On January 17, 2024, the Departments of Health and Human Services, Labor, and the Treasury (collectively, the “Departments”) and the Office of Personnel Management issued a notice that they will reopen the period for submitting comments on the proposed rule, “Federal Independent Dispute Resolution (IDR) Operations” (the “Proposed Rule”) under the No Surprises Act (the “Act”).Continue Reading Comment Period for the No Surprises Act Proposed Rule, “Federal Independent Dispute Resolution (IDR) Operations,” Will Reopen
Lotan Barbaresso is an associate in the Governmental Practice in the firm's Washington, D.C. office.
On November 6, 2023, the Centers for Medicare and Medicaid Services (“CMS”) released the contract year 2025 proposed rule for Medicare Advantage (“MA”) organizations and Part D sponsors (the “Proposed Rule”). The Proposed Rule covers an array of regulatory topics including the Star Ratings program, marketing and communications, agent and broker compensation, health equity, dual eligible special needs plans (“D-SNPs”), utilization management, network adequacy, and access to biosimilars.Continue Reading CMS Promotes Competition, Transparency, Health Equity and More in the CY2025 Medicare Advantage and Part D Proposed Rule
The status of the independent dispute resolution (IDR) process under the No Surprises Act (NSA) is ever-evolving. Providers are waiting on the sidelines as cases weave their way through the court system. While the IDR process is currently on hold, it is incumbent on providers, payors, and individuals to remain vigilant and stay abreast of the forthcoming changes.Continue Reading Sheppard Mullin Webinar – No Surprises Act: Litigation Update and Recent Guidance
This month, pharmaceutical manufacturer, Merck & Co., Inc. (“Merck”), as well as four chambers of commerce, have filed suits against the federal government, arguing that the Medicare Drug Price Negotiation Program introduced by the Inflation Reduction Act of 2022 stands in violation of multiple constitutional provisions.Continue Reading The Drug Price Negotiation Program Faces Pushback from Private and Public Industry Participants
Effective March 1st, certain providers choosing to self-disclose Stark Law violations must use forms updated by the Centers for Medicare & Medicaid Services (“CMS”).Continue Reading CMS Streamlines Stark Law Self-Referral Disclosure Protocol (SRDP)
A. Health Care Providers Benefit from Internet and Social Media Presence.
Electronic medical record software and social media offer wide-ranging ways for health care providers to connect with their patients and the public. Having robust technology offerings support healthcare employers’ efforts to improve clinical integration and value-based care delivery efforts. It also provides greater patient access to healthcare information and engagement with their care team. Internet-based publishing and other social media channels allow healthcare providers opportunities for marketing and for patient education, and may expand access to health information for patients who may not seek regular medical care. There are huge benefits available from these resources for healthcare institutions and providers at every scale and in every specialty, which are likely to continue to expand in the future.Continue Reading Tick-Tock – Time for Healthcare Employers to Review Their Internet and Social Media Use Policies!
The abortion debate continues in America after the Supreme Court decision in Dobbs v. Jackson and the midterm elections on November 8th. Following our first post in this series, there have been a number of noteworthy developments* that occurred over the past month including several significant events at both federal and state levels as well as recent activity by registered voters during the midterms to protect access to reproductive care.Continue Reading Part 2: An Update on the Federal and State E-Roe-sion or P-Roe-tection of Abortion Rights
The Jackson v. Dobbs decision catalyzed a shift in the legal landscape of reproductive rights in the United States. The decision held that there is no federal constitutional right to an abortion, leaving the ability to regulate access to abortion services to the states. In the wake of this ruling, there have been a number of legal developments that range from states implementing laws that prohibit or restrict access to reproductive care, to federal agencies taking action to protect patient privacy and preserve access to reproductive care. Below are some of the most recent developments* at the federal and state levels:Continue Reading An Update on the Federal and State E-Roe-sion or P-Roe-tection of Abortion Rights
The Inflation Reduction Act (“IRA”) was signed into law by President Biden on August 16, 2022. The expansive legislation includes key health care provisions, including drug pricing reforms, inflationary rebates, Medicare Part D benefit redesign, as well as myriad other updates. Overall, the healthcare provisions of the IRA reflect the Administration’s goal of expanding the accessibility of healthcare to individuals by reducing costs to beneficiaries and capping charges by drug manufacturers. Nonetheless, additional clarification in the form of regulations is anticipated, as the text of the IRA defers multiple matters to the Department of Health and Human Services (“HHS”) for implementation.Continue Reading Healthcare Reforms Under the IRA: Expanding Access to Care
Since its passage in late 2018, the Eliminating Kickbacks in Recovery Act (EKRA) (18 U.S.C. § 220) has posed interpretive challenges. Our detailed critical analysis of EKRA is available here. EKRA prohibits, among other things, the exchange of remuneration for referrals of patients or patronage to a clinical laboratory, or an individual’s use of the services of a clinical laboratory. The law, however, leaves key terms undefined, including “referral”, “patronage”, and “use of services.” This ambiguity leaves unclear exactly which forms of conduct are prohibited by EKRA. Further, EKRA contains exceptions that overlap imperfectly with safe harbors under the Anti-Kickback Statute (AKS) and states, confusingly, that EKRA “shall not apply to conduct that is prohibited” by the AKS. The latter provision imperils the status of conduct that is within an AKS safe harbor, but which does not meet the requirements of an EKRA exception. No implementing regulations have been published to alleviate any of these ambiguities.Continue Reading California District Court Finds that EKRA Applies to Compensation Methodologies for Labs’ Employed Marketers Who Market to Physicians
President Biden issued Executive Order 13985, Advancing Racial Equity and Support for Underserved Communities Through the Federal Government (Executive Order) on inauguration day in 2021, signalizing the Administration’s intent to advance health care equity and racial justice in the United States by minimizing the influence of the social determinants of health. The Executive Order mobilized 90 federal agencies and 50 independent agencies to evaluate and implement action plans to reduce systemic barriers to access. On April 14, 2022, the U.S. Department of Health and Human Services (HHS), published the HHS Equity Action Plan (Action Plan).
Continue Reading The Biden Administration’s and HHS’s Plan to Advance Health Care Equity