The following LPG Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from July 19 - July 25. 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.
NON-CORONAVIRUS LEGISLATIVE UPDATE
House
On July 19, Rep. Vern Buchanan (R-FL) announced that he tested positive for COVID-19, despite being fully vaccinated.
On July 21, a bipartisan group of 20 Representatives created the Congressional Social Determinants of Health caucus working to overcome social and environmental barriers that impact health. The caucus is co-chaired by Reps. Cheri Bustos (D-IL), Tom Cole (R-OK), G.K. Butterfield (D-NC), and Markwayne Mullin (R-OK)
On July 21, the Energy & Commerce Committee held a markup and favorably reported the following 24 bills:
H.R. 4369, the “National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing Act”
H.R. 654, the “Drug-Free Communities Pandemic Relief Act”
H.R. 2051, the “Methamphetamine Response Act of 2021”
H.R. 2379, the "State Opioid Response Grant Authorization Act of 2021”
H.R. 2364, the “Synthetic Opioid Danger Awareness Act”
H.R. 2355, the “Opioid Prescription Verification Act of 2021”
H.R. 4026, the “Social Determinants of Health Data Analysis Act of 2021”
H.R. 3743, the “Supporting the Foundation for the National Institutes of Health (NIH) and the Reagan-Udall Foundation for the Food & Drug Administration (FDA)”
H.R. 550, the “Immunization Infrastructure Modernization Act”
H.R. 1550, the “Promoting Resources to Expand Vaccination, Education and New Treatments for HPV Cancers Act of 2021” or the “PREVENT HPV Cancers Act of 2021”
H.R. 951, the “Maternal Vaccination Act”
H.R. 4387, the “Maternal Health Quality Improvement Act of 2021”
H.R. 3742, the “Vaccine Information for Nursing Facility Operators Act” or the “Vaccine INFO Act”
H.R. 2347, the “Strengthening the Vaccines for Children Act of 2021”
H.R. 3894, the “Collecting and Analyzing Resources Integral and Necessary for Guidance for Social Determinants Act of 2021” or the “CARING for Social Determinants Act of 2021”
H.R. 4406, the “Supporting Medicaid in the U.S. Territories Act”
H.R. 2685, the “Understanding Cybersecurity of Mobile Networks Act”
H.R. 3919, the “Secure Equipment Act of 2021”
H.R. 4028, the “Information and Communication Technology Strategy Act”
H.R. 4032, the “Open RAN Outreach Act”
H.R. 4045, the “Future Uses of Technology Upholding Reliable and Enhanced Networks Act” or the “FUTURE Networks Act”
H.R. 4046, the “NTIA Policy and Cybersecurity Coordination Act”
H.R. 4055, the “American Cybersecurity Literacy Act”
H.R. 4067, the “Communications Security Advisory Act of 2021”
All 24 bills were favorably reported by the committee. Full Committee Action Summary is available here.
On July 23, Reps. Robin Kelly (D-IL) and Steven Horsford (D-NV) re-introduced the Medicare Dental Coverage Act to provide dental coverage under Medicare Part B. In this bill, patients would be responsible for 20% of the cost of preventive dental care and screenings.
Senate
On July 22, the Judiciary Committee held an Executive Business Meetingand marked up the following pieces of legislation:
On July 21, Sens. Elizabeth Warren (D-MA) and Chuck Grassley (R-IA) and Reps. Bill Pascrell (D-NJ), Brian Fitzpatrick (R-PA), and Lloyd Doggett (D-TX) urged Health & Human Services (HHS) Secretary Xavier Becerra to include the device identifier portion of a medical device’s unique device identifier in Medicare claims forms.
On July 22, Senate Republicans blocked consideration of the bipartisan $3.5 trillion infrastructure bill, though negotiations continue. Negotiators are considering repealing or delaying the Medicare prescription drug rebate rule, tapping unused provider relief fund money, and extending the Medicare sequestration cuts to help pay for this legislation.
NON-CORONAVIRUS REGULATORY UPDATE
On July 19, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule entitled Calendar Year (CY) 2022 Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems(CMS-1753-P). Under the rule, CMS proposes changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment system. The proposed rule also updates and refines the requirements for the Hospital Outpatient Quality Reporting (OQR) Program and the ASC Quality Reporting (ASCQR) Program, and updates Hospital Price Transparency requirements. The rule includes a Request for Information (RFI) focusing on the health and safety standards, quality measures and reporting requirements, and payment policies for Rural Emergency Hospitals (REHs). Finally, the rule updates and refines the design of the Radiation Oncology Model and seeks comment on the extent to which hospitals are using flexibilities offered during the COVID-19 public health emergency (PHE) to provide mental health services remotely and whether CMS should consider changes to account for shifting practice patterns. Comments are due by September 17. A fact sheet on the rule is available here.
On July 21, Acting FDA Commissioner Janet Woodcock published a blog advocating for building a more resilient supply chain and promoting the shortages prevention program. Commissioner Woodcock called for additional authority to address these issues.
On July 21, the FDA issued a notice entitled the Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability.
On July 22, CMS held a National Listening Session entitled National Coverage Determination (NCD) Analysis for Monoclonal Antibodies that Target Amyloid for the Treatment of Alzheimer’s Disease to examine whether Medicare will establish a national coverage policy for Biogen’s Alzheimer’s drug, Aduhelm, and any future monoclonal antibodies directed against amyloid with an indication for use in treating Alzheimer's disease.
On July 22, HHS announced more than $1.6 billion to support testing and mitigation measures in high-risk congregate settings to prevent COVID-19 and detect and stem potential outbreaks.
On July 22, the FDA issued a notice for a comment request entitled Recommended Content of Medical Product Communications That Are Consistent With the Food and Drug Administration-Required Labeling and Recommendations for Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities.
On July 22, CMS issued an informational bulletin noting that receiving Medicaid benefits or the Children’s Health Insurance Program (CHIP) has no bearing on an applicant’s immigration status. A summary of the bulletin is available here.
On July 22, the Health Resources & Services Administration issued a Public Comment Request and Information Collection Request entitled Rural Health Care Services Outreach Program Performance Improvement and Measurement Systems Measures
On July 22, CMS issued a payment advisory entitled Medicare Program; CY 2021 Alternative Payment Model (APM) Incentive Payment Advisory for Clinicians – Request for Current Billing Information for Qualifying APM Participants.
On July 23, the FDA issued a notice of availability entitled Guidance Documents Related to Coronavirus Disease 2019; Availability.
On July 23, the FDA issued a notice for a comment request entitled Prescription Drug Advertising.
On July 23, CMS issued a notice of funding opportunity entitled Reduction of Issuer Burden Through Technology Grant.
On July 23, White House Office of Management & Budget (OMB) concluded its review of the proposed rule from CMS entitled Reassignment of Medicaid Provider Claims (CMS-2444).
CMS will hold a virtual meeting on August 23 of the Advisory Panel on Hospital Outpatient Payment to advise HHS Secretary and the CMS Secretary concerning the clinical integrity of the Ambulatory Payment Classification groups and their associated weights, and supervision of hospital outpatient therapeutic services.
The CMS Advisory Panel on Outreach and Education will hold a virtual meeting on July 28 to advise and make recommendations to the HHS Secretary and CMS Administrator on opportunities to enhance the effectiveness of consumer education strategies for the Affordable Care Act Marketplace, Medicare, Medicaid, and CHIP.
The Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices will hold a meeting on September 29 and 30 to review and revise the list of vaccines for administration to vaccine-eligible children through the Vaccines for Children program.
NON-CORONAVIRUS WHITE HOUSE UPDATE
On July 20, President Biden nominated Jonathan Kanter as the Justice Department (DoJ) Assistant Attorney General for Antitrust.
CORONAVIRUS UPDATE
House
None of note.
Senate
On July 20, the Health, Education, Labor, & Pensions (HELP) Committee held a hearing entitled The Path Forward: The Federal Perspective on the COVID-19 Response. Chair Patty Murray (D-WA) emphasized the need to increase vaccine confidence, vaccination rates and put an end to the COVID-19. CDC Director Rochelle Walensky noted that the Delta variant is currently causing more than 80% of new COVID-19 cases in the U.S. Witnesses included: Acting FDA Commissioner Janet Woodcock; CDC Director Rochelle Walensky; Biden’s chief medical adviser and National Institute of Allergy and Infectious Diseases (NIAID) Director Anthony Fauci; and Assistant HHS Secretary for Preparedness and Response Dawn O’Connell.
Regulatory
On July 19, HHS Secretary Becerra issued the renewal of the PHE due to COVID-19 for another 90 days.
On July 19, FDA Chief Medical Device Regulator Jeff Shuren argued that the FDA should have greater regulatory flexibility and financial resources for interactive reviews, outside of PHEs.
On July 21, Occupational Safety and Health Administration (OSHA) extended the comment period of the OSHA Emergency Temporary Standards to August 20.
On July 22, HHS’ Office of the Assistant Secretary for Preparedness and Response held a meeting with COVID-19 test makers and labs to prepare for the next phase of the pandemic and discuss potential strategies to maintain preparedness efforts.
On July 22, the CDC Advisory Committee on Immunization Practices held a meeting considering COVID-19 vaccine safety, reviewing scientific data, and to vote on vaccine recommendations regarding COVID-19 boosters for immunocompromised people. The Committee continued to recommend the Johnson & Johnson (J&J) COVID-19 vaccine, as the benefit still outweighs the risks of negative side effects. The Committee also announced that it would not recommend a COVID-19 booster for people with compromised immune systems until the FDA recommended boosters. The draft agenda is available here.
On July 23, the FDA updated its FDA COVID-19 Response At-A-Glance Summary, which provides a quick look at facts, figures and highlights on the FDA's response efforts.
The COVID-19 Health Equity Task Force will hold a virtual meeting on July 30 to consider interim recommendations addressing future pandemic preparedness, mitigation, and resilience needed to ensure equitable response and recovery in communities of color and other underserved populations.
White House
On July 21, President Biden predicted that children under 12 could be eligible for a COVID-19 vaccine in the next few months.
On July 22, the White House announced $100 million to deploy federal health workers to support vaccine outreach and COVID-19 tracking in rural and heartland states.
On July 23, the U.S. purchased an additional 200 million Pfizer COVID-19 vaccine doses. These doses are expected to be delivered from October 2021 through April 2022.
Other
On July 19, a laboratory study suggested that the J&J COVID-19 vaccine is much less effective against the Delta and Lambda COVID-19 variants than against the original COVID-19.
On July 19, the Kaiser Family Foundation released a report that found that health care use decreased dramatically early in the pandemic, but has mostly rebounded, and from initial filings, most Marketplace-participating insurers are assuming COVID-19 will have no effect on their 2022 costs. The report noted that few insurers expect ongoing expenses for COVID-19 testing, treatment, and vaccinations to have a net impact on costs in 2022 and insurers are also considered telehealth use and other policy changes in 2022 initial rate filings.
On July 21, Pfizer announced a deal with Biovac, a South African biopharmaceutical company, to produce and distribute Pfizer’s COVID-19 vaccine within the African Union.
On July 21, a study published in the New England Journal of Medicine found that two doses of Pfizer's shot was 88% effective at preventing symptomatic disease from the Delta variant, compared to 93.7% against the Alpha variant, and two shots of AstraZeneca vaccine were 67% effective against the Delta variant, and 74.5% effective against the Alpha variant.
On July 23, an Israel health department report found that the Pfizer COVID-19 vaccine was 39% effective in preventing Delta variant infections, provided 88% protection against hospitalization, and 91.4% against severe illness caused by the Delta variant.
As of July 25, more than 188 million people in the U.S. have received the first dose of COVID-19 vaccines (more than 163 million have received both doses) and nearly 395 million doses have been distributed, according to the CDC COVID Data Tracker.
As of July 25, the U.S. had more than 34.4 million confirmed COVID-19 cases resulting in 610,720 deaths, according to the Johns Hopkins University & Medicine Coronavirus Resource Center. Last week, 40% of new cases are from Florida, Missouri, and Texas.
RULES AT THE WHITE HOUSE OMB
HHS-CMS
Modification of Limitations on Redesignation by the Medicare Geographic Classification Review Board (CMS-1762); Interim Final Rule; Received 2/26/21
Basic Health Program; Federal Funding Methodology for Program Year 2022 (CMS-2438); Final Rule; Received 5/12/21
FY 2022 Inpatient Rehabilitation Facility (IRF) Prospective Payment System Rate Update and Quality Reporting Requirements (CMS-1748); Final Rule; 7/6/21
Reporting Requirements Related To Air Ambulance and Agent and Broker Services and HHS Enforcement Provisions; Proposed Rule; 7/7/21
Most Favored Nation (MFN) Model (CMS-5528); Proposed Rule; 7/7/21
FY 2022 Inpatient Psychiatric Facilities Prospective Payment System Rate and Quality Reporting Updates (CMS-1750)’ Final Rule; 7/7/21
FY 2022 Hospice Wage Index, Payment Rate Update, and Quality Reporting Requirements (CMS-1754); Final Rule; Received 7/8/21
HHS-FDA
Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification; Guidance for Industry; Availability; Notice; 5/11/21
Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act; Draft Guidance for Industry; Availability; Notice; Received 5/11/21
Product Identifiers Under the Drug Supply Chain Security Act Questions and Answers; Guidance for Industry; Availability; Notice; 5/11/21
Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act; Draft Guidance for Industry; Availability; Notice; 5/11/21
Remanufacturing of Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Prerule; Received 5/26/21
REPORTS
HHS Office of Inspector General (OIG)
On July 19, OIG released an Advisory Opinion 21-09 regarding the use of a "preferred hospital" network as part of Medicare Supplemental Health Insurance policies.
On July 22, OIG released a report entitled New York Improperly Claimed $439 Million In Medicaid Funds for Its School-Based Health Services Based on Certified Public Expenditures. The report found that New York claimed unallowable Federal funds because it did not support that all random moments coded as health care were for Medicaid-eligible health services, resulting in an estimated $98 million in unallowable Federal funds. OIG recommended that New York refund unallowable funds and additional procedural recommendations to assist New York in preparing accurate, supportable claims. New York generally disagreed with the findings and recommendations. A summary of the report is available here.
On July 22, OIG released a report entitled Palmetto GBA, LLC, Accurately Calculated Hospice Cap Amounts but Did Not Collect All Cap Overpayments. The report found that Palmetto accurately calculated cap amounts but did not collect all cap overpayments or pay refunds associated with lookback years due to two internal policies, resulting in Palmetto not collecting lookback overpayments or sending refunds to hospices, resulting in $9.8 million in uncollected payments. OIG recommended that Palmetto collect the lookback overpayments and return lookback refunds, discontinue using its internal policies of waiving certain overpayment collections related to lookback years and start collecting all hospice cap overpayments and paying refunds in accordance with CMS requirements, and develop processes for communication between the departments directly and indirectly involved in hospice cap oversight. Palmetto agreed with the recommendations and described actions it has taken or plans to take to address our findings and recommendations.
On July 23, OIG released a report entitled Texas Made Unallowable CHIP Payments for Beneficiaries Assigned More Than One Identification Number. The report found that Texas claimed Federal reimbursement for unallowable CHIP payments made to Managed Care Organizations on behalf of beneficiaries who were assigned more than one identification number, resulting in $922,557 of improper payments. OIG recommended that Texas identify and recover unallowable CHIP payments, identify any other beneficiaries who are assigned more than one identification number, and strengthen its procedures for determining whether applicants are enrolled in any medical or public assistance benefit programs throughout the State and ensure that no beneficiary is assigned more than one identification number. The State agency agreed with most issues and associated recommendations. A summary of the report is available here.
Congressional Budget Office (CBO)
On July 21, CBO released a report entitled Federal Debt and the Statutory Limit, July 2021. CBO projects that if the debt limit is not raised, the Treasury would probably run out of cash and be unable to make its usual payments starting sometime in the first quarter of the next fiscal year, most likely in October or November. A summary of the report is available here.
On July 21, CBO released a report entitled Additional Information About the Updated Budget and Economic Outlook: 2021 to 2031. CBO projected deficit for 2021 is $3.0 trillion, $126 billion less than the deficit recorded last year.
Government Accountability Office (GAO)
On July 19, GAO released a report entitled COVID-19: Continued Attention Needed to Enhance Federal Preparedness, Response, Service Delivery, and Program Integrity. The report identified more ways to improve federal programs related to the pandemic and other future emergencies. This report made 15 new recommendations, including: requested that the CDC assess the agency's needs for goods and services for the manufacturing and deployment of diagnostic test kits in PHEs; the Office of the Assistant Secretary for Preparedness and Response should develop and document plans for restructuring the PHE Medical Countermeasures Enterprise; and that the CDC should strengthen its surge testing capacity. A summary of the report is available here.
On July 20, GAO announced it is seeking nominations for the GAO Health Information Technology Advisory Committee (HITAC) Seeking Nominations for Health IT Advisory Committee by August 24, 2021.
UPCOMING CONGRESSIONAL HEARINGS
House
Veterans' Affairs Health Subcommittee
Aging in Place: Examining Veterans' Access to Home and Community Based Services
July 27, 10:00 a.m. Webex
Energy & Commerce Health Subcommittee
The Path Forward: Advancing Treatments and Cures for Neurodegenerative Diseases
July 29, 11:00 a.m., Rayburn House Office, and Cisco Webex
Senate
HELP Committee
The Path Forward: Building on Lessons Learned from the COVID-19 Pandemic
July 27, 10:00 a.m., 430 Dirksen Senate Office Building
Witnesses include: Les Becker, Deputy Secretary of Innovation, Washington State Department of Health; Phyllis Arthur, Vice President, Infectious Diseases and Diagnostics Policy, Biotechnology Innovation Organization; David Janz Director, MD, Medical Critical Care Services, University Medical Center New Orleans; Anita Cicero, Deputy Director, Center for Health Security, Johns Hopkins Bloomberg School of Public Health.
Judiciary Committee
July 29, 9:00 a.m., 216 Hart Senate Office Building
The hearing will consider the following pieces of legislation:
Finance Committee
July 27, 9:30 a.m., 215 Dirksen Senate Office Building
Witnesses include: Benjamin Davis, Director Of International Affairs, United Steelworkers; Allan Huttema, Chairman, Northwest Dairy Association/Darigold Board of Directors; Michelle McMurry-Heath, MD, PhD, President and CEO, Biotechnology Innovation Organization, Beth Lowell, Deputy Vice President, U.S. Campaigns, Oceana.
OTHER HEALTH POLICY NEWS
On July 19, the DoJ objected to Purdue Pharma's proposed bankruptcy plan as being illegal and unconstitutional.
On July 19, Texas Attorney General Ken Paxton (R) filed for a preliminary injunction to reverse the Biden Administration’s decision to revoke the state’s Medicaid expansion waiver.
On July 20, a study published in JAMA found that medical debt in the U.S. reached $140 billion in 2020. In June 2020, nearly one in five Americans had medical debt in collections, averaging $429.
On July 21, AmerisourceBergen, Cardinal Health, McKesson, and J&J agreed to a $26 billion settlement with attorneys general from North Carolina, Tennessee, California, Colorado, Connecticut, Delaware, Florida, Georgia, Louisiana, Massachusetts, New York, Ohio, Pennsylvania, and Texas regarding the company’s contribution to the opioid crisis.
On July 22, Biogen released an open letter to the Alzheimer’s disease community arguing that the Alzheimer’s treatment, Aduhelm’s, approval has been the subject of extensive misinformation and misunderstanding.
On July 23, the Missouri Supreme Court unanimously reversed a lower court decision, deeming the state’s Medicaid expansion constitutional.
On July 23, Arkansas Governor Asa Hutchinson (R) submitted a request to the federal government to include work requirements in the state’s Medicaid program.