challenges, Uncertainty Make Health Care Reform Top Health Law Issue”
BNA’s Health Law Reporter, January 5, 2012
Michael Peregrine spoke extensively on the top compliance and governance issues facing healthcare providers in 2012. Mr. Peregrine cited the “responsible corporate officer doctrine” as a major concern, “as the Obama Administration continues to focus on individual accountability for corporate criminal activity.” He also warned that efforts to streamline health system corporate structures “need to be balanced with the increasing importance of attentive oversight from governing boards.”
Michael W. Peregrine, Health, Health Care Law Reform
“Nevada Cancer Institute Bid Unopposed”
The Deal Pipeline, January 5, 2012
James Kapp III, Gary Gertler and Esther Chang were noted as representing the successful stalking horse bidder in the $18 million sale of Nevada Cancer Institute’s oncology treatment business.
Esther Chang, Gary B. Gertler, James W. Kapp III, Corporate, Health
“McDermott Launches in Turkey via Fora & Sanli Link-Up”
The Lawyer (UK), January 4, 2012
John Callahan discussed the Firm's new relationship with Istanbul-based Fora & Sanli and the work the two firms will be doing together on health-focused M&A. The Turkish healthcare sector is currently of interest to foreign and domestic investors, who are taking advantage of opportunities presented through leveraged buy-outs and PPP deals.
“McDermott Secures Turkey Launch as Firm Targets Healthcare M&A Work”
Legal Week (UK), January 3, 2012
John Callahan said that McDermott will “fill the void that currently exists in Turkey for qualified, health-focused M&A expertise” by setting up a preferred provider relationship with Istanbul’s Fora & Sanli. The two firms will work with international clients on health sector transactions in Turkey and the surrounding region.
“Industry Insiders Clarify MSSP Participation in Multiple ACOs”
ACO Business News, January 2012
J. Peter Rich said that under final Medicare rules for accountable care organizations (ACOs), a primary care physician’s taxpayer ID number (TIN) “must be exclusive to one ACO (and will determine the Medicare beneficiaries attributed to that ACO).” Mr. Rich added that a physician could theoretically participate in a second ACO by billing under the TIN of a medical group, practice association or hospital.
2011
“Firm Life”
Chicago Lawyer, December 15, 2011
Randall Ortman has been appointed as a board of directors member for the Lesbian and Gay Bar Association of Chicago.
“Early EMR Adopters Get a Break; Tougher Criteria Delayed to 2014”
American Medical News, December 12, 2011
Stephen Bernstein said the “main message” of a government announcement giving physicians who earn 2011 federal electronic medical record incentives more time to meet tougher standards for additional bonuses “is that there are federal government programs out there to help physicians, and the federal government isn’t going to stop offering help.” Mr. Bernstein said this is particularly relevant for physicians who are undecided about making a significant investment in electronic recordkeeping but who want to participate in new Medicare payment models.
“CMS Supports Medicare Plans’ Ability to Collect Under Secondary Payer Law”
BNA Health Law Resource Center, December 8, 2011
Arthur Sapper said that a Centers for Medicare & Medicaid Services memo urging Medicare Advantage organizations to collect for services when other entities are primary payers is important because previous court decisions indicated no such collection right existed. “Although you can’t ‘unring’ bells when it comes to previous court rulings,” Mr. Sapper added, courts in future decisions will need to defer to the CMS view that previous decisions misunderstood the statute.
Arthur G. Sapper, Health, OSHA, MSHA & Catastrophe Response
“Life Support for Ailing Hospitals?”
Kaiser Health News, December 8, 2011
Eric Zimmerman said that possible cuts in federal spending to support small, rural “critical access hospitals” could result in hospital closures that “can have an outsized economic impact” on the towns where the hospitals are located. “Hospitals are like schools,” Mr. Zimmerman asserted. “Businesses aren’t going to locate in a town where there aren’t schools, and they aren’t going to locate in a town where there isn’t a hospital.”
“Capital Sources: Health-Care Technology Sector ‘White Hot’ for Investors”
Daily Business Review, December 7, 2011
Ira Coleman, who focuses on healthcare industry mergers & acquisitions and recapitalizations, said that the “last two years have been incredibly active” for such transactions, adding that he currently has “three deals that are active and another one in the pipeline. That’s very busy for me and my team.” Mr. Coleman noted that healthcare has “been a white-hot sector, because M&A activity came back and everybody wanted to be in health care.”
“Physicians Uncertain About Taking Part in ACOs”
American Medical News, December 5, 2011
Anne Hance suggested that “in a large part, it’s going to be a business decision that takes in a variety of factors” as to whether physicians join the collaborative accountable care organizations (ACOs) encouraged by the health reform law.
Anne W. Hance, Accountable Care Organization Resource Center, Health
“Nevada Cancer Institute Looks to Sell”
Deal Pipeline, December 5, 2011
James Kapp, Gary Gertler and Esther Chang were noted as representing the proposed stalking horse bidder in the Chapter 11 bankruptcy sale of a Nevada nonprofit cancer institute’s oncology treatment business.
Esther Chang, Gary B. Gertler, James W. Kapp III, Corporate, Health
“Power Circuit: Morgan Lewis Loses One Partner, Gains Another”
Washingtonian, November 30, 2011
Christopher May, Rita Weeks, David Crump, Alison Levin Nadel, Nathaniel Dorfman, Caroline Hong Ngo, Timothy Shuman, Amy Hooper Kearbey, Joanna Kerpen were cited as the Firm’s ten new Washington, D.C. partners effective January 1, 2012. The article also said that the Firm welcomed a new partner from Morgan Lewis & Bockius, Karol Lyn Newman who has joined the Energy Advisory practice.
David O. Crump, Nathaniel J. Dorfman, Amy Hooper Kearbey, Joanna C. Kerpen, Christopher L. May, Alison Levin Nadel, Karol Lyn Newman, Caroline Hong Ngo, Timothy S. Shuman, Rita Weeks, Employee Benefits, Energy Advisory, Health, Intellectual Property, International Tax, IP Litigation, Patent Prosecution, Tax
“In the Law Firms”
Chicago Daily Law Bulletin, November 28, 2011
Erin Arnold (Trial), Brett Johnson (Employee Benefits), Kevin Miller (Health), Maureen O’Brien (Employee Benefits), Amol Parikh (Intellectual Property) and Adam Sherman (Private Client) were the Chicago office lawyers among the 29 new global partners that McDermott announced effective January 1, 2012.
Erin Arnold, Brett R. Johnson, Kevin L. Miller, Maureen O'Brien, Amol Parikh, Adam Sherman, Employee Benefits, Health, Intellectual Property, Private Client, Trial
“Budget Panel Fails to Reach Deal, Triggering Health Cuts in 2013”
BNA Health Law Resource Center, November 22, 2011
Eric Zimmerman warned that, although the congressional debt reduction panel did not agree on larger Medicare payment cuts than the automatic 2% reduction set for 2013, “Just because we have dodged the bullet for now does not mean we have dodged it for good.” Mr. Zimmerman said that physicians “ignore … at [their] own peril” the fact that Congress will continue to target health spending as the main driver of federal spending, resurrecting some of the same cuts discussed by the deficit panel.
Eric Zimmerman, Health, Health Care Law Reform
“Clock’s Ticking: Deadlock Leaves Industry Anxious”
Modern Healthcare, November 21, 2011
Eric Zimmerman suggested that the Supercommittee’s failure to agree on debt reduction provisions “doesn’t mean that other proposals can’t come together in either chamber in the month that’s remaining.” He added that once the clock starts ticking on automatic spending cuts on January 2, “Congress can come in any time before 2013 specifying how cuts can be made between now and then.”
Eric Zimmerman, Health, Health Care Law Reform
“As Health Lobby Looks Past Supercommittee, ‘Doc Fix’ Trumps Medicare Cuts”
The Hill, November 21, 2011
Eric Zimmerman predicted that, although Medicaid reimbursement to physicians is shielded from automatic cuts that kick in following failure of a congressional panel to agree on specific deficit reductions, “it’s just a matter of time before we’re back in the same kind of dialogue” on how to reduce payments to doctors.
Eric Zimmerman, Health, Health Care Law Reform
“Esther Chang – McDermott Will & Emery”
National Law Journal, October 31, 2011
Esther Chang was selected for the publication’s “Minority 40 Under 40” list of top young lawyers, which called her “a leading transactional attorney and an expert in health care fraud and privacy issues.” In addition to working on such matters as the country’s largest hospital M&A deal in 2010, Ms. Chang has also taken a major role in pro bono cases involving human trafficking. As she said of such work, “I just want to know that once my life ends, I made a difference.”
“Asymmetry in the Ability to Communicate CER Findings”
States News Service, October 31, 2011
Paul Radensky was quoted by the National Pharmaceutical Council as saying that, while there are a number of health databases available, not all health care stakeholders have access to the information – even if it helps with patient care management. Dr. Radensky suggested that, with proper regulation, broader access to public databases could facilitate more informed decisions on health treatment.
Paul W. Radensky M.D., Health, Life Sciences & Medical Products Litigation, Life Sciences - Health
“CMS Loosens Marketing Guidelines, Meaningful Use Requirements for ACOs”
BNA Daily Health Care Report, October 27, 2011
Lauren Haley said that the final rule from the Centers for Medicare and Medicaid Services (CMS) for accountable care organizations (ACOs) loosens “a bit” the requirements on how ACOs can market themselves to Medicare beneficiaries. Marketing materials cannot be misleading or confusing, cannot imply CMS endorsement and cannot interfere with beneficiary freedom of choice, she noted. Ms. Haley anticipated that CMS will maintain oversight and monitoring of ACO marketing activities.
Lauren N. Haley, Accountable Care Organization Resource Center, Health
“Breaking the Rules”
Modern Healthcare, October 24, 2011
Michael Peregrine pointed out the benefit of a new government rule eliminating the requirement that each hospital within a healthcare system maintain its own board, saying that the previous rule made hospitals “re-populate all of these boards with competent, non-conflicted and sophisticated members. That’s an enormous burden.”
“Bringing ACOs Back to Life”
Hospitals & Health Networks Daily, October 21, 2011
Anne Hance praised the final Centers for Medicare and Medicaid Services (CMS) rule on accountable care organizations, saying that it “certainly shows an effort by CMS to be responsive to the comments it received” on a preliminary rule issued earlier.
“Providers Praise ACO Final Rule, but Say Program Participation Remains Unclear”
BNA Health Care Daily Report, October 21, 2011
Lauren Haley said that the final rule on accountable care organizations (ACOs) showed that the government “tried to listen to industry concerns” about an earlier preliminary rule, but she noted that although the rule’s reduction in quality measures “sounds good, … I’m not sure it is enough” to encourage hospitals to accept the “major burden” of collecting quality data. Ms. Haley concluded, “Truthfully, at the end of the day, this is a business decision” whether providers want to form an ACO.
Lauren N. Haley, Accountable Care Organization Resource Center, Health
“U.S. District Court Judge in Rhode Island Says Network Owes Fiduciary Duty to Nonprofit Hospital”
Rhode Island Lawyers Weekly, October 20, 2011
Christopher Jedrey, asserting that a recent court ruling leaves no doubt that there is fiduciary duty between health systems and nonprofit hospital subsidiaries, advised organizations “to make sure the ‘purposes clauses’ of the articles of organization of the subsidiaries say that they exist to support the system as a whole.” If that is done, he added, “The likelihood of a conflict of interest is low.”
“Can the FDA Be a Catalyst for Innovation?”
Genetic Engineering & Biotechnology News, October 15, 2011
Paul Radensky called the development of therapeutic diagnostics “an area of great interest and concern” for the direction of FDA regulation, particularly for regulating in vitro diagnostics as medical devices. He cited as a challenge “the accuracy, reliability, and reproducibility of the test with respect to the information furnished by the test.”
Paul W. Radensky M.D., Health, Life Sciences & Medical Products Litigation, Life Sciences - Health
“The Bare Essentials”
Modern Healthcare, October 10, 2011
Lauren Haley said that it is an ambitious target for the Department of Health and Human Services to release by May 2012 a final rule on essential health benefits to be covered in insurance offered through the health reform law’s state insurance exchanges. “If this is going to go live when it’s slated to go live, [health] plans need time to figure this all out,” she stated. “The startup is not an easy task.”
Lauren N. Haley, Health, Health Care Law Reform
“McDermott’s Joshua Buchman on Exclusion and the Responsible Corporate Officer Doctrine”
Corporate Crime Reporter, October 10, 2011
Joshua Buchman discussed increased federal prosecutor application of the responsible corporate officer doctrine to “assign personal individual responsibility to corporate executives and managers for the conduct of entities for which they work.” He said its use in the healthcare sector would be “not necessarily in a criminal sense,” but instead by the Office of Inspector General to address “excluding people from Medicare, Medicaid and other health care programs.” Mr. Buchman called this another example “of the government pushing the envelope and … expanding theories of liability in almost every aspect of health care enforcement.”
Joshua T. Buchman, Health, Health Care Law Reform
“People on the Move”
Congressional Quarterly, October 7, 2011
Glenn Engelmann and Susan Lee were cited as new members of the life sciences practice in McDermott’s Washington office. Mr. Engelmann had formerly been Vice President and General Counsel at AstraZeneca Pharmaceuticals and held a committee chairmanship with the Pharmaceutical Research and Manufacturers of America, while Ms. Lee’s past experience included Vice President for Economic Policy at the Center for American Progress and consultant at McKinsey & Co.
Glenn Engelmann, Susan S. Lee, Health, Life Sciences & Medical Products Litigation, Life Sciences - Health
“New Hires: Firm Adds to Life Sciences Practice”
Washington Post’s Capital Business, October 3, 2011
Glenn Engelmann and Susan Lee were recognized for joining McDermott Will & Emery’s Life Science Practice Group. Both lawyers' photos were included with the story.
Glenn Engelmann, Susan S. Lee, Health, Life Sciences & Medical Products
“Movers & Shakers: October 3, 2011”
The Deal Pipeline, October 3, 2011
Glenn Engelmann and Susan Lee were noted for recently joining McDermott Will & Emery’s Life Sciences Practice Group.
Glenn Engelmann, Susan S. Lee, Health, Life Sciences & Medical Products
“Power Circuit”
Washingtonian, September 28, 2011
Glenn Engelmann (former general counsel at AstraZeneca Pharmaceuticals) and Susan Lee were noted as new Washington office members of McDermott’s Life Sciences practice.
Glenn Engelmann, Susan S. Lee, Health, Life Sciences & Medical Products
“AstraZeneca GC Engelmann Jumps to McDermott Will”
Blog of Legal Times, September 27, 2011
Glenn Engelmann, now Life Sciences senior counsel with McDermott in Washington, formerly was the top counsel for leading pharmaceutical company AstraZeneca, where he advised company leadership on a variety of legal and regulatory matters. Associate Susan Lee, who joins him in the Life Sciences practice, has a strong background in matters involving the Food & Drug Administration and clinical trials.
Glenn Engelmann, Health, Life Sciences & Medical Products
“The Churn: Lateral Moves and Promotions in the AmLaw 200”
AmLaw Daily, September 27, 2011
Glenn Engelmann was noted as the new Life Sciences senior counsel in McDermott’s Washington office. A former Vice President and General Counsel at AstraZeneca, Mr. Engelmann will focus on complex legal and regulatory issues affecting the pharmaceutical industry.
Glenn Engelmann, Health, Life Sciences & Medical Products Litigation
“AstraZeneca GC Joins McDermott’s Life Sciences Group”
Law360, September 27, 2011
Glenn Engelmann, former general counsel at AstraZeneca Pharmaceuticals, joined the Life Sciences practice in McDermott’s Washington office. Mr. Engelmann said he was “drawn to McDermott’s multidisciplinary and coordinated approach to life sciences.” His experience handling regulatory investigations and patent litigation was praised by Stephen Bernstein, who said that Englemann knows “firsthand the concerns and motivations that drive our clients.” Also joining the Washington Life Sciences practice was associate Susan Lee, who will focus on regulatory compliance and public policy matters.
Stephen W. Bernstein, Glenn Engelmann, Susan S. Lee, Health, Life Sciences & Medical Products
“Health Cuts Would Be Spread Over a Wide Variety of Programs”
Boston Globe, September 20, 2011
Eric Zimmerman said that an Obama Administration deficit reduction plan that includes Medicare and Medicaid cuts “will not likely advance as a package,” but stakeholders such as teaching hospitals and drug manufacturers “would dismiss it at their peril” because “individual aspects of it most certainly could advance.”
Eric Zimmerman, Health, Health Care Law Reform
“Industry to Supercommittee: Back Exchange Program”
Modern Healthcare, September 19, 2011
Eric Zimmerman criticized efforts by the Administration and Congress to squeeze cost savings from healthcare providers by attempting to crack down on alleged waste, fraud and abuse, “all for seemingly no reason than this is part of the oversight effort and fraud-crackdown effort – without errors and incidents that warrant that kind of scrutiny.” Noting that “politically, it’s easy to do” such investigations, Mr. Zimmerman warned that “at some point it adds to the cost of healthcare because of the administrative burden on the healthcare provider.”
“Boards Watch Anxiously as Nonprofit Pay Draws States’ Scrutiny”
Chronicle of Philanthropy, September 18, 2011
Michael Peregrine predicted that “other states are going to jump in” to copy the inquiries begun or legislation introduced in several states regarding alleged excessive compensation to charity executives, largely because “the attorneys general in states that have staff to pursue nonprofit compensation will find it politically expedient to do so.” Mr. Peregrine added that charity boards can thus no longer afford to rubber-stamp the compensation recommendations of consultants.
“Rural Hospitals Sue for $86M in Medicare Reimbursements”
Blog of Legal Times, September 16, 2011
Ankur Goel explained that a group of rural hospitals he represents is suing the Department of Health and Human Services for lost reimbursements from a Medicare calculation adjustment that “is going to fall on these primarily rural hospitals and the change in policy is going to negatively affect them financially.” He added, “The lawsuit is just intended to pay the reimbursement in accordance with the statute.”
“Lawsuit Filed Over Small-Hospital Reimbursement”
Modern Healthcare, September 15, 2011
Ankur Goel, representing a group of mainly rural hospitals suing the federal government to recoup Medicare payments reduced under a new process and to change the reimbursement formula, expressed doubt that the government “has the authority to adjust the rates in the way that they did under the Medicare statute,” adding that Medicare had “reached the same conclusion several times over the past few years, and we agree with their prior determinations on that.”
“U.S. Targets Drug Executives”
Wall Street Journal, September 13, 2011
Michael Peregrine called the “responsible corporate officer doctrine,” which creates personal and criminal liability for executives whose companies violate the law, the “ticket around the need to prove criminal intent” for federal prosecutors. For that reason, Mr. Peregrine said, the doctrine “puts the pistol to the head of the very senior executives.”
“Movers: New Arrivals”
National Law Journal, September 12, 2011
David Spackman was noted for joining the Firm’s Boston office as counsel. Mr. Spackman will focus on corporate governance, executive compensation and conversion transactions as a member of the health industry advisory practice group.
“Under Pressure”
Modern Healthcare, September 5, 2011
Bernadette Broccolo said that some hospitals are resisting the use of web-based “cloud computing” data storage services for a number of reasons, especially the risk that such services will not meet data privacy requirements. Healthcare providers, she noted, “have additional risks and liability exposures tied to the accuracy, completeness, timeliness and overall integrity of the information because it relates to patient care.” Ms. Broccolo added that such resistance may dissipate as more large hospitals and health systems adopt cloud computing.
Bernadette M. Broccolo, Health
“Against the Rule”
Modern Healthcare, September 5, 2011
Jessica Roth said that the Centers for Medicare and Medicaid Services (CMS) “decided to take a different approach” to measuring hospital efficiency than the historical length of stay standard, and instead opted to “measure efficiency through cost” in newly issued rules. This means that after a patient enters a hospital, CMS will take into account all of the care provided for a 30-day period, including patient satisfaction and outcome, to determine spending on that beneficiary.
“Avoid These HIPAA Land Mines Involving Your Practitioners’ Cell Phones”
Part B Insider, September 2011
Stephen Bernstein warned that, although texting patient health information is not technically illegal under HIPAA, it may be prohibited by more protective state laws. “From a HIPAA security standpoint, it’s better not to send emails and texts” with such information, Mr. Bernstein said, “but between the two, emails are safer than texts and, when possible, emails should be encrypted.”
“Movers and Shakers”
The Deal Pipeline, August 26, 2011
David Spackman was noted for joining the health industry advisory practice of McDermott’s Boston office. Mr. Spackman, previously director of the Division of Public Charities in the Massachusetts Attorney General’s office, will focus on corporate governance and executive compensation issues.
“Back in the Game: AHA’s Numbers Up as Investments Drive Income”
Modern Healthcare, August 22, 2011
Robert Louthian III, commenting on the American Hospital Association’s 40% 2010 increase in lobbying expenses, contended that, “Given the critical importance of healthcare reform, and the fact that AHA is one of the leading associations representing that industry, I don’t think the increase in lobbying expenditures year over year is anything particularly unusual or unexpected.”
Robert C. Louthian III, Health
“Former Division Chief with AG’s Office Joins McDermott”
Massachusetts Lawyers Weekly, August 16, 2011
David Spackman, new counsel in the Boston office’s health industry advisory practice group, previously had public interest oversight responsibility for 22,000 Massachusetts public charities as Director of the Division of Public Charities in the state’s Attorney General Office. That included regulatory review and approval of the first-ever sale of a Catholic nonprofit health system to a private equity firm. Before his government assignment, Mr. Spackman spent more than two decades in private legal practice.
“The Churn: Lateral Moves and Promotions”
AmLaw Daily, August 16, 2011
David Spackman joined McDermott’s Boston office as counsel in the health industry advisory practice group. Mr. Spackman was most recently director of the Division of Public Charities in the Massachusetts Attorney General’s office, and focuses his practice on governance, executive compensation and conversion transaction issues in the healthcare sector.
“Appeals Court Strikes Health Insurance Requirement”
Associated Press, August 13, 2011
J. Peter Rich noted that, despite rulings by lower courts, the U.S. Supreme Court has not ruled on the “specific issue” of the health reform law’s provision requiring individuals to buy health insurance. Mr. Rich said it is not unconstitutional for individual states like Massachusetts to have such a provision, but the federal requirement “really is a case of first impression, although the Obama administration may try to argue otherwise.”
“Eleventh Circuit Rules Individual Mandate Is Unconstitutional”
Blog of Legal Times, August 12, 2011
J. Peter Rich predicted that the U.S. Justice Department will have “a tough decision to make” on whether to have the full Eleventh Circuit review a three-judge panel’s rejection of the health reform law’s mandatory insurance provision, because the full court could strike down the entire law. Even so, Mr. Rich said he expects the U.S. Supreme Court to wait until the Fourth Circuit rules before taking the issue up.
“Payment Boost – But Future Adjustments Concern Hospitals”
Modern Healthcare, August 9, 2011
Jessica Roth said that although the Centers for Medicare and Medicaid Services (CMS) have more than doubled their diagnosis-related reimbursement groups to distinguish the severity of cases, it still does not appear to cover all outpatient reimbursement needs. “The argument is,” she noted, “that CMS in their simple math doesn’t account for a natural increase in case mix because of this trend of being able to deliver more complex care in outpatient settings.”
“DeVry Buys Caribbean Med School”
The Deal, August 5, 2011
Ira Coleman, Joshua Spielman and Danielle Golino were legal co-counsel to 1,000 student medical school American University of the Caribbean NV in its $235 million acquisition by DeVry Inc
Ira Coleman, Danielle E. Golino, Joshua (Jed) E. Spielman, Health
“Potential Medicare Payment Cuts Alarm Doctors, Hospitals”
Boston Globe, August 3, 2011
Eric Zimmerman predicted “there will be a lot of hand wringing and anxiety over the next four months as we work through this process” of Congress considering modifications to the automatic Medicare cuts contained in the deficit-reduction act. “Health care providers right now are trying to weigh whether they would be better or worse off with the [automatic] cuts or whatever the [Congress] recommends,” Mr. Zimmerman noted, adding that Medicare providers feel they already gave “their pound of flesh” through reimbursement cuts in the health reform law.
“Debt Limit Deal Sets Up Year-End Battle Over Medicare Cuts”
Bloomberg News, August 2, 2011
Eric Zimmerman, speaking of a 12-member congressional panel that under the deficit-reduction law must recommend reductions to Medicare and other programs by year-end, noted that “Medicare is always on the table. We just spent the last six weeks battling over Medicare cuts, and now we’re going to be doing it for the next four months.”
“Unraveling Data Breaches”
Health Data Management, August 2011
Daniel Gottlieb spoke extensively on data security breaches at HIPAA-covered entities. Noting that most entities have a remediation plan but need to recheck that it is comprehensive and tough, he observed, “Once people understand the data that’s at high risk, they do the right thing. They’re not happy about it, but they’re doing it.” This includes notifying patients about a breach, which Mr. Gottlieb recommends doing with public relations staff who are “more touchy feely than what you typically get out of a lawyer.” If data breach victims are offered credit monitoring, Mr. Gottlieb suggested contacting insurers for volume-based discounts.
Daniel F. Gottlieb, Global Data Privacy Programs, Health
“Health Industry Fears Double Whammy in Medicare Cuts”
The Hill’s Healthwatch, August 1, 2011
Andrea Bergman said that lobbyists for healthcare providers must at year’s end make a case to Congress against drastic Medicare physician reimbursement rate cuts, given that the new deficit reduction legislation already sets the stage for sharp Medicare spending cuts. The worry, she noted is that in its upcoming action Congress may “forget that they just gouged” providers after good-faith negotiations in the deficit legislation.
“Despite IOM Call to Scrap 501(k) Process, Pathway Revamp Likely”
InsideHealthPolicy.com, July 29, 2011
James Cohen said that, although the Institute of Medicine has called for eliminating the FDA’s medical device review policy, it likely will not mean broad legislative reforms. Instead, he cited smaller piecemeal reforms being implemented by the FDA’s Center for Devices and Radiological Health (CDRH). “There’s already a 25 point action plan that CDRH is in the process of implementing,” Mr. Cohen stated. “In the current legislative environment, FDA is unlikely to seek new legislation.”
“Benefit Recipient? Disruptions May Be Coming”
MSNBC, July 28, 2011
Eric Zimmerman commented on the deficit talks in Washington and the impacts of a possible interruption in Medicare reimbursements to hospitals and other providers. He noted that millions of claims come in to the federal government every day from health care providers for surgery, therapy and other services for Medicare beneficiaries. “It is possible that that could get suspended or disrupted in the event there are choices that have to be made about how limited federal dollars are going to go out,” Zimmerman said. “Every day that there is a disruption caused by the debt limit crisis, that’s a cash flow problem for hospitals, physicians and nursing homes, anyone who furnishes services to Medicare beneficiaries.”
“As Comment Period Ends, FDA Seeks to Clarify Conflict of Interest Rules”
Genetic Engineering & Biotechnology News, July 27, 2011
Jennifer Geetter said that FDA clarification on conflict of interest rules for clinical researchers tied to companies or institutions “should be seen as a floor and not a ceiling.” She urged “a more robust, more deliberate process” in which organizations tell researchers or doctors, “These are the types of financial interests that if you have, you’ll have to disclose. We’ll decide if they’re conflicts of interest, and how they can be managed.”
“Medicare at 67: The Next Big Change?”
Politico Pro, July 27, 2011
Eric Zimmerman said that, although the healthcare coverage assured by the health reform law could make an increase in the Medicare eligibility age more acceptable, such a scenario “assumes a lot of things, including that all the changes in the reform law work as advertised.”
“Health Reform Has an Antitrust Angle”
National Law Journal, July 25, 2011
Ashley Fischer said that healthcare provider accountable care organizations that are encouraged by the health reform law to share patient information and services “are absolutely critical” to the law’s success because currently “there’s no mechanism to make sure care is not duplicative.” She noted that antitrust regulators “did establish a safe harbor to give those ACOs that qualify some assurances” that collaboration will not raise antitrust issues, but added the hope that the FTC and DOJ can revise the safe harbor “to make it more palatable” to ACO stakeholders.
Ashley McKinney Fischer, Health
“In Information-Gathering Mode, CMS Undecided on Payment Structure for Genetic Tests”
Genome Web, July 19, 2011
Paul Radensky, assessing efforts by the Centers for Medicare & Medicaid Services (CMS) to determine payment policies for molecular diagnostics, said that new payment strategies beyond the existing physician fee schedules (PFS) are needed to capture the value of these tests for patient care. “Trying to convince everyone at CMS that everything has to fall under the PFS or that nothing should fall under the PFS would make no sense,” Mr. Radensky stated.
“Fight for Independence”
Modern Healthcare, July 18, 2011
Eric Zimmerman said that, although Congress relies on the “well-respected” Medicare Payment Advisory Committee (MedPAC) for ideas to reduce Medicare costs, those ideas are “merely recommendations.” By contrast, he noted, the Independent Payment Advisory Board established by the health reform law “has authority to put forth recommendations that, unless Congress acts, will become law. So it’s invested with enormous authority and additional powers that MedPAC does not have.” For that reason, he added finding IPAB members who will pass Senate scrutiny could be difficult.
“Hostile Reception: Value-Based Purchasing Changes Get Poor Reviews”
Modern Healthcare, July 11, 2011
Eric Zimmerman said that the Centers for Medicare and Medicaid Services' (CMS) new rule on outpatient reimbursement for ambulatory surgery centers (ASCs) may be difficult for some smaller or single-specialty ASCs to meet. “There’s a difficult and delicate balance that CMS needs to strike here,” he observed, noting that the rule is challenging to ASCs because it focuses more on hospital-related measures.
“Latest Draft of Hatch IVD Bill Contains New Regulatory Proposals”
GenomeWeb, July 6, 2011
Paul Radensky and Eric Zimmerman spoke about representing an industry coalition to clarify reimbursement reforms and incentives for innovative non-device diagnostic tests. “We’ve been looking at options to have a more predictable system in place to assign different payment rates and codes … so the payor actually knows what it is they’re paying for,” Mr. Radensky stated. Mr. Zimmerman added that “the current [reimbursement] system is not working well and that it does not appropriately incentivize the development of these tests.”
Paul W. Radensky M.D., Eric Zimmerman, Health
“McDermott Advises Atrius Health on Integration of New Group Affiliate”
Healthcare Finance News, June 23, 2011
Christopher Jedrey, Charles Buck, Ashley Fischer and Carla Hine represented Atrius Health Groups in negotiations and regulatory approvals to add a sixth nonprofit community-based physician group. The transaction will make Atrius Health the largest physician-led health system in Massachusetts. The article noted that Chambers USA ranked McDermott as the only tier one US health law practice in 2011.
Charles Buck, Ashley McKinney Fischer, Carla A. R. Hine, Christopher M. Jedrey, Antitrust & Competition, Health
“Tufts Hospital Seeking $11.2m from Lifespan”
The Boston Globe, June 11, 2011
Michael Peregrine said that a ruling by a federal court that the former owner of a Boston hospital was negligent in its fiduciary duties “is going to put more pressure on health care systems that have come together and are having growing pains. When you have a federal case that’s saying the nature of the relationship created a fiduciary responsibility, which [was] breached, that could destabilize [hospital] systems that are under stress — maybe blow them up.’’
“Fla. Hospital not Immune from FCA Suit, Judge Rules”
Law360, June 7, 2011
Anthony Upshaw, T. Reed Stephens, David Crump and Amandeep Sidhu were noted as McDermott’s counsel in defense of a Daytona Beach, Florida medical center against Fair Claims Act allegations made by an employee.
David O. Crump, Amandeep S. Sidhu, T. Reed Stephens, Anthony N. Upshaw, Health, Trial
“Fiduciary Failure”
Modern Healthcare, June 6, 2011
Michael Peregrine called a US district court judge’s decision that a health system owes fiduciary duty to a subsidiary hospital “a very big deal,” because it was the first such ruling on a federal court level. “If you pulled together a system over the past couple of years, or if you have a system that has some unhappy members, or if you’re looking at forming a new system, you definitely have to read the decision,” Mr. Peregrine said.
“Losing Some Advantage”
Modern Healthcare, June 6, 2011
Anne Hance said that the health reform law’s emphasis on funneling more Medicare reimbursement payments to Medicare Advantage plans with higher quality and efficiency means that “some of the smaller plans and lower quality plans may completely on their own decide they’re going to have a hard time competing” and either consolidate or pull out of the market. Ms. Hance added, “That analysis is probably happening over the next one to three years as these payment methodologies are implemented,” noting that some analysis has already begun.
“Knowing Who’s Messing with Your Medical Records”
CBS MoneyWatch.com, June 6, 2011
Daniel Gottlieb estimated that, while HIPAA enables consumers to get a list of who has examined their medical records, the allowed exclusions mean that “less than one percent of the requests” made to examine records will actually be shown. Noting that a new proposed HHS rule would require medical institutions to provide individuals with all requesters of their medical records, Mr. Gottlieb asserted, “That’s a lot more information.”
Daniel F. Gottlieb, Global Data Privacy Programs, Health
“Tenet, HCA Easier Targets Than Medicare in Biden’s Debt Talks”
Bloomberg News, June 2, 2011
Eric Zimmerman predicted that deficit reduction plans in Congress will likely seek to cut payments to or demand concessions from Medicare service providers, leaving the companies in a tough spot. “The bulk of what would be in any deal would affect those providers, and they should be concerned about what kind of exposure they have,” Mr. Zimmerman said. He added that he doubts the companies have “a great understanding or appreciation” of what they face.
Eric Zimmerman, Health, Health Care Law Reform
“Federal Court Finds Nonprofit Health System Liable for Misconduct, Fiduciary Duty Breach”
BNA Health Care Daily Report, June 1, 2011
Michael Peregrine said a court ruling that a nonprofit health system failed its fiduciary duty to properly advise its nonprofit hospital subsidiary will have “significant implications” for the growing number of health system/hospital affiliations and “may increase the structural instability of systems already experiencing tension amongst corporate partners.”
“OIG Says Health IT Security Controls Lacking as ONC Points to HIPAA Rules”
Inside CMS, May 26, 2011
Daniel Gottlieb said that the HHS Office of Inspector General (OIG) “is calling for general health IT standards” for Medicare contractors, and “that’s what the HIPAA security rule provided.” Rather than criticize the HHS Office of National Coordinator (ONC) for coming up with its own standards, Mr. Gottlieb added, OIG should expect ONC to “continue assisting covered entities to comply with the current HIPAA security standards.”
Daniel F. Gottlieb, Global Data Privacy Programs, Health
“OIG Audit Findings Point to Concerns About Effectiveness of HIPAA Security Rule”
BNA Health IT Law & Industry Report, May 24, 2011
Daniel Gottlieb pointed out that, because “the HIPAA security standards have been effective since 2005 and already provide for general IT security controls,” the HHS Office of Inspector General’s criticism of the Office of National Coordinator for not having health IT security standards was made in a vacuum. Mr. Gottlieb added his assessment that ONC avoided data security controls that overlapped the existing HIPAA Security Rule, and that it was likely awaiting final rules implementing HIPAA changes under the HITECH Act.
Daniel F. Gottlieb, Global Data Privacy Programs, Health
“Asleep at the Switch”
Modern Healthcare, May 23, 2011
Daniel Gottlieb asserted that the HHS Office of Inspector General criticized the Office of the National Coordinator for failing to promote health data security “without looking at the broader regulatory environment in the healthcare industry.” Because HIPPA already provides data protection, Mr. Gottlieb said, “I don’t think there’s a need for overlapping standards.” He added that, for data security, the HHS Office of Civil Rights “is trying to work more with providers on compliance than working on more big fines,” which may not maximize compliance efforts.
Daniel F. Gottlieb, Global Data Privacy Programs, Health
“OIG Says Health IT Security Controls Lacking as ONC, Legal Expert Point to Existing HIPAA Rules"
Inside Health Policy, May 18, 2011
Daniel Gottlieb, discussing a new report by the HHS Office of Inspector General (OIG) concerning data security, said that OIG and the HHS Office of National Coordinator (ONC) should continue assisting covered entities to comply with current HIPAA security standards. “The OIG is calling for general health IT standards, that’s what the HIPAA security rule provided,” Mr. Gottlieb stated. “It is correct that there’s not a complete set of general health IT standards included in ONC regulations. The ONC did that purposefully because it felt that the HIPAA security standards address that need.”
Daniel F. Gottlieb, Global Data Privacy Programs, Health
“The Proposed Waivers of Fraud and Abuse Laws for ACOs”
BNA Health Care Fraud Report, May 4, 2011
Daniel Melvin, as author of this bylined article, assessed the provisions of the federal government’s proposed waivers of fraud and abuse laws, which would allow accountable care organizations to participate in Medicare’s Shared Savings Program. He wrote that the waivers do not address a number of significant fraud and abuse concerns, and spelled out additional waivers they believe are necessary if ACOs are to operate successfully in the Shared Savings program, and reduce waste and excess cost in the health care system.
“The Top Five Traps in Health Care M&A Transactions”
VC Experts, May 4, 2011
Sandra DiVarco singled out due diligence and self-disclosure of potential problems, government regulation and accreditation, antitrust scrutiny, tax-exemption issues and Catholic health care governance concerns as “significant liability and transaction risks” when health care organizations merge or are acquired. All these considerations are related to the “intricate regulatory scheme” that governs the U.S. health care system, and Ms. DiVarco warned that failure by transaction participants to comprehend regulatory complexities “is a recipe for potential deal disaster.”
“Orthopods Who Own MRIs Perform More Back Surgery”
Outpatient Surgery, May 2011
Jerry Sokol advised that the safest way for physicians to have financial interests in MRIs without violating the Stark Law’s provisions against self-referral is for only a single group practice to own and operate the MRI and bill for its services as part of their group practice.
“Fiesta Bowl’s Board Fumbled Oversight”
NonProfit Times, May 1, 2011
Michael Peregrine called the apparent executive conduct oversight failures by the board of the nonprofit Fiesta Bowl organization “a free lesson for nonprofits” regarding governance issues. He stated, “Boards should figure out, in my organization, is bad news getting to the board, the audit committee, so the board can take action?” Mr. Peregrine urged nonprofit board members to be alert for “something so out of the ordinary – on its own or in connection with others – to cause a reasonable person to say, ‘This doesn’t look right, it’s troubling – this bothers me.’”
“Healthcare Reform: Tax-Exempt Hospitals and Accountable Care Organizations (ACOs)”
Health Lawyers Weekly, April 29, 2011
Robert Louthian III warned of the apparent IRS position that ACO activities in themselves do not meet the charitable 501(c) exemption for nonprofit hospitals. There may be possible tax-exempt hospital compliance in providing Medicare and Medicaid services through ACOs if there is no “proscribed inurement of net earnings or more than incidental private benefit for the private parties.” Otherwise, the authors wrote, “the IRS has suggested by negative implication” that participation in private payor ACOs is not a charitable activity.
Robert C. Louthian III, Health
“Supreme Court Rejects Fast-Track Health Care Appeal”
Law360, April 25, 2011
J. Peter Rich stated that the US Supreme Court’s refusal to make an early review of challenges to the health care reform law “does not lead to the conclusion that the court will eventually uphold the constitutionality of the individual [coverage] mandate or even of the health reform law as a whole.” But he added that if the court later overturns the entire law, its decision “will have an even more profound impact because the law would then be much farther down the road in its implementation.”
“Should Specialists Join ACOs?”
Becker’s Hospital Review, April 12, 2011
J. Peter Rich warned that if procedure-oriented specialists do not join hospital accountable care organizations, “the primary care physicians in the ACO could shift the specialist’s referrals to someone else.” Mr. Rich said that an ACO formed with private payors could require contracts that would spell out the specialist’s obligations and the way payments would be distributed, while adding that not all specialists would have contracts.
J. Peter Rich, Accountable Care Organization Resource Center, Health
“Accountable Care Organization Model Will Require Health IT Infrastructure, Experts Say”
BNA Health IT Law & Industry Report, April 12, 2011
Bernadette Broccolo said that health care providers transitioning to Accountable Care Organizations will not be able to meet any of the necessary requirements “without the right HIT [health information technology] infrastructure and strategy.” Ms. Broccolo singled out cloud computing platforms as one cost- and time-effective solution for integrating systems and electronic health records.
Bernadette M. Broccolo, Accountable Care Organization Resource Center, Health
“Reform the Hard Way”
Modern Healthcare, April 11, 2011
Eric Zimmerman noted that the massive changes to Medicaid and Medicare in the U.S. House Republicans’ budget proposal are at this point high-level and general in nature. “Without detail we don’t know to what extent those would be eliminated,” he said of Medicaid requirements. “You could assume that the benefit and eligibility requirements would be left to states’ discretion.”
Eric Zimmerman, Health, Health Care Law Reform
“Fla. Hospital Not Immune to FCA Suit, US Says”
Law360, April 6, 2011
T. Reed Stephens, representing a Florida hospital that faces a False Claims Act action in federal court, said his client is taking the lawsuit allegations very seriously, but thinks the suit should be dismissed. The hospital contends it is a state agency and, under the 11th Amendment, cannot be sued in federal court by the plaintiff, its director of physician services.
“Fiesta Bowl’s Lesson: Boards Must Watch for Red Flags”
Chronicle of Philanthropy, April 6, 2011
Michael Peregrine commenting on the malfeasance uncovered in the management of a major football bowl game’s nonprofit organization, called “the sheer magnitude of what went wrong … a whopper [and] staggering.” Even so, he said, boards of nonprofit organizations “are not required to act until they are told about reasons to be suspicious.”
“Accountability Arrives”
Modern Healthcare, April 4, 2011
David Klatsky discussed the uncertainty over which patients will be assigned to the accountable care organizations (ACOs) created by the health reform law. He said the current CMS position that assignments will be made retroactively at the end of the performance year is “basically saying [to providers] that because you don’t know who is assigned to you, it means you have to treat everyone with the same standard.” Although providers prefer more certainty, Mr. Klatsky added that “the concept of accountable care – whether it’s couched in ACOs, value-based purchasing, bundled payments – is here to stay.”
David L. Klatsky, Accountable Care Organization Resource Center, Health
“Policies Prohibiting Self-treatment Protect Medical Staffs, Physicians, and Families”
Credentialing & Peer Review Legal Insider, April 2011
Sandra DiVarco supported ethical restrictions on physicians treating their family members, saying such treatment “puts the patient in a really awkward position, and it also makes the physician less likely to do the full gamut of examination or interview of the patient. For example, a patient may be reticent to speak candidly about sensitive matters, like sexually transmitted disease or dysfunction, with his or her sibling or parent.” However, Ms. DiVarco supported physicians explaining medical terms and issues to family members, asserting that “to help someone understand something is far different than diagnosing them or trying to treat them.”
“Lobbying World”
The Hill, March 31, 2011
Andrea Bergman was noted as McDermott new senior director of legislation and health policy in the Washington, DC office. Ms. Bergman previously was a lobbyist for two major corporations and a trade association in the health care sector, and was also a senior legislative and policy adviser to Sen. Mike Crapo.
Andrea M. Bergman, Government Strategies, Health
“Most Influential Lawyers”
National Law Journal, March 28, 2011
Eric Zimmerman was one of just 34 influential lawyers singled out by readers and researchers as among those who “have clout … to shape the world and the way it works.” The NLJ called him “an expert in Medicare” who is “often at the top of their list” for hospitals and drug companies needing help in Congress. Mr. Zimmerman “was involved in shaping half a dozen targeted provisions” of the 2010 health care reform act according to the NLJ, and he himself added about the act’s impact that “it’s just the beginning, like Medicare in 1965.”
Eric Zimmerman, Government Strategies, Health
“DC Bar Announces 2011 Candidates”
Blog of Legal Times, March 15, 2011
“DC Bar Names Candidates for Elections”
Washington Business Journal, March 16, 2011
Ankur Goel was noted as an incumbent board member running for re-election to the District of Columbia Bar Board of Governors. Mr. Goel focuses on litigation and enforcement matters as a partner in the Firm’s Washington office.
“Do Good, Sure, But Do It Right”
Corporate Counsel, March 15, 2011
Michael Peregrine cautioned corporate counsel who join nonprofit organization boards that nonprofits are “a fundamentally different kind of legal animal” in which the fiduciary duties of board members “are owed to the mission of the organization” and not to shareholders or investors. He also warned that nonprofit board conflicts of interest “are always a big deal to regulators,” and that nonprofits are not immune from compliance problems, fraud and embezzlement. More positively, Mr. Peregrine advised, “Don't be too concerned with your own liability as a board member,” and focus instead on making “a major contribution to the way the nonprofit board goes about its business.”
“The Return of the Responsible Corporate Officer Doctrine”
National Law Journal, March 14, 2011
In a bylined article, James Cohen and Michael Peregrine co-authored a bylined article concerning the increased use of the Responsible Corporate Officer Doctrine (RCOD) by the Food & Drug Administration and other federal regulatory agencies to make corporate officers responsible for “public welfare-based crimes,” even if they were unaware of or did not participate in the problematic conduct. The partners pointed out that the FDA has publicly discussed its intent to aggressively apply the RCOD to the health care sector, especially drug and medical device companies. Because there are no clearly identified guidelines for RCOD conduct, the best way for executives to reduce their prosecution risk is to improve the effectiveness of their corporate compliance programs.
James S. Cohen, Michael W. Peregrine, Health
“Proposed Rule Leaves Many Questions”
Hospital Peer Review, March 1, 2011
Pharmacy News, March 1, 2011
Jessica Roth suggested that the Centers for Medicare & Medicaid Services (CMS) mortality reporting requirements in its proposed rule on value-based purchasing should “utilize that reporting structure for determining points related to outcome. So, perhaps hospitals that are better than the national average would get 10 points on that measure. Hospitals that are at the national average would get five points. Hospitals that are worse would get none.” This concept, she added, would ensure “actually reflecting care that's within the hospital’s control.” Ms. Roth concluded that using “general categories rather than raw mortality rates” would be considered fairer by “most people … even CMS.”
“OCR Fines Medical Group $4.3M, Reaches Settlement in Record Enforcement Actions”
Report on Patient Privacy, March 2011
Stephen Bernstein said the HHS Office of Civil Rights (OCR) HIPAA violation fine against a Maryland medical group that refused to release patient records or to comply with OCR’s investigation “is mostly about the failure to cooperate with the government, which has been quite team-oriented” in HIPPA inquiries until now. Mr. Bernstein called the medical group’s actions “over the top on failure,” and said the lessons for companies in similar situations are to “forge ahead and implement your policies and procedures, and build internal teams that can be responsive to accidents and exposures. Have a team ready to go, and cooperate with OCR.”
Stephen W. Bernstein, Health, Health Care Law Reform, Health Information Privacy, HIPAA
“HIPAA Fine is a First”
Modern Healthcare, February 28, 2011
Stephen Bernstein said of an HHS Office of Civil Rights (OCR) fine against a Maryland company for violating patients’ HIPAA rights by denying them access to their medical records, and failing to cooperate with an OCR investigation of the matter: “I don’t know of a situation where parties [like the company] haven’t cooperated. And my guess is that’s what upset OCR.” He urged healthcare organizations to have privacy compliance policies in place, “so when OCR calls, you’re in a position to have a conversation that is cooperative, open and upfront.”
Stephen W. Bernstein, Health, Health Care Law Reform, Health Information Privacy, HIPAA
“White House Proposes Two-Year Medicare Physician Payment Remedy”
BNA’s Health Care Daily, February 15, 2011
Eric Zimmerman asserted that the Obama Administration’s FY 2012 budget proposal to cancel for two years the proposed Medicare reimbursement cuts to physicians “illustrates the need to address this problem comprehensively and permanently.” The cuts were first implemented by Congress in 2010 but have been postponed several times, and Mr. Zimmerman noted that “the escalating costs of annual postponements are becoming cost prohibitive and limit Congress’s ability to address other equally pressing Medicare program concerns.”
Eric Zimmerman, Health, Health Care Law Reform
“Health Care Ruling Raises New Question for High Court”
Law360, February 1, 2011
Peter Rich held that court rulings in Florida and Virginia that the health reform law’s individual insurance mandate is unconstitutional, with the Florida court saying that the mandate invalidated the entire law, makes it likely that the Supreme Court will rule sooner on the issue. As he explained, if the individual mandate, which is effective in 2014, cannot be severed from the law as the Virginia court held, the Supreme Court will want to rule on the entire law so that the government does not have to unwind provisions implemented earlier. Mr. Rich added that if only the mandate is struck down, “that is the beginning of the end for the individual health insurance market as far as private insurance companies are concerned.”
“The Health Care Ruling: The Experts Speak”
Wall Street Journal, January 31, 2011
Peter Rich made this prediction if the Supreme Court adheres to either of two district court rulings that the health reform bill and/or its individual coverage mandate are unconstitutional:
“We are likely to see a mass exodus of private health insurance carriers from the individual insurance market – particularly if there is an acceleration of the trend among state insurance regulators to try to block premium increases…. The ‘Affordable Care Act’ would then have perversely made health insurance not only affordable but unobtainable for the increasing number of Americans who have no access to either group health insurance or governmental health programs.”
J. Peter Rich, Accountable Care Organization Resource Center, Health
“President Obama Renominates Berwick to CMS Administrator Post”
BNA’s Health Care Daily Report, January 28, 2011
Eric Zimmerman addressed the President Obama’s renomination of Donald Berwick, interim administrator of the Centers for Medicare and Medicaid Services, to permanently head CMS despite Republican opposition. Mr. Zimmerman noted that if Berwick is rejected, “the prospect of losing him at the end of the year and finding another administrator in an election year would be disruptive for the agency.”
“Tax-Exempt Hospital Health Care Reform Needs Clarification, ABA Sections Say”
Health Care Daily Report, January 21, 2011
Ralph DeJong was cited as co-author of a joint ABA Section of Taxation and Health Law Section letter asking IRS clarification on the health care reform law’s limits on hospital charges to financially needy patients. The law requires using a complex mix of the best commercial and Medicare rates, but the authors state that rates billed to patients will often differ from rates charged due to discounts and volume differences among payers. “We believe many hospitals will be reluctant to use a single best rate [because] disclosing such a rate may put hospitals at a disadvantage when negotiating with insurers,” they note.
“New GOP House Majority Sets Sights on Repeal of Health Reform”
BNA’s Health Care Daily Report, January 4, 2011
Eric Zimmerman said the appointment of an interim head for the Centers for Medicare & Medicaid Services (CMS) shows that “the administration will either have to identify a candidate who is less polarizing and more acceptable to Senate Republicans or continue the course of recess appointments and acting administrators…. Without a congressionally approved leader, the agency and the administration’s health reform implementation objectives will suffer.” Mr. Zimmerman predicted “more short-term fixes” for CMS, because “comprehensive solutions are too expensive and elusive, and Congress missed its best opportunity – i.e., health care reform – to do something bold to address this problem.”
Eric Zimmerman, Health, Health Care Law Reform
“Republicans Seek to Bleed Obama’s US Health Reform”
Reuters, January 4, 2010
Eric Zimmerman observed that if congressional Republicans do not want to fund the start of implementing health care reform as part of a general budget vote, “they could just dig in their heels and refuse to pass a [spending] bill. We’ll have to see who is willing to succumb in that game of chicken and what the public thinks of that.”
Eric Zimmerman, Health, Health Care Law Reform
“Remaking the Market”
Managed Healthcare Executive, January 2011
Anne Hance, assessing the startup of such health reform law components as the medical loss ratio, said it has been “challenging from an implementation perspective,” adding that “it’s really been a sprint to get this first round of short-term market reforms implemented.” Ms. Hance used an analogy of sprint versus marathon for the long-term application of the law’s provisions, calling regulation-response dynamic “a cycle that will be repeated over and over again” and noting that “the ability to anticipate and respond” will be “critical” for health insurers.
2010
“Illinois Attorneys Examining State Laws, Rules for Legal Barriers to Statewide HIE”
BNA Health IT Law & Industry Report, December 6, 2010
Bernadette Broccolo said that where state laws require patient consent for electronic health information exchange (HIE), there is still a question of whether consent should be opt-in or opt-out. “The real concern with opt-in is patients will be reluctant and nervous, even with good protection, and we’ll end up with incomplete information for treatment purposes and incomplete information that’s too sparse to be statistically significant for research.” Ms. Broccolo added that the Illinois HIE task force she co-chairs will look at state and federal laws that protect health information privacy “in a way that harmonizes the laws and creates some consistency.”
Bernadette M. Broccolo, Electronic Data Management, Privacy & Discovery, Health, Health Care Law Reform, Health Information Privacy, HIPAA
“Attorney Says AMA’s Principles for ACOs Noncontroversial, but Could Use Tweaking”
BNA’s Health Law Reporter, December 2, 2010
J. Peter Rich called the American Medical Association’s principles for developing accountable care organizations in accord with the health reform act “pretty uncontroversial” because they affirm the “consensus that physicians will play a primary role in ACO governance.” However, he criticized the AMA’s call to separate ACO and hospital boards, saying, “As a practical matter, it is unlikely an ACO-member hospital will consent to governance by a board that does not include any of its board members.” He also cited the lack of guidance on encouraging patients to remain in an ACO, saying that will make substantial cost savings “difficult if not impossible.”
J. Peter Rich, Health, Managed Care
“Expanding Practice to Provide Integrated Cancer Care”
Journal of Oncology Practice, November 2010
Daniel Gottlieb discussed a federal commission that is preparing recommendations regarding referrals for radiation therapy within a multi-specialty group practice. He stated that an outright prohibition of such referrals would be unlikely, because “many of the country’s leading physician groups would be forced to reorganize into separate single-specialty practices or disband.” Other options could involve greater clinical integration, or adjusted Medicare reimbursement. Mr. Gottlieb said the complexity of the issue could mean that the commission’s recommendations could be delayed until 2011.
Daniel F. Gottlieb, Health, Health Care Law Reform, Life Sciences & Medical Products
“Illinois Attorneys Examining State Laws, Rules for Legal Barriers to Statewide HIE”
BNA Health IT Law & Industry Report, November 30, 2010
Bernadette Broccolo said that where state laws require patient consent for electronic health information exchange (HIE), there is still a question of whether consent should be opt-in or opt-out. “The real concern with opt-in is patients will be reluctant and nervous, even with good protection, and we’ll end up with incomplete information for treatment purposes and incomplete information that’s too sparse to be statistically significant for research.” Ms. Broccolo added that the Illinois HIE task force she co-chairs will look at state and federal laws that protect health information privacy “in a way that harmonizes the laws and creates some consistency.”
Health, Health Care Law Reform
“Health Care IT to Benefit from Reforms, Payment Pressures”
Dow Jones LBO Wire, November 30, 2010
Sandra DiVarco noted that, while private equity investors can benefit from higher spending in information technology outsourcing due to the health care reform law, they should also be wary of heightened federal compliance oversight aimed at identifying health care reimbursement fraud. “Private equity investors have to understand how the companies they are investing in are getting ready for change” in compliance enforcement, Ms. DiVarco warned.
Sandra M. DiVarco, Health, Health Care Law Reform
“Lawyer Heads State Task Force on Health Data”
Chicago Daily Law Bulletin, November 29, 2010
Bernadette Broccolo, co-chair of the Illinois Legal Task Force on Health Information Exchange, explained that federal law is pushing an “aggressive move toward electronic exchange of health information,” and her task force will determine how to make such an exchange possible in light of patient privacy laws. Ms. Broccolo said persons with privacy concerns represent “competing interests” with others who assert they are “tired of giving … information several times within the same health system, within the same community.”
Bernadette M. Broccolo, Health, Health Care Law Reform, Health Information Privacy
“D.C. Moves”
The National Law Journal, November 29, 2010
Lauren Haley was featured for joining the Firm’s Washington office as a health law partner who will counsel health care organizations on regulatory and compliance issues. Ms. Haley was previously with the Program Integrity Group of the Centers for Medicare and Medicaid Services.
“Hospitals after Healthcare Reform: ‘Big Guys Getting Bigger’”
Fortune, November 11, 2010
Christopher Jedrey stated that under the new healthcare reform law, “the costs of care risk to the providers” will be “way too much for most systems to bear alone.” The result, he said, will be “a lot more activity” involving consolidation of providers, which “will be big guys getting bigger.” Mr. Jedrey predicted that “you’ll see … changes in two directions. The percentage of for-profit hospitals will increase, and the non-profit sector will become more dominated by large systems. What will decrease will be the number of free-standing non-profits ….”
Christopher M. Jedrey, Health, Health Care Law Reform
“Reform: Round Two”
Modern Healthcare, November 8, 2010
Eric Zimmerman said that even though the new Republican House of Representatives majority wants to overturn the health care reform act, a more plausible strategy would be to use “a variety of tools and parliamentary maneuvers available to try to create mischief. Some of those could include withholding funds” for more than 100 initiatives that require funding. Other possible tactics are using the Congressional Review Act or the Corrections Calendar to overturn regulations, or repealing the Independent Payment Advisory Board, but Mr. Zimmerman saw little prospect for their success – the former requires approval of both houses, the latter requires spending cuts to offset proposed savings.
Eric Zimmerman, Health, Health Care Law Reform
“Mergers Between Insurers and Hospitals Expected to Accelerate”
American Medical News, October 25, 2010,
“The Tension in Hospital-Insurer Acquisition Talk”
Nashville Post, October 26, 2010
John Callahan said of health sector mergers that “health care reform policies are driving consolidation, and at the same time antitrust enforcement is scrutinizing consolidation.” He sees consolidation driven by pressure on hospitals and physicians to make reform-related investments, stating, “Not only do you have to provide a higher quality service, you have to be able to prove that you did so. Right now hospitals don’t have the infrastructure to meet those reporting requirements, and certainly very few physicians offices do.”
“Caritas Says It Will Continue to Fund Workers’ Pensions”
Boston Business Journal, October 22, 2010
Christopher Jedrey, who represented nonprofit Caritas Christi Health Care system in its acquisition by a private equity firm, said that, while not required by law to fund its 13,000 pension plans, the system believes it “has a moral obligation” to arrange for funding because “these are their current and former employees.”
"Speakers: ACO Regulations Uncertain, But Providers Should Still Start Integrating"
BNA’s Health Care Daily Report, October 14, 2010
Christopher Jedrey discussed regulation of accountable care organizations (ACOs). ACOs are evaluated for Medicare reimbursement on overall cost and quality of care, and Mr. Jedrey noted that this will require hospitals and physicians to change their current fee-for-service model that rewards volume of services provided. That paradigm shift will change the financial incentives of these providers, moving them toward bundled and shared savings payments, he added. Although participation in an ACO is voluntary and under current rules there is no clear incentives for physicians to join one, Mr. Jedry said that in the new health reform environment providers “will be leaving a significant amount of money on the table” if they do not integrate with an ACO.
Christopher M. Jedrey, Health, Health Care Law Reform
Gary Davis was quoted by Florida Trend (October 8) concerning the renaming of two Brevard County, Florida not-for-profit organizations that provide health care services in the county. The renaming was required by their sale to a for-profit organization. Mr. Davis, who represented the not-for-profits, said of them, “Right now there are two legally separate foundations …. Essentially they are operating as parallel organizations.” He added that a former executive of one of the organizations “will be running both for the moment.”
Gary Scott Davis, Health, Health - General Counsel
"Proton pros and cons | Some cite dearth of studies on effectiveness; others see therapy's unique value"
Modern Healthcare, September 27, 2010
John Callahan discussed proton therapy centers, which may offer more precise tumor irradiation than traditional radiation therapy. Mr. Callahan said that, despite the cost of creating such facilities, "when a healthcare center is looking at making this investment they're looking at whether one of their competitors will do it first, so it motivates them to move to get the competitive advantage." He added that there are other benefits for providers, who "can brand the proton center and that gives them the ability to offer a service that their competitors can't and possibly get a National Cancer Institute designation. With that can come research funds." If hospitals can find investors to share the cost, Mr. Callahan added, "Now the hospital has to ask, 'Is this the best way to spend $20 million?'"
“HHS Will Not Renew SACGHS Charter, Ending Committee's Decade-Long Tenure in October”
Genomeweb.com, September 23, 2010
Sheila Walcoff was quoted regarding the charter expiration and final meeting of the HHS Secretary's Advisory Committee on Genetics, Health, & Society, which was created in 2002 to address topics critical to the advancement and adoption of genetic technologies and information. As a member of the Committee, Ms. Walcoff stated: "I believe it has advanced the debate on key issues related to genomics and personalized medicine that will influence the development of the future of health care and research in a meaningful way."
, Health
"Advantage for foreign pharmacies on the German market"
Financial Times Deutschland, September 21, 2010
Stephan Rau comments on the German regulations of price maintenance and the ongoing competitive advantage for foreign pharmacies, as compared to German pharmacies, on the German market.
“How far can providers go? | Regulators grapple with antitrust, fraud-and-abuse issues under reform”
Modern Healthcare, September 20, 2010
J. Peter Rich addressed the health care reform law’s implications for Accountable Care Organizations (ACOs). The law requires Medicare to reward providers that work together in ACOs to improve care, but Mr. Rich asserted that “I’m not sure there are any answers” to the antitrust and fraud-and-abuse issues raised by such collaboration. He noted that many providers are holding off on ACO participation, and added: “There are a lot of question marks here. Everybody’s excited about doing something, but they’re waiting to see what that something is.”
"Expansion of McDermott's Health and Life-Science Practice in Munich"
Juve online, September 9, 2010
Brief message concerning the expansion of McDermott's Health and Life-Science Practice in Munich. Jana Grieb is expected to join the Firm in December as a counsel.
“HHS OKs First 2,000 Recipients in $5 Billion Early-Retiree Health Insurance Program”
Best’s Insurance News, September 1, 2010
Joel Michaels spoke about the federal government’s approval of the first round of applicants for the Early Retiree Reinsurance Program, which covers health insurance for retirees between 55 and 65. Mr. Michaels pointed out that the program is “first come, first served,” adding, “If you haven’t gotten in line in time, you’ll be out of luck” to receive funding coverage. He also noted that insurers have been permitted to submit claims on behalf of participating plan sponsors, which will also drain funding.
Joan Polacheck told the Healthcare Financial Management Association (www.hfma.org) that the health reform law’s fraud-fighting and other regulatory initiatives mean that “the natural tendency will be for legal and compliance [officers] to work even more closely together than in the past.” Ms. Polacheck cited in particular the impetus that the law gives to hospital-physician integration, which will raise legal and compliance issues involving antitrust, HIPAA privacy and security, fair market value of compensation arrangements, and filing of enrollment applications.
Christopher Jedrey was quoted by The Wall Street Journal (August 16) in a story on increased private equity investments in the health care sector. Citing the fragmentation among health care providers when compared to insurers, Mr. Jedrey said acquisitions and other forms of consolidation show that the “provider side is bulking up to catch up with the payer side.” He added that private equity mergers and investments will help providers make technology investments and other performance enhancements required by the health reform law, such that the recent increase in consolidation is an “intensification of an existing pattern” toward cost saving.
Christopher M. Jedrey, Health, Hospital and Health System Transactions, Life Sciences & Medical Products
Daniel Gottlieb spoke at length to Mississippi Medical News (July 2010) concerning possible action by Medicare regulators to restrict physician referrals of patients to in-office diagnostic imaging. Due to concerns about too many costly in-office referrals, "The imaging industry has had somewhat of a target on its back for awhile now," Mr. Gottlieb said. He noted that several levels of restricting in-office clinical integration are being considered, but added that the issue is not clear-cut. "Skewed clinical decision-making based on the financial interest of the referring physician" is something the government "wants to avoid," Mr. Gottlieb stated, but there also are quality and efficiency benefits to "receiving all the services the patient needs in an integrated care setting." Mr. Gottlieb concluded it is unclear what Medicare will do because "trying to balance the goals of cost reduction with the goals of quality care [is] somewhat of a conundrum."
Anne Hance and Joel Michaels were both cited by InsideHealthPolicy.com in its August 5 story about how HHS Secretary Kathleen Sebelius is asking state officials if they are ready to enforce consumer protection provisions of the health reform law that take effect 9/23/10. Ms. Hance noted that the law gives states the “first go” at enforcement, with the federal government stepping in if necessary. Mr. Michaels summarized Sebelius’s approach on this “sensitive issue” as “let me check with you [the states] and see if you have the capacities” for enforcement. He added that the biggest question is whether states have the human resources and funding needed to support enforcement.
Anne W. Hance, Joel L. Michaels, Health
Jennifer Geetter reviewed for Health Information Compliance Insider (August 2010) how the Department of Health & Human Services Office for Civil Rights will require protection of electronic personal health information (PHI) in accord with the 2009 HITECH Act and with HIPAA requirements. The Act requires de-identifying electronic health records so they are no longer considered PHI, and Ms. Geetter stated that "central to this exercise is high confidence that the remaining information cannot be re-identified and linked to a specific person." She added that de-identification is not simple, because it involves "concerns and questions about when information is really de-identified and how best to balance privacy risks with risks that the information will be rendered useless for other important public priorities, such as research." Click here to read the full article.
Jennifer S. Geetter, Health, HIPAA, HIPAA Privacy Solutions
Stephen Bernstein was quoted in a July 23 Boston Business Journal article on the new federal guidelines for use of electronic medical records. Mr. Bernstein said that greater demand by health care providers means that companies that offer services to facilitate use of these records “are likely to become acquisition targets, or to do acquisitions themselves.” He added that there will also be business opportunities for “vendors who can come in midyear and analyze for providers how they are progressing toward compliance” with the guidelines.
Daniel Gottlieb spoke to Briefings on HIPAA (August 2010) regarding proper procedures for health care organizations to protect the security of paper and electronic personal health information (PHI) records. He advised that paper records be secured by such physical safeguards as locked doors and cabinets, security cameras and burglar alarm systems. Paper PHI disposal should be done to the specifications of the National Institute of Standards and Technology. Relying on electronic rather than paper PHI is the most practical solution, but Mr. Gottlieb warned that electronic PHI stored on desktop computers should be encrypted and password protected, and the computers themselves should be locked to alarm-protected office furniture.
Daniel F. Gottlieb, Global Data Privacy Programs, Health, HIPAA
James Cohen, former senior official at the U.S. Food & Drug Administration, was featured in a July 12 Law360 story about his move to head the FDA practice at McDermott’s Washington, D.C. office. Mr. Cohen, who most recently was with a national law firm, has 17 yeas of senior FDA regulatory experience with regard to enforcement, drugs and biologics, and will counsel clients on compliance in the development, approval and distribution of pharmaceuticals, biologics and medical devices. Saying that McDermott has “one of the largest and most prestigious health care practices in the world,” Mr. Cohen called the firm “a powerful platform to advise and defend clients during a time of unprecedented regulatory activity and change in the health care industry.”
Gary Scott Davis was quoted in Modern Healthcare (July 5) regarding the new health reform law’s lack of guidance on structuring accountable care organizations, which Congress intended as a cost-containment measure. Speaking of how the Centers for Medicare and Medicaid Services will work with such organizations, Mr. Davis stated, “CMS is really making this up as they go along, as is the private-sector marktplace.”
Daniel Gottlieb made recommendations to Briefings on HIPAA (June 2010) concerning steps that health care organizations can take to prevent the loss of employee laptop computers that contain confidential personal health information. He advised securing such laptops to desks or other furniture with cable locks where possible, and prohibiting employees from checking luggage containing the laptops on airplanes. Mr. Gottlieb also suggested purchasing laptops with hardware-based encryption technology, and configuring both laptop and desktop computers to shut down automatically or to enter a password-protected screensaver mode if left inactive for 15 to 30 minutes.
Daniel F. Gottlieb, Global Data Privacy Programs, Health, HIPAA
Shelia Walcoff was mentioned by The Hill (June 21) as new lobbyist for the Diabetes Access to Care Coalition with regard to the Medicare medical equipment supplies competitive bidding program.
, Government Strategies, Health
Joel Michaels spoke to The National Law Journal (June 21) about the concerns that the new medical-loss ratio rules in the health reform law are raising for insurers. The rule sets a minimum percentage of premiums that must go to cover health care services in comparison to overhead expenses, but Mr. Michaels said it is not clear if expenses such as subcontracting pharmacy benefit management counts as “care.” The medical-loss ratio “is not an easy issue,” Mr. Michaels said. “I think there will be a lot of time spent on that for the next couple of years.”
Ankur Goel was quoted on June 21 in Modern Healthcare regarding the new health reform law’s expansion of penalties for health care providers that fail to return Medicare and Medicaid reimbursement overpayments to the government within 60 days after they are discovered. Unanswered questions about when the restitution period starts if an overpayment is discovered mean, said Mr. Goel, “The challenge is, how does a provider act in a responsible, straightforward way in meeting its legal obligation but in a context where not everything is always clear.”
Ankur J. Goel, Health, Health - Insurance
Stephen Bernstein told The National Law Journal (June 21) that the new health reform law is spurring an increase in mergers and acquisitions among health care providers looking to increase capacity to care for the larger number of insured persons. Citing a 10 percent to 20 percent boost in health sector merger activity since the law’s passage, Mr. Bernstein said of the increase: “The [reform] bill supercharged it.”
H. Guy Collier was mentioned on June 14 by Blog of the Legal Times for his election to a three-year term on the board of governors of the District of Columbia Bar. Mr. Collier practices in health law as a partner in McDermott’s Washington office.
Eric Gordon was noted in The National Law Journal (June 14) for being named head of McDermott’s Los Angeles office. Mr. Gordon is currently partner-in-charge of the California health law practice and national co-chair of the academic medical center practice for the Firm.
McDermott’s selection to receive the first national level award for health law practice from Chambers was covered in JD Journal (June 11). Chambers called the Firm “a gigantic presence in the world of U.S. healthcare, advising a range of industry heavyweights on the most complex issues. McDermott’s Health Industry Advisory Practice Group was also the only one to receive a Tier 1 ranking in the first-ever Chambers national health law rankings.
T. Reed Stephens and Ankur Goel were featured in a June 9 BNA Health Law Reporter story on an expected increase in Stark Law fraud and abuse litigation by the Department of Justice against health care providers. Mr. Stephens warned that technical violations, as opposed to outright fraud, would still trigger litigation, and advised providers to proactively review physician agreements and self-disclosure options. Mr. Goel agreed that “prospective corrective action is the first thing you need to do if you discover a violation. It’s important to take action through the lens of how it will be included in a disclosure.” Mr. Goel added that such actions could include terminating affected physician relationships, making refunds related to prohibited referrals, or providing a disclosure report to one of several federal enforcement agencies.
Ankur J. Goel, T. Reed Stephens, Health
Eric Gordon’s appointment as new head of McDermott’s Los Angeles office was covered by The Recorder on June 2. He will be the fourth lawyer to lead the office since it opened in 1987, and he adds his new responsibilities to those as partner-in-charge of the Firm’s California health law practice and national co-chair of McDermott’s Academic Medical Center practice. “I’ll still have a full-time practice,” Mr. Gordon also noted, one that focuses on fraud, abuse and compliance issues and on health care transactions.
Eric B. Gordon M.D., Health, Life Sciences & Medical Products
John Callahan was quoted by Dow Jones Private Equity Analyst on June 2 concerning the likelihood that the health care reform law will create new opportunities in the health sector for buyout and venture firms. For example, he noted, proposed but yet undefined reimbursement cuts may make organizations like smaller specialty hospitals targets for consolidation by private equity firms. “No matter how you slice it, there will be an opportunity to do roll-ups,” Mr. Callahan said.
Michael Peregrine commented for BNA’s Daily Health Care Report (May 28) on the Internal Revenue Service’s new requirements for hospital organizations to qualify for federal tax exemption. The IRS issued the requirements in accord with provisions of the health care reform law, and Mr. Peregrine said that “the original provisions of the [law] sketched the legislative expectations only in the broadest possible strokes…. We all knew the devil was in the forthcoming details.” He added that the IRS requirements contain useful “nuggets” of clarification and guidance, particularly with regard to the definition of “extraordinary collection actions” by exempt hospitals.
Michael W. Peregrine, Health, Tax Exemption
Eric Gordon was quoted by Bloomberg Government Wire on May 12 regarding the likely increase in government efforts to collect Medicare overpayments after passage of the health reform law. He said the law will have a “substantial impact” on the amount of overpayments that are not refunded, adding that providers who don’t refund overpayments risk penalties and litigation. “You now have the False Claims Act clock ticking if providers know of an overpayment,” Mr. Gordon stated, particularly because the law allows whistleblowers to file refund claims on behalf of the government and keep a portion of any recoveries.
Daniel Melvin and Christopher Jedrey discussed in Healthcare Finance News (May 11) how the new health care reform law could impact consolidation in the provider sector. Mr. Melvin noted that “all of the costs and [provider] pay cuts” in the law "are going to change the rules of the game. Health reform is likely to mean the acceleration of consolidation." Mr. Jedrey stated that the law’s extension of coverage to millions more people means that "cost control will follow." This will spur consolidation, he said, because "the healthcare provider market is currently fragmented, causing duplications of overhead and services, creating more costly and sometimes sub-optimal care." Mr. Jedrey expects that physician groups and solo practices are less likely to be able to handle consolidation, to which Mr. Melvin added, "[W]e’re going to see clinical integration in healthcare, rather than full integration."
Christopher M. Jedrey, Daniel H. Melvin, Health, Life Sciences & Medical Products
Joel Michaels and Anne Hance commented on the new health care reform law for Healthcare Finance News (May 11). Mr. Michaels stated that many provisions of the law “are attempts to deal with perceived issues or defects in the marketplace,” adding that “there has been a tremendous emphasis on transparency.” He also cited the law’s significant efforts at insurance market reform regarding elimination of pre-existing conditions, prohibition on rescissions, guaranteed issue and the ability to renew a policy. Ms. Hance expressed skepticism that penalties for employer coverage mandates would force insurers to provide coverage as Congress intended. By contrast, she said, the law’s fines against persons who don’t purchase health benefits by 2016 make it more likely that individuals will buy coverage.
Anne W. Hance, Joel L. Michaels, Health
Christopher Jedrey was quoted on May 7 by the Boston Globe concerning six Catholic hospitals in Boston that are being purchased by a private equity firm. Mr. Jedrey, who represented the hospitals, stated that “a primary public interest served by the transaction is that it will provide the resources necessary to transform a crucially important, but financially challenged, system into a financially sustainable, lower-cost, high-quality, community-based provider of hospital and other health care services in the Commonwealth.” He added that the hospitals, which had previously been operated as non-profits, will contribute substantial tax revenue as for-profit institutions while continuing to spend on free care for the uninsured and on community services.
Christopher M. Jedrey, Health, Hospital and Health System Transactions, Nonprofit Organizations
Joel Michaels spoke to Best’s Insurance News on May 6 about the health reform law’s $5 billion program to help employers cover health benefit costs for enrolled retirees who are too young for Medicare. Mr. Michaels said that, because they may submit claims on behalf of participating plan sponsors, health insurers need to be aware of the program, “because they’re going to get questions from their employer purchasers. There may be some administrative issues for the insurers to have to deal with or address.” He added that interested employers and insurers should move quickly before program funding is depleted: “It’s first-come, first-serve. If you haven’t gotten in line in time, you’ll be out of luck.”
Eric Zimmerman commented for Modern Healthcare (May 3) on the health care reform law’s provision that enables hospitals to purchase discounted outpatient drugs through a government program, but that does not include an inpatient drug provision. “It’s not a hassle-free program,” he said, because “hospitals will need to take steps to ensure compliance,” such as separating outpatient and inpatient drug purchases. “This brings administrative challenges and complications,” he noted. However, Mr. Zimmerman added, because the program as a whole benefits hospitals, “there continues to be a great deal of interest in expanding inpatient drugs to the program. It’s appealing to large numbers of members in the House. It will certainly get another hearing.”
Eric Zimmerman, Health, Life Sciences & Medical Products
Daniel Gottlieb was quoted throughout a lengthy Health Information Compliance Insider (May 2010) review of the HIPAA requirement to protect the privacy of electronic personal health information (PHI). He warned that “many covered entities, including large and small healthcare providers and health plans, have not implemented electronic data encryption…and other security measures that would render PHI unusable…" But Mr. Gottlieb also said that more than technology is involved: "Security breaches can result from both inadequate technical, physical and administrative safeguards and … from rogue behavior by thieves and disgruntled employees." For covered entities he stressed "the importance of conducting a thorough assessment of the risks to the security of paper and electronic information and implementing security measures that both comply with the HIPAA security standards and mitigate the risks."
Daniel F. Gottlieb, Electronic Data Management, Privacy & Discovery, Global Data Privacy Programs, Health, HIPAA
Joel Michaels was quoted on April 26 by Best’s Insurance News regarding the payment cuts imposed by the health reform bill on Medicare Advantage, a program that has allowed insurers to offer expanded benefits in comparison to basic Medicare. Although some higher cost insurers may be hurt by the cuts, Mr. Michaels said that “plans who are able to manage the[ir] costs fairly well will do OK.”
Joel Michaels discussed several key aspects of the new health reform bill’s impact on insurers with Best’s Insurance News on April 19. He said that if individual mandate penalties and lower-income subsidies lead more people to use the centralized state exchanges for standardized health benefit plans, “maybe this could work well for insurers.” Mr. Michaels also touched on the issue of medical loss ratio (MLR) rules, which mandate the minimum percentages of premiums that insurers must pay on health care costs. “The big question for MLR will be the standard” for administrative costs, he said. “How do you define what’s included under claims costs and non-claims costs?”
Paul Radensky and T. Reed Stephens were interviewed on April 16 by BNA’s Daily Health Care Report concerning the impact of the health reform law on the life sciences industry. Mr. Radensky discussed the greater opportunities for drug and medical device makers through the bill’s national long-term care insurance program and its mandated coverage for routine care in clinical trials. However, he also cited cost pressures that the industry will face both from health care providers and from an independent advisory board that will set Medicare reimbursement rates. Mr. Stephens noted that fees and taxes in the bill also will have a negative impact on life sciences companies. He singled out as examples the pharmacy benefit manager provision on the pricing of generic drugs, the required annual fee on dispensing brand-name drugs, and the new tax on medical device manufacturers.
Paul W. Radensky M.D., T. Reed Stephens, Health, Life Sciences & Medical Products, Life Sciences - Health
Christopher Jedrey and Daniel Melvin both spoke to BNA’s Daily Health Care Report (April 15) about the impact that the health care reform law’s lower reimbursement rates will have on hospitals. Mr. Jedrey said that the law has provisions that can “soften the blow” for hospitals that perform well on quality measures, but smaller hospitals and academic medical centers may lose their market share of payments to lower cost providers. "Hospitals that don’t control the flow of ‘at risk’ funds into the provider system will become vendors to those that do," he stated. Mr. Melvin noted that increased costs and reimbursement costs "will change the rules of the game" for ancillary service providers, adding that this will put pressure on such providers to make "strategic decisions" on whether to consolidate or to form partnerships, joint ventures or otherwise join higher paid primary care hospitals.
Christopher M. Jedrey, Daniel H. Melvin, Health, Health - General Counsel
Ankur Goel was quoted on April 12 by Report on Medicare Compliance concerning the health reform law’s new Stark Law self-disclosure rules on reimbursement overpayments. He noted that the law now makes kickbacks with regard to illegal remuneration an explicit violation of the False Claims Act, and creates “a clear statutory requirement to repay overpayments. There is no ambiguity.” Because of these and other changes in the law, Mr. Goel said that “hospitals will want to step their game on the compliance side because the government’s tools are that much more powerful.”
Ankur J. Goel, Corporate Responsibility and Governance, Health
David Ivill was cited in an April 5 Crain’s New York Business story about how New York hospitals and their residents may get back nearly $1 billion in FICA taxes that they paid prior to April 1, 2005. Because of successful litigation that McDermott pursued against the IRS on behalf of hospitals seeking refunds of the FICA payments, the agency agreed to the pre-2005 refunds on March 2.
Eric Zimmerman spoke to BNA Health Care Daily Report on April 1 regarding a new Centers for Medicare and Medicaid Services (CMS) rule for reimbursement of ambulatory surgery centers (ASCs). The rule was intended to raise ASC reimbursement closer to that of hospital outpatient procedures, but Mr. Zimmerman said ASCs will still be paid only 62 percent of the hospital rate for the same procedure. In addition, some 350 procedures are subject to an ASC payments cap, which Mr. Zimmerman says means “there’s not a lot of payment incentive” to perform the procedures in an ASC. He that the new health care reform law requires CMS to work with ASCs on how to incorporate value-based purchasing (VBP) into ASC procedures, but “there’s no telling” if VBP will become a requirement for ASCs. “Congress is taking it one step closer,” he added.
Eric Zimmerman, Health, Life Sciences & Medical Products
H. Guy Collier, Jr. was mentioned in Washington Lawyer (April 2010) for his appointment as chair of the board of directors at the Children’s Law Center. Mr. Collier is a partner in the Firm’s Washington, D.C. office, counseling health care and other non-profit clients.
H. Guy Collier, Health, Nonprofit Organizations
Ankur Goel spoke to BNA’s Health Care Daily Report (March 31) about the health care reform law’s expansion of the False Claims Act (FCA) and other enforcement mechanisms. “Anytime the government’s role in the health care system increases, so does its enforcement arsenal and compliance expectations,” he said, adding that all the compliance changes in the law “are consistent with that.” Mr. Goel specifically cited the law’s clarification that providers and suppliers must notify the government of an overpayment involving Medicare, Medicaid or the Children’s Health Insurance Program. “Congress has clearly foreclosed any debate or ambiguity about whether there is an obligation by expressly stating that the obligation creates a link to the FCA,” he stated.
Ankur J. Goel, Corporate Responsibility and Governance, Health
Joel Michaels commented for Reuters on March 30 about the health care reform law’s substantial increase in the individuals eligible for the Medicaid program. He noted that, while the increase could give insurers leverage to get better rates from providers, power could shift to primary-care doctors, who will be in even greater demand. “A big risk going forward will be the ability of the [insurance] plans to control the payments and costs at the provider level,” Mr. Michaels said. “The provider dynamic issue is the most uncertain piece.”
Eric Zimmerman assessed the health care reform law’s implementation challenges in a March 29 Reuters dispatch. Speaking of Democrats and advocacy groups who are the law’s strongest supporters, Mr. Zimmerman said that “in order to win the public sympathy and win public support they are not only going to want the implementation to be smooth, but also for the public to recognize the benefits coming out of health reform,” adding, “It’s going to be a challenge.” Mr. Zimmerman also noted the opposition to require all persons to purchase or otherwise have health insurance, and said that if the coverage mandate is struck down it would “blow a gaping hole in the whole framework of reform.” Among the newspapers in which the story appeared was the Vancouver Sun.
H. Guy Collier, Jr. was included in a March 29 Blog of Legal Times story about candidates for top leadership positions with the District of Columbia Bar. Mr. Collier, a partner in the Firm’s Washington, D.C. office, is one of 10 candidates for five open positions on the Bar’s board of directors.
Michael Peregrine commented on March 29 for Modern Healthcare regarding the impact of the health care reform law on tax-exempt hospitals. The law requires these hospitals to take a variety of steps to demonstrate they are fulfilling all their community and financial assistance responsibilities. Mr. Peregrine considered it unlikely that not-for-profit hospitals could lose their tax-exempt status under the law, but he warned that flouting the law could result in public relations difficulties beyond the law’s $50,000 penalty for falling short of their charity care obligations.
Michael W. Peregrine, Health, Tax Exemption
Sheila Walcoff was quoted by The National Law Journal on March 15 concerning provisions in the health reform bill that will give the Food & Drug Administration (FDA) new powers to approve generic biologic drugs, called biosimilars. She noted that the difficulty in making a biosimilar is akin to exactly copying a chicken soup recipe – “you’re working with a natural source, and every chicken is different.” For that reason, Ms. Walcoff said, “The most important issue is determining what level of clinical evidence will be necessary to give confidence to consumers that a product is safe and effective. The FDA has already given it a lot of thought,” she added. “The career staff are going to want to make sure they are exactly right on the science given the level of congressional interest in drug safety.”
, Health
Christopher Jedrey was interviewed February 24 by Health Leaders Media concerning the interaction between potential health reform legislation and ongoing consolidation in the health care industry. "Consolidation is ongoing on the provider and the insurer side, and will come from the cost and quality pressures that are driving reform legislation," Mr. Jedrey said. He noted that the last reform effort in the 1990s was a major driver for consolidation on the insurer side, and now believes that "the pendulum is swinging back" toward more consolidation among providers, both physicians and hospitals. "Providers are scrambling to catch up with the insurers to consolidate and achieve a similar level of cost efficiencies, particularly as physicians seek to participate in the value-based purchasing systems of hospitals," Mr. Jedrey stated, "and insurers are working collaboratively with the provider community to help realize their cost reduction goals."
Christopher M. Jedrey, Health, Health - Insurance
Michael Peregrine was quoted by BNA’s Health Law Reporter (February 11) concerning the impact that changes to the federal sentencing guidelines could have on the compliance programs of hospitals and health systems. Mr. Peregrine said the changes emphasize that “the definition of what constitutes an ‘effective compliance plan’ … remains living, breathing and subject to periodic modification.” He noted that some elements of effectiveness include a strong document retention program and a direct compliance officer reporting relationship to the board of directors. Mr. Peregrine added that the guidelines also cite self-reporting, cooperation with authorities and restitution of damages as desirable responses after an organization detects criminal conduct.
Michael W. Peregrine, Conflicts of Interest - Health, Corporate Responsibility and Governance, Health
Michael Peregrine was quoted in a January 18 Modern Healthcare article about a not-for-profit health system’s purchase of a stake in a health and wellness company whose CEO had sat on the health system’s board but resigned after the board voted to make the purchase. While not commenting on the transaction directly, Mr. Peregrine noted that not-for-profits must adhere strictly to conflict of interest policies in transactions involving board members’ companies, and that such transactions face greater scrutiny “regardless of whether it’s a ‘good deal’ or not.” He added that scrutiny by regulators and credit analysts is focusing on sophisticated private equity transactions by not-for-profit hospitals (such as in this case), because of doubts that the hospitals’ boards and executives have the ability to manage these investments.
Michael W. Peregrine, Conflicts of Interest - Health, Corporate Responsibility and Governance, Health, Nonprofit Organizations
Joel Michaels gave his thoughts on healthcare reform to Legal BisNow on January 28. “Scaling back health reform will be harder than it looks,” Mr. Michaels stated. “Eliminating consideration of preexisting conditions, for example, doesn't work without requiring individuals to purchase insurance. The individual parts are so interdependent that dealing with only one feature can create other imbalances that are problematic.”
Eric Zimmerman told Modern Healthcare on January 25 that he is “still confident that healthcare reform will be enacted. It’s too much of a priority for the administration, and Congress hasn’t sunk this much time into it” for it to fail. Mr. Zimmerman said he believes that House consideration of the Senate’s reform bill “remains the only possible pathway to getting reform done,” adding that he expects President Obama’s State of the Union address will give House members an incentive to vote for the Senate bill. “I think that the Democrats will realize that it is less desirable to do nothing, even if enacting health reform is not universally popular,” Mr. Zimmerman stated. Click here to view the full article.
Eric Zimmerman, Health, Life Sciences & Medical Products
Michael Peregrine and Kerrin Slattery were quoted in Chicago Lawyer (January 2010) on the evolution of the health law field. Ms. Slattery cited the trend in which many community-based hospitals and small stand-alone hospitals have been combined into larger health systems, and said that health reform legislation could "change the way health care facilities deliver services in general, and therefore the landscape of legal services sought and delivered will also change." Mr. Peregrine added that this, along with other complex health sector developments in the past five to seven years, means that health provider organizations "are relying more on their in-house attorneys for less complex matters in an effort to save on costs, and enlisting [outside counsel] to do more regulatory, executive compensation and transactional work that is beyond the expertise of the in-house staff." Click here for the full article.
Michael W. Peregrine, Kerrin B. Slattery, Health
AmLaw Daily interviewed Eric Zimmerman (January 21) regarding the prospects for passage of health reform legislation. "I'm very confident that health care reform will be enacted," he declared. "The question is what will it look like, and when will it be enacted." He based his belief on the effort expended on the legislation to date: "Health care reform...has consumed a great deal of time, attention and resources from Congress and the administration for the past year...at the expense of other issues, like the economy and jobs." Saying he did not "think it's likely" that reform will have bipartisan approval, Mr. Zimmerman stated that Democratic leadership will "figure out its strategy and pursue one." He added that McDermott will "help businesses navigate these shoals" once reform is passed.
Eric Zimmerman, Health, Life Sciences & Medical Products
Eric Zimmerman was quoted by BNA's Medicare Report (January 2010) concerning the impact that the current lack of a permanent administrator at the CMS will have as health care reform legislation is implemented. "The administration is going to have a lot at stake with the implementation [of reform], which will be almost as important politically as enacting reform in the first place," he said. "It is in the administration's interests that the implementation go smoothly, that deadlines be met, and that Congress be satisfied. That is a tall order without a permanent administrator." Zimmerman also noted as a key 2010 Medicare issue the outcome of a number of budget neutrality adjustment appeals regarding reimbursement, which are currently pending before the Provider Reimbursement Review Board. Click here to view the full article.
Eric Zimmerman, Government Strategies, Health
Michael Peregrine was quoted in a January 4 Modern Healthcare story about how tax-exempt hospitals and health systems are likely to face more scrutiny than ever from federal regulators, state prosecutors, the media and the general public. Governance is an especially hot issue, because, as Mr. Peregrine noted, “The IRS has clearly seen enough examples of bad boards where they know what they look like. If you’re really pushing the edge of the envelope in a way that is not supportable, you’re going to see more challenges from the IRS” and from state attorneys general over governance matters. And, Mr. Peregrine added, if malfeasance is found, regulators will push for resignations of board members as well as executives.
Michael W. Peregrine, Corporate Responsibility and Governance, Health, Nonprofit Organizations, Tax Exemption
Paul DeStefano was mentioned in a January 4 National Law Journal feature on significant new law firm lateral hires. Mr. Stefano joined McDermott’s Menlo Park office as a member of the Health Industry Advisory and the Life Sciences & Medical Devices Practice Groups. He will counsel companies in the biotech-pharmaceutical sector on strategic planning, company formation, financing and operations.
Paul R. DeStefano, Health, Life Sciences & Medical Products
Reed Stephens told Law360 on January 1 that Bates and Patrick v. Unnamed Defendant will be a particularly important health law case in 2010. The case involves a nationwide Department of Justice investigation into false Medicare claims for kyphoplasty spinal surgery, and Mr. Stephens said that it “highlights the real risk associated with the relationship between pharmaceutical and device manufacturers and hospitals and doctors.” He added that providers must be able to prove that the procedures they bill for are medically necessary. Mr. Stephens represents a provider client in a similar case, which he sees either moving toward a “reasonable” resolution or to trial if the government is too aggressive.
T. Reed Stephens, Health, Health Care Litigation, Life Sciences & Medical Products, Trial
Michael Peregrine discussed for Law360 on January 1 the increase in the Department of Justice’s pursuit of health care billing fraud, particularly with regard to holding hospital boards and executives responsible for alleged violations. “The government has said quite regularly, ‘We’re looking at the source of the problem,’ and that’s worrying board members,” Mr. Peregrine stated. He cited the application to health care the “responsible corporate officer doctrine” already used in securities and environmental law, adding, “We’re watching closely just to see where the government is taking this” so far as holding directors responsible for violations of false claims laws, the Stark Law and HIPAA.
Michael W. Peregrine, Corporate Responsibility and Governance, Health
2009
Paul DeStefano was quoted in a December 28 Daily Journal story that reviewed the possible effect of health reform legislation on business combinations in the health care industry. He noted that reform bills have had little effect on mergers and acquisitions involving large pharmaceutical companies, mainly because those deals take too long to respond to rapidly changing legislative developments. “The cycle on product development is so long, so uncertain and so expensive, you can’t turn that ship based on a change made today,” Mr. DeStefano said.
Paul R. DeStefano, Health, Life Sciences & Medical Products Litigation, Life Sciences - Corporate, Life Sciences - Health
Eric Hargen discussed for FDA Week (December 25) provisions in the final Senate version of the health care reform bill that impose limits and hurdles on the Centers for Medicare and Medicaid Services (CMS) for using comparative effectiveness research (CER) to make reimbursement and coverage decisions. The new provisions “did nothing to disturb the underlying other provisions that guide CMS in using this data,” Mr. Hargen observed. He added that under the provisions “CMS has been given a framework in which to use [CER]. They’ve been given an implicit license to use it as long as they use it in a particular way.”
, Health
Paul DeStefano was cited by Biotech Business Week on December 14 for joining McDermott’s Silicon Valley office as a partner. Calling Mr. De Stefano “one of the nation’s elite attorneys in the biotech industry,” the article noted that he will provide guidance on the formation, financing and operations of companies in the biotech-pharmaceutical sector.
Paul R. DeStefano, Health, Life Sciences & Medical Products
Massimiliano Russo provided four articles in the 8-14 December 2009 issue of Il Sole 24 ore, which looked at pharma supply contracts with the Italian government (vaccines against H1N1 influenza) and the comparison with U.S. law.
Massimiliano Russo, Health, Italy
Paul De Stefano was mentioned in numerous media outlets on December 2 and 3 as he joined the Health Industry Practice Group and Life Sciences & Medical Devices practice at McDermott’s Silicon Valley office. Mr. De Stefano will focus on strategic planning and legal representation in the formation, financing and operation of biotech and pharmaceutical companies. Coverage appeared in (among others) Intellectual Property Today, BusinessWeek.com, Bizz.Yahoo.com, Law360, National Law Journal, Law.com, USA Today, The Recorder, LawFuel.com and Biovalley.
Paul R. DeStefano, Health, Life Sciences & Medical Products
Joan Polacheck was quoted in the December 2009 issue of Inside Counsel regarding health care reform legislation being considered by Congress. She stated that provisions to fight fraud by strengthening requirements that health care organizations return overpayments quickly will play a key role in funding the overall plan. “There will be enhanced scrutiny of the relationship between health care providers and insurance companies,” Ms. Polacheck stated, which will create increased pressure to identify and refund overpayments.
Joan Polacheck, Health, Health - Insurance, Reimbursement/Fraud & Abuse
Jerry Sokol was cited by Cataractoutsourcing.com on November 17 on the trend toward more mergers of hospitals and surgery centers. He stated that many of the mergers are aimed at increasing profitability, noting that, with the credit markets opening up and Medicare reimbursements getting squeezed more, surgery centers in particular should be looking at their merger options. Mr. Sokol added that the physician owners of such centers could consolidate the revenues of various facilities, reduce their overhead costs, minimize risks and perhaps increase distributions by means of a merger.
Jerry J. Sokol, Health, Health - M&A, Mergers & Acquisitions
Jean Marie Pechette was cited by AmLaw Daily’s “The Churn” on October 23 for joining McDermott’s Chicago office as a partner in the Health Law Department. Ms. Pechette was previously with Kelley Drye & Warren.
Jean Marie R. Pechette, Health
David Ivill was quoted by Crain’s Health Pulse in an October 20 story about litigation decisions that will enable New York State teaching hospitals to get refunds of FICA taxes that they had paid on medical residents’ stipends. McDermott represented two hospitals that won their challenges against the IRS in the Second Circuit Court, which upheld the student tax exemption for residents and their hospital employers. “The Second Circuit cases should help us shake loose settlements for the taxpayers” covered by the decision, noted Mr. Ivill.
David S. Ivill, Health, Nonprofit Organizations
Bernadette Broccolo discussed conflict of interest (COI) concerns for university technology transfer offices (TTOs) in the September 2009 issue of Technology Transfer Tactics. She noted that, particularly in medical research, TTOs must integrate with university compliance officers to ensure that there is no appearance of financial conflicts from consulting arrangements, research grants, company interests, reimbursement, and similar issues. These are "looked at individually and in the aggregate" by regulators, industry associations and the media, Ms. Broccolo stated, "particularly when you're talking about several relationships in the same entity." COI concerns arising from any financial relationship are "variations on a common theme," she added, and COI programs "should not stop with reporting, as so many have done in practice," but instead should actively identify potential problems and monitor compliance throughout the life of a project.
Bernadette M. Broccolo, Conflicts of Interest - Health, Health
Eric Zimmerman discussed how to influence the outcome of Centers for Medicare and Medicaid Services (CMS) regulations in an October 2 story by BNA’s Medicare Report. Noting that there are “many other points of entry” beyond the obvious of submitting comments and engaging Congress on rulemaking, Mr. Zimmerman advised contacting the right people at CMS even before the rulemaking process is too far developed. He recommended meeting with staff at all levels – career policy, senior political leadership, at the office of the secretary, and the office of the general counsel.
David Hanselman, Jr., spoke to Law360 on September 29 about a federal judge’s denial of class certification to a group of nurses who alleged that four Chicago area hospital systems violated antitrust law by colluding to suppress the nurses’ wages. The judge ruled that the plaintiffs did not have a viable method of showing classwide injury, which Mr. Hanselman, who represented one of the hospital systems, said “constitutes the death knell” for the litigation. “I can’t say that this effectively ends the case because plaintiffs’ lawyers can be creative,” he noted, “but it certainly is a significant blow to the plaintiffs’ case, and we’ll be anxious to see what they do from here.” Click here to read the full article.
David L. Hanselman Jr., Antitrust & Competition, Class Action, Health, Health Care Litigation, Trial
Joel Michaels was quoted in a September 24 American University American Today summary of a panel discussion, held at the Washington College of law, which discussed the health care reform debate. Mr. Michaels discussed the political opposition that the issue has generated, and noted, “When you talk about the public option, people say this is the government’s first step into creating a national health care system, and we don’t like it.”
"Penalty of kickbacks"
Frankfurter Allgemeine Zeitung, September 23, 2009
Stephan Rau comments the penalty of kickbacks. They are rarely punishable, but clearly interdicted according to §31 of the "Landesberufsordnungen der Ärzte".
Michael Peregrine was quoted in The Wall Street Journal’s Health Blog (September 16) concerning Sen. Max Baucus’ healthcare overhaul. Nonprofit hospitals are relieved that Sen. Baucus doesn’t include an excise-tax measure that had been recently contemplated for hospitals not offering enough charity care. “What the Baucus Bill proposes is a supplement to, rather than a replacement of, the community benefit standard and without the controversial excise tax and minimum patient charity care standards originally proposed by Senate Finance last May,” said Mr. Peregrine.
Michael W. Peregrine, Health, Nonprofit Organizations
J. Peter Rich spoke at length to HealthLeaders Media on September 15 regarding disruptive physician treatment of staff members. "In some cases the physicians are good at dealing with patients," he noted, "but when it comes to staff they can't keep their temper and they don't know how to treat people properly." Mr. Rich recommends that provider organizations hiring new physicians do a full due diligence screening of their past work history for signs of disruptive behavior. "It's easier to keep out a disruptive physician than to keep one out," he asserted. He also recommended writing into physician contracts that failure "to act in a civil manner toward colleagues, patients and others" is grounds for termination. Should there be disruptive behavior, Mr. Rich advised creating signed, dated documentation of it. "If this is a pattern that needs to be dealt with, it is important to have a paper trail," he said.
Michael Peregrine was quoted in Modern Healthcare on August 17 concerning a federal district court ruling that the interim CEO of a failing hospital was personally liable for $2 million in payroll taxes that were not paid during his tenure. Although this and a similar case had unique circumstances, Mr. Peregrine said that their idiosyncrasies should not obscure the basic lesson for any hospital: “When you’ve really got cash flow problems, board members and senior managers have to make sure they walk the [payroll tax] check to the mailbox.”
Monica Wallace was profiled in NIU Business (Summer 2009) as the recipient of the inaugural Executive Club scholarship award at Northern Illinois University College of Business. Ms. Wallace graduated summa cum laude and first in her class at NIU before attending the University of Iowa College of Law and entering practice at McDermott, where today she counsels clients in every major sector of the health care industry on regulatory issues and business transactions. She continues her contributions to Northern Illinois University by serving as a board member of the NIU Executive Club, helping plan the annual shadowing program for College of Business students, and doing on-campus recruiting for McDermott.
Michael Peregrine was quoted in BNA’s Health Law Reporter (July 30) concerning new Internal Revenue Service training materials for the leaders of nonprofit organizations. He called the best practices described in the materials “a good resource for nonprofit boards and their governance advisors,” saying that the materials address “governance ‘areas of interest’ that have not been as publicly pronounced before,” such as size, composition, authority allocation and key policies of boards. Mr. Peregrine asserted that “while the IRS may not be able to mandate specific governance practices, it is clearly extending its governance reach,” and added that the new training materials demonstrate that “the IRS is in it for the long haul as it relates to governance scrutiny.”
Michael W. Peregrine, Health, Nonprofit Organizations
Eric Zimmerman was quoted in Modern Healthcare (July 13) concerning an agreement that three hospital lobbying groups reached with Congress and the White House to reduce hospital reimbursement during the next 10 years and to make changes in physician self-referral to hospitals in which they have an ownership interest. “It looks like a lot for a little,” Mr. Zimmerman said of the agreement. “Physician ownership has been the top priority for the hospital lobby. It’s always confused me why that’s the top priority. It’s a little confounding that they would sacrifice so much to get assurance on this issue.”
Bernadette Broccolo was quoted in the July 6 issue of Modern Healthcare regarding the assertion by new IRS commissioner Sarah Hall Ingram that the IRS will more closely scrutinize governance practices of not-for-profit hospitals to ensure that they do not abuse their tax exemption. Noting that Ingram is building on the policies of her predecessor in pursuing once-controversial governance oversight, Ms. Broccolo said of the IRS: “They are going forth with confidence in that position. We’re not going to see a reversion to circumspection.”
Bernadette M. Broccolo, Health, Nonprofit Organizations, Tax Exemption
Michael Anthony told Lab Law Weekly (July 3) that the newest rankings for McDermott in Chambers USA, “particularly our position as the only Band 1 health care practice in Illinois, are a great honor.” He noted that because the Chambers researchers in part base their rankings on client feedback, “these results indicate that our dedication to legal excellence and industry knowledge is having a direct, positive impact on those we serve.” McDermott Illinois health law lawyers receiving Band 1 individual rankings, in addition to Mr. Anthony, are Bernadette Broccolo and Michael Peregrine. Ralph DeJong received “well regarded” recognition, while Kerrin Slattery was identified as “up and coming.”
Michael F. Anthony, Bernadette M. Broccolo, Ralph E. DeJong, Michael W. Peregrine, Kerrin B. Slattery, Health
Michael Anthony was quoted by Business & Finance Week regarding the launch of the Firm’s HealthCareLawReform.com blog. Mr. Anthony noted McDermott’s decades-long leadership in breadth and depth of health industry knowledge and stated, “This blog is designed to help bring that critical insight to stakeholders in the most immediate and useful way possible as we approach an era of unprecedented change in our nation’s health care system.”
Anne Hance was quoted by BNA’s Health Care Daily Report on June 29 regarding stepped up surveillance and enforcement actions by the Centers for Medicare and Medicaid Services (CMS). “The environment is really starting to change,” Ms. Hance noted, adding that she sees an “ever-increasing uptick” in CMS enforcement activities. Given that the health care reform bill before Congress expands penalties for Medicare/Medicaid coverage marketing violations, Ms. Hance warned companies in the health care sector that the climate will only get “tougher for all of you trying to do the right thing.”
Michael Peregrine commented in a June 17 Wall Street Journal story about a recent federal appeals court decision supporting an IRS penalty against a nonprofit hospital board chair for unpaid payroll and related taxes. The ruling, combined with increased IRS oversight of the tax-exempt sector, shows the extent to which board members can be held personally liable for a charity's decisions. As Mr. Peregrine observed, “This stuff is starting to spread like wildfire in boardrooms, and people are starting to get nervous.”
Michael W. Peregrine, Health, Nonprofit Organizations
Eric Zimmerman commented on the Obama health care reform proposal in a June 22 blog post for Healthcarelawreform.com. He noted that many of the anticipated Medicare program payment reductions and revisions are absent from the initial proposal draft, but added that “providers should not draw too much comfort from that. President Obama has called for more than $600 billion in savings from Medicare, and … [p]roviders should still expect significant savings provisions to be added later.” Mr. Zimmerman added that the proposal means health care service providers will “face new systems, obligations and incentives that will dramatically alter how providers furnish services and interact with Medicare and its beneficiaries.”
Karen Sealander is mentioned in a June 23 Washington Post article about advocacy efforts to include dental care in the Obama Administration’s health care reform plan. She noted that dental hygienists, as represented by the American Dental Hygienists' Association (a client of the Firm) foresee a bigger role for themselves in preventive dental care to the poor and under-served. The story described the Capitol Hill advocacy efforts by ADHA members from 39 states, under the slogan of “Put Teeth in Health Reform.”
Joshua Buchman and Ankur Goel were both quoted in a June 19 Law360 story on recent changes to the False Claims Act. Mr. Buchman noted that companies no longer must deal directly with the U.S. government to have False Claims Act liability. “The bottom line is, just because you're one or two or even three levels removed from the entity doing business with the U.S. government, you're not safe,” he said. Mr. Goel thus urged companies to review their compliance programs to demonstrate “the kind of diligence the law contemplates … to show that they are aware of what they're supposed to be doing and have made a reasonable effort to put a system in place,” he said.
Joshua T. Buchman, Ankur J. Goel, Corporate Responsibility and Governance, Health, Trial
McDermott Will & Emery was mentioned in the Chicago Daily Law Bulletin on June 17 for the launching of healthcarelawreform.com, a blog covering the various reform proposals. The article noted that McDermott lawyers will use the blog to comment on current and future reform proposals and to analyze their effect on the health care industry.
Arnold Pamplona was quoted in a June 18 Reuters dispatch concerning the Philippine American Bar Association’s stance on same-sex marriage in California. Mr. Pamplona is President of the Association, and he said the organization at first found it difficult to endorse same-sex marriage “because being Filipino American, the great majority of our members are Roman Catholic.” However, the organization has come to support the concept because of past discrimination against the Filipino community. “Until not too long ago it was illegal for Filipinos and whites to marry,” Mr. Pamplona said, “and a lot of our board members are married to Caucasians.”
Jeffrey Jung and John Tamisiea examined the increasing use of royalty financing techniques with respect to pharmaceutical and biotech assets as a source of capital in their article that appeared in The Deal Magazine on June 15. “As more market participants use royalty financing techniques as an alternative financing tool, and as the transactions continue to increase in size, there is likely to be a corresponding continued increase in transactional complexity,” the authors stated. Such transactions include investments in the anticipated future revenues from late development stage or precommercial launch products (“revenue interest” or “synthetic royalty” transactions), and various hybrid financing structures.
Jeffrey A. Jung, John P. Tamisiea, Corporate, Health, Healthcare Royalty Sales
Bernadette Broccolo discussed for Medical Research Law & Policy Report (June 9) a proposal by the National Institutes of Health to expand its management and oversight of conflict-of-interest policies for its grantees. Ms. Broccolo said that the proposal would identify conflict of interest by asking questions that “are very thorough and reflective of all the key considerations that have become part of the guidance we’ve been receiving from nongovernmental sources. And that’s important – very important....because the law has been perhaps at best a minimum standard.” Ms. Broccolo cited such points as the proposal’s focus on institutional conflicts of interest to demonstrate that it is “a really good effort to strike a balance between bringing things up to date but not being too prescriptive and recognizing that organizations need to have … flexibility for judgment.”
Bernadette M. Broccolo, Conflicts of Interest - Health, Health
Anne Hance gave an extensive interview to Medicare Part D Compliance Rules (June 2009) on new Medicare draft guidelines regarding Medicare Advantage (MA) and Part D plans. Ms. Hance said of the draft document overall that "it's not so much a huge directional shift. Rather, the changes that they've incorporated are really more minor tweaks and tend to offer clarification on issues that have been outstanding." However, the guidelines on compensation for plan-employed agents and brokers are "a pretty big deal because all of a sudden [companies] would have to completely modify" compensation structures for such persons. She also noted that the draft guidelines have other confusing provisions on the marketing of MA and Part D plans. Ms. Hance advised companies not to make immediate changes "given the fact that it's draft guidance, not final guidance," but suggested that they submit comments to CMS asking for clarification.
Michael Peregrine was quoted in the May 21 BNA Daily Health Care Report concerning proposed federal legislation to codify the requirements for determining if a hospital qualifies for tax-exempt status. Noting that the battle for hospital tax exemption standards has now been joined, although the details are not yet clear, Mr. Peregrine believes one clear component that will be defined is the concept of a minimum level of charitable patient care. "The other requirements don't necessarily carry the same level of concern as does the minimum level of care," he said, "although the annual community needs analysis could become somewhat of a burden if not precisely drawn." Mr. Peregrine added that the interesting debate will be over the definitions of "minimum level" and "charitable patient care."
Michael W. Peregrine, Health, Tax Exemption
Bernadette Broccolo commented for BioWorld Today on an agreement between President Obama and a coalition of industry, insurance, health care and labor leaders to cut health care costs by $2 trillion over 10 years. "The failure of health care reform in the past was all of these constituencies taking a siloed, self-interest approach," she stated. Ms. Broccolo said that many details have to be worked out on such key issues as health IT and comparative effectiveness research, adding, "the devil is in the details." But she also noted that the agreement is evidence that the President has been able to "break the log jam" that has impeded health reform in the past.
Bernadette M. Broccolo, Health
Bernadette Broccolo told Business Week (May 12) that the agreement between President Obama and major health care sector players to cut health care costs by $2 trillion "is very significant. It shows a dimension to the reform effort that no prior Administration was able to achieve. Ms. Broccolo said the importance of the agreement reflected the fact that "every one of the key constituencies is on the record. We all have a cynical side, but I think there is a real difference time in how serious all sides are."
Bernadette M. Broccolo, Health
Robert Nicholas analyzed the Seventh Circuit's decision in U.S. v. Farinella in a May 8 Washington Legal Foundation Legal Opinion Letter. The decision held that the Food & Drug Administration cannot merely rely on its own assertion and opinion when claiming that food or drug labeling is misleading and in violation of the law. Mr. Nicholas concluded that "one can make a compelling argument based on Farinella that . . . both the [Food & Drug] Act and the Constitution demand more than an assertion by the FDA about what something means . . . without any authoritative support whatsoever."
, Health, Life Sciences & Medical Products, Life Sciences - Health
Michael Peregrine was quoted by The Wall Street Journal on May 5 regarding more detailed disclosure on executive and trustee compensation that charities must make using new Form 990 annual reports to the Internal Revenue Service. Mr. Peregrine believes that the IRS intended the new form to involve board members more in the reporting process, stating that "The IRS feels the more the board is familiar with what's in the form, the more effective they will be in governance and oversight." He added that, for this reason, board members should be alert to and ask questions about potential conflicts of interest, excessive compensation or insider transactions revealed on the form.
Michael W. Peregrine, Conflicts of Interest - Health, Corporate Responsibility and Governance, Health
Jennifer Geetter was quoted by AISHealth.com on May 4 in a story about the Institute of Medicine's new recommended conflict of interest policies governing the relationships between health care institutions and pharmaceutical and medical device companies. "One of the challenges in management [of conflicts of interest] right now is most people recognize that they need to do it, but there are a lot of question marks around the how," Ms. Geetter said. "Now institutions are looking for matches between individual interests, imputed interests and institutional interests," which makes the process more inter-related and complex. She added concerning such relationships, "This is not just a compliance issue – it is a process issue. You [must] have a process in place that is flexible and elegant enough, that can handle all your problems, but is simple and transparent. And it has to be integrated into the other parts of your organization."
Jennifer S. Geetter, Conflicts of Interest - Health, Health
Bernadette Broccolo was quoted in an April 27 Modern Healthcare story about a healthcare communication systems company that formed an advisory board of seven nurse executives from hospitals that use the company's products. Ms. Broccolo believes that the advisors could still ethically discuss the company's products at their hospitals, but that they should disclose their advisory relationships and refrain from voting on product decisions to avoid any impression of bias. "What everyone is clamoring for first and foremost is . . . that any kind of participation in advisory groups of these kind[s] be made in the sunshine," she stated.
Bernadette M. Broccolo, Conflicts of Interest - Health, Health
Robert Nicholas analyzed the U.S. Seventh Circuit's decision in United States v. Farinella for Health Lawyers Weekly (April 24). The decision rejected the Food & Drug Administration's assertion that "misleading" product labeling violates the "misbranding" provisions of federal law. Although the case related to a food product, Robert noted that it has "significant potential applications" for prescription drug and medical device advertising and promotion, where "the FDA often relies only on its own expertise in deciding what meaning to ascribe to otherwise ambiguous and undefined representations."
, Health, Life Sciences & Medical Products, Life Sciences - Health, Life Sciences - Medical Products & Technology
Kate Feola was quoted in ePharmaceuticals (April 2009) about the Massachusetts Pharmaceutical and Medical Device Manufacturer Conduct regulations. Pharmaceutical and medical device companies must annually disclose to the Massachusetts Department of Public Health any payment or economic benefit with a value of at least $50 made for sales or marketing. Ms. Feola said that the disclosure requirements are not new to pharmaceutical companies. However, Ms. Feola said that Massachusetts is the first state to require financial disclosure by medical device companies which will increase compliance challenges facing the manufacturers. "Device manufactures have never had to think through what systems, whether manual or electronic, are necessary to ensure the company is accounting for all of the expenses that must be reported to the state, what accounts are those expenses coming from, and to whom they are being paid."
, Health, Life Sciences & Medical Products, Life Sciences - Health, Life Sciences - Medical Products & Technology
Robert Nicolas was quoted April 3 in Dickinson's FDA Webview concerning the Seventh Circuit Court of Appeals reversal in a jury conviction of a food manufacturer for misbranding food. The conviction had hinged on the FDA's unfounded assertion that a "best when purchased by" date was the same as an "expiration date" that could raise freshness or safety concerns for consumers. The attorney said that the FDA's interpretation lacked empirical support about the term's meaning, and added: "Surely the First Amendment demands at least some reliable extrinsic evidence . . . before FDA can simply assert, in the absence of any otherwise controlling authority, that consumers comprehend ambiguous advertising and labeling claims in the way the agency alleges."
, Health, Health - Product Regulation, Life Sciences & Medical Products
Christopher Jedry was cited in April 2 press reports on Business Wire and M2 Presswire concerning his online seminar, "Foundation Model Proposal for a Hospital." The seminar presentation is viewable on computer or iPod, and offers innovative ideas and best practices for structuring such a proposal.
T. Reed Stephens was quoted in a March 30 story in The National Law Journal concerning letters about marketing practices sent by the Food & Drug Administration (FDA) to pharmaceutical companies. State attorneys general increasingly use the letters to sue those companies for false advertising. Mr. Stephens urged companies who receive such letters to assess their marketing practices for compliance problems, adding that "[w]hen you get this type of regulatory action from the FDA that's public, you do need to take proactive measures to better understand what's going on under the hood of your car."
T. Reed Stephens, Government Strategies, Health, Life Sciences & Medical Products, Life Sciences - Health
Eric Zimmerman was extensively quoted in BNA's Daily Health Care Reporter on March 30 regarding final rules for the Centers for Medicare and Medicaid Services (CMS) to reimburse ambulatory service centers (ASCs). Mr. Zimmerman said the new rules "are really shaking up the industry" by more closely aligning ASC reimbursement with hospital outpatient surgical services. However, because of statutory budget constraints, CMS pays ACSs considerably less than hospitals. "It's outrageous to think that ACSs can furnish procedures for that little money," Mr. Zimmerman stated. ACSs seeking reimbursement must also submit quality and performance data, but Mr. Zimmerman noted that "there is no indication" that CMS will adopt industry suggestions for what this data should contain.
Eric Zimmerman, Health, Life Sciences & Medical Products, Reimbursement/Fraud & Abuse
Stephen Bernstein's article, "Appeals Court Ruling Severely Undermines Speech Rights" was republished in March 2009 in the American Health Lawyers Association Practice Groups Member Briefing.
Stephen W. Bernstein, Health, Life Sciences - Health
Michael Peregrine was quoted in the March 2009 issue of Trustee magazine regarding the increased scrutiny on board of director members as the result of the Sarbanes-Oxley Act and other regulations. "The job is not harder than before [and] Sarbanes-Oxley should not frighten people away," Mr. Peregrine said of potential directors. "Board work is not more risky, it just requires more self-reflection on the qualities of a good board and a better job of managing those duties. Liability is not greater than before, it's just the prism of how the board is looked at that has changed." Mr. Peregrine recommended that board members "be able to explain your fiduciary responsibilities," adding, "If you are informed and alert and do your homework, you should have no problem."
Michael W. Peregrine, Corporate Responsibility and Governance, Health
Robert Nicholas and Sheila Walcoff's article, "President Obama Announces FDA Commissioner and Deputy Commissioner Appointments" was mentioned in a March 17 story by Dickinson's FDA Webview.
, Health, Life Sciences & Medical Products, Life Sciences - Health
David Ivill was quoted in Crain's Health Pulse on March 13 concerning the easing of federal restrictions on stem cell research. Speaking of companies that are tissue banks and clinical laboratories in the state of New York, Mr. Ivill noted that "many of my clients say this promises more opportunities." He added that although New York imposes very strict regulation on the business practices of these companies, it is one of the few states funding millions of dollars in stem cell research.
Michael Peregrine was quoted on February 26 in The Chronicle of Philantrophy regarding the new Internal Revenue Service report on tax-exempt hospitals and executive compensation. Mr. Peregrine commented that, "charities need to take heed: Lawmakers and the American public today are questioning any institution that receives government assistance – whether it's bailout money or beneficial tax treatment." He continued, "They are saying, In this environment, with huge economic problems and deficits, tell me again why we are providing certain groups with tax exemptions….The IRS is saying, Everybody here play by the rules. And the broader charitable sector should say, All right, let me understand again what are those rules and double-check we are complying with them."
Michael W. Peregrine, Health, Nonprofit Compensation, Nonprofit Organizations, Tax Exemption
Michael Peregrine was quoted on February 26 in The Chronicle of Philanthropy regarding the criticism of Obama's plan to reduce charitable deductions for the wealthy. Mr. Peregrine said charities now face three factors that could cut into their deductions including, the bad economy, the proposed charitable-deduction limits and proposals by President Obama to end tax cuts for wealthy people that were introduced by President Bush. Mr. Peregrine is concerned that charities that are hurting for donations will be more susceptible to fund-raising scams. He said, "What is certain is that the perception that this will reduce charitable donations in the short term is going to draw out the fraudsters."
Michael W. Peregrine, Health, Nonprofit Organizations, Tax Exemption
Michael Peregrine was quoted on February 18 in the Chronicle of Philanthropy in an article regarding the recent report issued by the Internal Revenue Service regarding tax-exempt hospitals and executive compensation. Mr. Peregrine warned that charities need to take notice—lawmakers are paying particular attention to any institutions receiving government assistance. "They are saying, In this environment, with huge economic problems and deficits, tell me again why we are providing certain groups with tax exemptions," Mr. Peregrine said. "The IRS is saying, Everybody here play by the rules. And the broader charitable sector should say, All right, let me understand again what are those rules and double-check that we are complying with them," he added.
Michael W. Peregrine, Health, Nonprofit Compensation, Nonprofit Organizations, Tax Exemption
Michael Peregrine was quoted on February 16 in Modern Healthcare in an article regarding the Internal Revenue Service (IRS) report on nonprofit hospital executive pay and community benefits. The IRS found that executive pay at nonprofit hospitals is uneven compared to the community benefits provided by nonprofit hospitals. Mr. Peregrine noted that "the reports release amid public outcry over payouts to executives at failed corporations could put not-for-profit hospitals on the defensive." He added that the unfortunate timing may overshadow positive survey results that show hospitals largely comply with regulations, "The report makes it clear that hospitals have been playing by the rules," Mr. Peregrine noted. Mr. Peregrine provided similar comments regarding the IRS report to BNA's Health Care Reporter and EO Tax Today.
Michael W. Peregrine, Health, Nonprofit Compensation, Nonprofit Organizations, Tax Exemption
Michael Peregrine was quoted on February 13 in the Wall Street Journal in an article regarding a report issued by the Internal Revenue Service claiming that a small amount of nonprofit hospitals provide the most charity care and that the same nonprofit hospitals are overcompensating their top executives. "For the hospital sector, it's really unfortunate, the timing of this report, because this gets dropped into a real toxic environment," commented Mr. Peregrine. He continued, "You've got people really upset about government subsidies to organizations." Mr. Peregrine noted that many consider tax exemptions a form of subsidy.
Michael W. Peregrine, Health, Nonprofit Compensation, Nonprofit Organizations, Tax Controversy
Stephen Bernstein was quoted in the February 10 issue of Health Law360 in an authored article discussing IMS Health Inc. v. Ayotte.
Stephen W. Bernstein, Health, Life Sciences & Medical Products, Life Sciences - Health
Ankur Goel was quoted in the February 2 issue of Modern Healthcare in an article regarding Attorneys General authorities and their abilities to garner change and achievement. "If there's any connection, it's one of timing and the broad array of authorities attorneys general possess. In general, the intense political focus and concern about healthcare, as well as the increasing role of healthcare in the economy, are likely to be reflected in the level of government activity," Mr. Goel said.
Ankur J. Goel, Health, Health Care Litigation
Eric Zimmerman was quoted in the February 2 issue of Modern Healthcare in an article regarding physician-owned hospitals being worried about the priorities of the Federation of American Hospitals and the SCHIP bill that was passed. "It is likely that the House will take up the Senate bill – making a conference not necessary – and send it to the president. With that said, if this provision is not included in what is sent to the president, it will re-emerge again. Those who object to physician ownership of hospitals have made it clear that this is a priority and one they want to purse until they achieve their objective," Mr. Zimmerman said.
Eric Zimmerman, Health, Health Ventures/Physician Transactions
Russell Hayman and Jon Dean were quoted in the February 1 issue of Corporate Counsel in their co-authored article regarding how employers should handle the departure of an employee with caution.
Jon Dean, Russell Hayman, Health, Trial
Stephen Bernstein was quoted in the January 30 issue of the Washington Legal Backgrounder in an authored article discussing IMS Health Inc. v. Ayotte.
Health, Life Sciences & Medical Products, Life Sciences - Health
Stephen Bernstein was quoted in the January 29 issue of FDA Webview in an article regarding a New Hampshire law that violates the Firm Amendment because it prohibits the transfer of prescriber-identifiable information for use by drug companies field representations. "If the transfer of the information was the target of the conduct restraint, then, at a minimum, all the information transfers for all commercial uses would have been forbidden, instead of just those having to do with the ensuing commercial use in influencing physician behavior," Mr. Bernstein said.
Eric Gordon was quoted in the January 13 issue of Modern Healthcare in an article regarding the HHS's inspector general's office moving forward with a rural multiple-ownership deal. "The OIG is saying here that you need to be foursquare within the group practice definition—or very close to it—for us to bless this type of arrangement. They're saying 'We mean it, to be protected you need to qualify as a group practice,'" Mr. Gordon said.
Eric B. Gordon M.D., Health, Reimbursement/Fraud & Abuse
Eric Zimmerman was quoted in the January 9 issue of BNA’s Medicare Report in an article regarding Medicare legislation in 2009. "Congress will consider comprehensive Medicare legislation, including significant program payment reforms in 2009. There is enormous pent-up demand to address several systemic problems, including the physician payment update," Mr. Zimmerman said.
Eric Zimmerman was quoted in the January 5 issue of Modern Healthcare in an article regarding physician-owners expecting legislative action early in the year from Democrats who will now have greater majorities in Congress and support from a same-party president in the White House. "The topic remains a priority for healthcare leaders in Congress. A physician-ownership provision could appear in the reauthorization of the State Children's Health Insurance Program early in 2009, or perhaps in Medicare legislation later in the year," Mr. Zimmerman said.
Health, Health Ventures/Physician Transactions
Eric Zimmerman was quoted in the January 5 issue of Modern Healthcare in an article with respect to physician-owned hospitals. "A physician-ownership provision could appear in the reauthorization of the State Children’s Health Insurance Program early in 2009, or perhaps in Medicare legislation later in the year," Mr. Zimmerman said.
Eric Zimmerman, Health, Health Ventures/Physician Transactions
2008
David Marx was quoted in the December 30 issue of Global Competition Review in an article regarding Inverness Medical Innovations' settlement with the Federal Trade Commission (FTC) on charges that the company illegally sought to maintain its monopoly on pregnancy tests by acquiring assets from competitor ACON Laboratories. Inverness must sell the assets, including an intellectual property license for dye technology. "With this decision, the FTC shows it remains committed to enforcing antitrust laws in the health-care sector," said Mr. Marx. "The FTC has ensured that the market has returned to an even more competitive state than it was before Inverness acquired ACON's assets," he added.
David Marx Jr., Antitrust & Competition, Antitrust - IP, Health, Health - Antitrust, Intellectual Property
Michael Peregrine was quoted in the December 25 issue of BNA’s Health Law Reporter in an article regarding Senior Chuck Grassley discussing the possibility with other lawmakers of crafting legislation that would establish charity care and community benefit standards for nonprofit standards for nonprofit hospitals and accountability benchmarks for assessing whether exempt hospitals actually are meeting those standards. "Hospitals should not necessarily take comfort from the fact that Sen. Grassley’s previous efforts in this area never went anywhere," Mr. Peregrine said.
Michael W. Peregrine, Health, Hospital and Health System Transactions, Nonprofit Organizations, Tax Exemption
Daniel Melvin was quoted in the December 22 issue of Report on Medicare Compliance in an article regarding the recent answer to a FAQ that CMS posted regarding the final Medicare physician fee schedule regulation that will change the dynamic of mobile diagnostic testing relationships. "The new rule for mobile operators should never have been construed to require portable testing equipment and technologist leading companies to enroll in Medicare as IDTFs, but CMS made published statements suggesting that this was their intent," Mr. Melvin said.
Daniel H. Melvin, Health, Health Ventures/Physician Transactions, Reimbursement/Fraud & Abuse
Guy Collier was quoted in the December 2008 issue of Washington Lawyer in an article regarding the D.C. Bar Pro Bono Program Law Firm Clinic recently changing their name to the Advocacy & Justice Clinic. "The Pro Bono Committee felt strongly that the name should do much more to reflect the fundamental importance of the services offered to beneficiaries of the clinic, as well as the richness of the experience to participating law firm attorneys. At its most basic level, the clinic is all about lawyers advocating to ensure that low-income District residents have a voice and secure individual justice in areas that are vitally important in their day-to-day lives – housing, public benefits, and family law," Mr. Collier said.
H. Guy Collier, Health, Pro Bono & Community Service
Russell Hayman was quoted in the December 8 issue of American Medical News in an article regarding physicians being seldom named in false claims cases but are often in a position to blow the whistle on fraud that they observe. "Health care services account for roughly 10% of the nation's gross domestic product. Put that together with the fact it is so heavily regulated by the federal government and states, and you have a recipe for False Claims Act activities on the scale we've seen in recent years," Mr. Hayman said.
Russell Hayman, Health, Health Care Litigation, Trial
Karen Sealander's comments on the Obama Administration's initial choice of former Senator Tom Daschle to be Secretary of Health and Human Services were summarized by Healthcare IT News on November 19, 2008.
Robert Nicholas and Paul Radensky’s article "FDA and Drug Advertising: No Attention Deficit On Nooed For 'Substantial Evidence'" appeared in the November 7 issue of the Washington Legal Foundations' Legal Backgrounder.
Paul W. Radensky M.D., Health, Life Sciences & Medical Products, Life Sciences - Health
Michael Peregrine was quoted in the November 3 issue of Modern Healthcare in an article regarding a case in the Virgin Islands where a board chair for a public hospital was arrested and charged for an alleged role in what prosecutors describe as a "criminal enterprise" among the top three executives. Hospital trustees on the mainland may wonder what it says, if anything, about their own risk of becoming targets when things go horribly wrong under their watch. "We are entering into an environment of recrimination, and there will absolutely be spillover in the nonprofit world against boards for what I call preventable harm,'' Mr. Peregrine said.
Michael W. Peregrine, Corporate Responsibility and Governance, Health, Nonprofit Organizations, Tax Exemption
Russell Hayman was quoted in the November 1 issue of Healthcare Risk Management in an article regarding Staten Island University Hospital agreeing to pay $89 million in a False Claims Act settlement. "The SIUH case involved essentially three allegations," he said. "The lawsuits asserted that the hospital provided care in unlicensed beds, miscoded uncovered cancer therapies as covered therapies in order to obtain payment, and claimed an inflated number of medical residents in order to obtain graduate medical education expenses," Mr. Hayman said.
Russell Hayman, Health, Trial, White-Collar & Securities Defense
Michael Peregrine was quoted in the October 20 issue of Modern Healthcare regarding a Government Accountability Office (GAO) report that says the nation's approximately 2,900 nonprofit, non-government hospitals have made it all but impossible to uniformly measure community benefits across the country. Mr. Peregrine said the GAO report doesn't include any findings definitive enough to justify creating federal legislation mandating how not-for-profit hospitals report their community benefit, especially if that could lead to quotas.
Michael W. Peregrine, Health, Nonprofit Organizations
Michael Peregrine was quoted in the October 20 issue of Modern Healthcare in an article regarding Senator Chuck Grassley's intention to introduce new legislation in January that will attempt to define exact standards for tax exemption of not-for-profit hospitals, including community benefit. "The GAO report doesn't include any findings definitive enough to justify creating federal legislation mandating how not-for-profit hospitals report their community benefit-especially if that could lead to quotas. It doesn't provide the smoking gun that opponents of tax exemptions were looking for,'' Mr. Peregrine said.
Michael W. Peregrine, Health, Nonprofit Organizations, Tax Exemption
McDermott's On the Subject "FDA Challenges Implied Outcomes Claims For Several ADHD Products: An Analysis" was featured in the October 17 issue of Health Lawyers Weekly.
, Health, Life Sciences & Medical Products, Life Sciences - Health
McDermott's On the Subject "FDA Confirms Its View on Generic Drug Label Carve-Outs" was featured on October 9 in Health Law360.
, Health, Life Sciences & Medical Products, Life Sciences - Health
Jerry Sokol was quoted in the October 7 issue of Florida Medical Business in an article regarding the thriving business of ambulatory surgery centers. "The hottest thing going right now is that a lot of ASCs will start up physician-owned, and once they ramp up their earnings, they sell a piece to the national company," Mr. Sokol said.
Jerry J. Sokol, Ambulatory Surgery Centers (ASC), Health
Michael Peregrine was quoted in the October 7 issue of The Chronicle of Philanthropy in an article regarding the growing questions about the recent actions and responsibilities of boards of deeply troubled U.S. banks and companies that will eventually also be felt by nonprofit organizations. "A spillover to charities from some of the events going on in Wall Street and Washington is probable. Boards of tax-exempt organizations are beginning to brace themselves for the spillover: this climate of responsibility and possibly recrimination," Mr. Peregrine said.
Michael W. Peregrine, Corporate Responsibility and Governance, Health, Markets Restructuring, Tax Exemption
McDermott Will & Emery's White Paper entitled "FDA Challenges Implied Outcomes Claims for Several ADHD Products: An Analysis" was featured in the Guest Column on October 3 in Health Law360.
Paul W. Radensky M.D., Health, Life Sciences & Medical Products, Life Sciences - Health
McDermott was mentioned in the October 2 issue of FDA's Webview in an article regarding the Firm's On the Subject discussing the letters issued by the U.S. Food and Drug Administration's (FDA) Division of Drug Marketing, Advertising, and Communications alleging that promotional material for certain products intended for use in treating attention deficit hyperactivity disorder (ADHD) made implied claims about an effect on ADHD "outcomes" that were not supported by "substantial evidence." FDA Webview notes, "Attorneys at McDermott...say FDA's Warning Letters and notices of violation to several manufacturers of ADHD drugs mean that drug companies wanting to avoid a challenge from CDER's Division of Drug Marketing, Advertising, and Communications (DDMAC) should review ad and promotional materials in all therapeutic categories to determine whether they make implied outcomes claims of the kind alleged by DDMAC in the ADHD letters."
Paul W. Radensky M.D., Conflicts of Interest - Health, Health, Life Sciences & Medical Products, Life Sciences - Health
Robert Nicholas was mentioned in the September 2008 issue of Innsight Industry Newsletter in an article discussing the FDA's view on generic drug-label carve outs.
, Health, Life Sciences & Medical Products, Life Sciences - Health
Michael Peregrine was mentioned in the September 18 issue of The Earth Times and PR Newswire in an article regarding The University HealthSystem Consortium (UHC) recognizing five of its full academic medical center (AMC) members with the UHC 2008 Quality Leadership Award. Mr. Peregrine will present at the 8th Annual UHC Quality and Safety Fall Forum meeting in Arizona and will discuss staying focused and delivering results from the points of view of AMC board members, clinical and operational leaders, regulatorys, and direct patient care providers.
Michael W. Peregrine, Academic Medical Centers, Corporate Responsibility and Governance, Health
Ralph DeJong was quoted in the September 17 issue of BNA's Daily Tax Report in an article regarding the forthcoming guidance on tax code Section 457(f). "There are numerous opportunities under other available methods that are less onerous than 457(f) for executives of tax-exempt organizations to make elective deferrals of compensation that can be vested without running into some of the problems associated with Section 457(f)," Mr. DeJong said.
Ralph E. DeJong, Health, Tax Exemption
Bernadette Broccolo was quoted in the September 8 issue of The National Law Journal regarding McDermott's relationship with the medical device trade group, Advanced Medical Technology Association (AdvaMed). "The seminars are technically AdvaMed's, but the relationship gives the firm exposure to the hundreds of device companies, large, medium and small, that are members of AdvaMed," said Ms. Broccolo.
Bernadette M. Broccolo, Health, Life Sciences & Medical Products, Life Sciences - Health
Jerome Tichner was pictured in the September 5-11 issue of the Boston Business Journal regarding his involvement in raising nearly $300,000 in this year's Associates Drive to benefit Greater Boston Legal Services' Family Law Unit.
Michael W. Peregrine was quoted in the August 29 issue of BNA's Health Care Daily Report in an article regarding the U.S. Department of Justice's revisions to its corporate charging guidelines, which will have particular relevance for health care organizations being investigated by federal prosecutors. While the new privilege policy is significant, Mr. Peregrine said health care organizations should pay special attention to the discussion in the guidance on the role of effective corporate compliance programs in prosecutors' decisions to prosecute health care-related cases. Mr. Peregrine also said that changes announced by DOJ are "excellent reminders that the attorney-client privilege, when properly applied, remains a valuable concept."
Michael W. Peregrine, Corporate Responsibility and Governance, Health, Health Care Litigation, Trial
Michael Peregrine was quoted in the August 25 issue of Modern Healthcare in an article regarding the final revisions to the IRS' Form 990 for not-for-profit hospitals and other tax-exempt organizations. "Boards face more explicit questions on conflicts-of-interest, director and trustee independence, and board review of public reporting," said Mr. Peregrine.
Michael W. Peregrine, Health, Tax Exemption
Robert Nicholas was mentioned in the August 22 issue of FDA'sWebview in an article regarding his recent On the Subject discussing the FDA's Camptosar® decision.
, Health, Life Sciences - Health
Kate Feola was quoted in the August 21 issue of Rx Compliance Report in an article discussing the new disclosure law enacted in Massachusetts that requires drug and device companies to report any gifts to doctors of more than $50. "Vermont is the only state that has taken steps to enforce its marketing disclosure statute, to date," Ms. Feola said.
, Health, Life Sciences - Health
Michael Peregrine was quoted in the August 20 issue of Tax Analysts in article discussing the final instructions for the redesigned Form 990. "It will require tax-exempt organizations to confront potentially sensitive issues relating to board structure, conflicts management, and disclosure of compensation, as well as business and financial relationships between board members," Mr. Peregrine said.
Michael W. Peregrine, Corporate Responsibility and Governance, Health, Tax Exemption
Michael Peregrine was quoted in the August 20 issue of BNA's Health Care Daily in an article discussing the final instructions for the redesigned Form 990. "The final instructions to the Form 990 are indeed a significant tax planning document because they underscore, in bold type, the significance attributed by the IRS to effective governance of tax exempt organization," Mr. Peregrine said.
Michael W. Peregrine, Corporate Responsibility and Governance, Health, Tax Exemption
Michael Peregrine was quoted in the August 19 issue of The Chronicle of Philanthropy in an article discussing the final instructions for the redesigned Form 990. "These instructions are an exclamation point to the broad IRS discourse on the importance of corporate governance that has been Steve Miller's mantra for the last 24 months," Mr. Peregrine said.
Michael W. Peregrine, Corporate Responsibility and Governance, Health, Tax Exemption
Michael Peregrine was quoted in the August 6 issue of Tax Analysts in an article regarding revisions to the draft instructions to the redesigned Form 990 in response to public comments. "At least from a governance perspective, the IRS took seriously the comments it received on the draft instructions. Exempt organizations might want to review the final instructions closely for their implications on corporate governance, which are likely to be significant," Mr. Peregrine said.
Michael W. Peregrine, Health, Tax Exemption
Michael W. Peregrine was featured in the August 1 issue of Corporate Counsel in an article regarding a nine-step process by which nonprofit board and executive leadership can work together to enhance the profile of a nonprofit General Counsel.
Michael W. Peregrine, Health, Tax Exemption
David Ivill was quoted in the July 31 issue of The National Law Journal in an article regarding the client conflict of interest that made him leave McDermott in 2006 but later returned to the Firm in 2007.
McDermott Will & Emery was mentioned in the July 2008 issue of DTC Insights – DTC Forecast in an article summarizing McDermott's recent White Paper on Merck settling the Vioxx Litigation with State Attorneys General.
Paul W. Radensky M.D., T. Reed Stephens, Health, Health Care Litigation, Life Sciences - Health
Christopher M. Jedrey was selected for Nightingales Healthcare News' 2008 list of "Outstanding Hospital Lawyers," which appears in the July/August 2008 issue.
Christopher M. Jedrey, Academic Medical Centers, Health, Hospital and Health System Transactions
Sheila D. Walcoff was mentioned in the July 18 issue of the Sarasota Herald-Tribune regarding her recent move as partner in the Health Law Department of McDermott's Washington, D.C. office.
, Health
"Comparative analysis of structural model in health care reform"
Hessisches Ärzteblatt, July 2008
Stephan Rau is quoted regarding a comparative analysis of structural model in health care reform 2004 and 2005.
Daniel H. Melvin was quoted in the July 7 issue of Modern Healthcare in an article regarding CMS' newly proposed rules for gain-sharing and other pay-for-performance initiatives that could be a significant step toward loosening financial-arrangement restrictions that many believe prevent doctors and hospitals from aligning on quality-improvement and cost-savings efforts. "The OIG has never wavered from its opinion that gain-sharing violates the law, but in cases where hospitals have sought its opinion (about implementing gain-sharing) the OIG has said it wouldn't prosecute. But, I do think that hospitals will seek to develop programs now that a government agency is looking favorably on gain-sharing,'' Mr. Melvin said.
Daniel H. Melvin, Health, Reimbursement/Fraud & Abuse
Michael W. Peregrine was quoted in the July 1 issue of The Wall Street Journal in an article regarding the dismissal of appeals against ex-New York Stock Exchange Chairman Richard Grasso to return a portion of his $187.5 million compensation package. "It's an incomplete decision from a nonprofit perspective. We're not going to have real closure on the merits. Having closure on merits would have provided some guidance to volunteer directors," Mr. Peregrine said.
Michael W. Peregrine, Health, Tax Exemption
John M. Callahan was mentioned in a press release published by Business Wire regarding McDermott's legal counsel to EyeCyte, Inc. in the company's Series A funding through an agreement with Pfizer. Under the terms of the deal, Pfizer has invested $3 million in Series A Preferred shares of EyeCyte, a company that believes to have developed a way to isolate and use stem cells to cure macular degeneration, retinopathy and other leading causes of blindness in the world. Mr. Callahan provided legal services to EyeCyte supporting this arrangement.
John M. Callahan, Health, Life Sciences & Medical Products Litigation, Life Sciences - Health
Ankur Goel was mentioned in the June 26 issue of Legal Bisnow in an article regarding his recent election to the D.C. Bar Board of Governors.
John M. Callahan was mentioned in the June 23 issue of PR-inside.com regarding McDermott’s legal counsel to EyeCyte, Inc. in the company’s Series A funding through an agreement with Pfizer. Under the terms of the deal, Pfizer has invested $3 million in Series A Preferred shares of EyeCyte, a company that believes to have developed a way to isolate and use stem cells to cure macular degeneration, retinopathy and other leading causes of blindness in the world. Mr. Callahan provided legal services to EyeCyte supporting this arrangement.
John M. Callahan, Health, Life Sciences & Medical Products, Life Sciences - Health
John M. Callahan was mentioned in the June 23 issue of Forbes.com regarding McDermott’s legal counsel to EyeCyte, Inc. in the company’s Series A funding through an agreement with Pfizer. Under the terms of the deal, Pfizer has invested $3 million in Series A Preferred shares of EyeCyte, a company that believes to have developed a way to isolate and use stem cells to cure macular degeneration, retinopathy and other leading causes of blindness in the world. Mr. Callahan provided legal services to EyeCyte supporting this arrangement.
John M. Callahan, Health, Life Sciences & Medical Products, Life Sciences - Health
Robert B. Nicholas was mentioned in the June 16 issue of the National Law Journal in an article regarding a new U.S. Food and Drug Administration final rule governing clinical trials held in foreign countries that will spark painstaking legal review of pharmaceutical companies' protocols for trials. "Adhering to the FDA's good clinical practices directives for studies done abroad means more work for clients and their attorneys. We'll be working with companies trying to structure clinical studies that they'll be conducting outside the U.S.," Mr. Nicholas said.
, Health, Life Sciences - Health
Sheila Walcoff was mentioned in The Washington Post and Congressional Quarterly Daily regarding her recent move to McDermott’s Health Law department and life sciences government strategies practice group in Washington, D.C.
Link to: Sheila Walcoff, Health, Life Sciences – Health, Government Strategies
Government Strategies, Health, Life Sciences - Health
Jennifer Geetter, Robert Nicholas and Paul Radensky had their On the Subject published in the May 30 edition of Health Law 360 regarding the FDA Draft Guidance on certification of compliance with the new FDAAA clinical trial registration and posting regime.
Jennifer S. Geetter, Paul W. Radensky M.D., Health, Life Sciences - Health
Robert Nicholas, Paul Radensky and T. Reed Stephens were mentioned in a May 29 article in FDA Webview regarding the recent White Paper they had authored regarding Merck’s $58 million settlement of consumer fraud claims by state attorneys general.
Paul W. Radensky M.D., T. Reed Stephens, Health, Life Sciences - Health
Sheila Walcoff was mentioned in the May 29 Legal Times blog regarding her recent move to McDermott’s Health Law department in Washington, D.C.
Jennifer Geetter was quoted in the May 21 issue of Health Law360 in an article regarding the Genetic Information Nondiscrimination Act, which seeks to prevent unauthorized or required genetic testing of workers by employers and insurers. "A majority of insurers will not be affected by the act because they already do not use risk rating procedures based on genetic testing or family history," Ms. Geetter said.
Jennifer S. Geetter, Health, Life Sciences - Health
Terese A. Mosher Beluris was quoted in the May issue of Healthcare Risk Management in an article entitled, "13 Hospital Workers Fired for Snooping in Britney Spears' Medical Records." The article discusses concerns associated with privacy breaches within the healthcare system. "The same mandates that require hospitals to store patients' files electronically in order to facilitate patient care also enable any person entitled to access a file to post it on MySpace in an instant," Ms. Beluris said. "Would Pentagon-level technology limit the risk? Perhaps," she added. "However, no hospital I know has a Pentagon-sized budget."
Terese A. Mosher Beluris, Health, HIPAA, HIPAA Privacy Solutions
Karen Sealander was mentioned in the The Hearing Review's, "The Insider", in an article regarding the McDermott-engineered victory at the Office of Personnel Management and the Lobby Day in Washington that McDermott orchestrated for the International Hearing Society's Board of Governors. "Advocacy is all about education and relationship-building and the Society's governors did just that. The IHS Board educated its elected representatives in Congress about the importance of hearing health to overall health and general well-being, the vital role of the hearing aid specialist, and the effectiveness but dramatic underutilization of hearing aids," Ms. Sealander said.
Michael Peregrine was quoted in the May 1 issue of BNA's Health Law Reporter in an article regarding the IRS not backing off of its plan to put more pressure on charities to develop better governance plans. "The comments of the current and former IRS officials underscore the significant level of governance oversight activity at the federal level, provide guidance on specific areas of legislative and regulatory concern with respect to governance, and give counsel meaningful 'ammunition' as they seek to advise their client executives and boards concerning the reasons for, and extent of, IRS and Senate Finance Committee Interest," Mr. Peregrine said.
Michael W. Peregrine, Health, Tax Exemption
Robert Nicholas was quoted in the April 2008 issue of Medical Marketing and Media regarding scientific 'free speech' being threatened. "Calls for an investigation into support for the American Heart Association (AHA) and American College of Cardiology stating are likely to convince other scientific groups not to speak out on issues of public concern," Mr. Nicholas said.
, Health, Life Sciences & Medical Products, Life Sciences - Health
Ankur J. Goel was mentioned in the April 21 issue of Modern Healthcare regarding the OIG's new self-disclosure protocol. "It's a signal that OIG is going to work to make these more acceptable to providers, or a better experience for providers," said Mr. Goel.
Robert B. Nicholas was quoted on April 14 by the National Law Journal in an article regarding the U.S. Food and Drug Administration's plan to post employees in the People's Republic of China. The FDA announced plans to post eight full-time, permanent FDA employees in China within the next 18 months, plus five local Chinese nationals to work with FDA staff. "A shift in China's regulatory regime for drugs, medical devices and foods isn't going to happen overnight, but its creation and development will create opportunities for lawyers working with U.S. and Chinese manufactures in China for many years to come," said Mr. Nicholas. "It takes knowledge, experience and training to get people to understand the consequences of how they prepare documents for contracts and for submission to various regulatory agencies," Mr. Nicholas added.
, Food and Drug Administration - Alcohol Regulatory & Distribution, Health
Ralph E. DeJong was quoted in the April 14 issue of Modern Healthcare regarding the new IRS Form 990. "Draft instructions released last week could significantly expand the number of key hospital and health system employees whose pay, bonuses and benefits must be reported," said Mr. DeJong.
Ralph E. DeJong, Health, Tax Exemption
Ralph DeJong was quoted in the April 14 issue of Modern Healthcare Online in an article regarding instructions for not-for-profit hospitals and health systems using the new Form 990. "Draft instructions released last week could significantly expand the number of key hospital and health system employees whose pay, bonuses and benefits must be reported," Mr. DeJong said.
Ralph E. DeJong, Health, Tax Exemption
Robert Nicholas was mentioned in the April 2008 issue of Medical Marketing & Media (MMM) Online in an article regarding calls for investigation into support for the American Heart Association (AHA) and American College of Cardiology. "No one can question the status of the AHA and American College of Cardiology as scientific speakers in the debate about some of the most important public health issues of our time, even if they receive some financial support from commercial interests," Mr. Nicholas said.
, Health
David Marx was quoted in the March issue of HealthLeaders in an article regarding the health industry's hospital consolidation wave. Mr. Marx discussed the effects of the FTC's investigation of a 2000 Evanston Northwestern Healthcare (ENH) merger that created a three-hospital system along Chicago's North Shore. Because the ENH case was so unusual in that the FTC waited so long after the merger to investigate, Mr. Marx noted that, "It is not discouraging anybody from doing what they think they need to do to be competitive in the marketplace, and that includes consolidations and collaborative ventures where appropriate." Mr. Marx warned, however, to keep the consumer in mind and remember that the FTC can challenge a merger after the fact, "…think about it from the perspective of the consumer because that's the way the agencies are going to look at the transaction and evaluate it," he said.
David Marx Jr., Health, Health - Antitrust, Hospital and Health System Transactions
Michael Peregrine was quoted in the March 28 issue of TaxAnalysts in an article regarding the new final regulations under section 4958 that were released by the IRS making clear that tax-exempt organizations that become involved in excess benefit transactions with disqualified persons will be in better shape if they discover the problem and take corrective action before the IRS gets involved. "The final regulations are significant from a corporate governance perspective. The regulations show that an organization's board must be aware of the circumstances under which excess benefit transactions can put exemption at risk," Mr. Peregrine said.
Michael W. Peregrine, Corporate Responsibility and Governance, Health, Tax Exemption
Ralph DeJong was quoted in the March 21 issue of BNA's Health Law Reporter in an article regarding the IRS intending to issue instructions for the new Form 990. "Entities need to prepare now for the new form. The new form begins operationally on the first day of the fiscal year beginning in 2008 and calendar year filers should have started to collect data and expand data," Mr. DeJong said.
Ralph E. DeJong, Health, Tax Exemption
Ralph DeJong was quoted in the March 21 issue of TaxAnalysts in an article regarding Part IV instructions for the hospital schedule of the redesigned Form 990. "This would be an explanation that many hospitals have until now included in their program services accomplishments section attached to their 990, and now that information has to be an express, explicit portion of the Schedule H filing," Mr. DeJong said.
Ralph E. DeJong, Health, Tax Exemption
Michael Peregrine was quoted in the March 6 issue of BNA's Health Law Reporter in an article regarding the IRS' releasing of an updated memorandum detailing those organizational structures and operational policies that it believes will improve governance of tax-exempt organizations. "The memorandum sheds important new light on the IRS' view of such important issues as governing board size, diligence and composition; oversight of sophisticated investment vehicles; and document retention and whistleblower policies," Mr. Peregrine said.
Michael W. Peregrine, Corporate Responsibility and Governance, Health, Tax Exemption
Ankur J. Goel was quoted in the February 29 issue of The Boston Globe in an article regarding the group of Massachusetts hospitals that will collect up to $200 million from the federal government over improperly calculated Medicare reimbursement rates. "The hospitals are gratified by the court's ruling that all wage data should be used when HHS calculates the wage index," Mr. Goel said. This case was also reported by BNA's Health Care Daily and The Daily News of Newburyport.
Joan Polacheck was quoted in the February 2008 issue of ABI/INFORM in an article regarding Stark law. "The law specifically prohibits physicians with a financial relationship with a hospital from making a referral to that hospital for the treatment of Medicare patients unless there is a specific exception. The problem is there is a lot of gray and disagreement about how the law is interpreted," Ms. Polacheck said.
Chip Kerby was quoted in the February 2008 issue of CFO Magazine about how now, progressive employers are thinking more broadly about how they manage health care, and searching for savings at the individual level. There is also a fiduciary risk associated with HRAs that should not be overlooked, said Mr. Kerby, especially since such accounts are not covered by ERISA.
, Employee Benefits, Employee Benefits Litigation, Health
Robert Nicholas was quoted in the February 22 issue of FDA Webview in an article regarding the statements issued by the American Heart Association and the American College of Cardiology regarding the results of the Vytorin ENHANCE study. "Given the core First Amendment value of scientific speech by AHA and ACC about the ENHANCE study results, and their unquestionably sensible— benign —recommendation that patients speak with their doctors before precipitously stopping Vytorin, the fact that they have become objects of congressional investigations and have even been asked to name names about the preparation of their respective statements, suggests that there is a chill wind on free speech blowing from Capitol Hill," Mr. Nicholas said.
, Health
T. Reed Stephens was quoted in the February 22 issue of Rx Compliance Report in an article regarding the FDA draft guidance that was issued regarding industry dissemination of medical or scientific journal articles. "Plaintiffs must push the envelope with state law consumer protection theories as an end-run around FDA's guidance," Mr. Stephens said.
T. Reed Stephens, Health, Life Sciences - Health
Reed Stephens was mentioned in the February 22 issue of RxCompliance Report in an article regarding the FDA draft guidance on industry dissemination of medical or scientific journal articles and how the guidance will impact the current enforcement frenzy surrounding off-label promotion. "Plaintiffs will push the envelope with state law consumer protection theories as an end-run around FDA's guidance," Mr. Stephens said.
Stephen W. Bernstein and Jennifer S. Geetter were quoted in the February 1 issue of Mass High Tech in an article regarding the state of Massachusetts funding stem cell research. "States see it as a hot new thing, and that's debatable. But in Massachusetts we have all the raw expertise and can use legislation to springboard what's already here," Mr. Bernstein said. "State programs can clarify legal aspects. It's an opportunity for states to clear up any state regulations which may impede stem cell research. State privacy laws are a patchwork, and you can get tangled in ways the legislation didn't intend," Ms. Geetter said.
Stephen W. Bernstein, Jennifer S. Geetter, Health, Life Sciences & Medical Products, Life Sciences - Health
Stephen W. Bernstein was quoted in the February 2008 issue of Briefings on HIPAA in an article regarding healthcare organizations facing the prospect of preemptive, third-party compliance evaluations because PricewaterhouseCoopers has contracted with CMS to conduct security audits of covered entities. "Because the scrutiny rule's implementation specifications are generally more technical and more apparently to employees than the privacy requirements, expect more feedback about security policies and procedures from staff members than from patients," Mr. Bernstein said.
Stephen W. Bernstein, Health, HIPAA
Russell Hayman has been selected as one of Nightingale's Healthcare News' "Outstanding Healthcare Litigators" for 2007. Mr. Hayman was recognized as having successfully defended a client in a qui tam case regarding allegation of plagiarism with respect to endocrinology data submitted to National Institutes of Health (NIH) in support of an NIH grant application. He was also recognized for having successfully defended a client against claim that genetic research data had been falsified. Mr. Hayman is one of the 12 healthcare litigators throughout the United States to make the list.
Christopher M. Jedrey was quoted in a January 25 article of Biotech Law Weekly in an article regarding the Dublin – Research and Markets video seminar with Mr. Jedrey focusing on the "Research and Markets: Understand the Strategy and Structure of Healthcare Transactions." The goal of the video seminar was to provide lawyers and executives with essential information about understanding the strategy and structure of healthcare transactions.
Christopher M. Jedrey, Health, Hospital and Health System Transactions
Eric Zimmerman was quoted in the January 18 issue of BNA’s Medicare Report in an article regarding the top Medicare issues to watch in 2008, specifically competitive billing. "Barring a stay on implementation or other substantial change to the program requirements or roll-out, competitive bidding will have a serious and negative impact on small DME suppliers," Mr. Zimmerman said.
Robert Nicholas was quoted in the January 14 issue of Product Liability Law 360 in an article regarding the growing "cosmeceuticals" industry. "When you work with clients who have products they want to bring to the market, frequently the question they ask is, 'What’s the fastest way to get it to the market?' There is a trade-off between speed to market and exclusivity or safety. In the absence of a safety issue, the FDA doesn't tend to aggressively regulate cosmetics. That's one reason why it's an attractive area for manufacturers, even if you have legitimate claims of 'pharmaceutical' results," Mr. Nicholas said.
, Health, Health - Product Regulation
Ralph DeJong was quoted in the January 7 issue of Modern Healthcare in an article regarding the overhauled Form 990 and its governance policies and executive pay and perks, including executive compensation breakdown. "This will end up being a far more reliable picture of compensation and all of its constituent elements," commented Mr. DeJong. Organizations that had hoped to avoid disclosing unusual perks for key officers are out of luck, added DeJong, who said tax officials responded to criticism of its draft with “smart and savvy” changes.
Ralph E. DeJong, Health, Tax Exemption
Michael Peregrine was quoted in the January 3, 2008 issue of BNA's Health Law Reporter in an article regarding top health law issues for 2008, including taxation affecting exempt health care organizations and governance issues. "The role of the federal government in the oversight of nonprofit health care facilities will continue to evolve with the ongoing interest of the Senate Finance Committee and the continued re-consideration of the community benefit standard – and its' community board component – for determining tax exemption eligibility," Mr. Peregrine said. He also commented that the IRS's new Form 990 places corporate governance of tax-exempt organizations front and center.
Christopher M. Jedrey was quoted in the January 2008 issue of ABI/INFORM in an article regarding community hospitals being clinically integrated. "A handful of recent FTC decisions offer more guidance for providers considering clinical integration. Providers need to demonstrate evidence of substantial commitment of staff and resources, shared electronic medical records, and incentives, such as enough shared financial risk. They also need to impose substantial penalties against outlier physicians who fail to embrace standardized best practices or improve the care they deliver. Providers need to convince the government that behavior will change," Mr. Jedrey said.
Bernadette Broccolo was quoted in the January 2008 issue of Briefings on HIPAA in an article regarding difficulties in trying to keep patient information private while conducting medical research. "The needs of the researchers will never be seen by regulators as greater than the privacy needs of the patients. However, obtaining patient authorization can be difficult and often impossible, especially when researchers need to access historical data from a large number of individuals and those individuals do not need a study for their own clinical care," said Ms. Broccolo.
Bernadette M. Broccolo, Health
H. Guy Collier was quoted in the January 2008 national edition of Metropolitan Corporate Counsel in an article regarding the D.C. Bar Association scheduling a four-part Introduction to Health Law Series of CLE Seminars. On January 24, Mr. Collier will provide an introduction to the U.S. health care system.
2007
Eric Gordon was quoted in the December 2007 issue of ABI/INFORM in an article regarding The Health & Human Services Office of Inspector General issuing an approval for unnamed hospital's plan to pay doctors for on-call service. The OIG is further investigating whether there is a need for payments and whether the payment arrangements reflect a fair market. "Generally, fair market value is defined as the value between two parties in an arm's length transactions, without taking into account the volume of business otherwise generated between them," Mr. Gordon said.
Paul W. Radensky was quoted in the December 2007 issue of Biotechnology Healthcare in an article regarding IVDMIA guidance. "Assays are not defined in the Food, Drug and Cosmetic Act or any other regulation. In effect, the guidance is being promulgated as if it were a rule, even though guidances are not supposed to be binding. The Health and Human Services secretary has reportedly stated that the FDA would not enforce the IVDMIA guidance before any policy," Mr. Radensky said.
Michael Peregrine was featured in the December 28, 2007 issue of Tax Analysts in an article where he discusses the Panel on the Nonprofit Sector's recently released Principles of Good Governance and Ethical Practice.
Michael Peregrine was quoted in a December 24, 2007 article in Crain’s Chicago Business in an article regarding the undisclosed compensation of Kaarina Koskenalusta, the head of the prosperous non-profit, Executive's Club of Chicago. "The IRS requires disclosure to be sure tax-exempt status doesn't result in excess pay. In this environment, boards have to be super-sensitive. You have to avoid the inference you're hiding excessive compensation," Mr. Peregrine said.
Michael Peregrine was quoted in the December 21, 2007 issue of the Wall Street Journal in an article regarding the IRS rolling back some of the elements hospital groups found in the new Form 990. Much of the new hospital-specific form won't apply until hospitals file for 2009. "The new forms are generally an improvement over this summer’s proposal. But the new regime will still be considerably tougher than what hospitals and other nonprofits currently file, particularly when it comes to disclosing governance procedures and potential conflicts of interest," Mr. Peregrine said.
Ankur Goel was quoted in the December 10, 2007 article in Report on Medicare Compliance in an article regarding the Centers for Medicare and Medicaid Services mandating compliance training for contracted providers of Medicare Advantage and Part D Plans. "This is a very clear trend. CMS is instructing Medicare Advantage organizations to insert themselves into compliance activities of providers at some levels," Mr. Goel said.
Michael Peregrine was quoted in the October 23 issue of BNA’s Health Care Daily in an article regarding The Panel on the Nonprofit Sector Organization issuing a guide on good governance principles for charities. "The recommendations were comprehensive and are likely to evolve into 'de facto' best practices for the nonprofit sector and should be carefully reviewed," he said. "These recommendations introduce into the governance discourse a new level of detail and specificity concerning proper practices and serve as a reminder that the attention and focus on nonprofit governance is likely to remain as a basic legal and compliance issue," Mr. Peregrine added.
Michael Peregrine was quoted in the October 22 issue of Modern Healthcare in an article regarding the Panel on the Nonprofit Sector releasing a report encouraging not-for-profit organizations to post their IRS Form 990s online. "For those hospitals that are voluntarily working to comply with Sarbanes-Oxley in an effort to be more transparent, the principles go way beyond those rules. What this will do is introduce into the governance discourse a new level of detail and specificity concerning proper practices," Mr. Peregrine said.
Eric Gordon was quoted in the October 22 issue of AMNews in an article regarding the Office of Inspector General’s backing a hospital’s plan to pay physicians for providing on-call emergency coverage. "What the OIG is trying to do is signal to the industry that there’s nothing inherently wrong with paying for on-call coverage when the service is actually needed and a hospital can demonstrate in good faith that it is trying to get coverage for its community," Mr. Gordon said.
Michael Peregrine was quoted in the October 18 article in Corporate Counsel in regards to the J. Paul Getty Trust. "The Getty's experience is a wonderful example of two things. When clients say, 'It can't happen to us,' he points to the trust. It's also a great example of how to respond to a problem and fix it," Mr. Peregrine adds.
Daniel Melvin was mentioned in an October 1 article published in International Medical News Group and Clinical Psychiatry News regarding CMS issuing the third phase of the final regulations implementing the physician self-referral rule, also known as the Stark law, but reverting back to the original stance it had in phase one. "This reversion to the initial Stark policy is among the most important changes in the 516-page document. The application of exceptions will be different going forward," Mr. Melvin said.
Ralph DeJong was quoted on September 10 on CFO.com regarding an IRS rule issued in late July that restores the existing tax code, forcing employers to take greater responsibility for developing and overseeing 403(b) plans into line with rules governing 401(k)s, which are offered by non-profits as well as many profit-making companies. Mr. DeJong contends that the need for change was likely induced by, "a vacuum of responsibility." He states that, "Historically, tax-exempt organizations that sponsored or made available 403(b) tax-sheltered annuities took a hands-off approach." Citing that compliance failures are the main reasons the IRS pushed through the new rule, Mr. DeJong states that the most noticeable change to the tax rules is that employers will have to develop a plan document that identifies how the vendor and the employer with work together to administer the 403(b) plan.
Ralph E. DeJong, Employee Benefits, Health
Donald C. Goldman was quoted in the September 2007 issue of the Chicago Lawyer in an article regarding the increasing salaries for first year associates. "Base salary is lockstep, but bonuses are based on productivity, exceptional quality, participation in administrative functions. I think creating two different classes of citizens, so to speak, may not be the right way to go,” Mr. Goldman said.
, Health
Guy Collier was mentioned extensively in the Summer 2007 issue of Richmond Law, the magazine of the University of Richmond School of Law, Mr. Collier’s alma mater The article, "Pro bono 'For the Public Good,'" profiles Mr. Collier’s role as a leading advocate for a project that matches older, senior lawyers with pro bono opportunities.
H. Guy Collier, Health, Pro Bono & Community Service
Michael Peregrine was quoted in the August 13 issue of Modern Healthcare in an article regarding a settlement agreement with the former directors and officers of the now-defunct Granada Hills Community Hospital in California. “Directors are going to feel more comfortable without too much fear of being sued,” Mr. Peregrine said.
Michael Peregrine was quoted in an August 6 article published by Crain’s Chicago Business regarding Chicago-area hospitals boosting spending on free medical care by $187.4 million and being scrutinized for their charitable practices. "Hospitals will need to fight to show the value they provide in exchange for their tax exemptions," Mr. Peregrine said.
Michael W. Peregrine, Health, Tax Exemption
Eric Zimmerman was quoted in the July 20 issue of BNA’s Medicare Report regarding The Centers for Medicare & Medicaid Services releasing a new rule which sets new payment rates for ambulatory surgery centers (ASCs) in 2008. "The ASC final rule is the most significant and substantial change to how and how much Medicare pays ASCs since the inception of the program 25 years ago," Mr. Zimmerman said.
Eric Zimmerman, Ambulatory Surgery Centers (ASC), Health
Michael Peregrine was quoted in the July 20 edition of The Wall Street Journal in an article regarding whether not-for-profit hospitals provide enough care to uninsured patients to warrant the sizable tax breaks they receive for charitable work. "Some people thought when Grassley lost his chairmanship, he’d go away. Not-for-profit hospitals clearly have a legislative fight on their hands," Mr. Peregrine said.
Paul Radensky was quoted in the July 2007 issue of Clinical Lab Products Magazine in an article regarding the new FDA draft guidance regarding in vitro diagnostic multivariate index assays (IVDMIAs). "I think you get universal agreement, including the FDA, that what was put in the September draft guidance was not clear,"Mr. Radensky said.
Paul W. Radensky M.D., Health, Life Sciences - Health
Michael Peregrine was quoted in the June 25 issue of Modern Healthcare in an article regarding the Smithsonian Institution having unchecked transgressions by its former secretary and they will now adopt a new set of practices to restructure its oversight of the institution. “Although the Smithsonian is a trust established by Congress, it is, like most hospitals, a 501©(3) charitable organization. These Smithsonian developments are likely to have a broad spillover effect on the nonprofit sector,” Mr. Peregrine said.
Ralph DeJong was quoted in the June 18 issue of Modern Healthcare in an article regarding the IRS expanding public reporting of what not-for-profit hospitals do for their communities to justify federal tax breaks. “The agency’s ambitious schedule leaves not-for-profits little time to review and change operations or governance policies, if necessary, before the start of fiscal 2008. For hospitals and health systems, the changes are likely to be substantital,” Mr. DeJong said.
Ralph E. DeJong, Health, Tax Exemption
John Callahan was quoted in the June 14 issue of Muskogee Phoenix in an article regarding the Muskogee Medical Center Authority asking the state attorney general for his opinion before giving millions to the city of Muskogee. Capella Healthcare is paying $120 million to lease Muskogee Regional Medical Center for the next 40 years. “It sounds like you don’t have a decision where the money is going to go. The attorney general may be very concerned with that. You should probably have that decided before you contact him,” Mr. Callahan said.
John M. Callahan, Health, Health - M&A, Life Sciences - Health
Robert Nicholas was quoted in a June 7 article published by The GMP Letter regarding the Form 483s and warning letters. "Firms should not be afraid to disagree with the FDA regarding inspectional observations cited in Form 483s and warning letters. The 483 or the warning letters are really FDA's observations. In fact, sometimes they're wrong," Mr. Nicholas said.
, Health
Bernadette M. Broccolo was quoted in the June 4 issue of Modern Healthcare in the cover story regarding how the IRS’ updated reporting rules for tax-exempt organizations could require full disclosure on community benefits and charity care. Revisions to Form 990 that boost data collection and public access could head off congressional action. “The legislative process would most likely take a lot more time for the kind of reforms (Baucus and Grassley are) looking for,” Ms. Broccolo said.
Bernadette M. Broccolo, Health, Tax Exemption
Ralph DeJong and Michael Peregrine were quoted in the June 4 issue of The National Law Journal in an article they co-wrote in regards to the recent decision in the controversial Spitzer v. Grasso litigation dealing with Grasso's excessive compensation payments. "This decision thus suggests, in a significant and dramatic way, the likely of different strategic options for both the "enforcer" of nonprofit corporation laws and for the subjects of that enforcement," Mr. DeJong and Mr. Peregrine wrote.
Ralph E. DeJong, Michael W. Peregrine, Executive Compensation, Health
Guy Collier was quoted in the June issue of Washington Lawyer in an article regarding the D.C. Bar Pro Bono Program and the work that McDermott has done for the District of Columbia Primary Care Association (DCPCA). McDermott attorneys were noted as “consistently being extremely responsive and great to work with… basically the hit of the board series.” “We tried to cover most of the regulatory issues that would be of interest to their board members, such as corporate compliance, health care fraud and abuse, federal tax exemption requirements,” Mr. Collier said.
Gordon Greenberg, Russell Hayman and Jonathan Lurie have been recognized as top lawyers in their industry by Super Lawyers in June 2007 as "Southern California Super Lawyers for the Family and Consumer." Mr. Greenberg and Mr. Hayman were recognized in the area of "When Disaster Strikes" and Mr. Lurie was recognized in the area of "Planning Your Future."
Gordon A. Greenberg, Russell Hayman, Jonathan C. Lurie, Health, Private Client, Trial
Michael Peregrine was quoted in the May 31 issue of BNA’s Health Law Reporter in an article regarding Democratic representative of California, Henry A. Waxman, asking compensation consulting firms to describe how consulting services provided to the top 250 U.S. companies could affect both for-profit and non-profit health care organizations. “The activities of Waxman and his Committee on Oversight and Government Reform,” as they relate to the independence of compensation consultants, “have a definite spillover impact on both for-profit and nonprofit health care sectors,” Mr. Peregrine said. “The no doubt well-intentioned efforts of Rep. Waxman and his committee may, however, have the unfortunate effect of focusing on just one of the many indicia of best practices, to the possible exclusion of the others,” Mr. Peregrine also noted.
Michael W. Peregrine, Health, Health - M&A
Michael Peregrine was quoted in The Wall Street Journal on May 9 regarding Dick Grasso, the former head of the New York Stock Exchange, winning a significant legal victory in his fight to keep his $187.5 million pay package. "Yesterday's appellate ruling amounts to a real threat to the broad enforcement powers of attorneys general. It may hamstring much of their oversight activity in the nonprofit sector," said Mr. Peregrine.
Anne Hance was quoted in the May 2007 issue of the Part D Insider in an article regarding the Medicare 2008 plan year. "In response to the many comments addressing vaccine administration reimbursement, CMS is taking time to finalize its operational guidance," said Ms. Hance.
Jerry Sokol and Joshua Kaye was quoted in the May 1 issue of Diagnostic Imaging in the article "Scan Time Leases: Referring Clinicians Mine for Gold in Radiology's Backyard." Imaging equipment leasing to referring physicians reveals wildly differing attitudes toward self-referral. Many physicians have become less guarded about their behavior as in-office imaging self-referral has proliferated. Mr. Sokol said, "Many imaging service operators have gained confidence in the legality of block leasing. It accounts for a majority of referring physician leasing contracts."
Jerry J. Sokol, Health, Health Ventures/Physician Transactions
Stephen Bernstein was quoted in the April 30 issue of The National Law Journal on law firms' involvement in the BIO conference in Boston. Mr. Bernstein mentioned the Firm's involvement in the conference as chairs of panel discussions, "We have gone for the substance of what the conference is about," and he also mentioned the Firm's evening reception.
Stephen W. Bernstein, Health, Life Sciences & Medical Products
McDermott Will & Emery was mentioned in the April 26 issue of the Pittsburgh Post-Gazette as the firm that is advising the University of Pittsburgh Medical Center on the development of "best-in-class" policies and processes for monitoring and managing individual and institutional conflicts of interest. Bernadette Broccolo is leading the client team on this matter.
Bernadette M. Broccolo, Health, Health - General Counsel
Michael Peregrine was quoted in the April 19 issue of BNA’s Health Law Reporter in the article "Judge Rules Two Nonprofit Hospitals May Leave Cincinnati Health Alliance." The article addressed two nonprofit hospitals that may withdraw from the Health Alliance of Greater Cincinnati, since the joint operating agreement binding them to the region's largest health care network allows their governing boards "to exercise ultimate authority for fulfilling their respective charitable missions." "This is a significant decision, which could lead to enhanced instability in nonprofit health systems formed through change of membership, affiliation, JOAs and other means," Mr. Peregrine said.
Michael W. Peregrine, Health, Tax Exemption
Michael Peregrine was quoted in the April 19 issue of BNA’s Health Law Reporter in the article "IRS Interim Report Should Address Community Benefit, Treasury IF Says." The article addressed the issue that the IRS should include in an upcoming report on tax-exempt hospitals an assessment of how those hospitals are complying with the community benefit standard for hospital tax exemption. "The report reflects the perspective of the General Accountability Office, and past statements by the IRS Commissioner, that it is often difficult to differentiate between for-profit and nonprofit providers in terms of community benefit and charity care provided," Mr. Peregrine said.
Michael W. Peregrine, Health, Tax Exemption
Michael Peregrine was quoted in the April 18 issue of BNA’s Health Care Daily in an article regarding two nonprofit hospitals in Ohio that can withdraw from the Health Alliance of Greater Cincinnati. "This is a significant decision, which could lead to enhanced instability in nonprofit health systems formed through change of membership, affiliation, and other means. This may especially be the case where controversy or disagreement has already arisen amongst system partners. The judge’s decision to allow the withdrawal of Christ and St. Luke's Hospital from The Health Alliance could thus contribute to any existing instability of already fragile affiliation," Mr. Peregrine said.
Michael W. Peregrine, Health, Health - M&A
Stephen Bernstein was mentioned in the April 13 edition of Government Health IT on American Health Information Community's apparent considering of applying HIPAA to Regional Health Information Organizations and questioning the appropriateness of such an extension. "It might be difficult to determine which portions of the HIPAA rules apply, given the variations among exchange organizations," Mr. Bernstein said.
Stephen W. Bernstein, Government Strategies, Health, HIPAA
Bernadette Broccolo was quoted in BNA’S Health Law Reporter in an article regarding an IRS directive that was issued stating that exempt hospitals might enter into certain arrangements with physicians to help facilitate their adoption of electronic health record technologies without violating federal tax laws. “While CMS’s regulations permitted hospitals to subsidize up to 85 percent of these HER system costs, it had been an open question as to whether IRS would embrace the same percentage given its exempt hospital and private inurement oversight perspective. That questions has now been answered,” Ms. Broccolo said.
Bernadette M. Broccolo, Health, Life Sciences & Medical Products Litigation, Life Sciences - Health, Tax Exemption
Anne Hance and Joel Michaels were quoted in the April 6 edition of BNA's Medicare Report in an article discussing the Centers for Medicare & Medicaid Services Draft 2008 Call Letter. "CMS has more than a year of Part D operational experience and is now looking for ways to direct the role the program can play on the larger Medicare front," Ms. Hance said. "From a larger perspective, it will be interesting to see whether and how some monitoring requirements will affect compliance issues," Mr. Michaels said.
Anne W. Hance, Joel L. Michaels, Health, Managed Care
Anne Hance was quoted in the March 27 issue of BNA's Health Care Daily Report in an article regarding Medicare Part D drug beneficiaries being financially responsible for prescription drugs given to them by emergency room doctors, even if those same products would have been covered had they received them from a retail pharmacy. "Doctors also face concerns about how they can help their patients navigate Part D issues. Physicians can identify issues their patients should consider when making a plan decision, including the pharmacy network and monthly premiums," Ms. Hance said.
Anne W. Hance, Health, Managed Care
Paul Radensky was quoted in the March 9 issue of the Silicon Valley/San Jose Business Journal in an article regarding the draft regulations from the FDA on genetic testing laboratories. "This is a major, substantive change in the rules and it should go through regular rule-making procedures. There are a number of provisions, when you have rule-making, in which the FDA has to explain the impact on small businesses. These are important protections that you don’t have from a draft guidance," Mr. Radensky said.
Ankur Goel was quoted in the February 26 issue of Report on Medicare Compliance in an article regarding quality, payment, compliance and enforcement issues. Goel specifically discussed the increasing intensity of Medicare documentation reviews. "Auditors are really digging in deeper and deeper. They are really delving into documentation requirements and questioning medical necessity," Mr. Goel said.
Ankur J. Goel, Health, Managed Care
David Marx was quoted in the February 17 issue of Modern Healthcare in regard to the Federal Trade Commission's request for additional information on Psychiatric Solutions' proposed acquisition of Horizon Health Corp. "It's indicative of an issue, but not necessarily indicative of a problem," commented Mr. Marx.
David Marx Jr., Antitrust & Competition, Health, Health - Antitrust
Paul Radensky was quoted in the February 14 issue of Pharmacogenomics Reporter in an article regarding the U.S. Food and Drug Administration's proposition to regulate a subset or complex laboratory-developed genetic tests. "The draft guidance raises ‘concerns over FDA's legal authority to regulate clinical laboratories,' is unclear over the definition of in vitro diagnostic multivariate index assays, and does not clearly identify the elements of an IVDMIA that comprise a medical device subject to FDA regulation versus those regulated under CLIA," Mr. Radensky said.
Michael Peregrine was quoted in the February 12 issue of Modern Healthcare Online in an article discussing the new guidelines that were distributed by the IRS for governing boards of tax-exempt organizations. "Not-for-profit hospitals should not be lulled into thinking the guidelines are insignificant just because the suggested practices are not breaking any new ground," Mr. Peregrine said.
Michael W. Peregrine, Health, Tax Exemption
Paul Radensky was quoted in the February 12 issue of Medical Device Week in an article regarding published guidance for in vitro diagnostic multivariate index assays (IVDMIAs or MIAs). "Guidance has raised a large number of issues, including FDA's authority to regulate these assays. Other issues include how the quality system regulations (QSRs) mesh with the Clinical Laboratory Improvement Amendments (CLIA) standards, which are overseen by the CMS," Mr. Radensky said.
Paul Radensky was quoted in the February 12 issue of The Gray Sheet in an article regarding laboratory stakeholders urging the FDA to ditch in vitro diagnostic multivariate index assays. "It's not all clear what an IVDMIA is. It begs the question to simply says, 'It's different,'" said Mr. Radensky.
Michael Peregrine was quoted in the February 6 issue of TaxAnalysts in an article discussing a list that was prepared by the IRS of preliminary guidelines designed to help charity boards improve their oversight of charities. "Charity boards should take a good look at the guidelines. I wouldn't just blow these off as insignificant or as breaking no new ground. The guidelines make a couple of important points," Mr. Peregrine said.
Michael W. Peregrine, Health, Tax, Tax Exemption
Michael Peregrine was quoted in the February issue of Corporate Counsel about the recent decision of the American Red Cross to reform their structure due to various congressional attacks throughout the years. "The politics probably played a big role in the Red Cross's reforms, too. They were reacting to the spotlight," Mr. Peregrine said.
Michael W. Peregrine, Health, Tax Exemption
Eric Zimmerman was quoted in a February 1 article in EndoNurse in regards to reimbursement for gastrointestinal (GI) procedures. "The march to the new payment system is definitely topic number one," Mr. Zimmerman said.
Eric Zimmerman, Health, Managed Care
McDermott client Murphy Oil Corporation was profiled in The Washington Post on January 31 for its contribution to the El Dorado Promise foundation, a scholarship program for El Dorado, Arkansas public school students. The foundation was established with the assistance of Robert Louthian and Robin Greenhouse. Murphy Oil contacted Ms. Greenhouse for assistance, and Mr. Louthian was instrumental in establishing the foundation and is currently in the process of obtaining a tax-exemption for the foundation.
Robin L. Greenhouse, Robert C. Louthian III, Health, Tax Exemption
Ira Rappeport was quoted in the January 29 issue of Flashwire Weekly in an article regarding health care M&A. "There are two trends, one is financial and one is related to health care. Hospital chains have to get bigger to deal with insurers and get better economies of scale. Also, hospitals have to deal with a new competitor in deals – private equity," Mr. Rappeport said.
Ira J. Rappeport, Health, Health - M&A, Mergers & Acquisitions
Eric Zimmerman was quoted in the January 24 issue of BNA's Health Care Daily in regards to President Bush's proposal for potential new use of safety net payment. "It is hard to judge the impact of the proposal, because details of how it would work are sketchy. But a plan to replace DASH funds for hospitals with payments for providers from health insurance coverage could work," Mr. Zimmerman said.
T. Reed Stephens was quoted in the January 16 issue of Rx Compliance Report. In regards to reviews of state False Claims Act statues, Mr. Stephens said, "State Attorney General offices are poised to continue their track record of successful enforcement against the industry. California and Texas will likely be in the forefront despite the negative view of their False Claims Act statutes rendered by the OIG." The article also highlighted Mr. Stephens' recent move to McDermott.
Stephan Rau was mentioned in the 8 January issue of The Lawyer starting as a new partner in the Munich Healthcare Department.
Eric Zimmerman was quoted in the January 8 issue of BNA's Health Care Daily in regards to health care being a prominent figure in the work of the Democratically controlled 110th Congress. "I expect 2007 to be a big year for Medicare legislation. There is incredible built-up demand. It has been more than three years since Congress advanced major Medicare legislation, and there are many areas that cry out for attention. Anything Democrats try to do to the prescription drug benefit, Medicare Advantage (managed care) program, or physician fee schedule will serve as a vehicle for a variety of other provisions," Mr. Zimmerman said.
Eric Zimmerman, Health, Managed Care
Michael W. Peregrine was quoted extensively in the the January 4 issue of BNA’s Health Law Reporter discussing taxation and charity care issues that health care providers will face in the coming year. He commented, "The new SEC rules on disclosure of executive compensation, coupled with the revisions to the Form 990, will have a significant effect on health care organizations. Another development in this area will be increased pressure on compensation committees to confirm that they have taken into consideration all elements of compensation. There are a series of governance issues all flying right now 'under the radar,' that could have a significant impact in 2007." He also noted Sarbanes-Oxley developments should be watched "as a variety of groups, including the Treasury Secretary and the U.S. Chamber of Commerce, seek to find a new 'balance' in the evolution" of corporate governance and responsibility laws.
Eric Zimmerman was quoted in the January 2007 issue of Today’s Surgicenter discussing the 4th Annual ASC Legislative Update. According to Mr. Zimmerman, the industry should focus on the reintroduction of bills such as these that cover the "conversion factor" for the new payment system. He also commented, "the ASC industry has a little under a year to lobby Congress for some kind of congressional intervention."
Eric Zimmerman, Ambulatory Surgery Centers (ASC), Health
2006
Ankur J. Goel was quoted in the December 25 issue of Report on Medicare Compliance on the Deficit Reduction Act's False Claims Act requirements, stating that "whether entities need to be in complete 100% compliance on Jan. 1 is debatable because the states haven’t instituted the requirements yet and this guidance just came out," Mr. Goel said. "If entities are in substantial compliance or have taken steps in good faith, they should be in good shape," he added.
Ankur J. Goel, Health, Reimbursement/Fraud & Abuse
Chip Kerby was quoted In the December 22 issue of Inside Consumer-Directed Care about the new HAS law setting the maximum annual contribution at the statutory limit. "Cutting the ties between the deductible and the maximum HSA contribution is critical to the growth of the account-based plans," Mr. Kerby said. "Essentially, you no longer have to burn through your entire HSA balance to cover the deductible," he added.
, Consumer-Driven Health Care, Employee Benefits, Health
Chip Kerby was quoted In the December 22 issue of Inside Consumer-Directed Care about Congress passing the long-sought-after HSA fixes. "Christmas came early for the HAS supporters," Mr. Kerby said.
, Consumer-Driven Health Care, Employee Benefits, Health
Michael W. Peregrine was quoted in the December 21 issue of BNA's Health Law Reporter about the DOJ issuing new guidelines that prohibit federal prosecutors from considering a corporation’s refusal to waive the attorney-client privilege as part of a charging decision in a criminal investigation. "Corporate executives should be more comfortable in seeking the advise of corporate counsel, with greater assurance that the attorney-client privilege will be respected," Mr. Peregrine said.
Stephen Bernstein was quoted by the Boston Business Journal on December 4 in an article regarding the growth of Boston's top five venture capital-backed pharmaceutical start-up companies. "In Massachusetts, part of the reason this sector is hot is that there is good clustering of companies, academia and capital," Mr. Bernstein said. "The markets are doing quite well and there's a lot of capital chasing a number of companies positioned in that three-to-five-year window when return is expected."
Stephen W. Bernstein, Health, Life Sciences & Medical Products
An interview with H. Guy Collier was featured in the Washington Lawyer's December issue on the Senior Lawyer Public Interest Project, an initiative of the D.C. Bar Pro Bono Program. Mr. Collier serves as vice chair of the D.C. Bar Pro Bono Program and heads the Senior Lawyer Public Interest Subcommittee.
H. Guy Collier, Health, Pro Bono & Community Service
Michael Peregrine was quoted in the October 20 issue of The Washington Post regarding the judge's ruling that former NYSE chief Dick Grasso breached his duty by failing to disclose his ballooning retirement fund in the years before his resignation. "This is the kind of decision that will make nonprofit CEOs sit up and take notice," commented Mr. Peregrine. "They're going to spill their coffee in their laps when they read this case."
Michael W. Peregrine, Executive Compensation, Health, Tax Exemption
Michael Anthony, Bobby Burchfield, Gordon Greenberg, Christopher Jedrey, Ray Lupo, Terry McMahon, Michael Pope, Richard Smith and Jeffrey Stone will be recognized in the fall edition of Lawdragon magazine on its annual survey of the top 500 lawyers in the United States, the Lawdragon 500.
Michael F. Anthony, Bobby R. Burchfield, Gordon A. Greenberg, Christopher M. Jedrey, Raphael V. Lupo, Terrence P. McMahon, Michael A. Pope PC, Richard W. Smith, Jeffrey E. Stone, Corporate, Health, Intellectual Property, Trial
Stephen Bernstein and Bernadette Broccolo were quoted in the August 24 issue of BNA's Health Law Reporter. Ms. Broccolo commented, "I'm not sure the government entirely realizes how big a task it's taken on for itself, but I do applaud the meaningful progress these regulations represent." Mr. Bernstein described the hurdles to implementing the 15 percent cost-sharing provision in the electronic health records exception. "There may be things hospital donors want to pay for and there may be things that they don't. There also may be things they are precluded from paying for that are still rolled into the package," he said.
Stephen W. Bernstein, Bernadette M. Broccolo, Health
Michael Peregrine was quoted in the August 12 issue of Outpatient Surgery Magazine in the article, "How Did CMS Settle on 62 Percent?" The article discussed that beginning in 2008, the Centers for Medicare and Medicaid Services would pay surgery centers 62 percent of what they pay hospital outpatient departments for providing the exact same procedures, even as they planned to eradicate ASC procedure groupers and link ASC payments to those hospitals that receive under OPPS. Mr. Peregrine was quoted saying that "It's important to note that the 62 percent relationship wouldn’t be permanent. Under the proposed methodology, CMS would recalculate the two conversion factors each year, and the hospital–ASC payment relationship would vary accordingly."
Michael W. Peregrine, Ambulatory Surgery Centers (ASC), Health, Managed Care
Chip Kerby was quoted in the August 11 issue of Inside Consumer-Directed Care in an article about the final HSA comparability guidance issued by the Treasury Department that went into eddect July 31. "Alot of employers use outside advisors to ensure that they're compliant with the rules. And there weren't many advisors that were very comfortable with the proposed [comparability] rules," he said. "Prior to this guidance, we scratched our heads when the [IRS] said 'through a cafeteria plan.' But now it's very clear," he added.
, Consumer-Driven Health Care, Employee Benefits, Health
Michael Peregrine was quoted in the August 10 issue of BNA's Health Law Reporter in the article "State Appeals Court Affirms Sanctions in Derivative Action Against Nonprofit Board." Mr. Peregrine was quoted saying that the decision "is very significant in that it is one of the rare instances where we have seen a 'derivative' cause of action used in the nonprofit health care context."
Michael W. Peregrine, Health, Tax Exemption
Michael Peregrine was quoted by Modernhealthcare.com on August 7 regarding oversight of executive pay, bonuses and perks among not-for-profit health systems. Mr. Peregrine was quoted saying that "not-for-profit system officials and consultants argued results revealed solid governance and a heightened sensitivity to calls for greater oversight of tax-exempt charities pay to keep top executives."
Michael W. Peregrine, Health, Tax Exemption
Eric Zimmerman was quoted in the July 21 issue of BNA's Medicare Report in an article about how a provision of the Deficit Reduction Act of 2005 will place a hold on Medicare payments for Part A and Part B claims for the last nine days of fiscal year 2006. Mr. Zimmerman noted that he told BNA that the payment delay is not something providers should be concerned about. "It may affect cash flow, but not significantly," he said. Mr. Zimmerman was also quoted saying, "It's an accounting trick that Congress used to contain the overall cost of the bill. By shifting some of the costs into later years, they were able to achieve the overall spending goals that they needed to be within."
Eric Zimmerman, Health, Managed Care
Doug Mancino and Christopher Jedrey were quoted in the July 5 issue of Tax Notes Today in an article discussing reactions to a recent questionnaire the IRS sent to tax-exempt hospitals inquiring about compensation practices and how much community benefits provide. "While the questionnaire asks good questions, answering some of them calls for multifaceted responses that don’t lend themselves to easy yes-or-no answers," said Mr. Mancino. Chris Jedrey also mentioned that he thinks bad debt is often synonymous with charity care. "I understand why the IRS wants to treat them as separate and distinct. However, a lot of hospitals don’t see a ‘clear bright line’ between bad debt and charity care," Mr. Jedrey added.
Christopher M. Jedrey, Health, Tax Exemption
Michael Peregrine was quoted in the July 5 issue of BNA's Health Law Reporter in the article "Court Blasts Prosecutors in KPMG Case; Ruling May Impact Health Care Investigations." The case is expected to impact the conduct of government investigations in many sectors, including health care. Mr. Peregrine noted that "the whole debate should also prompt health care corporations to revisit the indemnification and insurance protections they provide officers and directors."
Eric Zimmerman was mentioned in the June 2 issue of BNA’s Medicare Report in an article titled, "CMS Survey Seeks Financial Information for Specialty Hospital Report to Congress." Mr. Zimmerman was quoted saying that the survey is of a sensitive nature, seeking detailed information about physician investors in acute-care or specialty hospitals and about common joint venture arrangements between hospitals and physicians.
Michael Peregrine was quoted in the June 1 issue of BNA’s Health Law Reporter in an article regarding the IRS community benefit questionnaire, recently sent to hundreds of tax-exempt hospitals. "The questionnaire goes to the heart of a hospital's tax-exempt status and needs to be responded to with care, attentiveness and accuracy," Mr. Peregrine said.
Michael W. Peregrine, Health, Tax Exemption
Eric Zimmerman was quoted by Surgicenteronline.com in their June 2006 issue regarding compensation for orthopedic surgeries. Zimmerman notes that the Centers for Medicare and Medicaid Services (CMS) is currently working on a proposal to re-base ambulatory surgery center rates, and that the agency is expected to come out with a proposal to implement new payment amounts for ASC services, probably by the end of the summer or early next fall.
Eric Zimmerman, Ambulatory Surgery Centers (ASC), Health, Managed Care
Eric Zimmerman was quoted in the May 15 issue of Modern Healthcare in regards to a CMS report that focused on payment revisions for hospital inpatient and ambulatory surgical center services. The report also defined what a hospital is and reviewed procedures for enrollment. "The most significant (aspect) is that it signals that CMS is not likely going to be making the types of changes that opponents had hoped for."
Eric Zimmerman, Health, Managed Care
On May 10, McDermott was mentioned by name in The Wall Street Journal, The New York Times, Bloomberg, Associated Press, The Cleveland Plain Dealer, Business Week Online, WashingtonPost.com and MSNMoney.com as counsel for Cleveland Clinic in a matter the national media have been following. The Firm conducted a comprehensive review of policies, procedures and practices of trustees and phyisicians with respect to disclosure and management of relationships giving rise to conflicts of interest in governance, clinical decisions, scientific research and related publications.
Michael Peregrine was quoted in the May 5 issue of Rocky Mountain News in the article “Salaries Soar for Hospital Execs.” Mr. Peregrine said the allegations of excessive compensation at nonprofits is a very juicy story. "Politicians love to make hay of this,” he said. “But we have to come back and look at what the law allows. There is no inherent obligation to pay less at nonprofits."
Michael W. Peregrine, Health, Tax Exemption
Michael Peregrine was quoted in the May 4 issue of BNA's Health Law Reporter regarding executive compensation processes of nonprofit hospitals. He suggested they "focus on known 'trouble spots' independence of the process, including both committee members and advisers, transparency to the board of the recommendations, committee and board comprehension of retirement benefits and clarification of travel, entertainment, and discretionary expenditures."
Michael W. Peregrine, Executive Compensation, Health, Tax Exemption
Michael Peregrine was quoted in the April 20 issue of BNA's Health Law Reporter regarding the U.S. Sentencing Commission's April 5 vote to remove language in the Sentencing Guidelines that puts pressure on corporations under criminal investigation to waive attorney-client privilege and work product protection as a condition of being deemed cooperative with prosecutors. "The change will affect any regulated organization that has a compliance plan, including those in the health care industry," Mr. Peregrine said.
Michael W. Peregrine, Corporate Responsibility and Governance, Health, Tax Exemption
Michael Peregrine was quoted in the April 17 issue of Modern Healthcare regarding the Government Accountability Office’s second series of "soft-contact-audit" letters after a batch the GAO mailed earlier this year. "The GAO inquiry is distinct from the IRS probe,” Mr. Peregrine said. "Tax-exempt hospitals are facing two separate inquiries with overlapping issues this year."
Michael W. Peregrine, Corporate Responsibility and Governance, Health, Tax Exemption
Eric Zimmerman was quoted in the March 31 issue of BNA’s Medicare Report in the article "DRA's Medicare Reduction of $6 billion Reflects Reluctance to Reduce Spending." Regarding the Deficit Reduction Act of 2005 (DRA), Mr. Zimmerman said the budget resolution that is emerging from the Senate budget committee does not call for Medicare spending reductions. "Nevertheless, the House has not yet completed its resolution on the 2007 budget and may require Medicare to put spending reductions on the table," he said.
Eric Zimmerman, Health, Managed Care
Michael Peregrine was quoted in the March 27 issue of Modern Healthcare in an article regarding charity care accountability. "The tax-exempt status of non-for-profit hospitals probably won’t be revoked," Mr. Peregrine said, "But the IRS has said it fully intends to audit up to 650 hospitals this year to determine if they are complying with the community-benefit standard, ambiguous as it is."
Michael W. Peregrine, Health, Tax Exemption
Ankur Goel was quoted in the March 13 issue of BNA's Health Care Daily Report in the article "Rebate Disclosures for Drug Plans Seen as Burden, Possible Legal Risk." According to Mr. Goel, CMS' recent call letter stipulates that Part D sponsors have an obligation to find out about drug maker rebates and discounts paid to pharmacy benefit managers and long-term care pharmacies, report them to CMS, and reduce their charges to the federal government accordingly. "This would be a fairly significant policy if they finalize it that way," Mr. Goel said. "Right now, Part D sponsors don’t always know the amounts of these rebates," and not all of the rebates are passed along to the sponsors, he added.
Anne Hance was quoted in the March 10 issue of BNA's Medicare Report in the article "Draft Formulary, Transition Guides Have Strict Standards, New Timelines for 2007." Ms. Hance asserted the documents try to target problem areas, but mostly "maintains a similar approach" as those for the 2006 plan year. She said this is probably because CMS only had a couple of months of actual beneficiary experience to draw upon. "It will be interesting to see what the agency will do for 2008. We could potentially see significant changes," she said.
Anne W. Hance, Health, Managed Care
Joel Michaels was quoted in the March 10 issue of BNA's Medicare Report in the special report "Draft Formulary, Transition Guides Have Strict Standards, New Timelines for 2007." Mr. Michaels said the transition document is a reaction to he litany of problems that have occurred during the benefit’s implementation, particularly for residents of long-term care facilities and patients already stabilized on medications for psychiatric illnesses.
Michael Peregrine was quoted in the February 20 issue of Modern Healthcare in the article, "Keeping the Heat On," regarding continued scrutiny of healthcare organizations by the Internal Revenue Service. Mr. Peregrine said the multi-fronted assault on not-for-profit hospitals is partly driven by government officials angry at perceived abuses of tax-exempt status and hungry for tax revenue in an era of state and federal budget cuts. "Congress is pressuring the service to increase regulatory scrutiny of tax-exempts and it has a tremendous influence over the IRS," he said.
Michael W. Peregrine, Health, Tax Exemption
Eric Zimmerman was quoted in the February 10 issue of BNA's Medicare Report in the article "Budget Bill: Hospitals Spared Cuts, Specialty Report Due." Regarding the new Deficit Reduction Act, Mr. Zimmerman said the specialty hospital provisions in the act are "really mixed." The bill demonstrates that Congress has rejected, or displayed its unwillingness to address, the specialty hospital issue from an ownership perspective, he said. "I think you have a lot of would-be developers looking at this as if not a green light, certainly amber. It's a cautious environment."
Eric Zimmerman, Health, Managed Care
Chris Jedrey was quoted in the February 10 issue of The Boston Globe regarding electronic medical records. "Without electronic records, physicians will have difficulty performing in the future under insurance companies' pay-for-performance contracts," said Mr. Jedrey.
Michael Peregrine was quoted in the January 30 issue of Modern Healthcare in the article, "States Turn Up the Heat." Mr. Peregrine said not-for-profit boards will likely continue to face "disproportionately high regulatory pressure" to refine their governance policies relating to executive travel and benefits such as automobiles and housing. "In my judgment, states are better able to deal with issues of oversight," he said. "State government is closer to the front line."
Michael W. Peregrine, Health, Tax Exemption
Russell Hayman was quoted in the January 25 issue of Cal Law in the article "Medicare May Face Fraud Epidemic." With a steady stream of government cash lurking above the $5,100 mark, the eligibility gap "donut hole" gives an incentive for pharmacies "to report greater costs than what they actually incurred to qualify the other side of the donut hole," Mr. Hayman said. "I have never understood, from a legislative perspective and from a policy perspective, what was gained by creating the donut hole."
Russell Hayman, Health, Managed Care, Trial
Eric Zimmerman was quoted in the January 13 issue of BNA's Medicare Report in the article "Medicare Part D Drug Benefit Brings Significant Program Changes, Uncertainty." Regarding the new Medicare drug benefit, Mr. Zimmerman said, "Congress will be torn between wanting to create incentives in the program to entice beneficiaries to enroll and needing to contain program costs that are almost assuredly going to be higher than expected."
Eric Zimmerman, Health, Managed Care
Jerry Sokol was quoted in the January 2006 issue of Ambulatory Surgery Compliance & Reimbursement Insider regarding three legal business models ASCs can consider to profit from professional anesthesia.
Jerry J. Sokol, Ambulatory Surgery Centers (ASC), Health
Jerry Sokol was quoted in the January 2006 issue of Ambulatory Surgery Compliance & Reimbursement Insider regarding three legal business models ASCs can consider to profit from professional anesthesia.
Jerry J. Sokol, Ambulatory Surgery Centers (ASC), Health
2005
Eric Zimmerman was quoted in the December 20 issue of BNA's Health Care Daily Report in an article about the U.S. House of Representatives voting on December 19 to extend the current restrictions on the enrollment of new physician-owned, specialty hospitals. Mr. Zimmerman told BNA the bill contains a "healthy mix of things," but noted that many of the Medicare provisions are in effect for only one year, requiring lawmakers to revisit the issues in 2006.
Eric Zimmerman, Health, Managed Care
Eric Zimmerman was quoted in the December 20 issue of BNA’s Health Care Daily Report in an article about the House of Representatives voting on Dec. 19 to extend the current restrictions on the enrollment of new physician-owned, specialty hospitals. Mr. Zimmerman told BNA the bill contains a “healthy mix of things,” but noted that many of the Medicare provisions are in effect for only one year, requiring lawmakers to revisit the issues in 2006.
Eric Zimmerman, Health, Managed Care
Michael Peregrine was quoted in the October 31 issue of Modern Healthcare in the article "IRS Turns Up the Heat: Agency May Seek Data on Compensation, Benefits," advising not-for-profit hospitals to prepare for additional scrutiny from Washington concerning their tax-exempt status. "The underlying issue is: What is an individual hospital doing in terms of programs and activities to provide 'community benefits,' in order to justify their continued tax-exempt status," Mr. Peregrine said.
Michael W. Peregrine, Health, Tax Exemption
Michael Anthony was quoted in the October 24 issue of American Medical News in the article "After the Breakup: What Doctors Can Do When Hospitals Split Up." Mr. Anthony said the impact of ending a long-standing partnership can be keenly felt by physicians and may be a drain on their time. "It leaves physicians in a position of spending a lot of time reconstituting things and dealing with administrative things," he said. "It's very difficult on the doctors, and physicians don’t have a lot of time [for it]. This is carve-out time from their practice."
Christopher Jedrey was quoted in the October 2005 issue of The Exempt Organization Tax Review in an analysis of the Internal Revenue Service's proposed regulations addressing intermediate sanctions. Mr. Jedrey said the proposed regulations "provide useful guidance on significant, but in practice rarely encountered, circumstances."
Christopher M. Jedrey, Health, Tax Exemption
Michael Peregrine was quoted in the October 2005 issue of The Exempt Organization Tax Review in an analysis of the Internal Revenue Service's proposed regulations addressing intermediate sanctions. Mr. Peregrine said the proposed regulations will "raise the stakes" on the substance of an executive officer's intermediate sanctions review process. "I view these regulations as positive from the perspective of providing useful guidance, incentive for closer internal review of potential excess benefit transactions, and enhancing the importance of having the compliance officer focus on tax, as well as other, principal legal issues," Mr. Peregrine said.
Michael W. Peregrine, Health, Tax Exemption
Michael Peregrine was quoted in the September 19 issue of Modern Healthcare in an article regarding the IRS's proposed regulations that would threaten the tax-exempt status of not-for-profit hospitals and other 501(c)(3) organizations for committing excess-benefit transactions. With the proposed regulations, Mr. Peregrine said, the proposed rules for the first time expressly link maintaining exemption to avoiding excess-benefit transactions. "The proposed regulations put a real premium on internal tax compliance, another task for the compliance officer, because the IRS says things will go better if the organization finds the excess-benefit transaction itself and makes a good faith attempt to fix it before the IRS finds out," he said.
Michael W. Peregrine, Health, Tax Exemption
Michael Peregrine was quoted in the September 14 issue of Tax Notes Today regarding the IRS's released proposed regulations that seek to explain the circumstances under which the IRS will both impose intermediate sanctions and revoke tax-exempt status when excess benefit transactions involving exempt organizations occur. Mr. Peregrine said the proposed regulations will "raise the stakes" on the substance of an exempt organization's intermediate sanctions review process. He pointed out that now, for the first time, an exempt organization can be liable for excess benefit transactions by losing exemption; until now only the transaction participants were penalized. "That will back up general counsel who advise their clients to closely scrutinize potential excess benefit transactions," he predicted.
Michael W. Peregrine, Health, Tax, Tax Exemption
Michael Peregrine was quoted in the September 12 issue of BNA's Health Care Daily Report in regard to the IRS's September 8 proposed intermediate sanctions regulations that define when excess benefit transactions may place a nonprofit organization's exemption at risk. Mr. Peregrine said the proposed rules state "in clear terms that, if individuals associated with an organization engage in excess benefit transactions, the organization's exempt status will be at risk in appropriate circumstances."
Michael W. Peregrine, Health, Tax, Tax Exemption
Chip Kerby was quoted in the September 9 edition of Inside Consumer-Directed Care in an article about how Aetna and CIGNA Healthcare are improving price transparency with new services. New HSA regulations proposed by the Treasury Department could make it difficult for employers to reward employees who participate in wellness programs. The proposal also would prevent employers from making larger HSA contributions to lower-paid employees unless the HSAs are offered through a cafeteria plan. "There shouldn't be anything wrong with making a larger [HSA] contribution to rank-and-file employees, or to different bargaining units," said Mr. Kerby. He also noted, however, that the problem is more with the comparability rule itself than it is with the Treasury Dept.'s latest interpretation. This rule, Mr. Kerby explained, was developed for Archer medical savings accounts, which were available only to small employers and the self employed.
, Consumer-Driven Health Care, Employee Benefits, Health
Michael Peregrine was quoted in the August 25 issue of BNA's Health Law Reporter regarding the decision by the Minnesota District Court in favor of Medica Health Plans (Minnesota v. Medica Health Plans). Mr. Peregrine said the decision was noteworthy to the extent that it places certain boundaries on the otherwise broad jurisdiction of the attorney general with respect to oversight of nonprofit organizations and their boards. "It also serves as a reminder that corporate directors can successfully defend themselves against breach of fiduciary duty claims, despite the heated nature of the rhetoric applied against them," he added.
Michael Peregrine was quoted in the August 8 issue of Modern Healthcare in the article "Hard to Handle: New Guidance Helps Boards Navigate Sarbanes- Oxley." The Public Company Accounting Oversight Board on July 26 released rules on auditor independence that essentially makes is easier for hospitals and systems to hire their auditing firms to perform tax-related services. "Even if the standards issued by the PCAOB, which was created by Sarbanes-Oxley, don't apply directly to not-for-profit hospitals and systems," said Mr. Peregrine, "the standards should be viewed in the same way Sarbanes-Oxley is: as representing good policy."
Michael W. Peregrine, Health, Tax Exemption
Michael Anthony was listed as one of Nightingale's Healthcare News' "Outstanding Hospital Lawyers - 2005" in the July/August issue. Mr. Anthony was recognized for his recent work with TriHealth, a hospital system in Ohio, on its combination with a large medical group to expand an integrated delivery system; for his work with Promedica Health Systems on growth strategies; and for his work as general counsel to several large hospital-based systems.
Michael F. Anthony, Health, Health - General Counsel
Michael Peregrine was quoted in the August 1 issue of Modern Healthcare in the article "Providing Incentives: Execs See Modest Pay Gains as Focus Turns to Quality." As governing boards face scrutiny for how much executives get paid, healthcare executives can expect dwindling guarantees on their compensation. "Good governance put the focus on how the board arrives at compensation," Mr. Peregrine said.
Michael W. Peregrine, Health, Tax Exemption
Marilyn Lamar was quoted in the July 25 issue of The Deal regarding the implications of making medical records available online, specifically in reference to HIPAA regulations.
Eric Zimmerman was quoted in the July 14 issue of BNA's Health Care Daily Report in the article "Ambulatory Surgical Centers Relieved by Recent Rule, but Want New Pay System." Regarding the Centers for Medicare & Medicaid Services' decision to expand the number of procedures Medicare will cover if performed in ASCs, Mr. Zimmerman told BNA "there was some degree of relief that CMS did not proceed with many of the proposed deletions from [November 2004], and that they also added more procedures" than originally proposed. He noted, however, that there was also a great deal of disappointment that many other procedures were not added.
Eric Zimmerman, Ambulatory Surgery Centers (ASC), Health
John Callahan was quoted in the Summer 2005 issue of Outsourcing Essentials in the article "What critical factors must a company take into consideration when deciding which law firm to hire?" Mr. Callahan said companies must look for experienced lawyers when considering an outsourcing transaction. "Recognizing the complexity of most outsourcing contracts, it makes sense to hire legal advisors who have developed an expertise in negotiating the agreements typically used to outsource services. Lawyers who specialize in outsourcing are accustomed to reviewing outsourcing agreements, know how to cut through the morass of text and get to the heart of what is important. This includes negotiating meaningful performance standards."
Bernadette Broccolo was quoted in the June 27 issue of Modern Healthcare in the article "A Higher Standard" regarding the latest report from the Panel on the Nonprofit Sector that included 120 proposals for improving accountability and transparency for all not-for-profits. "I'm not a betting person, but my instinct tells me that we're going to get reform," Ms. Broccolo said. "And that reform will draw on the panel's proposals for ideas. The IRS has already outlined steps not-for-profits can take to show that their governing boards diligently sought out and evaluated appropriate salary data. If a full board or an authorized committee, none of which have a conflict of interest, approved compensation in advance; used comparable compensation data to arrive at an offer; and documented the rationale for a decision as it's being made, then the responsible board members have established a rebuttable presumption."
Bernadette M. Broccolo, Health, Tax Exemption
Robert Nicholas was quoted in the June 23 issue of The Boston Globe in an article addressing medical device companies' procedure on product recalls.
, Health
Michael Peregrine was quoted in Modern Healthcare on June 20, in the article "Economists Onboard." Regarding the possibility of the Senate Finance Committee passing new guidelines for not-for-profit businesses, Peregrine said "A lot of boards are going to have even more of an incentive to appoint people who bring a certain level of expertise. But the boards of larger, more sophisticated healthcare organizations are already looking to broaden their perspective. These billion-dollar-a-year organizations are looking to raise the bar, and they're well-served by having in their midst someone with broad experience." Even though the toughest new federal accounting rules don't yet apply to not-for-profit hospitals, the message remains clear: "The spin-off from Sarbanes-Oxley is to seek people with specific expertise, especially in the areas of healthcare financing," Peregrine said.
Michael W. Peregrine, Health, Tax, Tax Exemption
Russ Hayman was quoted in the June 13 issue of the National Law Journal in regard to corporate integrity agreements negotiated with the U.S. Department of Health and Human Services' office of the inspector general as a common form of corporation probation.
Russell Hayman, Health, Health Care Litigation, Trial
Eric Zimmerman was quoted in BNA's Medicare Report on June 10 in the article "Moratorium for Speciality Hospitals Ends; Providers Say Future Construction Unclear." According to Mr. Zimmerman, "under the former moratorium there were a number of ambiguities in the law that left ample room for would-be developers. The chances are that under a new moratorium, the ambiguities will continue to exist and developers may take advantage of them."
Eric Zimmerman was quoted in BNA's Health Care Daily Report on June 9 in an article regarding the June 8 expiration of the moratorium for new speciality hospitals. "Congress has sent a signal that there is a good likelihood that whatever extensions of the moratorium enacted will be retroactive. Developers should not look at this [the expiration of the moratorium] as a lapse period," Mr. Zimmerman said.
Michael Peregrine was quoted in the June 3 issue of Health Law Reporter in the lead article "Ways and Means Hearing, Grassley Letter Keep Congress' Foot on Nonprofit Hospitals." Mr. Peregrine said the May 26 hearings suggest "an increased likelihood" that Congress will propose nonprofit oversight legislation that could refine the criteria for tax-exempt hospitals and dictate nonprofit governance standards. "I think is fairly clear from the confluence of the Grassley letter and the focus of the hearings that Congressional leaders believe that the nonprofit, tax-exempt hospital industry deserves special legislative attention with respect to the criteria by which 501(c)(3) status is preserved under the Internal Revenue Code," Mr. Peregrine said.
Michael W. Peregrine, Corporate Responsibility and Governance, Health, Tax Exemption
Chip Kerby was quoted in the June 1 issue of Employee Benefits News in an article about the Medicare prescription drug benefit and how most employers are expected to take advantage of the government subsidy for retiree plans. "Coordinating benefits with Parts A and B is simpler because employers know what the charges are going to be. Right now, though, they do not know what Medicare will pay for certain drugs, as the pricing and formulary will not be finalized until later his year," Mr. Kerby said.
, Employee Benefits, Health, Managed Care
Eric Gordon was listed as one of Nightingale's Healthcare News' "Outstanding Fraud & Compliance Lawyers - 2005," in the May/June issue. Mr. Gordon was recognized for his experience in developing compliance plans, structuring complex business transactions and developing compensation plans for academic medical centers, hospital systems, medical device manufacturers and research institutes. He was also recognized for his work as Stark counsel in False Claims Act qui tam litigation.
Eric B. Gordon M.D., Health, Reimbursement/Fraud & Abuse
Eric Zimmerman was quoted in Modern Healthcare on May 30 in an article regarding the moratorium on physician self-referral to specialty hospitals that is set to expire June 8, 2005. "I think there are very clear signals that any extension of the moratorium is very much in doubt right now," said Mr. Zimmerman. "Making it permanent is highly unlikely."
Eric Zimmerman, Health, Health Ventures/Physician Transactions
Eric Zimmerman was quoted in BNA Medicare Reporter on May 13 regarding the proposed Hospital Fair Competition Act of 2005. "The bill effectively precludes specialty hospitals from whole hospital exception in the Stark physician self-referral law, but does not define specialty hospitals further than how they are defined in the 2003 Medicare law," he said. "The law remains vague about what defines a specialty hospital, and the Grassley-Baucus bill potentially leaves room for physician-owners to adjust their models to provide a greater number of services but essentially function still as single-specialty facilities, eligible for Medicare and Medicaid reimbursement." He added the bill "would have the intended effect of preventing specialty hospital developers from opening new facilities, at least in the short term, because Grassley and Baucus were clear in the legislation that they intended the bill to be enacted retroactively."
Gary Scott Davis was quoted extensively by Managed Care Magazine in a May 2005 story about consumer-directed health plans (CDHPs). Mr. Davis held that for such plans to achieve cost savings, "They can't simply say to the consumer, 'Take responsibility.' Many people would argue that that is naïve at best and — at worst — irresponsible." He noted that consumers too often feel that CDHP decisions are made only for the good of the plan: "When consumers feel that they are getting the short end of the stick, that the only reason they are being told to do something is because it's going to benefit the plan in a pecuniary manner, they are not apt to follow that advice." Mr. Davis added that for CDHPs to be successful, it can only be "where the consumer is confident that...recommendations are coming from the plan strictly in terms of what's in the best interest of the patient. And that will be a challenge."
Gary Scott Davis was quoted in the May 2005 issue of Managed Care in the article "Are Consumers Really Directing Their Own Care?" Mr. Davis said that while people often believe that the consumer becomes the epicenter of the decision-making process in consumer-directed health plans, that's not entirely true. "For consumer-directed health plans to really get the benefit of what they are supposed to be achieving -- which is overall reduction in the cost of health care -- they can't simply say to the consumer 'Take responsibility.' Many people would argue that that is naive at best and -- at worst -- irresponsible."
Gary Scott Davis, Consumer-Driven Health Care, Health
Michael Peregrine was quoted in the April 14 issue of Health Law Reporter in an article regarding the April 5 Senate Finance Committee hearing to discuss changes addressing compensation issues and business operations of nonprofit health care organizations to improve transparency. Mr. Peregrine said, "In particular, the larger health systems ought to take very close note of Commissioner Everson's comments on the similarity of the nonprofit and for-profit models among health care systems." Leadership can expect to be both "perplexed and chagrined by the several proposals to eliminate the rebuttable presumption of reasonableness under the IRS' intermediate sanctions rules," Mr. Peregrine added.
Michael W. Peregrine, Health, Tax, Tax Exemption
William Smith was quoted in the April 4 issue of Modern Healthcare on proposed rules in the bankruptcy bill regarding bankruptcy hospitals and nursing homes exiting from Medicare and Medicaid. Bill commented that when a hospital or nursing home bankruptcy has arisen the various court circuits have handled the situation differently. Some circuits have decided that the CMS can exclude a provider in bankruptcy from Medicare without going through the bankruptcy courts while other circuits require that bankruptcy courts be involved in the decision.
William P. Smith, Health, Restructuring & Insolvency
Russ Hayman was quoted in the March 14 issue of Report on Medicare Compliance. In the article entitled "Nursing Home Was Sold Before Conviction," he commented on the government wielding multiple enforcement weapons at a wayward facility. Mr. Hayman stated, "It's just a question of how much the authorities want to pile on." The standard for proving a crime is the hardest to meet. He continued, "if that's met, they can pile on civil penalties and administrative penalties."
Russell Hayman, Health, Health Care Litigation, Trial
Paul Lawrence was selected as one of Nightingale's Healthcare News', "2004 Outstanding Healthcare Transaction Lawyers." Paul will be presented this prestigious award at a dinner in conjunction with the Sixth Annual Conference on Healthcare Transactions, sponsored by Renaissance American Management, Inc. and the BeardGroup. For more information on this conference and awards dinner, visit http://www.healthcaredatasource.com/healthcare_transactions_conference.html/.
Paul F. Lawrence, Health, Health Ventures/Physician Transactions
Michael Peregrine was quoted in the February 17 issue of Health Law Reporter in an article regarding the most recent chapter of an ongoing compliance review of Minnesota's nonprofit health care organizations by Attorney General Mike Hatch. Although the report reflects only one Attorney General's interpretation of the law, Mr. Peregrine stated that "it may have broader significance, outside Minnesota, than one might think at first glance… With respect to charity care, nonprofit hospitals are well advised to set aside concerns about the strength of his legal interpretations and his jurisdictional basis, and to focus more on the ‘big picture' projected by his compliance reviews."
Michael W. Peregrine, Health, Tax, Tax Exemption
Max Reynolds was quoted in the February 16 issue of Health Care Fraud Report in an article regarding a gainsharing arrangement reached between an unnamed hospital and a group of heart surgeons. The Inspector General (IG) of the Department of Health and Human Services gave approval for the venture which proposes cost-cutting recommendations for operating room practices that result in inappropriate or wasteful use of medical supplies. However, some health care lawyers do not see the IG's advisory opinion breaking new ground in the gainsharing area. "It doesn't advance the ball all that much," Mr. Reynolds stated.
, Health, Health - General Counsel
Max Reynolds was quoted in the February 4 issue of Modern Healthcare's Daily Dose regarding the issue of hospital gain-sharing. "Hospitals should take solace in the MedPac recommendation and the fact that the inspector general's office has told providers more advisory opinions on gain-sharing will be forthcoming...but this opinion doesn't provide that much additional cover or assistance."
, Health
Amy Gordon was quoted in the February issue of CFO Magazine in regard to company wellness programs and how it relates to employee and health privacy issues. "With the Health Insurance Portability and Accountability Act bona fide wellness program guidance still in proposed form, there have currently been no published cases focusing on discrimination issues with regard to employer-sponsored workplace wellness programs," commented Ms. Gordon. She continued by saying these cases could take years to show up in the court system.
Amy M. Gordon, Employee Benefits, Health, HIPAA
Michael Peregrine was quoted in "With Charity for All?" published in the February issue of Corporate Counsel in regard to nonprofit organizations choosing to implement some of the Sarbanes-Oxley provisions. Mr. Peregrine commented that the efforts by nonprofit corporations to effect these reforms within their own governance structure is a "validation that people think Sarbanes-Oxley principles make good sense. But it is also a sign that [GCs] want to keep their organizations out of trouble." In addition, a sidebar story, "Both Sides Now," written by Mr. Peregrine accompanied this article, and addressed why general counsels of nonprofit organizations are becoming champions of "corporate responsibility."
Michael W. Peregrine, Corporate Responsibility and Governance, Health, Tax Exemption
Michael Peregrine was quoted in the January 31 issue of Modern Healthcare in an article detailing the challenges faced by the University of Iowa Hospitals and Clinics following the resignation of the president of Iowa's Board of Regents, John Forsythe. Attorney General Tom Miller believed that Forsythe's position as CEO of Wellmark Blue Cross and Blue Shield prevented him from exercising supervisory authority as Regent president without running afoul of the law prohibiting conflicts of interest. Mr. Peregrine stated, "Iowa's difficulties are likely to surface elsewhere, as more hospital systems work to improve oversight by bringing experienced business executives to their boards."
Michael W. Peregrine, Health, Tax Exemption
Michael Peregrine was quoted in the January 31 issue of the National Law Journal in regard to nonprofit organizations choosing to implement some of the Sarbanes-Oxley provisions. Mr. Peregrine commented that the efforts by nonprofit corporations to effect these reforms within their own governance structure is a "validation that people think Sarbanes-Oxley principles make good sense. But it is also a sign that [GCs] want to keep their organizations out of trouble."
Michael W. Peregrine, Corporate Responsibility and Governance, Health, Tax, Tax Exemption
Michael Peregrine was quoted in the January 20 issue of BNA's Health Law Reporter regarding the U.S. Supreme Court's ruling that U.S. Sentencing Guidelines violated the Sixth Amendment right to a jury trial. Mr. Peregrine commented that the ruling in no way lessens the need to heed policy considerations behind U.S.S.G. Chapter 8 on compliance plans. "Regardless of what the Supreme Court said, my guess is that these considerations will survive as they reflect the view of regulators and of courts concerning the director's oversight obligations," commented Mr. Peregrine.
Michael Peregrine was quoted in the January 6 issue of Health Law Reporter in an article regarding a review by the IRS of executive compensation arrangements utilized by tax-exempt organizations to reward their top officers. Although no cases have surfaced yet, lawyers representing nonprofit health care organizations will be watching this area closely in 2005. Mr. Peregrine stated, "I think these high-profile cases will jolt some health care organizations which heretofore thought that their own executive compensation processes were meeting IRS standards."
Michael W. Peregrine, Health, Tax, Tax Exemption
2004
Chip Kerby was quoted in the December 20 issue of theAmerican Medical News in regard to Health Savings Accounts (HSAs). "HSAs allow people with high-deductible health insurance plans to contribute to an account that can be used to pay for a broad variety of qualified medical expenses ranging from hospital inpatient stays to over-the-counter drugs", commented Mr. Kerby.
Eric Zimmerman was quoted in the December 6 issue of Part B News in an article regarding how next year there may be 25 new procedures payable to the ASCs under a proposed CMS revision to the ASC list. Mr. Zimmerman believes the proposed changes could hurt single-specialt