Health Care Watch: October 14, 2023
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from October 8 – October 14. 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 9, the House GOP Doctors Caucus released a policy proposal that would change the Medicare Physician Fee Schedule by offering flexibility surrounding the amount of money the Centers for Medicare & Medicaid Services (CMS) is able to spend – as CMS is currently limited by a budget neutrality requirement. The proposal would also update Medicare’s calculation of how much it costs to operate a physician practice.
On October 11, House Republicans voted to select House Majority Leader Steve Scalise (R-LA) as their nominee for Speaker. Rep. Scalise defeated Judiciary Chairman Jim Jordan (R-OH) in a secret ballot vote with reported results being 113 members for Leader Scalise and 99 members for Rep. Jordan. However, on October 12, Rep. Scalise announced that he will no longer seek the speakership as he was unlikely to secure the 217 votes needed on the House floor.
On October 13, Rep. Austin Scott (R-GA), an ally of Leader Scalise, officially filed to run against Rep. Jordan in the race for Speaker; however, Rep. Jordan defeated Rep. Scott in a 124-81 secret ballot vote later that day. It has been reported that 20 or more Republicans will not vote for Rep. Jordan on the floor, casting significant doubt on his candidacy.
On October 13, four centrist Democrats sent a letter to Acting Speaker Rep. Patrick McHenry (R-NC) stating that they support giving him temporary, expanded authorities that would allow the House to take up the most urgent bills — such as government funding plans.
Senate
On October 11, the Health, Education, Labor & Pensions (HELP) Committee announced that it will hold a hearing on the nomination of Monica Bertagnolli – the White House’s pick to lead the National Institutes of Health (NIH). The hearing will take place October 18, at 10:00 AM EST.
REGULATORY UPDATE
On October 10, the Department of Health & Human Services (HHS), through the Administration of Children and Families (ACF), announced $16.7 million in new grant awards to support 39 Community Economic Development (CED) projects. The grants will stimulate the creation of more than 575 new, full-time jobs with sustainable wages for individuals living in low-income communities in 26 states.
On October 10, CMS approved Washington state’s request to provide behavioral health services through community-based mobile crisis intervention teams. This makes Washington state the 11th state to adopt the flexibility.
On October 10, the Food & Drug Administration (FDA) posted the list of Center for Devices and Radiological Health (CDRH) guidance documents it intends to publish in fiscal year 2024. CDRH invites the public to submit comments on any or all the guidance document topics here.
On October 11, CMS’ Center for Medicare and Medicaid Innovation (Innovation Center) provided an update on the development of three drug pricing models that are being pursued in response to President Biden’s Executive Order 14087 Lowering Prescription Drug Costs for Americans. The models will include fixed Medicare copayment up to $2 a month for 150 drugs; a Medicaid cell and gene therapy model with states that will potentially launch by 2025; and a Medicare accelerated approval model that will extend to drugs beyond oncology drugs. Additional information can be found here.
On October 11, HHS Secretary Xavier Becerra issued a statement on World Mental Health Awareness Day 2023. Secretary Becerra highlighted the agency’s commitment to various mental health services, including Community Health Centers, expanded services in schools, Certified Community Behavioral Health Clinics, and the 988 Suicide & Crisis Lifeline.
On October 11, FDA announced the creation of a new Digital Health Advisory Committee to help the agency explore the complex, scientific and technical issues related to digital health technologies (DHTs) such as artificial intelligence/machine learning (AI/ML), augmented reality, virtual reality, digital therapeutics, wearables, remote patient monitoring and software. The committee will consist of a core of nine voting members including the chair. Those interested in serving or nominating a representative can find more information here. The committee should be fully operational in 2024.
On October 12, CMS released the 2024 premiums, deductibles, and coinsurance amounts for the Medicare Part A and Part B programs, and the 2024 Medicare Part D income-related monthly adjustment amounts. The annual deductible for Medicare Part B will be $240 in 2024, an increase of $14 from 2023. The Medicare Part A inpatient hospital deductible will be $1,632 in 2024, an increase of $32 in 2023. In 2024, the inpatient hospital coinsurance amount will be $408 per day for the 61st through 90th day of a hospitalization ($8 more than 2023) in a benefit period and $816 per day for lifetime reserve days ($16 more than 2023). More information on the 2024 Medicare Parts A and B premiums and deductibles can be found here. The 2024 Part D income-related monthly adjustment amounts for high-income beneficiaries can be found here.
On October 13, HHS, through the Administration for Strategic Preparedness and Response (ASPR), announced the selection of initial next-generation vaccine candidates and more than $500 million in awards for Project NextGen. The awards announced will support companies as they prepare their vaccine candidates for Phase 2b clinical evaluation. Awards include:
$8.5 million to CastleVax for a vector-based intranasal vaccine candidate;
$10 million to Codagenix for a live-attenuated intranasal vaccine candidate; and
$10 million to Gritstone Bio for a self-amplifying mRNA vaccine candidate.
Additional awards include over $240 million for investment in cold-chain sample management, genomic sequencing, and increased central laboratory capacity for sample testing, and over $241 million to support new technologies that will improve national preparedness for future COVID-19 outbreaks and patient access.
On October 13, CMS issued a National Coverage Analysis (NCA) Decision Memo removing the restrictive national coverage determination (NCD) for positron emission tomography (PET) beta amyloid imaging. In the absence of the NCD, CMS will allow Medicare Administrative Contractors (MACs) and Medicare Advantage plans to make determinations on covering the tests, which is expected to allow wider access to newer Alzheimer’s disease drug that combat beta amyloid plaque.
On October 13, CMS announced the 2024 Medicare Advantage (MA) and Part D Star Ratings and open enrollment. As a result of the new methodology adopted by CMS, a significant number of plans lost their 5 Star rating. This will impact the supplemental benefits these plans offer. Open enrollment begins October 15 and ends December 7.
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
Independent Dispute Resolution Operations (CMS-9897); Proposed Rule; 8/29/23
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
CY 2024 Changes to the End-Stage Renal Disease (ESRD) Prospective Payment System and Quality Incentive Program (CMS-1782); Final Rule; 10/10/23
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
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
OCR
Safeguarding the Rights of Conscience as Protected by Federal Statutes; Final Rule; 9/15/23
REPORTS
HHS Office of Inspector General (OIG)
On October 10, HHS OIG released a report examining expanded hospital transfer payment policies for discharges to post-acute care (PAC). OIG found that an expanded hospital transfer policy for discharges to PAC would result in significant cost savings to the Medicare program, and Medicare transfer payments would exceed hospital costs to provide care for most of the claims hospitals submit to Medicare. Of the 100 claims in OIG’s sample, 99 could have had transfer payments that were based on a reduced per diem rate (rather than the full payment) that would have resulted in net Medicare cost savings of $1 million. This amount represents the difference between the amount paid to the hospitals under the current policy for discharges to PAC and the amount that would have been paid if the policy had been expanded to include the MS-DRGs associated with OIG’s sampled claims. OIG stated that CMS officials had not conducted an updated analysis of claims data since 2005. OIG recommends that CMS conduct an analysis of its hospital transfer payment policy for discharges to PAC and expand the policy as necessary.
UPCOMING HEARINGS
House
Ways & Means Committee
October 17; 9:00 AM EST; Greenville NC
Field Hearing: on Access to Health Care in America: Challenges in Rural and Underserved Communities
Oversight Subcommittee
October 19; 9:00 AM; 1100 Longworth
Investigating Pandemic Fraud: Preventing History from Repeating Itself
October; TBD
Markup of drug and device legislation and hearing on the status of CMS’ Center for Medicare & Medicaid Innovation
Energy & Commerce Committee
Health Subcommittee
October 19; 10:00 AM; 2123 Rayburn
What’s the Prognosis?: Examining Medicare Proposals to Improve Patient Access to Care & Minimize Red Tape for Doctors
Witnesses: Meena Seshamani, MD, Director, Center for Medicare, CMS; Leslie Gordon, Director, Health Care, GAO; Paul Masi, Executive Director, Medicare Payment Advisory Commission
Senate
HELP Committee
October 18; 10:00 AM; 430 Dirksen
Nomination of Monica Bertagnolli to be Director of the National Institutes of Health
Witnesses: Monica Bertagnolli
October 27; 9:00 AM; Nicholas Music Center, Rutgers University
Field Hearing: Overworked and Undervalued: Is the Severe Hospital Staffing Crisis Endangering the Well-Being of Patients and Nurses?
October; TBD
Nonprofit Hospital Business Practices
Finance Committee
October 18; 10:00 AM; 216 Hart
Medicare Advantage Annual Enrollment: Cracking Down on Deceptive Practices and Improving Senior Experiences
Witnesses: Christina Reeg, Ohio Senior Health Insurance Information Program Director, Ohio Department of Insurance; Cobi Blumenfeld-Gantz, Co-Founder & Chief Executive Officer Chapter; Krista Hoglund, Chief Executive Officer, Security Health Plan.
Budget Committee
October 18: 10:00 AM; SD-608
Improving Care, Lowering Costs: Achieving Health Care Efficiency
Witnesses: Dr. Matthew Fiedler, Senior Fellow, The Brookings Institution; Leemore Dafny, Professor, Harvard Business School and Harvard Kennedy School; Alan Kurose, Chair, Rhode Island Foundation, and Former President Coastal Medical; Theo Merkel; Director of Private Health Reform Initiative, Senior Research Fellow, Paragon Health Institute, and Senior Fellow at the Manhattan Institute; Chapin White, Director of Health Analysis, Congressional Budget Office
OTHER POLICY NEWS
On October 9, Robert F. Kennedy, Jr, announced that he will run as an independent in the 2024 Presidential election.
On October 9, thousands of Walgreens pharmacy staff walked out in protest of working conditions that they state place employees and patients at risk. The protests could impact hundreds of stores nationwide.
On October 14, California Governor Gavin Newsom (D) signed legislation into law that will raise the minimum wage for most health care workers in the state to $25 per hour.