Health Care Watch: October 28, 2023
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from October 23 – October 28. 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 October 20, a bipartisan group of more than one hundred members of Congress, led by Rep. Greg Pence (R-IN) and Jared Golden (D-ME), sent a letter to Department of Health & Human Services (HHS) Secretary Xavier Becerra urging him to reconsider the proposed minimum federal staffing standards for nursing homes. The letter states that these standards would limit care for older adults, drive up state Medicaid costs and lead to nursing home closures.
On October 24, Rep. Mike Johnson (R-LA) won a closed-door vote to become the Republican party’s fourth Speaker nominee. On October 25, Rep. Johnson was elected as Speaker, securing 220 votes on the floor – ending the three week period in which the House of Representatives did not have a formal Speaker.
On October 25, Speaker Johnson proposed a floor vote on the Departments of Labor, HHS, and Education and the Department of Agriculture appropriations bills the week of November 13.
On October 25, the Energy & Commerce Health Subcommittee held a hearing examining the minimum staffing and Medicaid access proposed rules introduced by the Biden Administration. The hearing discussed the implications of both rules on nursing home health and patient quality of care.
On October 25, Energy & Commerce Committee Chair Cathy McMorris Rodgers (R-WA), Health Subcommittee Chairman Brett Guthrie (R-KY), and Oversight & Investigations Subcommittee Chairman Morgan Griffith (R-VA) sent a letter to Centers for Disease Control and Prevention (CDC) Director Mandy Cohen requesting documents and information related to CDC’s continued dissemination and reliance on COVID tracker data, which the letter states may contain inaccurate numbers.
Senate
On October 23, Health, Education, Labor & Pensions (HELP) Committee Chairman Bernie Sanders (I-VT), sent a letter to HHS Inspector General Christi Grimm, urging a thorough investigation into the National Institutes of Health (NIH) after it proposed granting an exclusive patent license to a company linked to a former employee for a treatment for cervical cancer that could potentially be worth hundreds of millions of dollars. Chairman Sanders is requesting that HHS’s Office of Inspector General (OIG) immediately initiate an investigation into this matter.
On October 25, the HELP committee voted 15-6 to advance the nomination of Monica Bertagnolli as Director of NIH.
On October 26, Finance Committee Chairman Ron Wyden (D-OR) led Committee Democrats in sending a letter to Centers for Medicare & Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure. The letter asks that the agency take additional steps to protect seniors from deceptive practices used by marketing middlemen in Medicare Advantage (MA). The letter urges CMS to leverage every opportunity to identify bad actors who are taking advantage of Medicare beneficiaries and to maintain robust enforcement of these MA marketing requirements.
REGULATORY UPDATE
On October 23, CDC issued a Health Alert Network (HAN) Health Advisory to provide options for clinicians to protect infants from respiratory syncytial virus (RSV) in the context of a limited supply of nirsevimab. In the context of limited supply during the 2023–2024 RSV season, CDC recommended prioritizing available nirsevimab doses for infants at the highest risk for severe RSV disease: young infants (age <6 months) and infants with underlying conditions that place them at highest risk for severe RSV disease.
On October 24, HHS Secretary Xavier Becerra, his Chief of Staff Sean McCluskie, Counselor to the Secretary Stacy Sanders, and CMS Chief of Staff Erin Richardson held a roundtable with health care and consumer advocacy organizations to discuss how these groups can work together with the Biden-Harris Administration to educate consumers about the new Medicare prescription drug benefits under the Inflation Reduction Act, and how they can amplify this education during Medicare’s Open Enrollment period, which began on October 15 and runs through December 7.
On October 24, the FDA approved Tibsovo (ivosidenib) for the treatment of adult patients with relapsed or refractory (R/R) myelodysplastic syndromes (MDS) with an isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test. This is the first targeted therapy approved for this indication.
On October 25, the Cybersecurity and Infrastructure Security Agency (CISA) and HHS co-hosted a roundtable discussion on the cybersecurity challenges that the U.S. healthcare and public health (HPH) sector system faces, and how government and industry can work together to close the gaps in resources and cyber capabilities. Ahead of the roundtable, CISA and HHS released a cybersecurity tool kit that includes resources tailored for the healthcare and public health sector. The toolkit can be found here.
On October 25, CMS announced that Affordable Care Act (ACA) Marketplace consumers can preview their health care coverage options and see detailed information about 2024 health insurance plans and prices offered in their area ahead of the Open Enrollment period that begins November 1.
On October 25, CMS released a fact sheet for the ACA Marketplace 2024 open enrollment period. The fact sheet details the enrollment timeline, eligibility requirements, and other frequently asked questions.
On October 25, CMS released the October 2023 Skilled Nursing Facility (SNF) Quality Reporting Program (QRP) data. The data is available on Care Compare and Provider Data Catalog (PDC).
On October 26, FDA advised the public, including healthcare providers, of the possible risks that products containing live bacteria or yeast, which are commonly called probiotics, pose to preterm infants in hospital settings. The agency recently sent a letter to healthcare providers warning them about this topic and has issued two warning letters to companies for illegally selling their products for use in treating or preventing certain diseases in preterm infants.
On October 26, CMS announced that it will host a live Q&A session regarding the Health Equity Confidential Feedback Reports released on October 16, 2023. The Q&A session will give participants an opportunity to ask and learn about answers to commonly asked questions regarding the report’s methodologies and interpretations from CMS subject matter experts. Registration for the event can be found here.
On October 27, HHS Secretary Xavier Becerra sent a letter to COVID-19 therapeutics manufacturers, distributors, pharmacies and the health care payer community. The letter asks for ongoing partnership during the transition of the COVID-19 oral antiviral treatments from government distribution to traditional health care distribution channels.
On October 27, CMS released the Federal Independent Dispute Resolution (IDR) Operations Proposed Rule. The proposed rule addresses specific issues critical to improving the functioning of the Federal IDR process under the No Surprises Act (NSA) in response to feedback and challenges noted by interested parties. Overall, if finalized, this proposed rule would facilitate improved communications between payers, providers, and certified IDR entities; adjust specific timelines and steps of the Federal IDR process; establish new batching provisions; create more efficiencies; and change the administrative fee structure to improve accessibility of the process. It is the Departments’ intention that together, these proposals would result in improved operations of the Federal IDR process and more timely payment determinations. A fact sheet detailing the rule can be found here. Comments are due on January 2, 2024.
On October 27, CMS issued the 2024 End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) Final Rule. The final rule updates payment rates and policies under the ESRD prospective payment system (PPS) for renal dialysis services furnished to Medicare beneficiaries on or after January 1, 2024. The rule also updates the acute kidney injury (AKI) dialysis payment rate for renal dialysis services furnished by ESRD facilities for calendar year (CY) 2024. For CY 2024, CMS is increasing the ESRD PPS base rate to $271.02, increasing total payments to ESRD facilities by approximately 2.1%. A fact sheet detailing the rule can be found here.
WHITE HOUSE
On October 25, the Biden Administration asked Congress to provide $1.55 billion in supplemental funding to help strengthen addiction treatment, overdose prevention measures, and recovery support services in all States, Territories, and Tribal Nations.
On October 27, it was reported that President Biden will issue an Executive Order (EO) dealing with Artificial Intelligence (AI) in health care. The EO is expected to give HHS 180 days to develop a strategy to determine whether AI is sufficiently high-quality to for use in health care, to analyze how non-discrimination laws might intersect with AI, how AI could be used to detect errors, and if AI could be used to craft personalized immune response profiles for patients, among other tasks.
RULES AT THE WHITE HOUSE OFFICE OF MANAGEMENT & BUDGET (OMB)
Pending Review
CMS
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
Appeal Rights for Certain Changes in Patient Status (CMS-4204); Proposed Rule; 9/18/23
Disclosures of Ownership and Additional Disclosable Parties Information for Skilled Nursing Facilities and Nursing Facilities (CMS-6084); Final Rule; 9/19/23
CY 2024 Home Health Prospective Payment System Rate Update and Home Infusion Therapy Services Payment Update (CMS-1780); Final Rule; 9/27/23
CY 2024 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates (CMS-1786); Final Rule; 10/2/23
Interoperability and Prior Authorization for MA Organizations, Medicaid and CHIP Managed Care and State Agencies, FFE QHP Issuers, MIPS Eligible Clinicians, Eligible Hospitals and CAHs (CMS-0057); Final Rule; 10/25/23
Healthcare System Resiliency and Modernization (CMS-3426); Proposed Rule; 10/12/23
FDA
Drug Products or Categories of Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act; Proposed Rule; 8/29/23
Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations; Final Rule; 9/7/23
Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability (CDER, 2023-357); Notice; 10/23/23
Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability (CDER, 2023-356): Notice; 10/23/23
OCR
Safeguarding the Rights of Conscience as Protected by Federal Statutes; Final Rule; 9/15/23
Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing; Final Rule’ 10/19/23
SAMHSA
Medications for the Treatment of Opioid Use Disorder; Final Rule; 10/24/23
REPORTS
Office of Inspector General (OIG)
On October 23, OIG released a report examining states challenges meeting third party liability (TPL) requirements for ensuring that Medicaid functions as the payer of last resort. OIG found that states reported that they continue to experience several challenges in their efforts to meet TPL requirements, including: difficulties obtaining complete, accurate, and up-to-date coverage information from Medicaid enrollees and providers; difficulties obtaining timely and reliable coverage information from third parties; difficulties coordinating TPL with out-of-State third parties; technical issues related to third-party coverage information received and electronic billing of Medicaid claims with third parties; a lack of Federal prompt payment requirements and penalties for third parties that do not cooperate with States' efforts to meet TPL requirements; difficulties coordinating TPL with TRICARE; and difficulties coordinating TPL with Medicare. OIG recommends that CMS develop an action plan that addresses States' ongoing TPL challenges. OIG made six additional procedural recommendations and one recommendation involving $1.25 million in questioned costs. All recommendations can be found in the complete report.
UPCOMING HEARINGS
House
Ways & Means Committee
November
Markup of drug and device legislation and hearing on the status of CMMI
Senate
Finance Committee
Week of November 6
Markup up legislation extending existing health care policies under the committee’s jurisdiction, including mental health and pharmacy benefit manager policies
HELP Committee
TBD
Non-profit Hospital Business Practices
OTHER POLICY NEWS
On October 23, the Medicare Payment Advisory Commission (MedPAC) announced the policy issues the commission will be working on during the 2023–2024 meeting cycle. In the coming months, the Commission will:
Analyze the adequacy of Medicare’s fee-for-service payments for hospitals, clinicians, outpatient dialysis facilities, skilled nursing facilities, home health agencies, inpatient rehabilitation facilities, and hospice agencies;
Engage in work on MA and plans to discuss MA coding intensity, standardizing enrollee cost sharing and certain supplemental benefits, favorable selection in MA, and dual-eligible special needs plans; and
Work on several other issues in the Medicare program, including methods of updating payment rates under the physician fee schedule, payments for certain types of cases in inpatient rehabilitation facilities, staffing at skilled nursing facilities, the Acute Care Hospital at Home program, generic drug prices in the Medicare Part D program, and Medicare coverage of and payment for software.
On October 27, MedPAC released its November 2023 public meeting topics and times. The meetings will take place on November 2 and 3. Topics being discussed include rural emergency hospitals, dual-eligible special needs plans, the MedPAC work plan, Medicaid coverage of and payment for software as a medical device, favorable selection in MA, and evaluating access in MA. More information about topics and times can be found here.