Health Care Watch: July 6, 2021
The following Health Care Watch provides a summary of legislative and regulatory health care activities from June 28 - July 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.
NON-CORONAVIRUS LEGISLATIVE UPDATE
House
On June 28, the Appropriations Committee released 302(b) appropriation discretionary spending amounts for fiscal year (FY) 2022. Proposed topline funding includes $26.6 billion for the Agriculture-Food and Drug Administration (FDA) Committee and $237.5 billion for the Labor-Health & Human Services (HHS)-Education Committee. These Committees have yet to publish their respective spending reports. On June 30, the Appropriations Committee approved the FY 2022 Agriculture, Rural Development, FDA, and Related Agencies bill by voice vote. A summary of the spending bill is available here.
On June 28, the House approved the National Science Foundation for the Future Act in a 345-67 vote. This bill increases funding for science and technology research and establishes a new division within the National Science Foundation for advanced technologies and other cutting-edge research, to promote U.S. competitiveness with China.
On June 29, Ranking Member Kevin McCarthy (R-CA) announced the Republican Healthy Future Republican Task Force members:
Devin Nunes (R-CA);
Brett Guthrie (R-KY);
Brad Wenstrup (R-OH);
Mike Kelly (R-PA);
Kevin Hern (R-OK);
Rick Allen (R-GA);
Victoria Spartz R-(IN);
Mariannette Miller-Meeks (R-IA);
Greg Murphy (R-NC);
Jim Banks (R-IN);
Richard Hudson (R-NC);
Larry Bucshon (R-IN);
Morgan Griffith (R-VA);
John Joyce (R-PA);
Tom Cole (R-OK);
Bruce Westerman (R-AR); and
Beth Van Duyne (R-TX).
On June 29, Rep. James Comer (R-KY), Steve Scalise (R-LA), and Jim Jordan (R-OH) held a forum to discuss and examine the origin of COVID-19.
On June 30, the Appropriations Committee held a markup FY2022 Agriculture, Rural Development, FDA, and Related Agencies Appropriation bill; and the FY2022 Military Construction, Veterans Affairs, and Related Agencies appropriation bill. The bill text is available here.
On July 1, the Select Subcommittee on the Coronavirus Crisis held a hearing entitled Hybrid Hearing on “Building Trust and Battling Barriers: The Urgent Need to Overcome Vaccine Hesitancy.” Chairman James Clyburn (D-SC) advocated for increasing COVID-19 vaccine education and outreach efforts to address vaccine hesitancy. Witnesses include: Georges Benjamin, M.D., Executive Director, American Public Health Association; Joshua Garza, Coronavirus Survivor; Katy Milkman, Professor of Operations, Information, and Decisions, Wharton School, Professor, Division of Health Policy, Perelman School of Medicine, University of Pennsylvania; Jerome Adams, M.D., Former U.S. Surgeon General; and Sophia Bush, Actress, Activist, Entrepreneur.
On July 2, Energy & Commerce Committee Chair Frank Pallone (D-NJ) announced that Jeff Carroll will be leaving his position as Energy & Commerce Staff Director at the beginning of August. Tiffany Guarascio will replace Carroll as Staff Director and Waverly Gordon will become Deputy Staff Director and General Counsel.
Senate
On June 28, Minority Leader Mitch McConnell (R-KY) urged President Biden to ensure that Majority Leader Chuck Schumer (D-NY) and House Speaker Nancy Pelosi (D-CA) delink the bipartisan infrastructure deal from a larger, partisan infrastructure package.
On June 30, Democratic Sens. Michael Bennet (D-CO) and Tammy Baldwin (D-CO) urged HHS Secretary Xavier Becerra and Centers for Medicare & Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure to review issues surrounding care for older LGBTQ adults, especially around those receiving palliative and hospice care.
NON-CORONAVIRUS REGULATORY UPDATE
On June 28, CMS announced Daniel Tsai will become Deputy Administrator and Director of Center for Medicaid and CHIP Services.
On June 28, CMS issued a proposed rule entitled Updating Payment Parameters, Section 1332 Waiver Implementing Regulations, and Improving Health Insurance Markets for 2022 and Beyond. This rule proposes to reinstate previous requirements that Federally-facilitated Exchange (FFE) Navigators provide consumers with information and assistance on post-enrollment topics and expand the interpretation of providing consumers with information and assistance related to basic concepts and rights of health coverage and how to utilize it. The rule also proposes an extended open enrollment period from November 1 to December 15 by a month, until January 15, and allows those who fall under 150% of the federal poverty level to sign up each month. Finally, the rule proposes to repeal the Exchange Direct Enrollment option that allows states to privatize their state marketplaces and proposes modifications to 1332 State Innovation Waivers implementing regulations. Comments are due by July 28. A fact sheet on this rule is available here. A summary of the rule is available here.
On June 28, CMS issued a proposed rule entitled CY 2022 Home Health Prospective Payment System (PPS) Rate Update; Home Health Value-Based Purchasing Model Requirements and Proposed Model Expansion; Home Health Quality Reporting Requirements; Home Infusion Therapy Services Requirements; Survey and Enforcement Requirements for Hospice Programs; Medicare Provider Enrollment Requirements; Inpatient Rehabilitation Facility Quality Reporting Program Requirements; and Long-term Care Hospital Quality Reporting Program Requirements. The rule proposes routine updates to the Home Health PPS, including the Home Health Patient Directed Groupings Model (PDGM), a revised case-mix adjustment methodology that was implemented on January 1, 2020. Notably, the rule does not provide relief for the -4.36% behavioral adjustments applied by CMS to the rates in CY2020 and CY2021; thus, this reduction to the rates continues to apply. Overall, the rule proposes a 1.8% increase in Medicare payments for home health for FY2022. The rule also proposes a national expansion of the home health value-based purchasing model starting in CY2022, and several new policies related to quality reporting. CMS includes several requests for information (RFIs) in the proposed rule, including seeking feedback on ways to advance health equity for all patients and Fast Healthcare Interoperability Resources in support of Digital Quality Measurement in Quality Reporting Programs. Comments are due by August 27. A fact sheet of the rule is available here. A summary of the rule is available here.
On June 29, Substance Abuse and Mental Health Services Administration (SAMHSA) issued a notice entitled the 2022 National Survey on Drug Use and Health
On June 28, the Drug Enforcement Administration issued a final rule entitled Registration Requirements for Narcotic Treatment Programs With Mobile Components. The rule would make it easier for mobile vans to deliver methadone to those suffering from opioid addiction.
On June 28, the White House Office of Management & Budget (OMB) received a final rule from the FDA entitled Medical Device De Novo Classification Process.
On June 28, OMB received a final rule from the HHS Office of the Secretary entitled Streamlining HHS Guidance Practices.
On June 29, OMB concluded its review of the interim final rule from CMS entitled Basic Health Program; Federal Funding Methodology for Program Year 2022 (CMS-2438).
On July 2, the FDA released a report entitled Drug Shortages for CY2020. The report notes that the medical product supply chain was impacted by COVID-19, leading to drug product supply disruptions and shortages. The report identified 43 new shortages out of 83 ongoing shortages caused by increased demand for certain products and workforce disruptions in manufacturing plans.
On July 1, CMS announced that consumers who received or are approved to receive unemployment compensation for any week beginning in 2021, may be able to find even lower cost plans and save extra money on out-of-pocket expenses through HealthCare.gov.
On July 1, HHS, the Department of Labor, the Department of the Treasury, and the Office of Personnel Management released an interim final rule with a comment period entitled Requirements Related to Surprise Billing; Part I. This rule establishes new protections from surprise billing and excessive cost-sharing for consumers receiving health care items and services. This rule implements many of the No Surprises Act requirements for issuers, providers, facilities, and other stakeholders and implements the following provisions:
Bans surprise billing for emergency services;
Bans high out-of-network cost-sharing for emergency and non-emergency services;
Bans out-of-network charges for ancillary care at an in-network facility in all circumstances; and
Bans other out-of-network charges without advance notice.
Fact sheets on the interim final rule are available here and here. A summary of the report is available here.
On July 1, CMS proposed a rule entitled End-Stage Renal Disease (ESRD) PPS, Payment for Renal Dialysis Services Furnished to Individuals with Acute Kidney Injury, ESRD Quality Incentive Program, and ESRD Treatment Choices Model. The rule proposes a CY2022 ESRD-PPS base rate of $255.55, an increase of $2.42 compared to the CY2021 final rule base rate of $253.13. The proposed rule provides for an increase to the ESRD-PPS base rate for CY 2022 of 1.0% and the application of the wage index budget neutrality adjustment factor (.999546). The rule also proposes changes to the ESRD Treatment Choices (ETC) Model, which is a mandatory payment model that is focused on encouraging greater use of home dialysis and kidney transplants, to reduce Medicare expenditures while preserving or enhancing the quality of care furnished to Medicare beneficiaries. Finally, the proposed rule includes several requests for information on topics that are relevant to the ESRD Quality Incentive Program (QIP) and to inform payment reform under the ESRD PPS. Comments on the rule are due August 31. A fact sheet on the rule is available here.
On July 1, the Federal Trade Commission announced investigation priority areas for the next ten years, including COVID-19-related harms and health care businesses, including pharmaceutical companies, PBMs, and hospitals.
NON-CORONAVIRUS WHITE HOUSE UPDATE
On July 1, the White House appointed Danielle Carnival as senior adviser to White House Office of Science and Technology Policy Director Eric Lander to further support cancer research and other initiatives.
CORONAVIRUS UPDATE
House
None of note.
Senate
None of note.
Regulatory
On June 28, the HHS Office of Minority Health announced $250 million in grant awards to 73 local governments as part of the Advancing Health Literacy to Enhance Equitable Community Responses to COVID-19 initiative to identify and implement best practices for improving health literacy to enhance COVID-19 vaccination and other mitigation practices among underserved populations.
On June 30, the National Institutes of Health released results from a study that compares rapid antigen and laboratory PCR approaches for COVID-19 serial screening. The study found that both testing methods were equally effective in detecting COVID-19 when tests were given regularly, every three days.
White House
On July 1, the White House released state fact sheets highlighting the need for the Bipartisan Infrastructure Framework.
On July 1, the White House released the U.S. COVID-19 Global Response and Recovery Framework to address the COVID-19 pandemic, outlining five objectives:
Accelerate widespread and equitable access to and delivery of safe and effective COVID-19 vaccinations, with no strings attached;
Reduce morbidity and mortality from COVID-19, mitigate transmission, and strengthen health systems, including to prevent, detect, and respond to pandemic threats;
Address acute needs driven by COVID-19, mitigate household shocks, and build resilience;
Bolster economies and other critical systems under stress due to COVID-19 to prevent backsliding and enable recovery; and
Strengthen the international health security architecture to prevent, detect, and respond to pandemic threats.
Other
On June 28, a study published in Nature found that the Pfizer and Moderna COVID-19 vaccines may protect against COVID-19 for years, adding to the evidence that the mRNA vaccines may not need boosters.
On June 29, Moderna announced that its COVID-19 vaccine is effective against the COVID-19 delta variant.
On June 29, Sanofi committed to invest $477 million annually to its mRNA Vaccine Center of Excellence to accelerate the development and delivery of next-generation vaccines.
On June 30, the U.K. Joint Committee on Vaccination and Immunisation issued interim recommendations for the government to plan for COVID-19 vaccine third-dose administration for vulnerable people in September. The vulnerable populations the committee noted included care home residents and staff; people over 70; health care workers; clinically vulnerable adults, and those who are immunosuppressed.
On June 30, Pfizer indicated that it aims to submit its COVID-19 vaccine for authorization for kids aged 5 to 11 by September or October.
On June 30, CureVac announced that its COVID-19 vaccine achieved vaccine efficacy of 48% from its Phase IIb/III trial.
On June 30, Johnson & Johnson (J&J) announced its plans to begin COVID-19 vaccine clinical trials for those 12 to 17 years old in the fall. J&J also announced it will provide protection against the delta variant.
On July 1, the University at Albany released a report commissioned by New York Governor Andrew Cuomo (D) on health disparities that were exacerbated by COVID-19 and the disproportionate harm COVID-19 caused minority communities, both socially and economically. The report called for improved data and data collection on the impact of COVID-19 on New York’s Indigenous communities and Indigenous communities generally, utilize this data to identify differences in how different minority groups experienced COVID-19, and further identify differences and their causes.
As of July 5, over 182 million people in the U.S. have received the first dose of COVID-19 vaccines (more than 157 million have received both doses) and more than 383 million doses have been distributed, according to the CDC COVID Data Tracker.
As of July 5, the U.S. had more than 33.7 million confirmed COVID-19 cases resulting in 605,535 deaths, according to the Johns Hopkins University & Medicine Coronavirus Resource Center.
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
CY 2022 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS-1751); Proposed Rule; Received 3/30/21
CY 2022 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates (CMS-1753); Proposed Rule; 5/11/21
Basic Health Program; Federal Funding Methodology for Program Year 2022 (CMS-2438); Final Rule; 5/12/21
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; 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; 5/26/21
REPORTS
Health & Human Services (HHS) Office of Inspector General (OIG)
On June 28, OIG released a report entitled CMS's Controls Related to Hospital Preparedness for an Emerging Infectious Disease Were Well-Designed and Implemented but Its Authority Is Not Sufficient for It To Ensure Preparedness at Accredited Hospitals. The report found that CMS' controls were well-designed and implemented, but its authority is not sufficient for it to fulfill its responsibility to ensure that accredited hospitals would maintain quality and safety during an emerging infectious disease emergency. OIG found that CMS could not determine that all accredited hospitals updated their emergency preparedness plans to include emerging infectious diseases planning until 2022 due to accreditation organizations' quality and safety inspection cycles. As COVID-19 emerged, CMS requested accreditation organizations to perform special targeted infection control surveys to help accredited hospitals prepare for COVID-19 patients but the agency could not require these surveys. OIG recommended that CMS make regulatory changes to allow the agency to require accreditation organizations to perform special surveys and address the risks presented by a public health emergency. CMS agreed with the recommendation. A summary of the report is available here.
On June 28, OIG released a report entitled Medicare Hospital Provider Compliance Audit: Staten Island University Hospital. OIG found that the Staten Island University Hospital did not fully comply with Medicare billing requirements, resulting in overpayments of nearly $11.8 million. OIG recommended that the hospital refund to the Medicare contractor the overpayments and strengthen controls to ensure full compliance with Medicare requirements. A summary of the report is available here.
On June 29, OIG released an advisory opinion regarding a spinal implant manufacturer’s proposal to offer its products to hospitals at a reduced price if the hospitals agree to assume certain duties related to the products.
On June 30, OIG released a report entitled 2020 Performance Data for the Senior Medicare Patrol Projects. The report found that in 2020, the 54 Senior Medicare Patrol (SMP) projects had a total of 5,720 active team members who conducted a total of 9,870 group outreach and education events, reaching an estimated 425,103 people. SMP projects reported $16.8 million in expected Medicare recoveries in 2020. In 2020, SMP projects were not able to conduct in-person outreach events and face-to-face individual interactions as they have done in the past, due to COVID-19. The SMP program also released two consumer fraud alerts on COVID-19 and genetic testing and provided OIG with 42 reports-referred to as Special Notifications-of new fraud trends based on ground level insights from the SMP projects. A summary of the report is available here.
On June 30, OIG released a report entitled Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2021. The report found that the rate of Part D plan formularies' inclusion of the 195 drugs commonly used by dual eligibles is high, with some variation, and that the percentage of drugs to which plan formularies applied utilization management tools remained the same between 2020 and 2021. OIG concluded that the inclusion rates for the 195 drugs commonly used by dual eligibles are largely unchanged from previous reports. Part D formularies include roughly the same high percentage of these commonly used drugs in 2021 as they did in 2020. This report did not include recommendations. A summary of the report is available here.
Government Accountability Office (GAO)
On June 28, GAO released a report entitled Cybersecurity: HHS Defined Roles and Responsibilities, but Can Further Improve Collaboration. GAO found that HHS entities lack effective cybersecurity information sharing and identified opportunities to strengthen information sharing with sector partners. GAO identified seven recommendations to HHS to improve its collaboration and coordination within the department and the sector. A summary of the report is available here.
Congressional Budget Office (CBO)
On July 1, CBO released a report entitled An Update to the Budget and Economic Outlook: 2021 to 2031. The report found that the federal budget deficit will reach $3.0 trillion and the federal debt will reach 103% of Gross domestic product (GDP) in FY2021. CBO estimates that the real GDP will grow by 7.4% in CY2021. A summary of the report is available here.
HEARINGS
House
Appropriations Agriculture, Rural Development, FDA, and Related Agencies Subcommittees
FY 2021 Agriculture, Rural Development, FDA, and Related Agencies Subcommittee Markup
July 6, 6:00 p.m., 2118 Rayburn House Office Building
Appropriations Labor, HHS, Education, and Related Agencies Subcommittee
FY Appropriations 2022 Markup: Labor, HHS, Education, and Related Agencies
July 12, TBD
Appropriations Committee
FY Appropriations 2022 Markup
July 16-17, TBD
Senate
None of note.
OTHER HEALTH POLICY NEWS
On June 28, the Supreme Court declined to review the American Hospital Association’s (AHA) appeal involving HHS’ site-neutral payment regulations and reducing Medicare reimbursement for health exams at hospital-owned clinics.
On June 29, Avalere Health released a report that found that there was an accelerated nationwide growth in acquisitions of physician practices and employed physicians, due to COVID-19. By January 2021, hospitals and corporate entities owned nearly 50% of physician practices and 25% of physician practices.
On June 29, the AHA and other hospital associations voiced their opposition to using an extension of mandatory sequestration and unspent COVID-19 provider relief funds to finance the proposed infrastructure package. In a separate letter, the AHA asked the Occupational Safety and Health Administration to delay the compliance schedule of its COVID-19 emergency temporary standard for health care.
On June 29, Walmart began selling private-label versions of Novo Nordisk’s rapid-acting analog insulin products for cash prices that are lower than the cash price of the authorized generic made by Novo Nordisk.
On June 29, the Bipartisan Policy Center released a report presenting recommendations to improve the resilience of the U.S.’s health and public health systems to address COVID-19 and future public health crises, including creating clarity and accountability in federal leadership and operations during a pandemic; improving public health information technology and data systems; and committing the U.S. to more and consistent funding of public health to prepare for inevitable public health crises.
On June 29, the lawsuit between New York and a group of drug manufacturers and distributors, including Teva Pharmaceuticals, Allergan, Endo Pharmaceuticals, McKesson Corp. and their affiliates, regarding their participation in the opioid crisis began.
On June 29, Community Catalyst and other state consumer health advocacy groups called for Congressional leaders and President Biden to address health inequities, improve affordability and quality of coverage, expand access to comprehensive coverage, and strengthen existing programs to better serve consumers.
On June 30, GoodRx released a study that found that the price of generic drugs can be marked up 6,000% across different hospitals.
On July 1, Oklahoma Medicaid expansion went into effect, making it the 39th state with Medicaid expansion and the fifth to approve it as a ballot initiative. CMS announced that approximately 190,000 individuals between the ages of 19-64 in Oklahoma are now eligible for health coverage.
On July 2, the Supreme Court announced it will review American Hospital Association v. Becerra, the dispute between the hospital industry and the federal government over Medicare outpatient reimbursement to 340B hospitals. The Court also announced it would hear Empire Health Foundation v. Becerra, which centers on how CMS calculates payments to disproportionate share hospitals, and CVS Pharmacy v. Doe, to review ACA “enforcement mechanisms” of other federal antidiscrimination statutes.