The following LPG Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from June 6 - 12. 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 8, the Ways & Means Committee held a hearing entitled The President's Proposed Fiscal Year (FY) 2022 Budget with the Department of Health and Human Services (HHS). Many members from both parties and HHS Secretary Xavier Becerra advocated for extending telehealth flexibilities created during COVID-19. Members and Sec. Becerra also discussed the following topics: expanding Medicaid, oversight and transparency around nursing homes, surprise billing, increasing access to mental health care, the issue of unaccompanied minors at the border and the foster care system, supporting domestic supply chains for medical resources, increasing health care affordability, Medicare insolvency, supporting critical access and safety net hospitals, maternal health, addressing health disparities, and other topics.
On June 8, the Oversight & Reform Committee held a hearing entitled The SACKLER Act and Other Policies to Promote Accountability for the Sackler Family’s Role in the Opioid Epidemic.Oversight and Reform Committee Chair Carolyn Maloney (D-NY) and the witnesses advocated for the SACKLER Act and argued that the Sacklers have never been held accountable for the harm they inflicted and contributions to the opioid epidemic. Witnesses included: Maura Healey, Attorney General, Massachusetts; Lawrence Wasden, Attorney General, Idaho; and Patrick Radden Keefe, Author, Empire of Pain: The Secret History of the Sackler Dynasty.
On June 9, the Budget Committee held a hearing entitled The President’s FY 2022 Budget. Office of Management & Budget (OMB) Acting Director Shalanda Young was the sole witness during the hearing.
The House will consider H.R. 1187, the Corporate Governance Improvement and Investor Protection Act, which would require the disclosure of key environmental, social, and governance metrics to shareholders of public companies so that corporations can be held accountable for their decision-making relating to equity, justice, and public health, during the week of June 14.
The House will hold committee business the week of June 7 and will return for session on June 14.
Senate
On June 8, the Budget Committee held a hearing entitled The President's FY 2022 Budget Proposal. Budget Committee Ranking Member Lindsey Graham (R-SC) argued that the budget would create a devastating debt burden and the tax increases included in the budget would drive business away from the U.S. OMB Acting Director Shalanda Young was the sole witness during the hearing
On June 8, the Health, Education, Labor & Pensions (HELP) Committee held a hearing entitled Nominations of Dawn O’Connell to be Assistant Secretary for Preparedness and Response and Miriam Delphin-Rittmon to be Assistant Secretary for Mental Health and Substance Use. Chair Patty Murray (D-WA) urged the committee to support the nominees in order to strengthen public health infrastructure and address substance use disorders and mental illness challenges. Witnesses included: Dawn O’Connell and Miriam Delphin-Rittmon.
On June 8, the Senate voted 68-32 to pass the U.S. Innovation and Competition Act, which supports U.S. manufacturing and research and other provisions to promote U.S. competitiveness relative to China. A summary of the bill is available here.
On June 9, the Appropriations Labor, HHS, Education and Related Agencies Subcommittee held a hearing entitled Hearing on the President’s FY 2022 Budget Request for HHS. Members and Becerra discussed the following topics: mental health and substance use disorder treatment, investing in domestic supply chains, maintaining and modernizing the Strategic National Stockpile, supporting unaccompanied minors at the border and in HHS facilities, supporting and expanding access to telehealth, taking action on ‘junk plans,’ investigating creating a public option, reaching COVID-19 vaccine goals and supporting global vaccine efforts, investing in childcare, and other topics.
On June 10, the Finance Committee held a hearing entitled The President’ FY 2022 HHS Budget. Members and Becerra discussed the following topics: drug pricing, Medicare insolvency, expanding access to health care, health equity, supporting home and community-based care, and other topics. Senate Finance Chair Ron Wyden (D-OR) said he is interested in updating his 2019 drug pricing bill with Sen. Chuck Grassley (R-IA) and voiced support of allowing Medicare to negotiate drug prices, though Sen. Grassley argued that any bill that includes Medicare negotiation will not pass the Senate.
On June 10, the Appropriations Agriculture, Rural Development, Food & Drug Administration (FDA), and Related Agencies Subcommittee held a hearing entitled FY2022 Budget Request for the Food and Drug Administration. Members and Acting Commissioner Woodcock also discussed the following topics: supporting domestic supply chains, balancing innovation with safety, FDA data modernization, the opioid crisis and opioid use disorder treatments, and other topics.
NON-CORONAVIRUS REGULATORY UPDATE
On June 5, HHS released a report that found that 31 million Americans have health coverage through the Affordable Care Act (ACA) and that there have been reductions in the uninsured rates in every state since ACA coverage expansions took effect.
On June 7, the Centers for Medicare & Medicaid Services (CMS) released the Accountable Health Communities Health-Related Social Needs Screening Tool and report to quickly identify health-related social needs, such as food insecurity, housing instability, and lack of access to transportation, among community-dwelling Medicare and Medicaid beneficiaries. This resource enables staff to connect beneficiaries with community resources to address unmet needs. A fact sheet on the tool is available here.
On June 7, OMB concluded its review of the proposed rule entitled Rescission of the Final Rule “Implementation of Executive Order on Access to Affordable Life-Saving Medications.” This rule aims to retract the Trump Administration rule to pass insulin and EpiPen discounts to patients.
On June 8, CMS announced that Erin Richardson will be Administrator Chiquita Brooks-LaSure’s chief of staff and Jon Blum will serve as CMS’ Principal Deputy Commissioner.
On June 8, OMB received an interim final rule from CMS entitled Requirements Related to Surprise Billing; Part I (CMS-9909). This rule begins implementation of the No Surprises Act to limit surprise medical billing.
On June 10, the CMS’ Health Care Payment Learning & Action Network (LAN) launched the Health Equity Advisory Team to support LAN priorities and initiatives to achieve more equitable health outcomes.
On June 10, the National Institutes of Health released a plan to address structural racism in the biomedical research enterprise, including developing robust health disparities/equity research; improving its internal culture; being transparent and accountable; and changing the extramural ecosystem so that diversity, equity, and inclusion are reflected in funded research and the biomedical workforce.
On June 10, FDA issued a notice entitled Study of Disclosures to Healthcare Providers Regarding Data That Do Not Support Unapproved Use of an Approved Prescription Drug.
FDA will hold a virtual public meeting on June 18 to discuss the financial transparency and efficiency of the Prescription Drug User Fee Act, the Biosimilar User Fee Act and Generic Drug User Fee Amendments.
NON-CORONAVIRUS WHITE HOUSE UPDATE
On June 8, the Biden Administration released a report on Building Resilient Supply Chains, Revitalizing American Manufacturing, and Fostering Broad-Based Growth as directed under Executive Order 14017 America’s Supply Chains to strengthen domestic supply chains to promote economic security, national security, and domestic jobs. The Administration announced that it will immediately support the domestic production of critical medicines through HHS under the Defense Production Act. This will include establishing a public-private consortium for advanced manufacturing and onshoring of domestic essential medicines production; identify 50 to 100 drugs for an enhanced onshoring effort; and committing $60 million to develop technologies to increase domestic manufacturing capacity. A fact sheet on the report is available here.
On June 11, the Administration and the G7 committed to the following initiatives to:
Accelerating the global vaccination effort through vaccine donations and funding;
Providing funding in support for programs that provide assistance to help countries and health systems prepare for vaccination around the world and to support ‘last mile’ vaccinations;
Expanding emergency responses and providing emergency assistance to at risk regions, including by delivering lifesaving medical supplies, oxygen, diagnostics, therapeutics, and supporting regions experiencing COVID-19 surges;
Boosting the global COVID-19 vaccine supply chain and supporting surge capacity;
Advancing global health security to prevent future biological catastrophes through strengthening the rapid detection of infectious disease threats and supporting the creation of a catalytic global health security financing mechanism; and
Further investing in the global recovery from COVID-19.
CORONAVIRUS UPDATE
House
On June 8, Energy & Commerce Committee Republicans urged the Centers for Disease Control and Prevention (CDC) to investigate early COVID-19 cases and unexplained deaths within the U.S. to determine if COVID-19 was present in the U.S. earlier than December 13, 2019.
Senate
None of note.
Regulatory
On June 7, CDC released a report finding that currently authorized mRNA COVID-19 vaccines reduce the risk of COVID-19 infection by 91% for fully vaccinated people.
On June 9, CMS announced an additional payment amount for administering in-home COVID-19 vaccinations to Medicare beneficiaries who have difficulty leaving their homes or are otherwise hard-to-reach. Medicare will now pay an additional $35 per dose for COVID-19 vaccine administration in a beneficiary’s home, increasing the total payment amount for at-home vaccination from $40 to $75 per vaccine dose. For a two-dose vaccine, the total payment is $150 for the administration of both doses. A summary of the reimbursement adjustment is available here. A breakdown of the claims reimbursement rates is available here.
On June 9, HHS issued a letter to providers and insurers reminding them that it is still illegal to bill patients for COVID-19 vaccines and testing, following recent reports of ongoing concerns about Americans facing costs associated with COVID-19 vaccinations or testing.
On June 9, HHS entered into a procurement agreement with Merck for 1.7 million courses of its COVID-19 treatment, molnupiravir, for $1.2 billion.
On June 10, the FDA Vaccines and Related Biological Products Advisory Committee held a virtual meeting discussing the approach to issuing EUAs for children to receive COVID-19 vaccines. Briefing documents for the meeting are available here.
On June 10, the Department of Labor and the Occupational Safety and Health Administration issued Emergency Temporary Standards (ETS) to address the hazards of exposure to COVID-19. The workplace guidelines will only apply to health care settings and include providing masks, having physical barriers, enforcing social distancing, providing proper ventilation, and other guidance. A summary of the ETS is available here. A summary of the guidance is available here.
On June 10, the FDA extended the expiration date of Johnson & Johnson's (J&J) COVID-19 vaccine by to 4.5 months, an increase from the three months.
On June 11, FDA issued a notice to solicit comments on the proposed study entitled Accelerated Approval Disclosures on Direct-to-Consumer Prescription Drug Website.
On June 11, the Health Resources & Services Administration (HRSA) released revised reporting requirements for Provider Relief Fund (PRF) payment recipients including extending the deadline for providers to report information, reducing burdens on smaller providers, and extending key deadlines for expending PRF payments for recipients who received payments after June 30, 2020. The revised reporting requirements will be applicable to providers who received payments exceeding $10,000 from the PRF General Distributions, Targeted Distributions, and/or Skilled Nursing Facility and Nursing Home Infection Control Distributions. A summary of the reporting requirements is available here. An updated FAQ of PRF requirements is available here.
On June 11, FDA deemed the 60 million COVID-19 J&J vaccine doses from the Emergent manufacturing plant ‘not suitable for use.’
CDC’s Vaccine Advisory Committee will hold a meeting on June 18 to assess cases of heart problems diagnosed in people who received Pfizer or Moderna COVID-19 vaccines.
The COVID-19 Health Equity Task Force will hold a virtual meeting on June 25 to consider interim recommendations addressing the inequities and the impact of long-COVID, and access to personal protection equipment, testing, and therapeutics.
White House
On June 8, negotiations between President Biden and the group of Republicans led by Sen. Shelley Moore Capito (R-WV) over an infrastructure package broke down. President Biden will continue the negotiation process with a bipartisan group of senators, coined the ‘G20,’ including Sens. Rob Portman (R-OH), Mitt Romney (R-UT), Joe Manchin (D-WV), Bill Cassidy (R-LA), and Kyrsten Sinema (D-AZ).
On June 9, Andy Slavitt stepped down as senior adviser of the White House Covid-19 response team.
On June 8, the White House announced it will purchase 500 million doses of Pfizer's COVID-19 vaccine and will donate them to 100 countries by June 2022, with the first 200 million doses to be distributed by the end of 2021.
Other
On June 6, 100 former presidents, prime ministers, and foreign ministers urged the G7 to pay for global COVID-19 vaccinations in order to prevent COVID-19 from mutating and returning as a worldwide threat.
On June 7, OraSure announced that it has received FDA Emergency Use Authorization (EUA) for its COVID-19 rapid antigen tests, InteliSwab.
On June 8, Pfizer announced it will increase clinical trials of its COVID-19 vaccine for children 5-11 and children under 5 and begin testing the effectiveness of lower vaccine doses for these age groups.
On June 9, a study published in the Journal Nature Medicine found that the AstraZeneca COVID-19 vaccine had a slightly increased risk of certain bleeding disorders and possibly other rare blood problems.
On June 10, Moderna filed for EUA for its COVID-19 vaccine to be used for adolescents 12 to 17.
On June 10, EU lawmakers voted in favor of waiving patents for COVID-19 vaccines to increase access to the vaccines.
As of June 11, over 173 million people in the U.S. have received the first dose of COVID-19 vaccines (more than 143 million have received both doses – 64.3% of adults) and more than 374 million doses have been distributed, according to the CDC COVID Data Tracker.
As of June 11, the U.S. had more than 33 million confirmed COVID-19 cases resulting in 599,736 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 Home Health Prospective Payment System Rate Update, Home Infusion Therapy Services, and Quality Reporting Requirements (CMS-1747); Proposed Rule; Received 4/30/21
CY 2022 Changes to the End-Stage Renal Disease (ESRD) Prospective Payment System and Quality Incentive Program (CMS-1749); Proposed Rule; 5/3/21
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
Requirements Related to Surprise Billing; Part I (CMS-9909); Interim Final Rule; 6/9/21
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
HHS-HRSA
Rescission of the Final Rule “Implementation of Executive Order on Access to Affordable Life-Saving Medications”; Proposed Rule; 5/10/21
REPORTS
Health & Human Services (HHS) Office of Inspector General (OIG)
On June 9, OIG released a report entitled Opportunities Exist for CMS and Its Medicare Contractors To Strengthen Program Safeguards To Prevent and Detect Improper Payments for Drug Testing Services. The report identified three weaknesses in the Medicare contractors' established program safeguards for preventing and detecting improper payments for drug testing services and promoting provider compliance with Medicare requirements:
Clear and consistent requirements or guidance for laboratories to use when determining the number of drug classes to bill for definitive drug testing services;
Procedures for identifying or limiting the frequency of drug testing services (e.g., the number of drug tests performed per year) for each beneficiary across all Medicare jurisdictions; and
Consistent requirements in their Local Coverage Determination (LCDs) or any procedures for identifying claims for direct-to-definitive drug testing.
OIG recommended that CMS work with contractors to take necessary steps to determine whether clinical evidence exists to support a single, specific reasonable and necessary standard for drug testing services and establish a National Coverage Determination or more consistent requirements for drug testing services; clearly indicate in LCDs, local coverage articles, or other instructions on how laboratories should determine the number of drug classes for billing definitive drug testing services; implement a system edit or procedure to identify and limit the frequency of drug testing services per beneficiary across all Medicare jurisdictions; determine whether a postpayment medical review is necessary for laboratories that have been paid for excessive definitive drug tests in a 1-week period for the same beneficiary; and consider addition a modifier to claims for definitive drug test indicating whether a test was based on results obtained by presumptive drug test. CMS agreed with the fourth and fifth recommendations but not the rest of the recommendations. A summary of the report is available here.
On June 11, OIG released a report entitled Medicare Hospice Provider Compliance Audit: Professional Healthcare at Home, LLC. The report found that Professional Healthcare received some Medicare reimbursement for hospice services that did not comply with Medicare requirements due to a lack of documentation or the clinical record did not support the beneficiary's terminal prognosis, resulting in at least $3.3 million in unallowable Medicare reimbursement. OIG recommended that Professional Healthcare refund Medicare overpayments and strengthen its policies and procedures to ensure that hospice services comply with Medicare requirements. Professional Healthcare disagreed with OIG’s findings and recommendations. A summary of the report is available here.
Congressional Budget Office (CBO)
On June 8, CBO released a report entitled Monthly Budget Review: May 2021. The report found that federal budget deficit was $2.1 trillion in the first eight months of FY 2021, $184 billion more than the deficit recorded during the same period last year. Revenues were up by an estimated $587 billion and outlays rose by an estimated $771 billion. A summary of the report is available here.
Government Accountability Office (GAO)
On June 10, GAO posted a blog entitled Want Proof of Your COVID-19 Vaccination? An App Could Be Coming. The blog noted that digital vaccine credentials could support more efficient travel but also raise concerns about data privacy.
HEARINGS
House
Energy & Commerce Health Subcommittee
Booster Shot: Enhancing Public Health through Vaccine Legislation
June 15, 10:30 a.m., Webex
Legislation to be considered includes:
H.R. 550, the "Immunization Infrastructure Modernization Act"
H.R. 951, the "Maternal Vaccinations Act"
H.R. 979, the "Vaccine Fairness Act"
H.R. 1452, to direct the Secretary of Health and Human Services to publish the formula the Secretary uses to determine the allocation of COVID-19 vaccines, and for other purposes
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. 1978, the "Protecting Seniors Through Immunization Act of 2021"
H.R. 2170, the "Helping Adults Protect Immunity Act" or the "HAPI Act"
H.R. 2347, the "Strengthening the Vaccines for Children Act of 2021"
H.R. 3013, the "COVID Vaccine Transportation Access Act"
H.R. 3655, the "Vaccine Injury Compensation Modernization Act"
H.R. 3742, the "Vaccine Information for Nursing Facility Operators Act" or the "Vaccine INFO Act"
H.R. 3743, the "Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act"
Education and Labor Committee
Examining the Policies and Priorities of the U.S. Department of Health and Human Services
June 16, 9:00 a.m., Zoom
Witnesses include: HHS Secretary Xavier Becerra
Senate
Finance Fiscal Responsibility and Economic Growth Subcommittee
Promoting Domestic Competition and International Competitiveness
June 16, 2:30 p.m.
Health, Education, Labor & Pensions Committee
June 16, 12:00 a.m.
OTHER HEALTH POLICY NEWS
On June 7, a study published in Health Affairs found a 35% decrease of emergency room visits during COVID-19 across medical and surgical visit types.
On June 7, Missouri Governor Mike Parson (R) signed SB 63 which creates a statewide prescription drug monitoring program in the state of Missouri to improve monitoring prescribing practices of opioids and other prescribed controlled substances.
On June 9, Nevada Governor Steve Sisolak (D) signed Senate Bill 420 to create a state-managed health insurance plans by 2026. Nevada is the second state to offer a public option.
On June 8, a study released in Health Affairs found that Medicare Advantage (MA) enrollment among Black people, dual-eligibles, and those residing in the most disadvantaged areas outpaced growth of White and non-dual eligibles from 2009 through 2018, though beneficiaries in these groups also tended to have lower quality options from which to choose.
On June 8, a study released in Health Affairs comparing MA and traditional Medicare. MA was associated with more preventive care visits, fewer hospital admissions and emergency department visits, shorter hospital and skilled nursing facility lengths-of-stay, and lower health care spending. The study found that MA outperformed traditional Medicare in most studies comparing quality-of-care metrics.
On June 8, the Colorado legislature passed House Bill 1232 Standardized Health Benefit Plan Colorado Option which would require private insurers to offer a standardized health benefit plan in order to reduce health care costs by 15%.
On June 9, PwC's Health Research Institute released a study projecting that employer medical costs will rise 6.5% in 2022 due to the impacts of COVID-19.
On June 9, 22 health organizations urged HHS, the Department of Treasury, and the Department of Labor to effectively implement the No Surprises Act; implement the legislation in a way that provides consumers with clear, comprehensive protections against surprise bills where they have not knowingly obtained out-of-network care; and implement the law in a way that ensures the independent dispute resolution (IDR) process does not lead to higher costs for patients.
On June 11, Association of American Medical Colleges released a report finding that the U.S. could see an estimated shortage of between 37,800 and 124,000 physicians by 2034, including shortfalls in both primary and specialty care.