Health Care

The U.S. Department of Health and Human Services (“HHS”) has announced proposed changes (the “Proposed Rule”) to 42 C.F.R. Part 2 (“Part 2”). While the Health Insurance Portability and Accountability Act (“HIPAA”) governs the privacy and security of protected health information generally, Part 2 specifically governs the medical records of federally assisted substance use treatment programs (“SUD Records”).
Continue Reading Proposal to Overhaul Privacy Law Governing Substance Use Disorder Treatment Records

During the COVID-19 pandemic, Medicare coverage expanded to include a vast arsenal of tools that help patients access medical services while keeping patients and practitioners safe. Many of these tools involve telehealth services and were made possible by the COVID-19 emergency blanket waivers, which went into effect when the U.S. Department of Health & Human Services (“HHS”) declared a Public Health Emergency (the “PHE”). Some of these tools:
Continue Reading Finding Our Way Out of the Pandemic Haze: What Telehealth Tools Are Medicare Providers Allowed to Keep, and Which Must They Leave Behind?

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

In our decades working with complex organizations on their Ethics & Compliance (E&C) programs, my colleagues and I have seen a wide variety of structures. While we readily concede there is no one way to structure an E&C program, we have come to believe there are a few traits common to the best programs. Our fourth installment of OIG Shorts reviews traits common to the best programs.

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Continue Reading Organizational Integrity Shorts: Structure Matters

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

Welcome to our third installment of OIG Shorts. Ethics & Compliance programs that buck up against an employee’s reality—whether that reality is real or perceived—have less chance of succeeding. In this third edition of our OIG Shorts series, we explore the importance of developing what we call Reality-Based E&C Programs.

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Continue Reading Organizational Integrity Shorts: Reality Based Ethics & Compliance 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

Welcome back to our second installment of OIG Shorts. In this post, the Sheppard Mullin Richter & Hampton LLP Organizational Integrity Group focuses on the difference between Checking Boxes and Solving Problems from an Ethics & Compliance (E&C) perspective.

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Continue Reading Organizational Integrity Shorts: Everyone Benefits When An Ethics & Compliance Program Is Integrated Throughout An Organization

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

Over the course of the next few months, the Sheppard Mullin Organizational Integrity Group will be exploring a number of complex compliance matters in a series we call “OIG Shorts.”
Continue Reading Organizational Integrity Shorts: Everyone Benefits When An Ethics & Compliance Program Is Integrated Throughout An Organization