Health Care Watch: September 9, 2023
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from September 3 – September 9. 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 September 7, Ways & Means Committee Chairman Jason Smith (R-MO) released a request for information (RFI) letter to the health care community requesting comments and input on solutions to help remedy disparities in access to care for Americans – particularly those in rural and underserved communities. As part of the RFI, Chairman Smith highlighted five areas of interest: payment disparities between different geographic areas, long-term financial health of providers and facilities, payments for identical care provided in varying sites of service, bringing new professionals into the health care workforce, and innovative care models and technology to improve patient outcomes. Submissions are due by October 5.
On September 8, Energy & Commerce Committee Chair Cathy McMorris Rodgers (R-WA) and Ranking Member Frank Pallone (D-NJ), Ways & Means Committee Chairman Jason Smith, and Education & the Workforce Chair Virginia Foxx (R-NC) circulated a legislative package aimed at increasing health-care transparency and extending critical health programs. Major provisions of the bill include pharmacy benefit manager (PBM) reform, site-neutral payments for physician-administered drugs, extending funding for community health centers, and increasing hospital price transparency. Legislative text can be found here. A section-by-section summary can be found here. The House is expected to consider this legislation this fall.
The House returns from its August recess on September 12.
Senate
On September 6, Health, Education, Labor & Pensions (HELP) Committee Ranking Member Bill Cassidy (R-LA) released a white paper on artificial intelligence (AI) and its potential benefits and risks to society. The framework contains substantial information surrounding AI in health care administration and coverage and speaks to the importance of having AI regulations be sector specific.
On September 6, Appropriations Committee Chair Patty Murray (D-WA) and Ranking Member Susan Collins (R-ME) announced the Senate will soon consider the Fiscal Year (FY) 2024 Military Construction, Veterans Affairs, and Related Agencies; Transportation, Housing and Urban Development, and Related Agencies; and Agriculture, Rural Development, Food & Drug Administration (FDA), and Related Agencies appropriations bills.
On September 6, Majority Whip and Chair of the Judiciary Committee Dick Durbin (D-IL) met with Rahul Gupta, M.D., Director of the Office of National Drug Control Policy (ONDCP). Among other topics, Durbin and Gupta discussed ONDCP reauthorization, child online safety legislation that the Judiciary Committee advanced this summer, reform of Section 702 of the Foreign Intelligence Surveillance Act and combating drug overdose deaths.
On September 7, HELP Committee Ranking Member Bill Cassidy (R-LA) issued an RFI from stakeholders on ways to improve health care data privacy protections to safeguard sensitive information while balancing the need to support medical research. Ranking Member Cassidy notes that, currently, health data that is collected from new technologies such as wearable and smart devices, and health and wellness apps is not protected under the Health Insurance Portability and Accountability Act (HIPAA). The deadline to submit feedback is September 28.
REGULATORY UPDATE
On September 1, Humana sued the Biden administration arguing that the Medicare Advantage (MA) Risk Adjustment Data Validation (RADV) program audit rule released earlier this year violated federal law. Humana argued that the rule, which would retroactively recoup payments when audits uncover charges for diagnoses that are not in the patients’ medical record, was "arbitrary and capricious," and threatened "unpredictable consequences for Medicare Advantage organizations and the millions of seniors who rely on the Medicare Advantage program for their healthcare."
On September 5, the Centers for Medicare & Medicaid Services (CMS) announced the States Advancing All-Payer Health Equity Approaches and Development Model (“States Advancing AHEAD” or “AHEAD Model”). Through this new voluntary model, CMS will partner with states to redesign statewide and regionwide health care delivery to improve the total population health of a participating state or region by improving the quality and efficacy of care delivery, reducing health disparities, and improving health outcomes. CMS will issue awards to up to eight states. Each state selected to participate in the AHEAD Model will have an opportunity to receive up to $12 million from CMS to support state implementation. Under the model, states would agree to give hospitals a fixed amount of money each year to account for traditional, fee-for-service Medicare and Medicaid payments.
On September 7, the Department of Health & Human Services (HHS), through its Office for Civil Rights (OCR), announced a proposed rule that would prohibit discrimination on the basis of disability. The rule, Nondiscrimination on the Basis of Disability in Programs or Activities Receiving Federal Financial Assistance, updates provisions that help individuals with disabilities access health and human services under Section 504 of the Rehabilitation Act of 1973. The proposed rule ensures that medical treatment decisions are not based on biases or stereotypes about individuals with disabilities, clarifies obligations for web, mobile, and kiosk accessibility, establishes enforceable standards for accessible medical equipment, and prohibits the use of value assessment methods that place a lower value on life-extension for individuals with disabilities. A fact sheet can be found here. Comments are due on November 7, 2023.
On September 7, FDA announced that its Nonprescription Drug Advisory Committee will meet on September 11 and 12 to discuss whether phenylephrine, a common ingredient in oral cold medicines, should no longer be considered safe and effective. In a briefing document, FDA said agency scientists have confirmed the ingredient has a high first-pass metabolism effect when taken by mouth, rendering it ineffective when taken as a pill or liquid medication.
On September 7, FDA finalized guidance that outlines a risk-based approach for whether biocompatibility testing is needed for medical devices using an international standard.
On September 8, CMS issued a fact sheet providing “key information” on the process for the first round of negotiation under the IRA drug negotiation program. The fact sheet includes information how drugs selected for the first round of negotiation and how CMS will develop the initial offer – among other topics.
WHITE HOUSE
On September 7, the President's Council of Advisors on Science and Technology recommended that the White House create a national patient safety team to help reduce high levels of dangerous care in the medical system. The council stated that progress in addressing preventable harms like medication errors and hospital-acquired infections has been "unacceptably slow," necessitating a White House-led initiative to improve patient safety.
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
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
Federal Independent Dispute Resolution Process Fees (CMS-9890); Proposed Rule; 8/29/23
Independent Dispute Resolution Operations (CMS-9897); Proposed Rule; 8/29/23
Request for Information Regarding Coverage of Over-the-Counter Preventive Products (CMS-9891); Notice; 9/6/23
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 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
REPORTS
Government Accountability Office (GAO)
On September 5, GAO released a report examining the effects of rebates on plan formularies and beneficiary spending in Medicare Part D. GAO found that Part D plan sponsors received $48.6 billion in rebates from drug manufacturers in 2021. Three therapeutic drug classes accounted for 73% of rebates: 1) endocrine metabolic agents, including antidiabetic drugs; 2) blood modifiers, including anti-stroke drugs; and 3) respiratory agents, including anti-asthma drugs. GAO recommends that CMS monitor the effect of rebates on plan sponsor formulary design and on Medicare and beneficiary spending to assess whether rebate practices are likely to substantially discourage enrollment by certain beneficiaries. HHS did not concur with GAO's recommendation.
Office of Inspector General (OIG)
On September 6, OIG released a report examining nursing home challenges preparing for public health emergencies and natural disasters. OIG found that an estimated 77% of nursing homes located in areas at greater risk for natural disasters reported experiencing challenges with emergency preparedness activities. Administrators reported concerns across seven topic areas, with activities related to ensuring proper staffing during emergencies and transporting residents during evacuations being the most problematic. An estimated 62% of nursing homes reported at least one challenge regarding staffing and an estimated 50% noted at least one challenge regarding transportation. Other challenges reported by some nursing homes related to securing beds for evacuated residents and planning for infection control and quarantine during emergencies. OIG found that nursing homes reporting challenges had lower community resilience compared to other nursing homes, indicating that availability of community resources may be a factor in nursing homes' experience with preparedness activities.
On September 7, OIG released a report examining home health agencies' (HHAs) failure to report major fall injury and hospitalization among their Medicare patients. OIG found that 55% of falls identified in Medicare claims were not reported in associated OASIS assessments as required. Falls reporting on OASIS assessments was worse among younger home health patients (compared to older patients) and patients who identified as Black, Hispanic, or Asian (compared to White). Reporting was also lower among for profit HHAs as compared to nonprofit and government-owned agencies. Notably, HHAs with the lowest Care Compare major injury fall rates reported falls less often than HHAs with higher Care Compare fall rates, indicating that Care Compare does not provide the public with accurate information about how often home health patients fell. OIG recommends that CMS: 1) ensure the completeness and accuracy of the HHA reported OASIS data used to calculate the falls with major injury quality measure; 2) use data sources, in addition to OASIS assessments, to improve the accuracy of quality measure related to falls with major injury; 3) ensure that HHAs submit required OASIS assessments when patients are hospitalized; and 4) explore whether improvements to the quality measure related to falls can also be used to improve accuracy of other home health measures.
UPCOMING HEARINGS
House
Energy & Commerce Committee
Health Subcommittee
September 14; 10:00 AM; 2123 Rayburn
Legislative Proposals to Prevent and Respond to Generic Drug Shortages
Legislation under consideration: H.R. ___, the Stop Drug Shortages Act; H.R. 3008, the Drug Shortage Prevention Act of 2023 (Rep. Jacobs); H.R. 3810, the Drug Origin Transparency Act of 2023; H.R. 3793, the Ensuring Access to Lifesaving Drugs Act of 2023; H.R. 167, the Patient Access to Urgent-Use Pharmacy Compounding Act of 2023
Health Subcommittee
September 19; time TBD
Hearing on innovation
Oversight and Investigations Subcommittee
September 20, time TBD
Hearing on IRA Implementation
Oversight and Accountability Committee
Health Care and Financial Services Subcommittee
September 14; 10:00 AM; 2247 Rayburn
The Inflation Reduction Act: A Year in Review
Witnesses: Preston Brashers, Senior Policy Analyst, The Heritage Foundation; Joel White, President, Council for Affordable Health Coverage.
Veterans Affairs Committee
September 14; 10:30 AM; 360 Cannon
VA Electronic Health Record Modernization: Get Well Soon?
Ways & Means Committee
October
Markup of drug and device legislation
OTHER POLICY NEWS
On September 6, Astellas Pharma withdrew its lawsuit challenging the Inflation Reduction Act (IRA) drug negotiation program. When CMS last week revealed its list of the first 10 drugs eligible for Medicare price negotiations, Astellas’ Xtandi was not on the list despite many analysts predicting the drug would be subject to the first round of negotiation. In a statement, the company said its decision to withdraw the lawsuit does not change its belief that the negotiation powers created by the IRA are “bad policy and unconstitutional.”
On September 7 and 8, the Medicare Payment Advisory Commission (MedPAC) held its September meetings to discuss MA, the Acute Care Hospital at Home (ACHaH) program and ambulatory surgical centers.