Pharmaceutical manufacturers are challenging the breadth of the Federal Anti-Kickback Statute (“AKS”) in federal court, arguing that the government is harming the very vulnerable patients it aims to serve by prohibiting cost-sharing subsidies for life-saving oncology drugs. In October, we discussed the Office of Inspector General’s (“OIG”) Advisory Opinion No. 22-19 (the “Advisory Opinion”), which declared that a charitable organization funded by manufacturers would violate the AKS if it offered certain cost-sharing subsidies under Medicare Part D (“Part D”), even if the organization was independently run and patients had equal access to discounts for 90% of drugs on the market. On November 9, 2022, the Pharmaceutical Coalition for Patient Access (“PCPA”), presumably the organization behind the Advisory Opinion, filed a lawsuit against OIG, seeking declaratory judgment that its cost-sharing program is legal under the AKS and that the Advisory Opinion violates the Administrative Procedure Act (“APA”) and the First Amendment.[1]

Continue Reading Pharmaceutical Manufacturers Ask EDVa to Allow Cost-Sharing Under the AKS

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

On June 30, 2022, Governor Gavin Newsom signed legislation to stabilize and promote the retention of California’s healthcare workforce in response to the COVID-19 pandemic. This response included the allocation of $1.3 billion for retention payments to physicians and other clinical and non-clinical healthcare workers. California’s Department of Health Care Services (“DHCS”) will administer the distribution of those funds through its Hospital and Skilled Nursing Facility COVID-19 Worker Retention Payment program (the “WRP”). The program is designed so that WRP payments will first be made to eligible employers, who then will pass through the WRP funds to individual physicians and other healthcare workers. In order to receive WRP funds, California employers must register with and provide certain information to DHCS on an expedited timeline.

Continue Reading Important Deadline Approaches for California Healthcare Employers to Apply for Worker Retention Payments

On Monday, we discussed that the Centers for Medicare and Medicaid Services (“CMS”) has heightened oversight of Medicare Advantage (“MA”) organizations’ and Part D sponsors’ marketing practices. We also noted that the United States Senate Committee on Finance (the “Committee”) sent letters to 15 state insurance commissioners and state health insurance assistance programs, requesting data and information on MA marketing complaints in August 2022. Yesterday, the Committee, chaired by Ron Wyden, released a report entitled Deceptive Marketing Practices Flourish in Medicare Advantage (“the Report”).

Continue Reading Senate Committee Issues Report On Deceptive Marketing Practices in Medicare Programs

CMS announced today a further extension until February 1, 2023, of the deadline for its publication of the long-awaited final rule on the use of extrapolation and the application of a fee-for-service adjuster (FFS Adjuster) in risk adjustment data validation (RADV) audits of Medicare Advantage organizations (MAOs).

Continue Reading CMS Pushes Publication of Final FFS Adjuster for RADV Audits Rule to February 1, 2023

In May, we discussed the final rule on Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs (the “Final Rule”) issued by the Centers for Medicare and Medicaid Services (“CMS”). In the Final Rule, CMS established certain marketing and communication requirements for Medicare Advantage (“MA”) organizations and Part D prescription drug sponsors (PDPs), intending to address complaints of inappropriate marketing that indicated it CMS received from beneficiaries and their caregivers.

Continue Reading CMS Heightens Oversight of TPMO Marketing Programs, Restricts TV Advertisements

Increasing Unionization Efforts in the U.S. Labor Market and Healthcare Sector

In recent months, the United States has seen workers’ unionization and collective bargaining efforts gain momentum across industries, including healthcare. Current reporting attributes this growth in organized labor activities to the tight labor market, heightened risks to some workers during the pandemic, a favorable political environment, and increased awareness among workers. At the same time, healthcare workers in particular are reporting higher rates of burnout, depression, and stress, causing some to consider leaving the industry.

Continue Reading How Healthcare Employers Can Prepare for Employee Unionization Efforts

On October 21, 2022, the Centers for Medicare and Medicaid Services (CMS) announced changes to its Special Focus Facility (SFF) program, including new steps to address nursing home facilities that fail to graduate from the SFF program in a timely manner, or “yo-yo” back into non-compliance after graduating from the SFF program. These changes are consistent with the Federal government’s goal of improving safety and quality of care for the nation’s roughly 1.5 million nursing home residents.

Continue Reading Long Term Care Update: CMS Revises Criteria for its Special Focus Facility Initiative

Effective January 1, 2024, the recently enacted California Assembly Bill 1278,[1] requires a physician and surgeon (defined as a physician and surgeon licensed pursuant to the Medical Practice Act or an osteopathic physician and surgeon licensed by the Osteopathic Medical Board of California under the Osteopathic Act, but not a physician or surgeon working in a hospital emergency room) to provide a written or electronic notice of the Open Payments database to a patient at the initial office visit. The written or electronic notice shall contain the following text:

Continue Reading California Passes First State Law Requiring Physicians to Disclose Open Payments Database to Patients

On October 5, 2022, the Office of Inspector General (“OIG”) posted Advisory Opinion No. 22-19 (the “Opinion”), which limits the ability of pharmaceutical manufacturers to offer cost-sharing subsidies to Medicare Part D (“Part D”) beneficiaries via 501(c)(3) charities without running afoul of the Federal Anti-Kickback Statute (the “AKS”).

Continue Reading OIG Limits Pharmaceutical Manufacturers’ Ability to Offer Drug Cost-Sharing Subsidies

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