Health Care Watch: August 5, 2023
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from July 30 – August 5. 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 July 28, Energy & Commerce Committee Chair Cathy McMorris Rodgers (R-WA) released a legislative discussion draft with policy proposals to address ongoing drug shortages. The proposal aims to provide market flexibility, increase transparency for pharmacy benefit managers (PBMs), and address supply chain disruptions. Comments are requested by August 25. The legislative text can be found here and a summary can be found here.
On August 2, Energy & Commerce Committee Chair Rodgers (R-WA), Health Subcommittee Chairman Brett Guthrie (R-KY), and Oversight & Investigations Subcommittee Chairman Morgan Griffith (R-VA) sent a letter to the Government Accountability Office (GAO) requesting an examination of the risks and benefits derived from gain-of-function research involving pathogens with pandemic potential. The letter also requests that GAO gather more information about the way gain-of-function research is being defined and used by various U.S. agencies.
REGULATORY UPDATE
On July 28, the Food & Drug Administration (FDA) approved RiVive, a naloxone hydrochloride nasal spray for over-the-counter (OTC), nonprescription use for the emergency treatment of known or suspected opioid overdose. This is the second nonprescription naloxone product the agency has approved.
On July 31, the Centers for Medicare & Medicaid Services (CMS) issued the Fiscal Year (FY) 2024 Skilled Nursing Facility Perspective Payment System final rule. The final rule will increase payments by a net 4%, or $1.4 billion, in FY 2024 relative to FY 2023 levels. This includes a 3% market basket increase which was reduced by a 0.2% productivity cut, increased by a 3.6% market basket forecast error adjustment for FY 2022, and reduced by a 2.3% behavioral adjustment related to the transition to the patient-driven payment model. The final rule also includes updates to the SNF Quality Reporting Program (QRP) and the SNF Value-Based Purchasing (VBP) Program for FY 2024 and future years, including the adoption of a measure intended to address staff turnover. A fact sheet on the rule can be found here.
On July 31, CMS released 2024 projected Medicare Part D premium and bid information. CMS provides this information to assist Part D plan sponsors finalize their offerings and help enrollees understand overall Part D premium trends ahead of Medicare open enrollment. The average total Part D beneficiary premium is projected to decrease by 1.8%, from $56.49 in 2023 to $55.50 in 2024.
On July 31, CMS announced a new nationwide voluntary model, the Guiding an Improved Dementia Experience (GUIDE) Model, which aims to improve the quality of life for people living with dementia through a package of care coordination and management, caregiver education and support, and respite services. Through the GUIDE Model, CMS will test an alternative payment for participants who deliver key supportive services to people with dementia, including comprehensive, person-centered assessments and care plans, care coordination, and 24/7 access to a support line. CMS will release the application for GUIDE in fall 2023. Prior to the application release, interested organizations are encouraged to submit letters of intent to CMS by September 15, 2023. The model will run for eight years beginning July 1, 2024.
On July 31, Department of Health & Human Services (HHS) Secretary Xavier Becerra announced the formation of the Office of Long COVID Research and Practice. The Office of Long COVID Research and Practice will be located within HHS’s Office of the Assistant Secretary for Health under the leadership of the HHS Assistant Secretary for Health, Admiral Rachel Levine. The Office is charged with on-going coordination of the whole-of-government response to the longer-term effects of COVID-19, including long COVID and associated conditions and the implementation of the National Research Action Plan on Long COVID and the Services and Supports for Longer-Term Impacts of COVID-19.
On July 31, the National Institutes of Health (NIH) launched multiple clinical trials aimed at evaluating potential treatments for long COVID. The announcement comes from NIH’s RECOVER initiative. The studies will test at least four potential treatments for the condition, including drugs, biologics, medical devices and other therapies. The trials will be informed by the symptoms that other research has found have been the most burdensome for people with long COVID, such as nervous system dysfunctions like chronic fatigue and brain fog.
On August 1, CMS issued the FY 2024 Hospital Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital (LTCH) Prospective Payment System (PPS) final rule. The final rule implements an increase in operating payment rates of 3.1%. CMS estimates that the increase in operating and capital IPPS payment rates will generally increase hospital payments in FY 2024 by $2.2 billion. The final rule also adopts hospital quality measures to foster safety, equity, and reduce preventable harm in the hospital setting, and recognizes homelessness as an indicator of increased resource utilization in the acute inpatient hospital setting. A fact sheet on the rule can be found here.
On August 2, NIH Acting Director Lawrence Tabak announced Dr. Jeanne Marrazzo as Director of NIH’s National Institute of Allergy and Infectious Diseases (NIAID). Dr. Marrazzo is currently the Director of the Division of Infectious Diseases at the University of Alabama at Birmingham. She is expected to begin her role as NIAID Director in the fall.
On August 3, the Centers for Disease Control and Prevention (CDC) recommend that infants under 8 months old receive the antibody monoclonal antibody Beyfortus from Sanofi and AstraZeneca that protects them against respiratory syncytial virus (RSV) ahead of their first RSV season. The shot will be the first in the U.S. to protect all infants from RSV. The antibody was added to the Vaccines for Children Program. The recommendation follows a meeting of CDC’s Advisory Committee on Immunization Practices’ (ACIP), who unanimously voted in favor of the shot earlier in the day.
On August 3, CMS announced the surprise billing Independent Dispute Resolution (IDR) process is temporarily suspended after a federal district judge in Texas agreed with the state’s doctors that the administration violated the Administrative Procedure Act with its IDR fee increase and rules on claims batching. The Biden Administration is reviewing the court’s decision and evaluating the current system to see what is needed to comply with the order.
WHITE HOUSE
On August 3, the Biden Administration, through HHS, released a report showing that the national uninsured rate reached an all-time low of 7.7% in early 2023. The study estimates that approximately 6.3 million people have now gained coverage since 2020. Additionally, the report notes that approximately 5.8% of adults ages 18-64 reported having Marketplace coverage in early 2023 compared to 4.4% in 2020.
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
Independent Dispute Resolution Operations (CMS-9897); Proposed Rule; 8/3/23
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
Postmarketing Approaches to Obtain Data on Under-Represented Populations in Clinical Trials (Draft Guidance); Notice; 6/29/23
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
Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act--Compliance Policies; Guidance for Industry; Availability; Notice; 8/1/23
Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product--Compliance Policies, Rev; Notice; 8/1/23
REPORTS
Office of Inspector General (OIG)
On July 31, OIG released a report examining Medicare payments for accumulated repair costs for enrollee-owned wheelchairs. OIG found that accumulated costs of repairs paid by Medicare for some enrollee-owned wheelchairs that were within their 5-year reasonable useful lifetime (RUL) exceeded the federally recommended cost limit. For 504,794 of the 688,948 repairs (73%) that OIG reviewed, Medicare paid suppliers before the accumulated costs of repairing 77,200 wheelchairs had exceeded the federally recommended cost limit. The remaining 27% were paid after the accumulated costs of repairing the wheelchairs had exceeded the federally recommended cost limit, resulting in $30.1 million in potentially unallowable Medicare payments. OIG recommends that CMS work with the DME Medicare Administrative Contractors (DME MACs) to: 1) strengthen Medicare requirements to ensure that DME MACs review accumulated costs of repairs made to wheelchairs during their 5-year RUL, 2) implement system edits to identify for review claims for repairs made to wheelchairs during their 5-year RUL, and 3) take appropriate action for suppliers that consistently bill for repairs made to wheelchairs during their 5-year RUL that exceed the federally recommended cost limit.
On August 1, OIG released a report examining telehealth in 2020 and its impact on end-stage renal disease (ERSD) care. OIG found that providers documented limited information related to telehealth services in the medical records, but the ESRD-related telehealth service claim lines generally met certain Medicare requirements. Most medical records for sampled claim lines included documentation identifying that the service was provided via telehealth but did not include documentation that would allow OIG to determine whether the services were provided using 1) audiovisual interactive technology and 2) technology that was non-public-facing. OIG made no recommendations but believes that it would be beneficial for the medical records to document the type of telecommunications system used to perform the telehealth visit.
On August 1, OIG released a report examining monitoring of Medicaid community rehabilitation services in New York. OIG’s audit covered 325,776 claims for community rehabilitation services for which New York claimed Medicaid reimbursement totaling $1.1 billion ($621 million Federal share) during the audit period. New York generally complied with Medicaid requirements for claiming Federal reimbursement for community rehabilitation services. For 111 of the 120 sampled claims, New York properly claimed Medicaid reimbursement for all community rehabilitation services. However, New York claimed reimbursement for some unallowable community rehabilitation services for the remaining 9 sampled claims. Based on the sample results, OIG estimated that New York improperly claimed at least $19.9 million in Federal Medicaid reimbursement. OIG recommends that New York refund $19.9 million to the Federal Government, and improve its monitoring activities by increasing the number of case files reviewed when conducting monitoring visits at providers, and by providing formal guidance or training to providers to clarify Medicaid requirements.
Government Accountability Office (GAO)
On August 2, GAO released a report examining farm bureau health plans, health care sharing ministries, and fixed indemnity plans. GAO found that the benefits and other features of nine selected health plans and memberships varied, and state insurance officials stated that these plans tend to contain few consumer protections. These plans and memberships generally are not required to adhere to the requirements and consumer protections imposed by the Affordable Care Act on individual health insurance plans, such as the requirement to cover the 10 essential health benefits. GAO's analysis of documentation for these health plans and memberships found that they all included some coverage for hospital services and office visits for illness or injury, while coverage varied for routine examinations, prescription drugs and other types of services.
Other Health News
On July 31, the Medicare Payment Advisory Commission (MedPAC) released its 2023 data book on health care spending and the Medicare program. The data book provides data on Medicare spending, demographics of the Medicare population, beneficiaries' access to care, and quality of care in the program, among other information.