DOJ ANNOUNCES 2025 NATIONAL HEALTH CARE FRAUD TAKEDOWN RESULTS

On June 30, 2025, DOJ announced the results of its 2025 National Health Care Fraud Takedown, which, in collaboration with 12 state attorneys general, resulted in criminal charges against 324 defendants in 50 federal districts in collaboration with 12 state attorneys general across the United States.

DOJ ESTABLISHES FCA WORKING GROUP

On July 2, 2025, HHS and DOJ jointly announced the establishment of the False Claims Act Working Group. This new working group may indicate the government’s intent to take a more active role in evaluating and potentially intervening in § 3730(c)(2)(A) dismissals, which pertain to qui tam actions under the FCA.

JANSSEN CHALLENGES CONSTITUTIONALITY OF THE FCA QUI TAM PROVISIONS

Earlier this year, Janssen Products LP received a monetary judgment in the US District Court for the District of New Jersey for conduct related to a 2012 whistleblower lawsuit filed by former Janssen sales representatives. The judgment included $360 million in treble damages and $1.28 billion in civil penalties. On July 14, 2025, in a rare move, Janssen appealed the decision, challenging the constitutionality of the FCA’s qui tam provisions and the excessive nature of the penalties.

CMS RELEASES CY 2026 PHYSICIAN FEE SCHEDULE PROPOSED RULE

On July 14, 2025, the Centers for Medicare & Medicaid Services (CMS) released the CY 2026 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B [CMS-13271] Proposed Rule, which includes proposals related to Medicare physician payment and the Quality Payment Program.

CMS PROPOSES RPM REIMBURSEMENT UPDATES, REQUESTS INFORMATION ON REIMBURSING FOR SAAS

In recent years, CMS has expanded payment for remote monitoring services in an effort to recognize and pay for non-face-to-face services that improve care management for Medicare beneficiaries. In connection with the CY 2026 PFS proposed rule, CMS proposes several payment policy changes for remote monitoring services, including modifications to the remote physiological monitoring (RPM) and remote therapeutic monitoring (RTM) codes.

CMS RELEASES CY 2026 OPPS, ASC PAYMENT SYSTEM PROPOSED RULE

On July 15, 2025, CMS released the CY 2026 OPPS and ASC Payment System proposed rule [CMS-1834-P], which includes proposals to update payment rates and regulations affecting Medicare services furnished in hospital outpatient and ASC settings beginning in CY 2026.

CMS PROPOSES EXPANDED SITE-NEUTRAL PAYMENT POLICY FOR DRUG ADMINISTRATION SERVICES

In the CY 2026 OPPS proposed rule, CMS proposes to reduce hospital payments for drug administration services furnished at all off-campus hospital outpatient departments, with a stated goal of reducing Medicare costs and addressing payment disparities between hospital and physician office settings.

CMS RELEASES FY 2026 IPPS FINAL RULE

On July 31, 2025, CMS issued the FY 2026 IPPS and Long-Term Care Hospital (LTCH) Prospective Payment System final rule. The rule updates Medicare fee-for-service payment rates and policies for inpatient hospitals and LTCHs for FY 2026.

OIG ISSUES FAVORABLE ADVISORY OPINION ON PHARMACEUTICAL MANUFACTURER’S TRAVEL AND LODGING ASSISTANCE PROPOSAL

OIG issued a favorable advisory opinion regarding a pharmaceutical manufacturer’s proposal to provide assistance for certain travel, lodging, and associated expenses for qualifying patients receiving its autologous hematopoietic stem-cell based gene therapy.

OIG ISSUES NEGATIVE ADVISORY OPINION ON MEDICAL DEVICE COMPANY’S VENDOR PORTAL PROPOSAL

OIG issued a negative advisory opinion regarding a medical device company’s proposal to pay to access an electronic billing system operated by a third-party vendor that some of the company’s customers use for billing operations.

$1.55 MILLION CCPA SETTLEMENT CONTINUES COOKIE FOCUS, SIGNALS INCREASING ENFORCEMENT

The California attorney general proposed a $1.55 million settlement with Healthline Media LLC for alleged violations of the California Consumer Privacy Act (CCPA) and the state’s Unfair Competition Law. The case centers on the use of cookies that disclose sensitive health information.

FDA FOOD DYE PHASE-OUT CONTINUES

On July 14, 2025, the FDA announced its approval of gardenia blue for use in various beverages and candies. This follows the May 2025 approval of three other natural color additives: galdieria extract blue, calcium phosphate (white), and butterfly pea flower extract (blue, purple, and green).

HDHP TELEHEALTH SAFE HARBOR PERMANENTLY REINSTATED

On July 4, 2025, the president signed the One Big Beautiful Bill Act (H.R. 1), which permanently reinstates the telehealth safe harbor for high-deductible health plans (HDHPs) starting in 2025. This provision allows HDHPs to offer telehealth services at low or no cost, expanding access for millions of individuals and dependents.

WHITE HOUSE RELEASES AI ACTION PLAN

On July 23, 2025, the White House released “Winning the Race: America’s AI Action Plan,” a document outlining nonbinding policy goals for federal regulation and support of AI. The plan emphasizes US manufacturing, deregulation, and trade, in alignment with existing administration priorities.