Health Care Watch: August 26, 2023
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from August 20 – August 26. Where available, hyperlinks are included to the relevant documents. Please let us know if you have any questions or would like additional information on the items below.
LEGISLATIVE UPDATE
House
On August 21, the Freedom Caucus formally announced that its members will oppose a stopgap spending bill to keep the government open past September 30, 2023, if their legislative priorities are not met. The caucus is calling for the enactment of GOP border legislation, action to address “weaponization” of the Justice Department, and an end to recent Pentagon policies.
On August 24, Oversight Select Subcommittee on the Coronavirus Pandemic Chairman Brad Wenstrup (R-OH), sent a letter the Federal Bureau of Investigation (FBI) and the Department of Health & Human Services (HHS) asking for information regarding an unlicensed lab in California linked to a Chinese-owned company. The lab was reportedly conducting potentially dangerous experiments. The letter notes “it is highly concerning that an unlicensed lab operated by a Chinese company on American soil was apparently conducting dangerous research involving COVID-19 and other viruses.”
The House returns from its August recess on September 12.
Senate
The Senate returns from its August recess on September 5.
REGULATORY UPDATE
On August 21, the Centers for Medicare & Medicaid Services (CMS) released the first of a two-part guidance detailing the requirements and parameters of the Part D maximum monthly cap on cost-sharing payment program, established by the Inflation Reduction Act. CMS has renamed the program that is commonly referred to as copayment “smoothing” as the Medicare Prescription Payment Plan. The program begins in 2025 and requires all Part D plans to offer enrollees the option to pay out-of-pocket prescription drug costs in the form of capped monthly installment payments instead of all at once at the pharmacy. The draft guidance requests public comment on key elements of the new program. A fact sheet outlining the guidance can be found here. Comments are due on September 20.
On August 21, the Food & Drug Administration (FDA) approved Pfizer’s Respiratory Syncytial Virus (RSV) vaccine), Abrysvo, the first vaccine approved for use in pregnant individuals to prevent lower respiratory tract disease (LRTD) and severe LRTD caused by RSV in infants from birth through 6 months of age. Abrysvo is approved for use at 32 through 36 weeks gestational age of pregnancy.
On August 21, HHS Secretary Xavier Becerra announced Jeffrey Nesbit as the Assistant Secretary for Public Affairs.
On August 22, HHS’ Administration for Strategic Preparedness and Response (ASPR), awarded more than $1.4 billion for Project NextGen to support the development of a new generation of tools and technologies to protect against COVID-19. Awards announced include $1 billion to four BARDA Clinical Trial partners to support vaccine Phase IIb clinical trial studies, $326 million to Regeneron to support the development of a next-generation monoclonal antibody for COVID-19 prevention, $100 million to Global Health Investment Corp, and $10 million to Johnson & Johnson Innovation (JLABS).
On August 22, the U.S. Preventive Services Task Force published a final recommendation statement on pre-exposure prophylaxis (PrEP) for the prevention of HIV. Based on its review of the evidence, the Task Force recommended that healthcare professionals prescribe PrEP to people at increased risk for HIV to help prevent HIV.
On August 22, CMS announced that nearly 400 hospices are being considered for potential administrative action as of mid-August. The announcement comes after site visit initiatives and reports of fraudulent hospices, particularly in Arizona, California, Nevada, and Texas, some of whom have addresses listed that appeared to be non-operational. Hospices that can't demonstrate their compliance could be deactivated or revoked from Medicare.
On August 23, CMS released corrections to the Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs proposed rule. Corrections were minor and can be found here.
On August 23, HHS announced that it has awarded more than $64 million in funding to address the nation’s mental health crisis through the Substance Abuse and Mental Health Services Administration. Among the awards are $59.4 million in new funding to states and territories through the Community Mental Health Services Block Grant (MHBG) program. The funds released on August 23 were part of the mental health investment of the Bipartisan Safer Communities Act (BSCA) which allocated a total of $250 million in supplemental funding from FY 2022-2025.
On August 23, the Department of Justice announced the results of a coordinated, nationwide enforcement action to combat COVID-19 fraud, which included 718 enforcement actions – including federal criminal charges against 371 defendants – for offenses related to over $836 million in alleged COVID-19 fraud.
On August 23, HHS’ Office on Women’s Health (OWH) launched a new nationwide campaign, "Stronger than Sarcopenia,” to raise awareness of sarcopenia in women, a condition characterized by loss of muscle mass, strength, and function in adults 65 and older.
On August 24, CMS announced that the Medicare Shared Savings Program saved Medicare $1.8 billion in 2022 compared to spending targets for the year, representing the second-highest annual savings accrued for Medicare since the program’s inception more than ten years ago.
On August 24, FDA approved Tyruko (natalizumab-sztn), the first biosimilar to Tysabri (natalizumab) injection for the treatment of adults with relapsing forms of multiple sclerosis (MS). Tyruko, like Tysabri, is also indicated for inducing and maintaining clinical response and remission in adult patients with moderately to severely active Crohn’s Disease (CD).
On August 24, the Centers for Disease Control and Prevention (CDC) launched the Hospital Sepsis Program Core Elements to support all U.S. hospitals in ensuring effective teams and resources are in place to be able to quickly identify sepsis and save more lives. This new resource is intended to help hospitals implement, monitor, and optimize sepsis programs and improve survival rates.
On August 24, HHS’ Office for Civil Rights (OCR) announced a settlement with UnitedHealthcare Insurance Company (UHIC) concerning a potential violation of the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule's right of access provision. The rule requires that patients be able to access their health information in a timely manner. This investigation marks the 45th right of access case to be resolved via voluntary settlement. UHIC agreed to implement a corrective action plan and pay $80,000 to resolve this investigation.
On August 25, CDC announced that the Advisory Committee on Immunization Practices (ACIP) will meet September 12, 2023, to discuss whether to recommend updated COVID-19 vaccines. It is expected those shots will be available soon after expected approval in mid-September.
Reports indicate that CMS will release the names of the first 10 drugs that will be selected for the IRA’s drug negotiation program as early as August 29.
WHITE HOUSE
On August 23, the Biden Administration’s Cancer Moonshot initiative announced the launch of “Curing the Uncurable via RNA-Encoded Immunogene Tuning” (CUREIT), a project that aims to develop generalizable mRNA platforms that can be harnessed to train the immune system to more effectively fight cancer and other diseases. CUREIT will be led by a team at Emory University in Atlanta, Georgia, with up to $24 million in new funding from the Advanced Research Projects Agency for Health (ARPA-H).
On August 25, President Biden designated August 27 through September 2 as Overdose Awareness Week. President Biden highlighted past and future administrative actions aimed at curbing opioid overdose deaths including expanding state and community mental health and substance use disorder services and disrupting the flow of illicit drugs.
RULES AT THE WHITE HOUSE OFFICE OF MANAGEMENT & BUDGET (OMB)
Pending Review
CMS
Medicare Secondary Payer and Certain Civil Money Penalties (CMS-6061); Final Rule; 3/1/22
Minimum Staffing Standards for Long-Term Care Facilities (CMS-3442); Proposed Rule; 5/30/23
Streamlining the Medicaid, CHIP, and BHP Application, Eligibility Determination, Enrollment, and Renewal Processes (CMS-2421); Final Rule; 6/28/23
Mandatory Medicaid and Children's Health Insurance Plan (CHIP) Core Set Reporting (CMS-2440); Final Rule; 7/28/23
Clinical Laboratory Improvement Amendments of 1988 (CLIA) Fees; Histocompatibility, Personnel, and Alternative Sanctions for Certificate of Waiver Laboratories (CMS-3326); Final Rule; 7/31/23
CMS Enforcement of State Compliance with Reporting and Federal Medicaid Renewal Requirements Under Section 1902(tt) of the Social Security Act (CMS-2447); Interim Final Rule; 8/16/23
Strengthening Oversight of Accrediting Organizations (AO) and Preventing AO Conflict of Interest, and Related Provisions (CMS-3367); Proposed Rule; 12/27/22
Contract Year 2025 Policy and Technical Changes to the Medicare Advantage, Medicare Prescription Drug Benefit, and Medicare Cost Plan Programs, and PACE (CMS-4205); Proposed Rule; 8/24/23
FDA
Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, Neutral Manner in Advertisements in Television and Radio Format; Final Rule; 5/19/23
Communications from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Certain Legally Marketed Medical Products: Questions and Answers (CDER, 2023-155); Notice; 7/13/23
Medical Devices; Laboratory Developed Tests; Proposed Rule; 7/26/23
Drug Supply Chain Security Act Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs; Guidance for Industry; Availability; Notice; 8/24/23
REPORTS
Office of Inspector General (OIG)
On August 18, OIG released a report examining payments made to opioid treatment programs (OTPs) for opioid use disorder (OUD) treatment services. OIG found that Medicare made up to $17.8 million in potentially improper payments to OTPs, consisting of the following payments: $10.4 million for claims for which a bundled payment was made for a weekly episode of care; $5.1 million for take-home supplies of medication that were covered by other payments for take-home supplies of medication or by payments for weekly bundles that included medication; $1.3 million for OUD treatment services that were claimed without an OUD diagnosis; and $1 million in payments for intake activities that occurred a total of 14 or more times for the same enrollee during the audit period. OIG recommends that CMS: 1) work with Medicare Administrative Contractors (MACs) and other Medicare contractors to determine whether claims billed by OTPs for OUD treatment services complied with Medicare requirements; 2) instruct MACs to notify appropriate providers so that they can exercise reasonable diligence to identify, report, and return any overpayments; and 3) instruct MACs to implement edits in their claims processing systems to prevent an OTP from being paid for two weekly bundles with the same service date for the same enrollee at the same OTP.
UPCOMING HEARINGS
House
Energy & Commerce Committee
September 19; time TBD
Hearing on innovation
OTHER POLICY NEWS
On August 21, the Journal of Health Services Research released a study finding that low-income Medicare-enrolled patients and patients of color are more likely to be discharged from home health care without functional improvement than white and higher-income patients. The study found that 79% of white and higher-income patients had functional improvement compared with 76% for Asian American Pacific Islanders, 72% for Black and American Indian and Alaska Native patients, 71% for low-income and 70% for Hispanic patients.
On August 22, the Congressional Budget Office (CBO) announced the members of its Panel of Health Advisers for the coming year. The list of advisors can be found here.
On August 25, AstraZeneca filed a lawsuit against the Biden Administration challenging the IRA’s drug negotiation program. In addition to constitutional arguments, consistent with those included in previous challenges to the program, AstraZeneca’s complaint also centers on procedural arguments that CMS overstepped its authority in how it interpreted parts of the law – including the “bona fide” marketing standard for generic drugs. The complaint also argues that the IRA is inconsistent with the goals of the Orphan Drug Act (ODA), a federal statute designed to encourage manufacturers to invest in new therapies for rare diseases. Analysts expect that the manufacturer’s asthma drug Symbicort could be selected in the first round of negotiation.