Health Care Watch: September 16, 2023
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from September 10 – September 16. 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 12, the Select Subcommittee on the Coronavirus Pandemic and the Permanent Select Committee on Intelligence asked the Central Intelligence Agency (CIA) for documents regarding its determination on the origins of COVID-19 following information the committees received from an alleged CIA whistleblower. The whistleblower told the committees the agency paid six members out of a team of seven who had backed, with low confidence, a lab origin of the pandemic to change their position. The committees’ sent a letter to CIA Director William Burns asking for documents related to the team of seven officers. They also requested that former CIA Chief Operating Officer Andrew Makridis participate in a voluntary transcribed interview on September 26, 2023.
On September 14, the Energy & Commerce Committee held a hearing entitled Legislative Proposals to Prevent and Respond to Generic Drug Shortages. The committee discussed five pieces of legislation surrounding the generic drug shortage. Legislation discussed included: H.R.___, Stop Drug Shortages Act; H.R. 3008, Drug Shortage Prevention Act of 2023; H.R. 3810, Drug Origin Transparency Act of 2023; H.R. 3793, Ensuring Access to Lifesaving Drugs Act of 2023; and H.R. 167, Patient Access to Urgent-Use Pharmacy Compounding Act of 2023. A hearing memo can be found here.
On September 14, Energy and Committee Chair Cathy McMorris Rodgers (R-WA) Subcommittee on Oversight and Investigations Chairman Morgan Griffith (R-VA) and various other subcommittee chairs sent a letter to Department of Health and Human Services (HHS) Secretary Xavier Becerra renewing a request for documents related to their investigation on the origins of the COVID-19 pandemic. The Committees have also asked individuals such as Dr. Francis Collins, Dr. Lawrence Tabak, and Dr. Hugh Auchincloss to appear voluntarily for transcribed interviews. The letter states that if HHS does not meet the stated deadlines, the Chairs will be forced to consider the use of subpoenas to obtain the requested information.
On September 18, the House will consider H.R. 5378, the Lower Costs, More Transparency Act, under suspension of the rules. This means that a 2/3rds vote is required to pass the bill and it cannot be amended. This legislation would reform pharmacy benefit manager practices, require greater hospital price transparency, and reduce Medicare payments for physician-administered drugs outside of the office setting. Legislative text can be found here. A section-by-section summary can be found here.
House Republicans continue to explore ways to extend government funding, which expires on September 30. Latest reports indicate that the GOP moderates are engaged in conversations with the so-called Freedom Caucus to fund the government.
Rep. Chris Stewart’s (R-UT) resignation – due to his wife’s illness - became effective at midnight on September 16, narrowing the House Republican majority to just four seats.
Senate
On September 11, Finance Committee Chairman Ron Wyden (D-OR), and Sens. Chuck Grassley (R- IA), Ben Cardin (D-MD), and Todd Young (R-IN) sent letters to several organ procurement organization (OPO) executives and current and former board members of the Association of Organ Procurement Organization (AOPO). The letters are a continuation of the committee’s probe into potential financial conflicts of interest and abuse of taxpayer money in the organ procurement system.
On September 12, the Senate confirmed Tanya Bradsher as deputy secretary of the Department of Veterans Affairs (VA) in a 50-46 vote.
On September 13, Sens. Mark Warner (D-VA) and John Thune (R-SD), sent a letter to Drug Enforcement Administration (DEA) Administrator Anne Milgram urging the agency to ease access to care in its telemedicine prescribing proposal. The letter expresses support for the agency’s new engagement on a potential special registration for telehealth but shares concerns over the agency’s proposed rules on the future of prescribing controlled substances via telehealth. The letter calls for DEA to extend the 30-day supply permitted for prescribing many controlled substances before patients must see a doctor in person.
On September 13, the Senate voted 85-12 to invoke cloture on the motion to proceed to the first three appropriations bills on the Senate floor. The package includes the Fiscal Year 2024 Military Construction, Veterans Affairs, and Related Agencies; Agriculture, Rural Development, Food and Drug Administration, and Related Agencies; and Transportation, Housing and Urban Development, and Related Agencies appropriations bills—all of which passed out of Committee unanimously.
On September 14, Health, Education, Labor & Pensions (HELP) Committee Chairman Bernie Sanders (I-VT) and Ranking Member of the HELP Primary Health and Retirement Security Subcommittee Roger Marshall, MD, (R-KS), announced that they reached an agreement on legislation to address the primary care crisis. The Sanders-Marshall agreement provides over $26 billion in funding to expand primary care and address the health care workforce shortage. Among other provisions, the legislation provides $5.8 billion per year over the next three years in mandatory funding for community health centers, $55 million per year for school-based health services, and $3 billion in capital funding primarily to enable community health centers to expand dental care and mental health care in their facilities. A summary of the legislation can be found here. The full legislative text can be found here.
REGULATORY UPDATE
On September 8, HHS announced new details of its agreement with Regeneron to extend its public-private partnership to develop monoclonal antibodies as part of Project NextGen. The agreement included a clause where Regeneron committed that if a new product is commercialized, its list price in the United States will be equal to or less than its retail price in comparable markets globally.
On September 11, HHS’s Office for Civil Rights (OCR) announced a settlement of potential violations of the Health Insurance Portability and Accountability Act (HIPAA) Rules with LA Care, the nation's largest publicly operated health plan that provides health care benefits and coverage through state, federal, and commercial programs. Under the agreement, LA Care agreed to pay $1.3 million and to implement a corrective action plan.
On September 11, the Food & Drug Administration (FDA) approved and authorized, for emergency use, updated COVID-19 vaccines formulated to more closely target currently circulating variants. The actions relate to updated mRNA vaccines for 2023-2024 manufactured by Pfizer-BioNTech and Moderna. The vaccines are designed for individuals 6 months and older.
On September 12, the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) recommended that everyone 6 months and older get an updated COVID-19 vaccine to protect against the potentially serious outcomes of COVID-19 illness this fall and winter. CDC Director Mandy Cohen formally endorsed updated COVID-19 shots for all individuals 6 months and older following ACIP’s recommendation. Updated COVID-19 vaccines from Pfizer-BioNTech and Moderna will be available later this week.
On September 12, FDA’s Nonprescription Drug Advisory Committee voted unanimously that current scientific data does not support the effectiveness of phenylephrine, a common ingredient in over-the-counter cold drugs. The committee’s vote provides FDA an opening to withdraw phenylephrine-containing pill products from the market.
On September 13, the Centers for Medicare & Medicaid Services (CMS) announced the list of 34 drugs subject to the Part B inflation rebate for the upcoming quarter (October 1 – December 31, 2023). Drugs on this list will have adjusted coinsurance rates for the fourth quarter, resulting in savings for beneficiaries between $1 and $618 per average dose. A list of the drugs can be found here.
On September 13, FDA issued warning letters to eight companies for manufacturing or marketing unapproved ophthalmic drug products in violation of federal law. FDA is particularly concerned that these illegally marketed, unapproved ophthalmic drug products pose a heightened risk of harm to users because drugs applied to the eyes bypass some of the body’s natural defenses. The agency issued warning letters to Boiron Inc, CVS Health, DR Vitamin Solutions, Natural Ophthalmics, Inc., OcluMed LLC, Similasan AG/Similasan USA, TRP Company, Inc, and Walgreens Boots Alliance, Inc.
On September 13, HHS Secretary Xavier Becerra declared a Public Health Emergency (PHE) for the state of Georgia to address the health impacts of Hurricane Idalia. The declaration follows President Biden’s emergency declaration and gives CMS providers and suppliers greater flexibility in meeting emergency health needs of Medicare and Medicaid beneficiaries.
On September 14, CMS announced a Standing Technical Expert Panel (TEP) for the Development, Evaluation, and Maintenance of Post-Acute Care (PAC) and Hospice Quality Reporting Program (QRP) Measurement Sets. Acumen and Abt are convening the TEP to evaluate the measurement sets across the Inpatient Rehabilitation Facility (IRF), Long-Term Care Hospital (LTCH), Skilled Nursing Facility (SNF), Home Health (HH), and Hospice settings, with a focus on identifying measurement gaps, and ensuring measures align with CMS program requirements and goals. The TEP nomination period closes on October 11, 2023. Nominations can be made here.
On September 14, the Federal Trade Commission (FTC) released a statement, approved 3-0, stating that the agency will closely monitor whether drugmakers are inappropriately listing drug patents in the FDA’s Orange Book. FTC has stated that drugmakers could risk legal action for improper patent claims and listings.
On September 15, HHS, through the Health Resources and Services Administration (HRSA), announced more than $8 million through 18 awards to train primary care medical students, physician assistant students, and medical residents in providing culturally and linguistically appropriate care for individuals with limited English proficiency and individuals with physical or intellectual and developmental disabilities.
WHITE HOUSE
On September 12, the Biden Administration detailed the steps it has and will take to tackle cancer drug supply issues and to help mitigate and prevent impacts to patients. The Administration stated that for generic carboplatin and cisplatin, FDA worked closely with cancer drug manufacturers to help identify opportunities to increase manufacturing capacity and bring companies that had stopped producing those drugs back to the U.S. market. Additionally, the Administration stated that FDA is working closely with the five manufacturers of generic methotrexate for injection to help increase supplies during the shortage.
On September 13, the Biden Administration convened a meeting of the Cancer Cabinet to announce new actions federal agencies are taking to advance the mission of the White House Cancer Moonshot initiative. The announcement included: $240 million in additional investment this year to accelerate new ways to prevent, detect, treat, and survive cancer; a new “biomedical data fabric toolbox” to advance cancer research progress; a new nationwide health innovation network to bring cancer clinical trials to underserved communities and drive research progress; and many additional community-based projects.
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
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
Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications; Draft Guidance for Industry (CDER, 2023-150); Proposed Rule; 9/8/23
Defining Durations of Use for Approved Medically Important Antimicrobial Drugs Fed to Food-Producing Animals; Draft Guidance for Industry; Notice; 9/11/23
REPORTS
Office of Inspector General (OIG)
On September 12, OIG released a report examining CDC’s Vaccines for Children (VFC) Program. OIG found that CDC's VFC program recipients conducted enrollment site visits for all newly enrolled and reenrolling VFC providers as required, however, recipients did not meet all program requirements for conducting compliance site visits and storage and handling site visits. Specifically, recipients did not: 1) conduct compliance site visits in a timely manner at 11,499 of 39,120 enrolled and active providers (29%); 2) conduct storage and handling site visits at either of the 2 CDC-approved depot providers; 3) conduct storage and handling site visits for at least 5% of their providers; and 4) verify that providers completed follow up actions by the deadlines for 33,316 of 127,594 issues (26%) identified during compliance and storage and handling site visits. OIG recommends that CDC: 1) work with program recipients to implement a plan and timeline to conduct the required site visits that are overdue; 2) develop an action plan to enforce site visit requirements; 3) complete the development and implementation of internal written policies and procedures for VFC program oversight activities; and 4) update its PEAR online system to include interactive reminders or alerts related to overdue site visits and follow up actions.
On September 12, OIG released a report examining Medicare improper payments to acute care hospitals for inpatient claims. OIG found that Medicare improperly paid $41.4 million to acute-care hospitals for inpatient claims subject to the transfer policy. These hospitals improperly billed these claims by using the incorrect discharge status codes. Specifically, they coded these claims as discharges to home (6,338 claims) or to certain types of health care institutions (5,795 claims), such as facilities that provide custodial care, rather than as transfers to post-acute care. The total overpayment of $41.4 million represented the difference between the amount of the full MS-DRG payments and the amount that would have been paid if the per diem rates had been applied. OIG recommends that that CMS: 1) direct the Medicare contractors to recover from acute-care hospitals the portion of the $41.4 million in identified overpayments for the audit period that are within the 4-year reopening period; and 2) instruct the Medicare contractors to notify appropriate providers so that the providers can exercise reasonable diligence to identify, report, and return any overpayments in accordance with the 60-day rule.
On September 13, OIG released a report examining Substance Abuse and Mental Health Services (SAMHSA) oversight of certified community behavioral health clinic expansion grants. OIG found that SAMHSA's policies and procedures for awarding and monitoring CCBHC-E grants were not adequate to ensure that clinics complied with Federal requirements. Specifically, for 28 of the 30 CCBHC-E grants in the sample, SAMHSA's policies and procedures related to awarding CCBHC-E grants did not establish 1) required time frames for verifying that clinics met certification eligibility requirements, or 2) processes to verify that clinics entered into agreements with DCOs to provide certain services. Also, SAMHSA's policies and procedures related to monitoring CCBHC-E grants did not establish processes to verify that clinics 1) filled key personnel positions within established time frames or ensured that key personnel met level-of-effort requirements, 2) timely submitted financial reports, or 3) properly reported cash on hand. OIG made a series of recommendations to SAMHSA to improve its policies and procedures for awarding and monitoring CCBHC-E grants to ensure that clinics comply with Federal requirements.
UPCOMING HEARINGS
House
Energy & Commerce Committee
Health Subcommittee
September 19; 10:00 AM; 2322 Rayburn
Examining Policies to Improve Seniors’ Access to Innovative Drugs, Medical Devices, and Technology
Witnesses: Dr. Dora Hughes, Acting Director, Center for Clinical Standards and Quality, Acting Chief Medical Officer, Centers for Medicare & Medicaid Services; John Dicken, Director, Health Care – Public Health and Private Markets, GAO.
Oversight and Investigations Subcommittee
September 20, 2:00 PM, 2123 Rayburn
Hearing on Inflation Reduction Act Price Setting
Ways & Means Committee
September 19; 10:00AM; 1100 Longworth
Hearing on Reduced Care for Patients: Fallout from Flawed Implementation of Surprise Medical Billing Protections
September 25; TBD
Markup of Health Savings Account legislation
October; TBD
Markup of drug and device legislation and hearing on the status of CMS’ Center for Medicare & Medicaid Innovation
Oversight and Accountability Committee
September 19; 10:00 AM; 2154 Rayburn
The Role of Pharmacy Benefit Managers in Prescription Drug Markets Part II: Not What the Doctor Ordered
Senate
Finance Committee
Health Subcommittee
September 19; 10:00 AM; 215 Dirksen
Aging in Place: The Vital Role of Home Health in Access to Care
Witnesses: Carrie Edwards, Director, Home Care Services, Mary Lanning Healthcare; Judith Stein, Executive Director/Attorney, Center for Medicare Advocacy; Bill Dombi, President, National Association of Home Care & Hospice; David Grabowski, Professor, Harvard Medical School.
Health, Education, Labor & Pensions (HELP) Committee
September 21; 10:00 AM; SD-430
S. 1573, S. 2415, S. 1624, S._, Bipartisan Primary Care and Health Workforce Act
Legislation to be discussed: S. 1573, PREEMIE Reauthorization Act of 2023; S. 2415, Preventing Maternal Deaths Reauthorization Act of 2023; S. 1624, Gabriella Miller Kids First Research Act 2.0; S._, Bipartisan Primary Care and Health Workforce Act
OTHER POLICY NEWS
On September 8, the 988 mental health crisis line added American Sign Language (ASL) services for callers who are deaf and hard-of-hearing users.