The following LPG Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from January 4 - January 10. 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 6, President-elect Joe Biden announced that Operation Warp Speed (OWS) Chief Adviser Moncef Slaoui will transition out of his role early in the new administration. OWS Chief Operating Officer Gen. Gustave Perna will continue to lead vaccine distribution logistics in the incoming administration.
On January 8, Biden pledged to deploy all available doses of COVID-19 vaccines when he takes office, shifting from current Health & Human Services (HHS) plans to hold back on COVID-19 doses to ensure that those who received their first dose can get their second.
Biden announced a series of appointments and nominations this week, including:
U.S. Circuit Court Judge and former Supreme Court Nominee Merrick Garland for Attorney General;
Boston Mayor Marty Walsh for Secretary of Labor;
Governor Gina Raimondo (D-RI) for Secretary of Commerce;
Isabel Guzman for Administrator of the Small Business Administration;
Evan Ryan for White House Cabinet Secretary;
Kathleen Hicks for Deputy Secretary of Defense;
Colin Kahl for Under Secretary of Defense for Policy;
Elizabeth Cameron for White House National Security Council senior director for global health security and biodefense;
Bechara Choucair for COVID-19 vaccine coordinator;
Carole Johnson for COVID-19 testing coordinator and National Pandemic Testing Board Chair; and
Tim Manning for COVID-19 supply coordinator.
NON-CORONAVIRUS LEGISLATIVE UPDATE
On January 11, House Democrats may introduce Articles of Impeachment for President Trump following his role in inciting the violent protestors that stormed the Capitol last week. However, Senate Majority Leader Mitch McConnell (R-KY) downplayed the ability of the Senate to consider such actions before President-elect Joe Biden is sworn in on January 20. There have also calls for Vice President Mike Pence to invoke the 25th Amendment to immediately remove Trump from office. A handful of Republicans have also called for Trump’s removal.
Senate
On January 5, Jon Ossoff (D) and Rev. Raphael Warnock (D) won the two Georgia Senate seats after a runoff election. This election hands the Democrats a Senate majority, with Vice President-elect Kamala Harris serving to break the 50-50 tie. The State of Georgia has until January 22 to certify the results of the election.
House
On January 3, Rep. Nancy Pelosi (D-CA) was elected Speaker of the House for the 117th Congress.
On January 5, the House passed H.R. 22, the Congressional Budget Justification Transparency Act of 2021. The measure would force federal agencies to submit their budget justifications to a public online database and direct the Office of Management & Budget (OMB) to take inventory of the database.
NON-CORONAVIRUS REGULATORY UPDATE
On January 6, CMS released resources for Medicare Accountable Care Organizations (ACOs) and End-Stage Renal Disease Seamless Care Organizations (ESCOs), including a care transformation toolkit for telehealth, home visits, and timely access to skilled nursing facilities; four case studies of ACO and ESCO initiatives; and a home dialysis tip sheet.
On January 6, the Food & Drug Administration (FDA) issued a notice of availability entitled Safer Technologies Program for Medical Devices; Guidance for Industry and Food and Drug Administration Staff. The guidance describes the voluntary program for certain medical devices that significantly improve the safety of currently available treatments or diagnostics that target an underlying disease or condition associated with morbidities and mortalities less serious than those eligible for the Breakthrough Devices Program.
On January 7, CMS Administrator Seema Verma announced that CMS withdrew the Medicaid Fiscal Accountability Regulation rule. Some states were concerned these reforms could have resulted in cuts to the Medicaid program.
On January 7, CMS issued guidance entitled Opportunities in Medicaid and CHIP to Address Social Determinants of Health (SDOH). The guidance describes opportunities under Medicaid and CHIP to better address SDOH and support states with designing programs, benefits, and services that can more effectively improve population health, reduce disability, and lower overall health care costs in the Medicaid and CHIP programs by addressing SDOH.
On January 7, Assistant Secretary of HHS for Mental Health and Substance Use and SAMHSA Administrator Dr. Elinore McCance-Katz resigned after Trump’s inaction to quell the violent protests on January 6.
On January 7, the Centers for Disease Control and Prevention (CDC) awarded a contract to LabCorp to provide genomic sequencing of COVID-19 samples to survey changes in transmission and identify new variants.
On January 8, CMS announced its intent to expand the Home Health Value-Based Purchasing Model via rulemaking. CMS found that the model, which currently operates in nine states, has improved quality while reducing program spending – two requirements before models can be expanded nationwide. The expansion would begin no earlier than January 1, 2022. The CMS Actuary’s memo highlighted the expected savings from a nationwide expansion can be found here.
On January 8, HHS issued a final rule entitled Securing Updated and Necessary Statutory Evaluations Timely. The rule requires HHS to review and approve existing regulations every ten years or the rules automatically expire.
On January 8, CMS approved Tennessee’s waiver request to fund Medicaid through a block grant.
On January 10, it was reported that the Trump administration has instituted a new, nine-month process for eliminating approved Medicaid waivers. Specifically, reports indicate that CMS Administrator Seema Verma sent a letter asking states to sign an agreement “as soon as possible” to lock in the lengthy process if CMS decides to terminate, amend or withdraw a state’s Medicaid waiver in the future. According to Medicaid advocates, the new process will make it more difficult for the incoming Biden administration to quickly overturn certain controversial waivers approved by the Trump administration.
The FDA will host a meeting entitled Interim Assessment of the Program for Enhanced Review Transparency and Communication in the Biosimilar User Fee Act on January 27, 2021.
NON-CORONAVIRUS WHITE HOUSE UPDATE
On January 6, OMB received a final rule from the HHS Office for Civil Rights entitled Special Responsibilities of Medicare Hospitals in Emergency Cases, and Discrimination on the Basis of Disability in Critical Health and Human Services Programs or Activities.
On January 7, OMB received a final rule from CMS entitled Medicaid; Reducing Provider and Patient Burden by Improving Prior Authorization Processes and Promoting Patients' Electronic Access to Health Information (CMS-9123).
On January 7, OMB received a final rule from CMS entitled HHS Notice of Benefit and Payment Parameters for 2022 (CMS-9914).
On January 7, OMB concluded its review of a final rule from HHS entitled Securing Updated and Necessary Statutory Evaluations Timely.
CORONAVIRUS UPDATE
Legislative
On January 4, House Appropriations Ranking Member Kay Granger (R-TX) and Rep. Jake LaTurner (R-KS) tested positive for COVID-19.
Regulatory
On January 4, the FDA released a safety warning that the Curative SARS-Cov-2 test may result in false negative results and urged providers to consider retesting patients if they received a Curative COVID-19 test. The company said it has not changed its COVID-19 test performance or labeling.
On January 4, the FDA released a statement on following the authorized dosing schedules for COVID-19 vaccines: the agency does not support reducing the number of doses, extending the length of time between doses, changing the dose to half-doses, or mixing vaccines in order to immunize more people against COVID-19 due to the lack of evidence in support of these practices. This statement follows OWS considering giving half the recommended dose of Moderna’s COVID-19 vaccine to speed up immunizations in the U.S.. A fact sheet for health care providers administering COVID-19 vaccines is available here.
On January 5, the National Institutes of Health (NIH) announced that it may take two months to determine whether doses of the Moderna COVID-19 vaccine can be halved, to increase the supply of vaccines.
On January 5, the NIH announced Phase II/III clinical trials of two experimental monoclonal antibody therapies, BRII-196 and BRII-198, for those with mild or moderate COVID-19.
On January 5, the FDA updated its provider fact sheet and authorization letter for Pfizer’s COVID-19 vaccine, allowing vials that contain additional doses to be used.
On January 5, OWS announced that it will begin offering COVID-19 vaccine shots in pharmacies within the next two weeks.
On January 5, Surgeon General Jerome Adams urged states to speed up vaccinations by expanding to other priority groups if the prioritization process is slowing down vaccinations.
On January 5, the FDA highlighted new authorities from the Coronavirus Aid, Relief, and Economic Security Act, intended to enhance the FDA’s ability to identify, prevent, and mitigate possible drug shortages by enhancing the FDA’s visibility into drug supply chains.
On January 6, the CDC released a report finding that among 1.9 million people vaccinated with the Pfizer COVID-19 vaccine, only 21 experienced severe allergic reactions, deeming the vaccine’s benefits greater than risks.
On January 6, a study released in Science Magazine found that immunity from COVID-19 lasts 6 to 8 months or longer.
On January 6, HHS Secretary Alex Azar urged governors to offer COVID-19 vaccines to more people, including seniors and high-risk groups, to speed up vaccinations and prevent wasting doses. Secretary Azar posited that the holidays and overly detailed state plans have slowed vaccine distribution and predicted that vaccine administration would speed up soon.
On January 6, CDC announced $22 billion in COVID-19 funding to states, localities, and territories for testing, contract tracing, surveillance, containment, and mitigation, as directed by the Coronavirus Response and Relief Supplemental Appropriations Act.
On January 6, NIH Director Francis Collins said that COVID-19 variant B.1.1.7, has been identified in California, Colorado, Florida, Georgia, New York, Connecticut, Pennsylvania, and Texas.
On January 7, HHS extended the Community Based COVID-19 Testing partnership with commercial pharmacies until April 2021, due to a $550 million funding extension. This partnership established 3,300 COVID-19 testing locations in communities with moderate-to-high social vulnerability across the country.
On January 7, HHS renewed the public health emergency (PHE) due to COVID-19 for an additional 90-days (until April 21), the maximum extension allowed.
On January 8, the FDA announced that the FDA and CDC are working with manufacturers to evaluate whether existing COVID-19 diagnostic tests can detect the more contagious variant of COVID-19 from the U.K., B.1.1.7.
As of January 8, over 6.6 million people have received the first dose of COVID-19 vaccines and 22.1 million doses have been distributed, according to the CDC COVID Data Tracker. This trend falls short of the Trump Administration’s goal of vaccinating 20 million Americans before the end of 2020, though HHS officials said that the lag in reporting may be distorting current vaccination data. Biden criticized current vaccination efforts and accused the Trump Administration of falling behind, pledging that he would invoke the Defense Production Act, and set up mobile units and vaccination sites in communities to accelerate COVID-19 vaccination efforts. National Institute of Allergy and Infectious Diseases Director Anthony Fauci predicted that the U.S. could be administering a million COVID-19 vaccinations a day soon.
White House
None of note.
Other
On January 4, the U.K. began vaccinating its population with the AstraZeneca COVID-19 vaccine after the country authorized the vaccine on December 30. Previously, OWS Chief Advisor Slaoui announced that the FDA will not authorize AstraZeneca's COVID-19 vaccine before April 2021, due to the vaccine’s varying effectiveness across certain groups.
On January 4, Moderna announced plans to increase the company’s global COVID-19 vaccine production estimate from 500 million to 600 million doses, and aims to increase production to 1 billion doses for 2021.
On January 4, New York Gov. Andrew Cuomo (D) announced that the state’s hospitals must administer vaccines within a week of receiving them or face a fine and a reduction in future supplies. Florida Governor Ron DeSantis (R) announced a similar policy, with the state allocating more doses to hospitals that dispense them most quickly.
On January 4, a study published in medRxiv found that the new U.K variant of COVID-19 is more transmissible than the original variant.
On January 5, a study published in the Annals of Internal Medicine entitled Speed Versus Efficacy: Quantifying Potential Tradeoffs in COVID-19 Vaccine Deployment,found that a single-dose COVID-19 vaccine with 55% effectiveness may confer greater population benefit than a 95%-effective vaccine requiring two doses. This study supports continued investment in the pursuit of one-dose vaccine candidates due to the clinical and epidemiologic costs imposed by a two-dose vaccine.
On January 5, a study published in the JAMA Network Open estimated that 14.3% of the U.S. population had antibodies against COVID-19 by mid-November 2020 and that COVID-19 cases and deaths are likely higher than reported.
On January 6, a study published in the New England Journal of Medicine foundthat early administration of convalescent plasma to mildly ill older adults within days of developing symptoms reduced the progression of COVID-19.
On January 7, Moderna CEO Stephane Bancel predicted that Moderna’s COVID-19 vaccine may offer protection from COVID-19 for up to a couple of years.
On January 7, the American Hospital Association called for HHS Secretary Azar to establish a process within HHS with the ability to be able to coordinate the national efforts among all of the states and jurisdictions and the many stakeholders; answer all of the questions expeditiously; establish and maintain effective communication among all involved; and identify and resolve barriers to the rapid deployment of millions of doses of vaccines.
On January 7, a study published in bioRxiv suggested that the Pfizer COVID-19 vaccine may protect against the COVID-19 variants from the U.K. and South Africa.
On January 8, Democratic Governors from Michigan, California, Kansas, Illinois, Minnesota, New York, Washington, and Wisconsin urged HHS to release the COVID-19 doses currently being held to ensure that those who received their first dose can get their second, due to concerns about new COVID-19 variants.
As of January 10, the U.S. had 22,139,598 confirmed COVID-19 cases resulting in 372,552 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
Contract Year 2022 Policy and Technical Changes to the MA Program, Medicare Prescription Drug Benefit Program, Medicaid Program, Medicare Cost Plan Program, and PACE (CMS-4190); Final Rule; Received 9/28/20
Medicare Coverage of Innovative Technology (MCIT) and Definition of "Reasonable and Necessary" (CMS-3372); Final Rule; Received 12/14/20
Medicaid; Reducing Provider and Patient Burden by Improving Prior Authorization Processes and Promoting Patients' Electronic Access to Health Information (CMS-9123); Final Rule; Received 1/7/21
HHS Notice of Benefit and Payment Parameters for 2022 (CMS-9914); Final Rule; Received 1/7/21
HHS-IHS
Calendar Year 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 7, OIG released a report entitled Ohio Made Progress Toward Achieving Program Goals for Enhancing Its Prescription Drug Monitoring Program.The report identified that Ohio has improved their prescription drug monitoring programs by improving safe prescribing practices and preventing prescription drug abuse and misuse. OIG also found that Ohio complied with Federal requirements for submitting its Federal Financial Report and Annual Performance Report and publicly reported the five CDC-directed indicators. A summary of the report is available here.
Congressional Budget Office (CBO)
On January 7, the CBO released a report entitled CBO’s Recent Publications and Work in Progress as of January 1, 2021. The report highlights the CBOs recent work and summarizes its work in progress. A summary of the report is available here.
Government Accountability Office (GAO)
On January 4, the GAO released a report entitled Medicare Severe Wound Care: Spending Declines May Reflect Site of Care Changes; Limited Information Is Available on Quality. The report found that 287,547 Medicare fee-for-service beneficiaries had inpatient stays that included care for severe wounds in fiscal year (FY) 2018. CMS data showed that Medicare spending on stays for severe wound care was $2.01 billion in FY 2018, a decline of about 2% from FY 2016, as a result of decreases in both the total number of these stays, as well as spending per stay. GAO also found that Medicare beneficiaries continued to have access to other severe wound care providers, even with severe wound care decreasing. A summary of the report is available here.
UPCOMING HEARINGS
Senate
None of note.
House
None of note.
OTHER HEALTH POLICY NEWS
On January 4, GoodRx released an analysis entitled Live Updates: January 2021 Drug Price Increases. The analysis found that 582 branded drugs have increased by an average of 4.2%.
On January 4, it was announced that Haven – the joint venture between Amazon, Berkshire Hathaway, and JPMorgan – will disband by the end of February, after 3 years of operation. The venture was originally created to develop ways to lower health care costs and improve outcomes.
On January 5, 46Brooklyn, a market research firm, released a data set detailing prescription drug prices in the U.S. The data found that the median wholesale price increased 4.8% for 645 brand-name medicines.
On January 5, the Committee for a Responsible Federal Budget released a report entitled 2021 Deficit On Course to Hit $2.3 Trillion. The group estimated that the FY 2021 deficit will total $2.3 trillion, which is lower than the FY 2020 deficit of $3.1 trillion. The group also estimated the Gross Domestic Product to reach 10.4%.
On January 5, a study published in Health Affairs found that hospitals in states that expanded Medicaid eligibility benefited from declining uncompensated care costs and increased Medicaid revenue from 2013 to 2017, which may have made states in expanded states better prepared to financially recover from COVID-19 than states that did not expand eligibility.
On January 6, Insure.com released a survey of commercial health insurance customer satisfaction. The survey reported a wide variation in consumer satisfaction and that a majority of customers are pleased with their commercial health insurance coverage and plan to renew it for 2021.
On January 7, Illinois expanded Medicaid coverage to those 65 and older, who are undocumented or have been legal permanent residents for less than five years, and have income below the federal poverty level.
On January 14-15, MedPAC will hold its next public meeting. The Commission will discuss the following topics:
Assessing payment adequacy and updating payments: Hospital inpatient and outpatient services; and Mandated report: Expanding the post-acute transfer policy to hospice;
Assessing payment adequacy and updating payments: Physician and other health professional services;
Assessing payment adequacy and updating payments: Ambulatory surgical center services; Outpatient dialysis services; Hospice services;
Assessing payment adequacy and updating payments: Skilled nursing facility services; home health agency services; inpatient rehabilitation facility services; long-term care hospital services;
CMMI's development and implementation of alternative payment models;
Telehealth in Medicare after the public health emergency;
The Medicare prescription drug program (Part D): Status report;
Mandated report on the skilled nursing facility value-based purchasing program and proposed replacement; and
Medicare's vaccine coverage and payment policies.