Health Care Watch: July 23, 2023
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from July 16 – July 23. 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 18, the Veterans’ Affairs Health Subcommittee advanced several bills aimed at improving veterans’ health care, including the Expanding Veterans’ Options for Long Term Care Act, which would create a three-year pilot program to offer assisted living to veterans who need the services but are not eligible for nursing home care.
On July 18, Judiciary Committee Chairman Jim Jordan (R-OH) sent letters to the CEOs of Pfizer, Johnson & Johnson, and Merck requesting information on how and to what extent the Executive Branch has coerced and colluded with manufacturers and other intermediaries to censor speech. Chairman Jordan stated that it is investigating the companies for the role they may have played in this effort and has asked for responses by August 1.
On July 19, the Energy & Commerce Committee held a markup of multiple pieces of health care legislation, including bills aimed at expanding telehealth services, bolstering treatment and prevention for substance use disorders, preparing for the next public health emergency, and expanding primary care services. The committee advanced 15 bills including H.R. 824 - the Telehealth Benefit Expansion for Workers Act of 2023, which would permanently allow employers to offer telehealth as a tax-free benefit separate from their group insurance plans. The committee also passed legislation including H.R. 3836 – the Medicaid Primary Care Improvement Act, H.R. 4531 - the Support for Patients and Communities Reauthorization Act, H.R. 4421 – the Preparing for all Hazards and Pathogens Reauthorization Act, and H.R. 4420 - the Preparedness and Response Reauthorization Act.
On July 25, the House will consider H.R. 2544, Securing the Organ Procurement and Transplantation Network Act and H.R. 4368 - the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act of 2024.
Senate
On July 18, Health, Education, Labor and Pensions (HELP) Committee Chairman Bernie Sanders (I-VT) and Ranking Member Bill Cassidy (R-LA) issued a bipartisan proposal to reauthorize the Pandemic and All-Hazards Preparedness Act. The agreement includes a five-year reauthorization of the Food & Drug Administration’s (FDA) medical countermeasure priority review voucher program, a study on the feasibility of a prize program for drug innovation and provisions aimed at preventing drug shortages. Under this legislation, drugmakers would be required to alert the government if there is a permanent discontinuance or interruption of manufacturing of a drug or active pharmaceutical ingredient (API). The legislation would also require drugmakers to report information about where they source APIs and the amount of drugs made from APIs sourced from manufacturers. On July 20, the committee advanced this legislation by a 17-3 vote.
On July 19, HELP Committee Chairman Sanders released an $86 billion health care and provider workforce package. The package would reauthorize several federal health programs, increase access to primary care, and incentivize careers in health care. The legislation would also invest $20 billion per year over a five-year period to expand community health centers and expand the health workforce. The committee is holding a markup of the legislation on July 26. A summary can be found here.
On July 20, multiple pieces of legislation aimed at regulating pharmacy benefit managers (PBMs) were introduced in the Senate. Sens. John Thune (R-SD) and Sherrod Brown (D-OH) introduced legislation that would require PBMs to disclose information about how they define what medicines are limited access drugs that only certain specialty pharmacies can distribute. Additionally, Sens. Tom Carper (D-DE) and Chuck Grassley (R-IA), introduced the PBM Oversight Act of 2023 that would give the Centers for Medicare & Medicaid Services (CMS) the authority to provide oversight over PBMs and compel more transparency into how they select which medications are covered under a prescription drug plan.
On July 20, HELP Committee Ranking Member Bill Cassidy (R-LA) introduced the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Reauthorization Act of 2023, which reauthorizes programs that aim to bolster prevention, treatment, and recovery services for Americans with substance use disorders and mental illness. The SUPPORT Act is currently set to expire on September 30, 2023.
REGULATORY UPDATE
On July 16, Department of Health & Human Services (HHS) Secretary Xavier Becerra released a statement on the one-year anniversary of the launch of the suicide and crisis hotline, 988. Secretary Becerra stated that more than 5 million calls, texts, and chats have been answered via 988 over the past year.
On July 17, FDA approved Beyfortus (nirsevimab-alip) for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in neonates and infants born during or entering their first RSV season, and in children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.
On July 17, the Federal Trade Commission (FTC) sued to block health care data provider IQVIA’s acquisition of Propel Media, which owns advertising technology company DeepIntent. The merger would give IQVIA the leading position in the market for digital advertising of pharmaceuticals aimed at doctors, which the FTC said might increase costs for drugmakers.
On July 17, CMS proposed to remove its national coverage determination (NCD) for positron emission tomography (PET) beta amyloid imaging, allowing for easier access to the new Alzheimer’s disease drug Leqembi. PET scans for beta amyloid plaque are used in the diagnosis of Alzheimer’s, and detection is required as a condition of coverage for Leqembi.
On July 18, CMS announced that it will hold a national stakeholder call on August 1, 2023, to help inform the Transitional Coverage for Emerging Technologies (TCET) pathway and provide an opportunity for stakeholders to provide comments. The call will take place on August 1 from 3:00 – 4:30 PM ET. Registration can be found here.
On July 18, the Centers for Disease Control and Prevention (CDC) announced a meeting of the Advisory Committee on Immunization Practices (ACIP) on August 3 to vote on whether to recommend the RSV antibody vaccine. The committee will also decide whether the vaccine should be added to the Vaccines for Children program, which would require the federal government to pay for the vaccines for those who are uninsured or underinsured. The CDC is requesting public comments pertaining to this meeting.
On July 18, HHS suspend and proposed the debarment of Wuhan Institute of Virology, Chinese Academy of Sciences Capital Construction (WIV) from participating in United States Federal Government procurement and non-procurement programs. The decision comes after the institute’s failure to comply with demands to show that some of its experiments supported by U.S. grants before the pandemic didn’t constitute gain-of-function.
On July 19, HHS, through the Substance Abuse and Mental Health Services Administration (SAMHSA), announced awards in five grant programs devoted to combating multiple facets of substance misuse and the nation’s overdose epidemic. The grant awards total $47.8 million and will go towards substance use and treatment.
On July 20, HHS’ Office for Civil Rights (OCR) and FTC sent a letter to hospitals and telehealth providers cautioning them about the privacy and security risks related to the use of online tracking technologies that may be integrated into their websites or mobile apps that may be impermissibly disclosing consumers’ sensitive personal health data to third parties.
On July 20, CMS approved proposals from California and Kentucky for community-based mobile crisis intervention teams to provide Medicaid crisis services. California and Kentucky will be able to provide Medicaid services through mobile crisis teams by connecting eligible individuals in crisis to a behavioral health provider 24 hours per day, 365 days a year.
On July 20, FTC unanimously voted to disavow previous guidance opposing transparency requirements for PBMs as the agency continues to probe the industry. FTC sent a warning to the companies cautioning them against relying on "outdated" agency statements and studies that opposed more regulatory oversight and transparency of PBMs.
On July 20, the Drug Enforcement Administration (DEA) issued new prescribing guidance for schedule II narcotics in an effort to reduce the number of unused opioids that patients have in their homes after they’ve finished treatment.
WHITE HOUSE
On July 18, the Biden Administration held a roundtable at the White House with pharmacy chain and association leaders to discuss how pharmacies can work with the Administration to educate consumers about the new Medicare prescription drug benefits under the Inflation Reduction Act (IRA). This roundtable builds on a meeting HHS Secretary Becerra held with pharmacy leaders in March 2022. Attendees were encouraged to provide educational material in pharmacy locations, and on websites and social media accounts; partner with community organizations; engage in public education campaigns; and train staff to address questions about the new law, among other actions.
On July 21, the Biden Administration announced that retired Maj. Gen. Paul Friedrichs will lead the new pandemic preparedness office. Friedrichs, who has provided medical advice to the chair of the Joint Chiefs of Staff, helped manage the Pentagon’s COVID-19 response before retiring this summer. He will now lead the Office of Pandemic Preparedness and Response Policy as director, effective August 7, 2023.
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
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
FY 2024 Skilled Nursing Facility (SNFs) Prospective Payment System and Consolidated Billing and Updates to the Value-Based Purchasing and Quality Reporting Programs (CMS-1779); Final Rule; 7/3/23
FY 2024 Inpatient Rehabilitation Facility (IRF) Prospective Payment System Rate Update and Quality Reporting Program (CMS-1781); Final Rule; 7/5/23
FY 2024 Hospice Wage Index, Payment Rate Update, and Quality Reporting Requirements (CMS-1787); Final Rule; 7/5/23
FY 2024 Inpatient Psychiatric Facilities Prospective Payment System Rate and Quality Reporting Updates (CMS-1783); Final Rule; 7/6/23
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
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
REPORTS
Office of Inspector General (OIG)
On July 17, OIG released a report examining differences in targeted provider relief funds (PRF) allocation with respect to ethnicity and race of served populations. OIG found that communities with greater concentrations of Hispanic/Latino residents were generally associated with less 2020 COVID-19 targeted provider relief funding (PRF) for hospitals than communities with lower concentrations. OIG found the most notable trends in the allotment targeted to rural hospitals (about $9.7 billion): Communities with greater concentrations of Hispanic/Latino residents or Non-Hispanic Black residents were associated with less PRF per person than communities with smaller concentrations of Hispanic/Latino Residents or Non-Hispanic Black residents.
On July 17, OIG released a report examining HRSA COVID-19 Uninsured Program (UIP) payments to providers on behalf of individuals who had health insurance coverage and for services unrelated to COVID-19. The audit covered claims for 19 million patients with associated UIP provider payments totaling $4.2 billion with service dates from March 1 through December 31, 2020. OIG reviewed a stratified random sample of 300 patients with associated provider payments totaling $2.8 million. OIG found that 240 of the 300 sampled patients, UIP payments to providers for claims for COVID-19 services met program terms and conditions and were made on behalf of uninsured individuals. However, UIP payments for 58 sampled patients totaling $294,294 were improper because they were made on behalf of individuals who had health insurance coverage or were made for testing and treatment services that were not provided or were unrelated to COVID-19. OIG estimated that nearly $784 million of $4.2 billion (19%) in UIP payments made to providers during the audit period for approximately 3.7 million of 19.2 million patients were improper. OIG recommends that HRSA recover $294,294 in improper UIP payments.
On July 27, OIG released a report examining concerns regarding access to care in Medicaid managed care organizations (MCOs) due to high rates of prior authorization denials by some plans and limited state oversight Raise Concerns. OIG found that the MCOs included in the review denied one out of every eight requests for the prior authorization of services in 2019. Among the 115 MCOs in the review, 12 had prior authorization denial rates greater than 25% – twice the overall rate. Despite the high number of denials, most State Medicaid agencies reported that they did not routinely review the appropriateness of a sample of MCO denials of prior authorization requests, and many did not collect and monitor data on these decisions. OIG recommends that CMS: 1) require States to review the appropriateness of a sample of MCO prior authorization denials regularly, 2) require States to collect data on MCO prior authorization decisions, 3) issue guidance to States on the use of MCO prior authorization data for oversight, 4) require States to implement automatic external medical reviews of upheld MCO prior authorization denials, and 5) work with States on actions to identify and address MCOs that may be issuing inappropriate prior authorization denials.
UPCOMING CONGRESSIONAL HEARINGS
House
Energy & Commerce Committee
Oversight and Investigations Subcommittee
July 26; 10:00 AM; 2123 Rayburn
Stopping the Exploitation of Migrant Children: Oversight of HHS' Office of Refugee Resettlement
Oversight and Accountability Committee
July 27; 10:00 AM; 2154 Rayburn
Oversight and Reauthorization of the Office of National Drug Control Policy
Witness: Rahul Gupta, MD, Director, ONDCP
Select Subcommittee on the Coronavirus Pandemic
July 27; 2:00 PM; 2154 Rayburn
Because I Said So: Examining the Science and Impact of COVID-19 Vaccine Mandates
Ways & Means Committee
Week of July 24 TBD
Markup of legislation dealing with PBM reform and site neutral payments for physician-administered drugs
Senate
Finance Committee
July 26; 2:00PM; 215 Dirksen
Markup: Pharmacy Benefit Manager Proposals (TBD)
HELP Committee
July 26; 10:30 AM; 430 Dirksen
Markup: S. _, The Primary Care and Health Workforce Expansion Act
Appropriations Committee
July 27; 10:30 AM; 106 Dirksen
Markup: Fiscal Year 2024 Defense, Interior and Environment, Labor, Health and Human Services, Education, and Homeland Security Appropriations Acts
Joint Economic Committee
July 27; 10:00 AM; TBD
The Economic Impact of Diabetes
Witnesses: Janet Brown-Friday, President, Health Care and Education, American Diabetes Association; Benedic Ippolito, Senior Fellow, American Enterprise Institute; Mark Herman, MD, E.L. Wagner, MD, Chair of Internal Medicine II Chief, Section of Endocrinology, Diabetes, and Metabolism, Baylor College of Medicine
OTHER POLICY NEWS
On July 16, the Alzheimer's Association International Conference (AAIC) proposed new guidelines that would change the way doctors diagnose Alzheimer's disease. Under the rules, physicians would use a seven-point rating scale to assess the disease progression in their patients similar to the one used in cancer diagnoses.
On July 17, Lilly released late-stage trial data on its Alzheimer’s drug, donanemab. Data showed the drug significantly slowed the progression of Alzheimer's disease compared to placebo. The company has asked FDA to grant the drug traditional approval. If the FDA agrees, it would be the second drug granted traditional approval for Alzheimer's this year.
On July 18, Johnson & Johnson filed a lawsuit in the U.S. District Court for the District of New Jersey against HHS and CMS, challenging the drug pricing provisions of the Inflation Reduction Act (IRA). The suit alleges that the drug price negotiation process violates the manufacturer’s First and Fifth Amendment rights and details how negotiation is likely to impact their product Xarelto (rivaroxaban) which is expected to be selected for the first year of negotiation. The suit is the sixth legal challenge against the IRA’s negotiation program.