The following LPG Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from January 18 - January 24. 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.
BIDEN TRANSITION
On January 20, the Biden Administration officially announced acting agency leadership until President Biden’s nominees are confirmed, including Norris Cochran as Acting Health & Human Services (HHS) Secretary and Rob Fairweather as Acting Office of Management and Budget (OMB) Director. Liz Richter will be the Acting Administrator at the Centers for Medicare & Medicaid Services (CMS) and Jeff Wu will serve as Acting Deputy. Cochran also announced appointments for a series of HHS officials, including long-time aid to Xavier Becerra, Sean McCluskie, for HHS Chief of Staff; Rochelle Walensky as Director of the Centers for Disease Control and Prevention (CDC), and Anne Reid for HHS Deputy Chief of Staff.
On January 20, Joe Biden was sworn in as the 46th President of the U.S. and Sen. Kamala Harris was sworn in as Vice President.
The Biden Administration announced a series of appointments and nominations this week, including:
Pennsylvania Health Secretary Rachel Levine for HHS Assistant Secretary of Health;
Dr. Vivek H. Murthy for Surgeon General;
Andrea Palm for HHS Deputy Secretary;
Regina LaBelle for White House Office of National Drug Control Policy Director;
Topher Spiro for OMB Associate Director for Health;
Rob Friedlander for OMB Associate Director for Communications; and
Micky Tripathi for the National Coordinator for Health IT.
NON-CORONAVIRUS LEGISLATIVE UPDATE
On January 19, House Energy & Commerce Committee Chairman Frank Pallone (D-NJ) and Senate Finance Committee Ranking Member Ron Wyden (D-OR) urgedCMS Administrator Seema Verma to rescind guidance and letters to establish the procedures to slow the withdrawal of section 1115 Medicaid demonstrations. The Congressmen accused the guidance of violating federal procedural laws and of purposely delaying the Biden Administration’s ability to overturn Medicaid demonstrations.
On January 20, Vice President Kamala Harris swore into office Sens. Alex Padilla (D-CA), Jon Ossoff (D-GA), and Raphael Warnock (D-GA), officially transitioning the Senate Majority to the Democrats, with Harris serving to break the 50-50 tie. Chuck Schumer (D-NY) is now the Senate Majority leader.
House
On January 20, Appropriations Chair Rosa DeLauro (D-CT), Budget Chair John Yarmuth (D-KY), and Rep. Mike Quigley (D-IL) urged OMB to restore the role of apportioning funds to the OMB Deputy Associate Director; reverse Executive Order 13957 Creating Schedule F in the Excepted Service; recommit to the reliable, transparent, and expedient exchange of budget and appropriations information; re-enact the 73 rescission proposals and approve full-year account-specific apportionments.
On January 22, Energy & Commerce Committee Ranking Member Cathy McMorris Rodgers (R-WA) replaced Rep. Michael Burgess (R-TX) with Rep. Brett Guthrie (R-KY) as the Energy & Commerce Health Subcommittee Ranking Member.
The House will transmit the article of impeachment to the Senate on January 25. The Senate is constitutionally required to begin former President Trump's impeachment trial the day after the article is transmitted. Senators will be sworn-in on January 26 and the trial will begin on February 9.
Senate
On January 21, Sens. Susan Collins (R-ME), Bill Cassidy (R-LA), Lisa Murkowski (R-AK), Mitt Romney (R-UT), Rob Portman (R-OH), Jerry Moran (R-KS), Shelley Moore Capito (R-WV), Todd Young (R-IN), Joe Manchin (D-WV), Mark Warner (D-VA), Dick Durbin (D-IL), Jeanne Shaheen (D-NH), Angus King (I-ME), Maggie Hassen (D-NH), John Hickenlooper (D-CO), and Mark Kelly (D-AZ) announced their coalition committed to bipartisan work in the Senate.
The respective Senate committees held nomination hearings for Alejandro Mayorkas as Homeland Security Secretary, Janet Yellen as Treasury Secretary, Antony Blinken as Secretary of State, Lloyd Austin as Defense Secretary, Avril Haines as National Intelligence Director, and Pete Buttigieg as Transportation Secretary this week. On January 20, Avril Haines was confirmed as National Intelligence Director. On January 21, Gen. Lloyd Austin was confirmed as Defense Secretary.
Majority Leader Schumer and Minority Leader Mitch McConnell (R-KY) are negotiating an organizational resolution for the Senate. McConnell has asked Schumer to commit to maintaining the legislative filibuster, a major sticking point in the negotiating process.
NON-CORONAVIRUS REGULATORY UPDATE
On January 19, HHS Secretary Alex Azar delivered his final State of the Department speech and released the HHS 2020 Annual Report. Azar highlighted the agency’s COVID-19 efforts, including Operation Warp Speed vaccine, therapeutics, and testing efforts; the Strategic National Stockpile; HHSProtect data tracking; the National Institutes of Health (NIH) Community Engagement Alliance Against COVID-19 Disparities; and other efforts. Azar also highlighted HHS’ strategic goals and how they were achieved in 2020.
On January 19, HHS and the Office of the Surgeon General released a report entitled Community Health and Economic Prosperity: Engaging Businesses as Stewards and Stakeholders- A Report of the Surgeon General. The Surgeon General’s Report identified health disadvantages currently impacting Americans and outlines opportunities for businesses to invest in community health and improve business. A summary is available here.
On January 19, the HHS Office of the National Coordinator for Health Information Technology launched the Synthetic Health Data Challenge to encourage researchers and developers to validate synthetic health records, develop or improve the disease-progression and treatment modules used to create synthetic records, and spur novel uses of synthetic health data.
On January 19, the Health Resources & Services Administration (HRSA) awarded$90 million to 496 health centers across the nation and U.S. territories to increase the number of racial and ethnic minority patients with controlled blood pressure, as part of the National Hypertension Control Initiative: Addressing Disparities among Racial and Ethnic Minority Populations.
On January 19, the Food & Drug Administration (FDA) issued a notice entitledRequests for Proposals for Insulin Reimportation and Personal Prescription Drug Importation. This notice follows the September 24, 2020, requests for proposals for the reimportation of insulin and the personal importation of prescription drugs.
On January 19, CMS released 2021 Shared Savings Program data, finding that 477 Accountable Care Organizations were participating in the program at the beginning of 2021, the lowest participation since 2016, serving 10.7 million beneficiaries.
On January 19, CMS released the Calendar Year (CY) 2022 Request for Applications for the Part D Payment Modernization Model. There are a number of significant changes for the CY2022 model year, including:
Protected Class Requirements: Flexibility for participating plans to treat five of the six protected classes (anticonvulsants, immunosuppressants, antidepressants, antipsychotics, and antineoplastics) as they would other Part D drug classes;
Two-Drug Formulary Requirements: Flexibility to include on formulary at least one drug per class, instead of the current requirement of two drugs per class; and
Downsize Risk: Removal of the 10% downside risk for Part D sponsors participating in the Model (for CY2022 only).
On January 19, HHS Office of the National Coordinator for Health Information Technology (ONC) announced a series of investments to help increase data sharing between health information exchanges and immunization information systems. With the $20 million in funds received from the Coronavirus Aid, Relief, and Economic Security Act, the ONC will build on the Strengthening the Technical Advancement and Readiness of Public Health Agencies via Health Information Exchange Program, to help communities improve the sharing of health information related to vaccinations.
On January 20, Surgeon General Jerome Adams resigned from his post, following a request from President Biden. Dr. Adams will stay on as an adviser for short period of time.
On January 21, HRSA, in accordance with the Biden Administration’s “regulatory freeze” memorandum – as discussed below – temporarily delayed for 60 days a final rule that makes certain health clinics pass 340B discounts on insulin and epinephrine to patients. The rule was issued pursuant to former President Trump’s “Executive Order on Access to Affordable Life-saving Medications.” The effective date is delayed until March 22, 2021.
The FDA will host meetings entitled Interim Assessment of the Program for Enhanced Review Transparency and Communication in the Biosimilar User Fee Acton January 27 and Prescription Drug User Fee Act of 2017; Electronic Submissions and Data Standards on April 7.
NON-CORONAVIRUS WHITE HOUSE UPDATE
On January 20, Assistant to the President and Chief of Staff Ron Klain sent a memorandum to the heads of executive departments and agencies announcing a regulatory freeze on any new or pending federal rules or substantive actions.
CORONAVIRUS UPDATE
Legislative
The House is expected to consider a large COVID relief bill in early February. It is expected that the relevant committees will begin considering President Biden’s policies over the next couple of weeks.
Regulatory
On January 19, CMS released the fourth quarter Hospice Quality Reporting Program Quarterly Update.
On January 19, National Institute of Allergy and Infectious Diseases Director Anthony Fauci predicted that if COVID-19 vaccinations continue as planned, the U.S. could see a degree of normalcy by early-to-mid fall.
On January 19, the FDA and the Department of Commerce National Institute of Standards and Technology issued a memorandum of understanding defining an agreement through which both parties intend to collaborate to increase the U.S. medical supply chain resilience and advance domestic manufacturing of pharmaceuticals, biopharmaceuticals, and medical devices through the adoption of 21st century manufacturing technologies including smart technologies, emerging manufacturing processes, and artificial intelligence and machine learning.
On January 19, the FDA updated the Investigational COVID-19 Convalescent Plasma guidance, including recommendations when COVID-19 vaccine clinical trial participants, or received an authorized COVID-19 vaccine, qualify as convalescent plasma donors.
On January 19, the HHS Office for Civil Rights announced that it will exercise its enforcement discretion and will not impose penalties for violations of the Health Insurance Portability and Accountability Act for online scheduling of COVID-19 vaccinations appointments during the COVID-19 public health emergency. This exercise of enforcement discretion has retroactive effect to December 11, 2020.
On January 20, Acting FDA Commissioner Janet Woodcock announced that she will not participate in agency decisions on some COVID-19 treatments due to her involvement in COVID-19 treatment development in the past year with Operation Warp Speed. Dr. Woodcock will still participate in decisions about vaccines or diagnostics.
On January 22, the CDC released guidance regarding the administration of COVID-19 vaccines. The CDC adjusted recommendations, allowing for second shots to be administered up to six weeks after the first dose when the recommended timeline for receiving a second dose is unachievable.
On January 22, the CDC released a report that 10 cases out of 4 million experienced anaphylaxis reactions to the Moderna vaccine and 1,266 people experienced “adverse events.”
As of January 22, more than 17 million people have received the first dose of COVID-19 vaccines (3 million have received both doses) and more than 41.4 million doses have been distributed, according to the CDC COVID Data Tracker.
White House
On January 20, President Biden issued a number of Executive Orders (EOs) addressing climate change, immigration, COVID-19, and health, including:
EO on Protecting the Federal Workforce and Requiring Mask-Wearing, which includes a mask mandate on federal properties and creating a federal testing plan;
EO on Organizing and Mobilizing the United States Government to Provide a Unified and Effective Response to Combat COVID-19 and to Provide United States Leadership on Global Health and Security to improve global health and the global COVID-19 response.
EO On Advancing Racial Equity and Support for Underserved Communities Through the Federal Government to promote equity across the federal government.
EO on Revocation of Certain Executive Orders Concerning Federal Regulation
A fact sheet on all Executive actions on January 20 is available here.
On January 21, President Biden issued another set of EOs, including,
EO on Improving and Expanding Access to Care and Treatments for COVID-19 to accelerate the development of COVID-19 treatments; address the long-term effects of COVID-19; establish Production, Allocation, Distribution Targets for COVID-19 Treatments, and improve the access and affordability of COVID-19 Treatments and Care.
EO on a Sustainable Public Health Supply Chain, which includes invoking the Defense Production Act to increase the production of vaccine supplies and other COVID-19 resources, and Assure Pandemic Supply Chain Resilience
EO on Ensuring an Equitable Pandemic Response and Recovery, which would establish the HHS COVID-19 Health Equity Task Force, address Data Shortfalls, and Create a Vaccination Campaign to promote the vaccine in underserved communities and populations.
EO on Ensuring a Data-Driven Response to COVID-19 and Future High-Consequence Public Health Threats to improve Public Health Data and Analytics
EO on Establishing the COVID-19 Pandemic Testing Board and Ensuring a Sustainable Public Health Workforce for COVID-19 and Other Biological Threats, to establish a COVID-19 Pandemic Testing Board, create free COVID-19 testing for those without comprehensive health insurance and clarify health plans’ obligations to provide coverage for COVID-19 testing.
Biden also issued a memorandum for the Defense Secretary and Homeland Security Secretary and a National Security Directive:
Memorandum to Extend Federal Support to Governors’ Use of the National Guard to Respond to COVID-19 and to Increase Reimbursement and Other Assistance Provided to States, which fully funds National Guard COVID-19 efforts
National Security Directive on United States Global Leadership to Strengthen the International COVID-19 Response and to Advance Global Health Security and Biological Preparedness, to reenter the World Health Organization (WHO), join the COVID-19 Vaccine Global Access (COVAX), and combat COVID-19 globally.
On January 21, President Biden released a report entitled the National Strategy for the COVID-19 Response and Pandemic Preparedness. The report outlines steps to address the COVID-19 pandemic, including restoring trust; mounting a safe, effective, and comprehensive vaccination campaign; mitigating the spread through expanding masking, testing, data, treatments, health care workforce, and clear public health standards; expanding emergency relief and exercising the Defense Production Act, safely reopen schools, businesses, and travel, while protecting workers; protecting those most at risk and advance equity, including across racial, ethnic and rural/urban lines; and restoring U.S. leadership globally and build better preparedness for future threats. A fact sheet on the plan is available here.
The Biden Administration is expected to issue an EO preparing for a new HealthCare.gov enrollment period to help more of the uninsured get coverage during the pandemic.
Other
On January 19, the Independent Panel for Pandemic Preparedness and Response released an interim report for the WHO, finding that Beijing could have been more vigorous in applying public health measures when cases were first detected in the city of Wuhan and the WHO could have acted quicker to declare an international emergency.
On January 19, Pfizer released a study finding that the company’s COVID-19 vaccine is likely to be effective against the U.K. variant of COVID-19, B.1.1.7. The study has yet to be peer reviewed.
On January 19, the American Red Cross called for recovered COVID-19 patients to donate convalescent plasma for the treatment of COVID-19.
On January 20, the National Governors Association announced Pandemic and Disaster Response, Economic Recovery and Revitalization, and Community Renewal task forces to coordinate and lead bipartisan state and territorial efforts to respond to the ongoing COVID-19 pandemic, and lead economic recovery and community renewal efforts.
On January 21, Lilly found that the company’s COVID-19 antibody drug treatment, etesevimab and bamlanivimab, reduced patients’ viral levels better than bamlanivimab. Lilly also found that bamlanivimab significantly reduced the risk of contracting symptomatic COVID-19 among long-term care residents and staff.
On January 21, Pfizer announced that the company is willing to sell its COVID-19 vaccine directly to states if the federal government approves.
On January 22, British Prime Minister Boris Johnson announced that the U.K. COVID-19 may be associated with a higher degree of mortality, in addition to spreading more quickly.
On January 22, Pfizer announced the company finished enrolling 2,000 children 12-15 years old in a COVID-19 vaccine study.
States and local governments are reporting that they are running out of COVID-19 vaccines, impacting rapid distribution efforts.
As of January 24, the U.S. had 25,014,783 confirmed COVID-19 cases resulting in 417,539 deaths, according to the Johns Hopkins University & Medicine Coronavirus Resource Center.
RULES AT THE WHITE HOUSE OMB
Pending Review
HHS-CMS
Conditions for Coverage for End-Stage Renal Disease Facilities-Third Party Payments (CMS-3337-P); Received 6/6/19
Strengthening Oversight of Accrediting Organizations (AO) and Preventing AO Conflict of Interest, and Related Provisions (CMS-3367); Proposed Rule; Received 2/18/20
Revisions to Medicare Part A Enrollments (CMS-4194) Proposed Rule; Received 9/9/20
HHS-IHS
CY 2021 Reimbursement Rates; Notice; Received 12/2/20
HHS-OCR
Special Responsibilities of Medicare Hospitals in Emergency Cases, and Discrimination on the Basis of Disability in Critical Health and Human Services Programs or Activities; Final Rule; Received 1/6/21
REPORTS
HHS Office of Inspector General (OIG)
On January 19, OIG released a report entitled CMS and Its Contractors Did Not Use Comprehensive Error Rate Testing Program Data To Identify and Focus on Error-Prone Providers. The report found that CMS and its contractors did not use Comprehensive Error Rate Testing (CERT) data to identify and focus on error-prone providers for review and corrective action, resulting in $3.5 million in improper payments and 100 error-prone providers. OIG recommended that CMS review the list of 100 error-prone providers and further review them and use annual CERT data to identify individual providers that have an increased risk of receiving improper payments and apply additional program integrity tools to these providers. CMS did not concur with our recommendations. A summary of the report is available here.
On January 21, OIG released a report entitled Independent Attestation Review: Substance Abuse and Mental Health Services Administration (SAMHSA) Fiscal Year (FY) 2020 Detailed Accounting Report, Performance Summary Report for National Drug Control Activities, Budget Formulation Compliance Report, and Accompanying Required Assertions. The report reviewed the SAMHSA Office of National Drug Control Policy (ONDCP) Detailed Accounting Report, Performance Summary Report, and Budget Formulation Compliance Report. The review found that SAMHSA ONDCP all reports complied with federal requirements. A summary of the report is available here.
On January 22, OIG released a report entitled Choctaw Nation of Oklahoma Made Progress Toward Meeting Program Goals During the First Year of Its Tribal Opioid Response Grant. The report found that the Choctaw Nation met some program goals for its TOR grant during the first grant year and generally complied with Federal cost principles when administering its Tribal Opioid Response (TOR) grant. The Choctaw met prevention and recovery program goals and made progress toward meeting treatment program goals but encountered some challenges that prevented it from increasing the availability of medication-assisted treatment (MAT) services for Tribal members within its health care system. OIG found that the Nation claimed $2,405 in unallowable costs that the Nation said it refunded. OIG made procedural recommendations to train staff to identify contract costs that are allowable under Federal regulations and strengthen or establish policies and procedures regarding Tribal departmental responsibilities and staff access to contractual agreements. A summary of the report is available here.
Government Accountability Office (GAO)
On January 21, the GAO released a report entitled Rural Hospital Closures: Affected Residents Had Reduced Access to Health Care Services. GAO found that when rural hospitals closed, residents living in the closed hospitals' service areas would have to travel substantially farther to access certain health care services, with the median distance to access some of the more common health care services increasing about 20 miles and for less common services, distance traveled increased even more, from 2012 to 2018. The report also found that the availability of health care providers in counties with rural hospital closures generally was lower and declined more over time, compared to those without closures. A summary of the report is available here.
On January 21, the GAO released a report entitled Health Care Funding: Federal Obligations to and Funds Received by Certain Organizations Involved in Health-Related Services, 2016 through 2018. The report found that organizations that offer health-related services received almost $16 billion through HHS grants or cooperative agreements from 2016 through 2018 and nearly all of this funding was received by federally qualified health centers. A summary of the report is available here.
UPCOMING HEARINGS
Senate
Commerce, Science, and Transportation Committee
Hearing on the Nomination of Gina Raimondo as Commerce Secretary
January 26, 10 a.m. 253 Russell Senate Office Building
Energy and National Resources Committee
Hearing on the Nomination of Jennifer Mulhern Granholm as Energy Secretary
January 27, 9:30 a.m. 106 Dirksen Senate Office Building
Foreign Relations Committee
Hearings on the Nomination of Linda Thomas-Greenfield as the U.S. Representative to the United Nations
January 27, 10:00 a.m. 325 Russell Senate Office Building
House
None of note.
OTHER HEALTH POLICY NEWS
On January 19, Ohio Gov. Mike DeWine (R) announced a delay in the state’s work requirements for Medicaid beneficiaries due to the potential for the Biden Administration to ban the Medicaid Work Rule.
On January 20, the National Health Law Program petitioned CMS to withdraw guidance that established procedures for withdrawing or terminating a Section 1115 Medicaid Demonstration.