Health Care Watch: October 4, 2021
The following FHP Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from September 27 – October 3. 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
Senate
On September 30, the Senate passed a continuing resolution (65-35) to prevent a government shutdown and extend government funding until December 3. The package also includes funding for Afghan resettlement and disaster relief funds. This legislation does not address the federal debt ceiling which is expected to be reached in mid-October. The House then approved the package (254-175) and President Biden signed the legislation into law.
On September 30, details surrounding Sen. Joe Manchin’s (D-WV) proposed deal to Senate Majority Leader Chuck Schumer (D-NY) to cap the price of the reconciliation bill to $1.5 trillion was released. President Biden indicated that he would support a lower price tag for the reconciliation package. House Democrats are considering ways to trim the price tag of the $3.5 trillion reconciliation, including means-testing new Medicare benefits and cross-program funding reductions.
House
On September 28, the Education & Labor Committee held a hearing entitled How to Save a Life: Successful Models for Protecting Communities from COVID-19. Chair Suzanne Bonamici (D-OR) highlighted the importance of increasing COVID-19 vaccinations as an important health equity issue. Witnesses included: Leana Wen, Visiting Professor & Distinguished Fellow Fitzhugh Mullan Institute of Health Workforce Equity, The George Washington University Milken Institute, School of Public Health; Chris Pernell, Chief Strategic Integration and Health Equity Officer, University Hospital; Avik Roy, President, The Foundation for Research on Equal Opportunity; Viviana Martinez-Bianchi, Director of Health Equity and Associate Professor, Department of Family Medicine and Community Health, Duke University School of Medicine.
On September 28, the Judiciary Antitrust, Commercial, and Administrative Law Subcommittee held a hearing entitled Reviving Competition, Part 4: 21st Century Antitrust Reforms and the American Worker. Judiciary Committee Chairman Jerrold Nadler (D-NY) noted that consolidation has led to high levels of concentration in labor markets and called for increased antitrust enforcement.
On September 29, the Judiciary Committee held a markup of and favorably reported the following health legislation:
H.R. 2883, the Stop Stalling Access to Affordable Medications;
H.R. 2891, the Preserve Access to Affordable Generics and Biosimilars Act;
H.R. 2873, the Affordable Prescriptions for Patients Through Promoting Competition Act of 2021; and
H.R. 2884, the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act.
The House failed to consider the Senate-passed, $1.2 trillion bipartisan infrastructure package the week of September 27 because progressive Democrats are opposing the bill until an agreement is reached on the $3.5 trillion reconciliation package. President Biden met with House Democrats on October 1, urging progressives to support reducing the topline reconciliation number to $1.9 to $2.3 trillion and that both the infrastructure and reconciliation packages be considered simultaneously in the coming weeks. Speaker Nancy Pelosi set a new deadline of October 31 to consider the bipartisan bill.
NON-CORONAVIRUS REGULATORY UPDATE
On September 27, the U.S. Department of Health & Human Services (HHS) announced Lisa Pino as HHS Office for Civil Rights (OCR) Director.
On September 27, the White House Office of Management & Budget (OMB) concluded its review of a notice from the Food & Drug Administration (FDA) entitled Hospital and Health System Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Revised Draft Guidance for Industry; Availability.
On September 27, HHS issued a rule entitled HHS Grants.
On September 28, HHS released its Contingency Staffing Plan for Operations in the absence of an enacted annual appropriation.
On September 28, the Centers for Medicare & Medicaid Services (CMS) announced that to help efficiently administer influenza vaccines or pneumococcal vaccines to SNF residents during the COVID-19 PHE, effective as of September 20, 2021, CMS will exercise enforcement discretion with respect to the SNF Consolidated Billing Provisions.
On September 28, CMS released a RAND report entitled Disparities in Health Care in Medicare Advantage (MA) Associated with Dual Eligibility or Eligibility for a Low-Income Subsidy. The report found that dual-eligible MA beneficiaries and Medicare beneficiaries who are eligible for a Low-Income Subsidy (LIS) had worse quality of clinical care than other MA beneficiaries.
On September 28, HHS awarded $1 billion to Health Resources and Services Administration (HRSA) Health Center Program-funded health centers to support major health care construction and renovation projects, and strengthen primary health care infrastructure and advance health equity and health outcomes in medically underserved communities.
On September 28, Substance Abuse and Mental Health Services Administration (SAMHSA) announced the investment of $825 million to 231 Community Mental Health Centers across the U.S. to support and expand access to mental health and behavioral support.
On September 29, CMS issued a notice entitled Medicare Program: Adjustment to the Amount in Controversy Threshold Amounts for Calendar Year (CY) 2022. The notice announces the annual adjustment in the amount in controversy (AIC) threshold amounts for Administrative Law Judge (ALJ) hearings and judicial review under the Medicare appeals process. The calendar year 2022 AIC threshold amounts are $180 for ALJ hearings and $1,760 for judicial review.
On September 29, the FDA issued guidance entitled Benefit-Risk Assessment for New Drug and Biological Products.
On September 29, the FDA issued guidance entitled Investigator Responsibilities--Safety Reporting for Investigational Drugs and Devices.
On September 29, CMS released the 2022 premiums, deductibles, and other information for MA and Part D prescription drug plans. The average premium for MA plans will be $19 per month in 2022, compared to $21.22 in 2021. The average 2022 premium for Part D coverage will be $33 per month, compared to $31.47 in 2021. MA open enrollment begins October 15.
On September 30, HHS rescinded the Trump-era final rule entitled Implementation of Executive Order on Access to Affordable Life-Saving Medications that had required health centers to pass 340B discounts for insulin and injectable epinephrine to patients.
On September 30, the FDA issued a notice entitled Announcement of Office of Management and Budget Approvals.
On September 30, the FDA issued guidance entitled Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products.
On September 30, HHS, the Department of Labor, Department of Treasury, and the Office of Personnel Management (OPM) issued an interim final rule entitled Requirements Related to Surprise Billing; Part II. The rule establishes new protections from surprise billing and excessive cost sharing and implements additional protections against surprise medical bills under the No Surprises Act, including provisions related to the independent dispute resolution process, good faith estimates for uninsured individuals, the patient-provider dispute resolution process, and expanded rights to external review. The rule will take effect on January 1. A fact sheet of the rule is available here. A summary detailing consumer protections is available here.
On September 30, HHS, Labor, Treasury, and OPM launched a website to provide general information about No Surprises Act provisions and assist in the billing dispute resolution process between providers or facilities and health plans.
On September 30, HHS, Labor, Treasury, and OPM also released the Calendar Year 2022 Fee Guidance for the Federal Independent Dispute Resolution Process Under the No Surprises Act. This guidance provides the allowable fees certified independent dispute resolution entities will be able to charge in 2022, and the administrative fee that parties to a dispute must pay to access the federal independent dispute resolution process.
On September 30, CMS Chief Operating Officer Jon Blum indicated that the CMS’ Center for Medicare & Medicaid Innovation (CMMI) will pursue value-based care models, including using payment models to address health equity gaps, and will not focus on fully risk-based payment models.
On September 30, HHS OCR issued guidance regarding disclosures and requests for information regarding the COVID-19 vaccine.
NON-CORONAVIRUS WHITE HOUSE UPDATE
None of note.
CORONAVIRUS UPDATE
House
On September 28, Energy & Commerce Ranking Member Cathy McMorris Rodgers, Health Subcommittee Ranking Member Brett Guthrie, and Oversight & Investigations Ranking Member Morgan Griffith requested information and a briefing regarding the Centers for Disease Control and Prevention’s (CDC) decision not to collect data on breakthrough cases of COVID-19 unless the breakthrough cases result in hospitalization or death. The Republican leaders voiced their concern regarding the CDC potentially making decisions based on limited or unreliable data.
On September 29, the Oversight & Reform Coronavirus Crisis Subcommittee held a hearing entitled Upgrading Public Health Infrastructure: The Need to Protect, Rebuild, and Strengthen State and Local Public Health Departments. Witnesses included: Beth Resnick, Assistant Dean for Practice and Training, Senior Scientist. Bloomberg School of Public Health, Johns Hopkins University; Jennifer Bacani McKenney, Health Officer, Wilson County Kansas Health Department; Joseph Kanter, State health officer, medical director, Louisiana Department of Health; and Mysheika Roberts, Health Commissioner, Ohio Columbus Public Health.
Senate
None of note.
Regulatory
On September 27, the Office of the United States Trade Representative issued a notice entitled Notice of Product Exclusion Extensions: China’s Acts, Policies, and Practices Related to Technology Transfer, Intellectual Property, and Innovation. The notice extends tariff exclusions until November 14 to allow additional time to review comments and take further action on individual items.
On September 27, the CDC issued a request for information regarding the ability to provide electronic verification of COVID-19 vaccination and testing of CDC staff.
On September 28, the CDC reported that those who have received a COVID-19 vaccine booster have reported mild side effects, similar to those after a second dose.
On September 28, National Institute of Allergy and Infectious Diseases (NIAID) awarded $36.3 million to conduct research to develop vaccines to protect against multiple types of coronaviruses and viral variants.
On September 29, the Federal Communications Commission (FCC) announced $41 million for FCC’s COVID-19 Telehealth Program to reimburse health care workers providing telecommunications services, information services, and connected devices necessary to enable telehealth during COVID-19.
On September 30 the CDC urged pregnant people to get COVID-19 vaccinations, as COVID-19 cases, hospitalizations, and deaths increase and vaccinations among people who are pregnant lag.
Other
On September 27, Pfizer launched a Phase II/III study of its investigational novel oral antiviral candidate, co-administered with a low dose of ritonavir, for the prevention of COVID-19 infection for those exposed to the virus.
On September 28, Pfizer announced that it has submitted Phase II/III data to the FDA regarding its COVID-19 vaccine for children five to 11.
On September 28, Sanofi announced positive Phase I/II results for its mRNA COVID-19 vaccine but decided to not continue developing the vaccine. Sanofi will continue mRNA research on other infectious diseases, specifically a mRNA flu vaccine.
On September 28, a study released in PLOS Medicine found that 57% of COVID-19 survivors had one or more long-COVID symptoms during the 6 months after they recovered.
On September 29, Regeneron announced positive Phase III trial results of its antibody cocktail of casirivimab and imdevimab to treat COVID-19 in infected high-risk non-hospitalized patients.
On September 30, the Rural Policy Research Institute released a report that found that currently, rural COVID-19 mortality rates are more than double urban rates.
On October 1, Merck announced Phase III results that its oral COVID-19 antiviral drug, molnupiravir, reduced the risk of COVID-19 hospitalization or death for at-risk, non-hospitalized adult patients with mild-to-moderate COVID-19 by 50%. The treatment is also effective against COVID-19 variants, including the Delta variant.
On October 1, the Kaiser Family Foundation released a report that found that following vaccine rollout, weekly cases and deaths in long-term care facilities dropped, but then rapidly increased again due to the Delta variant. Deaths attributable to COVID-19 increased at a faster rate in nursing homes than among all others in the community between July and August 2021.
On October 1, California announced a COVID-19 vaccine mandate for public and private school children, following FDA approval.
On October 1, Supreme Court Justice Brett Kavanaugh announced that he tested positive for COVID-19.
As of October 1, more than 214 million people in the U.S. have received the first dose of COVID-19 vaccines (more than 184 million have received both doses) and more than 477 million doses have been distributed, according to the CDC COVID Data Tracker.
As of October 1, the U.S. had nearly 43.5 million confirmed COVID-19 cases resulting in 699,010 deaths, according to the Johns Hopkins University & Medicine Coronavirus Resource Center.
RULES AT THE WHITE HOUSE OMB
HHS-CMS
Request for Information: Transplant System Modernization (CMS-3409); Notice; 9/21/21
Prescription Drug and Health Care Spending (CMS-9905); Interim Final Rule; 9/24/21
HHS-FDA
Medical Device De Novo Classification Process; Final Rule; 6/28/21
Medical Devices; Ear, Nose and Throat Devices; Establishing Over-the-Counter Hearing Aids and Aligning Other Regulations; Proposed Rule; 8/18/21
Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products; Draft Guidance for Industry and Food and Drug Administration Staff; Availability; Notice; 8/18/21
HHS-Office of the Secretary
Securing Updated and Necessary Statutory Evaluations Timely; Proposed Rule; 8/31/21
Streamlining HHS Guidance Practices; Proposed Rule; 6/28/21
REPORTS
HHS Office of Inspector General (OIG)
On September 27, OIG released a report entitled Six of Eight Home Health Agency (HHAs) Providers Had Infection Control Policies and Procedures That Complied With CMS Requirements and Followed CMS COVID-19 Guidance To Safeguard Medicare Beneficiaries, Caregivers, and Staff During the COVID-19 Pandemic. The report found that six of the eight selected HHA providers had infection control policies and procedures that complied with CMS requirements and followed CMS guidance to safeguard HHA staff, Medicare beneficiaries, and caregivers during COVID-19. OIG found that one HHA provider did not comply with CMS requirements or follow CMS COVID-19 guidance, and this provider and another HHA provider's COVID-19 screening protocols for patients were not consistent with CMS guidance, putting staff and residents at risk. OIG recommended that CMS develop and share with the HHA industry information on COVID-19 infection prevention and control best practices that HHA providers can use to comply with CMS requirements and follow CMS guidance. CMS agreed with the recommendation. A summary of the report is available here.
On September 30, OIG released a report entitled High-expenditure Medicare drugs often qualified for Orphan Drug Act (ODA) incentives designed to encourage the development of treatments for rare diseases. The report found that a majority of the highest-expenditure drugs in Medicare have been granted at least one orphan designation, qualifying the manufacturers for ODA financial incentives. OIG noted that some of these orphan drugs generate significant Medicare expenditures and billions of dollars in annual revenue, while treating only rare diseases and conditions. OIG also noted that many of the high-expenditure orphan drugs were originally approved and are still primarily used to treat relatively common diseases or conditions. OIG concluded that orphan drug exclusions from the 340B Drug Pricing Program may provide significant financial incentives for manufacturers to seek orphan designation for drugs approved to treat common diseases or conditions. OIG highlighted that it is vital to ensure that the Orphan Drug Program continues to successfully encourage the development of drugs to treat rare diseases and conditions while taking into consideration questions surrounding affordability, profitability, and the meaning of rare use. FDA expressed concern with the narrow scope of OIG's report. A summary of the report is available here.
Government Accountability Office (GAO)
On September 27, GAO released a report entitled Medicaid Behavioral Health: CMS Guidance Needed to Better Align Demonstration Payment Rates with Costs and Prevent Duplication.The report found that five of the eight states that participated in a demonstration to establish federally funded-certified community behavioral health clinics (CCBHC) to provide a broad range of behavioral health services, mental health, and substance use services through their state Medicaid programs reported increased state spending on CCBHCs. Officials attributed this increase to an increased number of individuals receiving treatment, an increased array of services provided. The other three states noted that the demonstration resulted in spending decreases, because of the demonstration's enhanced federal Medicaid funding. Four of the eight states noted potential cost savings from reductions in more expensive care, such as emergency department visits. GAO recommended that CMS issue clear and consistent written guidance to help states better align payment rates with clinics' costs; and avoid potential duplication between CCBHC and other Medicaid payments. HHS agreed with the recommendations. A summary of the report is available here.
On September 28, GAO released a report entitled Addressing Fragmentation, Overlap, and Duplication: Progress in Enhancing Government Effectiveness and Achieving Hundreds of Billions of Dollars in Financial Benefits. The report found that Congress and executive branch agencies have made significant progress in addressing many of the 1,200 actions that GAO identified from 2011 to 2021 to reduce costs, increase revenues, and improve agencies’ operating effectiveness. One of the actions taken was HHS changing its spending limit determinations for Medicaid demonstrations, resulting in federal savings of approximately $120.8 billion from 2016 through 2020, with additional savings in the future. GAO noted that fully addressing the remaining 441 actions could save tens of billions more dollars and improve government services. A summary of the report is available here.
On October 1, GAO released a report entitled Medicare: Provider Performance and Experiences Under the Merit-Based Incentive Payment System (MIPS). The report found that over 90% of providers under Medicare’s MIPS earned less than 2% to their Medicare payments from 2017-2019. Stakeholders GAO interviewed identified some strengths and challenges related to the MIPS program, including that bonus points helped increase scores for certain providers who might otherwise be disadvantaged. CMS noted that the MIPS Value Pathways will help to address challenges identified in this report by standardizing performance measurement across specific specialties, medical conditions, or episodes of care. A summary of the report is available here.
Congressional Research Service (CRS)
On September 30, the CRS released a report Tax Provisions in the “Build Back Better Act:” The House Ways and Means Committee’s Legislative Recommendations.
UPCOMING CONGRESSIONAL HEARINGS
House
None of note.
Senate
None of note.
OTHER HEALTH POLICY NEWS
On September 27, the Urban Institute released a report entitled Strengthening Long-Term Services and Supports: The Difference Federal Investment Can Make that found that enhanced funding could substantially increase adequacy of and equity in home- and community-based services (HCBS) availability across the U.S., and boosting accountability and investment could forward the well-being of beneficiaries and their caregivers. The report found that permanently increasing each state’s HCBS federal medical assistance percentage by 10 percentage points would increase federal spending by about $104 billion over 8 years. Targeting federal dollars to bring low-spending states’ HCBS spending up to the national median would increase federal Medicaid HCBS spending by a projected $196 billion over eight years and could reach 970,000 more beneficiaries in these states.
On September 28, the Urban Institute released a report that found that less than half of all nonelderly uninsured adults have heard about the Marketplaces and fewer than a third heard about subsidies that make Marketplace coverage and care more affordable.
On September 29, the American Medical Association released a report that found that the majority of U.S. commercial health insurance markets are highly concentrated and average market concentration increased between 2014 and 2020.
On September 29, Mercer released a report that found that there will be health care workforce shortages in the next five years, including shortages in nurses and mental health providers. The report predicted that primary care will be increasingly provided by non-physicians.
On September 30, PhRMA sued to strike down an Arkansas law that requires manufacturers to provide 340B discounts to all pharmacies contracted by hospitals and other facilities in the federal drug discount program. As a note, six manufacturers are also in a legal battle with HHS over a similar federal requirement that the manufacturers argue is not authorized by the 340B statute.
On September 30, Public Citizen released a report that found that the U.S. spent $101.1 billion on the 20 top-selling drugs worldwide, compared to the rest of the world spending only $57 billion.
The Alliance for Health Policy will hold a virtual briefing with CMMI Director Elizabeth Fowler on October 5 at 12 p.m.
On October 7-8, the Medicare Payment Advisory Commission (MedPAC) will hold its October meeting. The meeting included sessions discussing:
· Addressing high prices of pharmaceutical products (and other technologies) covered under Medicare;
· Data on Medicare's net prices for prescription drugs and other drug pricing metrics;
· Congressional request: Vulnerable Medicare beneficiaries' access to care (final report);
· Exploring features of Medicare's alternative payment models
· Improving Medicare Advantage risk adjustment by limiting the influence of outlier predictions; and
· Medicare hospital wage index.