Health Care Watch: July 2, 2023
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from June 25 – July 2. 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 June 28, Chair of the Select Subcommittee on the Coronavirus Pandemic Brad Wenstrup (R-OH), sent a letter to the Centers for Disease Control and Prevention (CDC) asking the agency to turn over all records and communications between its outgoing Director Rochelle Walensky and the leader of the American Federation of Teachers. The letter cites concerns over the agency’s school reopening guidance during the COVID-19 pandemic.
On June 29, the Energy and Commerce Health Subcommittee reported that it plans to mark-up legislation to reauthorize the Pandemic and All-Hazards Preparedness Act on July 13, according to a tentative committee schedule. In preparation for the mark-up, Health Subcommittee Ranking Member.
The House will return from its July 4 recess on July 11.
Senate
The Senate will return from its July 4 recess on July 10.
REGULATORY UPDATE
On June 26, the Centers for Medicare & Medicaid Services (CMS) issued the End-Stage Renal Disease (ESRD) Prospective Payment System proposed rule to update payment rates, the Quality Incentive Program, and other policies for calendar year (CY) 2024. The rule also includes requests for information regarding ESRD payment and quality programs. CMS is proposing to increase the ESRD PPS base rate to $269.99, increasing total payments to ESRD facilities in CY 2024 by approximately 1.6%. The CY 2024 ESRD PPS proposed rule includes several new proposals including a policy that would recognize the costs of certain new drugs for a three-year period after their transitional add-on payments end. A fact sheet can be found here. Comments on the proposed rule are due by August 25.
On June 26, the National Cancer Institute (NCI), part of the National Institutes of Health (NIH), awarded $50 million to launch the Persistent Poverty Initiative – an initiative to alleviate the cumulative effects of persistent poverty on cancer outcomes by building research capacity, fostering cancer prevention research, and promoting the implementation of community-based programs. These awards create five new Centers for Cancer Control Research in Persistent Poverty Areas that will advance priorities of the Administration’s Cancer Moonshot to reduce inequities in the structural drivers of cancer and prevent more cancers by reducing tobacco use and ensuring access to healthy food.
On June 27, the Department of Health & Human Services (HHS) released a final rule that implements requirements from the 21st Century Cures Act to allow HHS’ Inspector General to investigate information-blocking claims and issue fines. Specifically, the final rule amends the OIG’s civil money penalty (CMP) regulations to: incorporate new CMP authority for information blocking; incorporate new authorities for CMPs, assessments, and exclusions related to HHS grants, contracts, other agreements; and increase the maximum penalties for certain CMP violations.
On June 27, CMS’ Center for Medicare & Medicaid Innovation (CMMI) released an updated fact sheet regarding the voluntary Enhancing Oncology Model (EOM). EOM is a 5-year voluntary model, beginning on July 1, 2023, that aims to improve quality and reduce costs through payment incentives and required participant redesign activities. Under EOM, participating Physician Group Practices (PGPs) take on accountability for their patients’ health care quality and for total spending during six-month episodes of care for Medicare patients with certain cancers. CMS provides participants with the option to bill for a Monthly Enhanced Oncology Services (MEOS) payment for Enhanced Services provided to eligible beneficiaries. The MEOS payment is higher for beneficiaries dually eligible for Medicare and Medicaid. According to CMS, 67 oncology physician group practices are signed up to participate in EOM. This is a notably smaller number of participants than under the predecessor Oncology Care Model (OCM) that included 122 practices.
On June 27, CMS issued guidance to state Medicaid and Children's Health Insurance Program (CHIP) agencies on new mandatory coverage requirements – authorized by the Inflation Reduction Act (IRA) – for approved adult vaccines recommended by the Advisory Committee on Immunization Practices (ACIP) without cost sharing. Beginning October 1, 2023, the IRA requires state Medicaid and CHIP agencies to cover and pay for both the procurement and administration of adult vaccines recommended by ACIP. The guidance outlines the requirements that states must meet to claim a one percentage point federal medical assistance percentage (FMAP) increase for these services.
On June 28, HHS and the Department of Justice (DOJ) announced that criminal charges have been filed against 78 defendants, including 24 licensed medical providers and 6 doctors, across 17 federal districts for their alleged participation in fraud schemes resulting in $2.5 billion false billings to federal programs. The defendants are accused of defrauding taxpayer-funded programs that aid the elderly and disabled.
On June 28, FDA approved Lantidra, the first allogeneic (donor) pancreatic islet cellular therapy made from deceased donor pancreatic cells for the treatment of type 1 diabetes. Lantidra is approved for the treatment of adults with type 1 diabetes who are unable to approach average blood glucose levels because of current repeated episodes of severe low blood sugar.
On June 29, CDC Director Rochelle Walensky endorsed the CDC Advisory Committee on Immunization Practices’ (ACIP) recommendations for use of new Respiratory Syncytial Virus (RSV) vaccines from GlaxoSmithKline and Pfizer for people ages 60 years and older, using shared clinical decision-making. The recommendation comes after FDA approved both GlaxoSmithKline’s and Pfizer’s RSV vaccines in May and after a CDC advisory committee last week endorsed the shots for older adults.
On June 30, CMS released revised guidance detailing the requirements and parameters of the new Medicare Drug Price Negotiation Program for the first round of negotiations, which will occur during 2023 and 2024 and result in prices that will be effective beginning in 2026. Changes include: clarifications of how CMS will identify selected drugs; revisions to and clarifications of the process applicable for participating drug companies of selected drugs (including allowing manufacturers to publicly discuss the negotiation process, and removing the data destruction requirements in the initial guidance); and the inclusion of additional opportunities for drug companies and members of the public to engage with CMS during the negotiation process on the selected drugs. A fact sheet on the revised guidance can be found here.
On June 30, CMS issued the Home Health Prospective Payment System proposed rule for CY 2024. Among other policies, the proposed rule provides information on home health utilization trends and solicits comments regarding access to home health aide services; implements home health payment-related changes; rebases and revises the home health market basket and revises the labor-related share; codifies statutory requirements for disposable negative pressure wound therapy; and implements the new items and services payment for the home intravenous immune globulin (IVIG) benefit. The proposed rule also includes changes to the Home Health Quality Reporting Program (HH QRP) requirements and the expanded Home Health Value-Based Purchasing (HHVBP) Model. Under the proposal, CMS estimates that Medicare payments to HHAs in CY 2024 would decrease in the aggregate by 2.2 percent, or $375 million compared to CY 2023. A fact sheet can be found here. Comments on the proposed rule are due August 29.
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
CY 2024 Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Medicare; Proposed Rule; 4/18/23
CY 2024 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates (CMS-1786); Proposed Rule; 4/20/23
Minimum Staffing Standards for Long-Term Care Facilities (CMS-3442); Proposed Rule; 5/30/23
Request for Information; Episode-based Payment Model (CMS-5540-NC); Notice; 6/9/23
Streamlining the Medicaid, CHIP, and BHP Application, Eligibility Determination, Enrollment, and Renewal Processes (CMS-2421); Final Rule; 6/28/23
Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals; the Long-Term Care Hospital Prospective Payment System; and FY 2024 Rates (CMS-1785); Final Rule; 6/29/23
FDA
Informed Consent: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Notice; 5/19/23
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
Fixed-Combinations and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment or Prevention of Human Immunodeficiency Virus-One Under the President's Emergency Plan for Acquir; Notice; 6/12/23
Prescription Drug User Fee Act Waivers, Reductions, and Refunds for Fixed-Combinations and Single-Entity Versions of Previously Approved Antiretrovirals under the President's Emergency Plan; Notice; 6/12/23
Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder; Draft Guidance for Industry and Food and Drug Administration Staff; Availability; 6/12/23
Postmarketing Approaches to Obtain Data on Under-Represented Populations in Clinical Trials (Draft Guidance); Notice; 6/29/23
CDC
Possession, Use, and Transfer of Select Agents and Toxins; Biennial Review; Proposed Rule; 6/26/23
REPORTS
Congressional Budget Office (CBO)
On June 26, CBO released a cost estimate report examining the Telehealth Expansion Act of 2023. The legislation would permanently allow high-deductible health plans to offer telehealth before patients hit their deductible. CBO estimates that the legislation would cost $5.05 billion. According to CBO, the costs would come from lost revenue from Social Security payroll tax collections.
On June 26, CBO published a report entitled, CBO’s Macroeconomic Analysis of Legislation, Health Care Modeling, and Support for the Legislative Process. In response to a request from Chairman Jodey Arrington (R-TX) of the House Committee on the Budget, CBO provided information about the office’s ongoing work in macroeconomic analysis of legislation, health care modeling, and supporting the legislative process.
Government Accountability Office (GAO)
On June 28, GAO published a report entitled, Medicaid: CMS Oversight and Guidance Could Improve Recovery Audit Contractor Program. GAO reviewed states’ use of the Medicaid Recovery Audit Contractor (RAC) program and CMS’ oversight of these programs. GAO found that 34 states and the District of Columbia (D.C.) did not participate in the RAC program during fiscal year (FY) 2021, mostly because they had other Medicaid program-integrity initiatives in place. GAO also found that CMS does not have written procedures for documenting and monitoring their approvals for exempting states from the Medicaid RAC program. GAO made four recommendations including: (1) CMS should establish and implement written policies and procedures to document and communicate an expiration date for a state’s exemption from the RAC program; (2) CMS should establish and implement written policies and procedures for the agency to monitor expiration dates; (3) CMS, in collaboration with the states, should describe the effectiveness of the RAC program and include recommendations for expanding or improving the program in their annual report to Congress; and (4) CMS should conduct a study to determine whether it is cost effective to require states to include payments to managed care organizations and their providers as part of the RAC program.
UPCOMING CONGRESSIONAL HEARINGS
House
Oversight and Accountability Committee
July 11; 10:00 AM; 2154 Rayburn
Investigating the Proximal Origin of a Cover Up
Energy & Commerce Committee
July 13; TBD
Markup of the Pandemic and All-Hazards Preparedness Act
Small Business Committee
July 13; 2:00 PM; 2360 Rayburn
Pandemic Fraud Accountability: Reviewing the SBA Inspector General’s COVID-19 Fraud Report
Oversight, Investigations, and Regulations Subcommittee
July 19; 10:00 AM; 2360 Rayburn
Burdensome Red Tape: Overregulation in Health Care and the Impact on Small Businesses