The following LPG Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from November 30 - December 6. 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 December 3, President-elect Joe Biden’s transition team met with the Centers for Disease Control and Prevention (CDC) Center for Surveillance, Epidemiology and Laboratory Services Director Michael Iademarco, Deputy Surgeon General Erica Schwartz, and Health & Human Services (HHS) Assistant Secretary for Health Admiral Brett Giroir to discuss increasing the COVID-19 testing supply and other COVID-19 updates.
On December 4, Biden announced plans to ask Americans to wear masks for his first 100 days in office, in addition to issuing a standing order mandating masks in certain places.
Biden announced a series of White House senior staff appointments this week, including an all-female White House communications team:
Kate Bedingfield as the White House Communications Director. Bedingfield served as the Communications Director for Biden during the Obama Administration and on Biden’s presidential campaign;
Jen Psaki as the White House Press Secretary. Psaki served as the White House Communications Director during the Obama Administration 2014 through 2016.
Pili Tobar as the White House Deputy Communications Director. Tobar served on Biden’s campaign and as the Deputy Director of America’s Voice;
Karine Jean-Pierre as the Principal Deputy Press Secretary. Jean-Pierre served as Vice President-elect Kamala Harris’ Chief of Staff during the campaign and worked for MoveOn.org;
Symone Sanders as Harris’ Senior Adviser and Chief Spokesperson. Sanders served on Sen. Bernie Sanders’ (D-VT) 2016 presidential campaign as National Press Secretary and also worked on the Biden campaign;
Ashley Etienne as Harris’ Communications Director. Etienne serviced as a former aide for House Speaker Nancy Pelosi (D-CA) and also worked on the Biden campaign;
Elizabeth Alexander as Jill Biden’s Communications Director. Alexander worked for Biden when he was in the Senate, served as Biden’s Press Secretary during the Obama Administration, and also worked on the Biden campaign;
Tina Flournoy as Harris’ Chief of Staff. Flournoy currently serves as former President Bill Clinton’s Chief of Staff;
Jeff Zients as the White House COVID-19 coordinator. Zients served as Biden’s transition co-chair and as a former Obama administration official; and
Dr. Anthony Fauci as Biden’s chief medical advisor and on the COVID-19 transition team. Fauci is the Director of the National Institute of Allergy and Infectious Diseases.
Biden also announced a series of White House nominations, including:
Brian Deese for White House National Economic Council Director;
Adewale “Wally” Adeyemo for Deputy Treasury Secretary;
Cecilia Rouse for the Council of Economic Advisers Chair;
Neera Tanden for Director of the White House Office of Management and Budget (OMB);
Heather Boushey and Jared Bernstein for Council of Economic Advisers; and
Dr. Vivek Murthy for Surgeon General.
NON-CORONAVIRUS LEGISLATIVE UPDATE
House
On November 30, Ways & Means members Lloyd Doggett (D-TX), Bill Pascrell (D-NJ), and Danny Davis (D-IL) objected to the proposed rule entitled Securing Updated and Necessary Statutory Evaluations Timely, calling the rule unnecessarily burdensome. The representatives raised concern with the rule potentially resulting in wasted resources, undermining program operations, and forcing the next Administration to divert resources away from addressing the COVID-19 pandemic.
On December 1, Energy & Commerce Committee Chairman Frank Pallone (D-NJ); Ways & Means Committee Chairman Richard Neal (D-MA); Education & Labor Committee Chairman Bobby Scott (D-VA); Senate Health, Education, Labor, & Pensions (HELP) Committee Ranking Member Patty Murray (D-WA), and Senate Finance Committee Ranking Member Ron Wyden (D-OR) voiced their opposition to the proposed rule entitled Benefit and Payment Parameters for 2022 and Pharmacy Benefit Manager Standards arguing that allowing states to eliminate Healthcare.gov jeopardizes access to high-quality health insurance plans and poses a significant risk to consumers.
On December 2, the House GOP elected Rep. Cathy McMorris Rodgers (R-WA) for House Energy & Commerce Committee Ranking Member for 2021, replacing Rep. Greg Walden (R-OR) who is retiring from the position. On December 3, House Democrats unanimously reelected Pallone as House Energy & Commerce Committee Chair. House Democrats also elected Rep. Rosa DeLauro (D-CT) as chair of the Appropriations Committee.
Senate
None of note.
NON-CORONAVIRUS REGULATORY UPDATE
On November 30, HHS issued a proposed rule entitled HHS Notice of Benefit and Payment Parameters for 2022 and Pharmacy Benefit Manager Standards. The rule proposes payment parameters and provisions related to the risk adjustment program; cost-sharing parameters and cost-sharing reductions; and user fees for Federally-facilitated Exchanges and State-based Exchanges on the Federal platform.
On November 30, the Centers for Medicare & Medicaid Services (CMS) issued a correction to the final rule entitled Specialty Care Models to Improve Quality of Care and Reduce Expenditures. This correction fixes technical and typographical errors in the final rule.
On December 1, CMS finalized updates to Medicare coverage policies for artificial hearts and ventricular assist devices. This update will end the requirement for artificial hearts to be covered by Medicare under the “coverage with evidence development” standard and allow for coverage decisions to be made by local Medicare Administrative Contractors.
On December 1, CMS issued a correction to the final rule entitled Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Final Policy Changes and Fiscal Year (FY) 2021 Rates; Quality Reporting and Medicare and Medicaid Promoting Interoperability Programs Requirements for Eligible Hospitals and Critical Access Hospitals. This correction fixes technical and typographical errors in the final rule.
On December 2, CMS issued a correction to the final rule entitled Extension of Compliance Dates and Timeframes in Response to the COVID-19 Public Health Emergency (PHE). This correction fixes typographical errors in the final rule.
On December 2, CMS issued a final rule entitled the Calendar Year (CY) 2021 Payment Policies under the Physician Fee Schedule (PFS) and Other Changes to Part B Payment Policies. The rule adjusts Medicare payments under the PFS, and other Medicare Part B issues. The final CY 2021 PFS conversion factor is $32.41, a decrease from the CY 2020 PFS conversion factor of $36.09, due to the budget neutrality adjustment to account for changes in relative value units. A fact sheet on the rule is available here. This rule includes:
Expanding telehealth service and provider coverage and revising the frequency limitation for rural beneficiaries but the rule does not include expansions of audio-only telehealth coverage after the PHE. Notably, Medicare does not have the statutory authority to pay for telehealth to beneficiaries outside of rural areas or allow beneficiaries to receive telehealth in their home, this change requires legislative action. A summary of telehealth changes is available here;
Clarifying remote physiologic monitoring coverage;
Maintaining payment rates for immunization administration;
Aligning evaluation and management (E/M) visit coding and documentation policies with recommendations from the CPT Editorial Panel for office/outpatient E/M visits;
Expanding practice and supervision requirements, such as allowing certified registered nurse anesthetists to supervise the performance of diagnostic tests;
Expanding the coverage of opioid use disorder treatment services to include opioid antagonist medications, specifically naloxone, for emergency treatment of opioid overdose and overdose education;
Finalizing changes to data reporting and extending the phase-in of payment reductions resulting from private payor rate implementation through CY 2024;
Changing quality performance standard and quality reporting requirements for the Medicare Shared Savings Program to reduce reporting burden and focus on patient outcomes. A fact sheet on the Quality Payment Program is available here;
Revising certain Medicare Diabetes Prevention Program (MDPP) policies during the COVID-19 PHE and future applicable 1135 waiver events. A fact sheet on the Final Policies for the MDPP Expanded Model is available here; and
Finalizing policies that will further reduce burden associated with repayment mechanisms for Accountable Care Organizations.
On December 2, CMS issued a final rule entitled CY 2021 Medicare Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System Final Rule (CMS-1736-FC). The rule finalizes the proposal to eliminate the “Inpatient Only” list of procedures for which Medicare will only pay when performed in the hospital inpatient setting with the list of services being phased out by CY 2024. The rule also allows CMS to continue the policy of paying for 340B-acquired drugs at average sales price (ASP) minus 22.5% to lower out-of-pocket drug costs. The rule establishes an updated methodology to calculate the Overall Hospital Quality Star Rating but is not finalizing the proposal to stratify readmission measures under the new methodology based on dually eligible patients. A fact sheet of the rule is available here. A summary is available here.
On December 3, CMS announced a new three-year, voluntary payment model entitled the Geographic Direct Contracting Model to test whether a geographic-based approach to value-based care can improve quality of care and reduce costs for Medicare beneficiaries across an entire geographic region. The model incentives the improvement of care across entire geographic regions through risk-sharing arrangements. Applications will be released January 2021 and will be due April 2, 2021. The first performance period will begin January 1, 2022. A fact sheet is available here.
On December 3, the Food & Drug Administration (FDA) issued a correction to the notice of availability entitled Formal Meetings Between the Food and Drug Administration and Abbreviated New Drug Application Applicants of Complex Products under Generic Drug User Fee Amendments.
On December 3, HHS issued a final rule entitled HHS Good Guidance Practices. This rule aims to ensure that the public receives appropriate notice of new guidance documents and that HHS guidance documents do not impose obligations on parties that are not already reflected in statutes or regulations.
On December 3, HHS released the HHS Action Plan and announced a partnership to reduce maternal deaths and disparities that put women at risk prior to, during, and following pregnancy. A summary of the plan is available here.
On December 3, CMS announced that 523,020 people selected plans through HealthCare.gov during the third week of enrollment, including 138,183 new enrollees. Thus far, 2,903,547 enrollees have selected plans through HealthCare.gov since enrollment opened on November 1.
On December 4, 48 Members of Congress urged House and Senate leaders to include provisions to make permanent expanded coverage of Medicare telehealth services in end of the year legislation. The members called to permanently waive geographic restrictions for originating sites, authorize health centers in rural and underserved areas to provide telehealth, and allow beneficiaries to use telehealth in their homes.
NON-CORONAVIRUS WHITE HOUSE UPDATE
On November 30, OMB received a proposed rule from the CMS entitled Reducing Provider and Patient Burden, and Promoting Patients' Electronic Access to Health Information (CMS-9123).
On December 1, OMB concluded review of a notice from the FDA entitled Best Practices in Developing Proprietary Names for Human Prescription Drug Products; Guidance for Industry; Availability.
On December 1, OMB concluded review of a notice from the FDA entitled Best Practices in Developing Proprietary Names for Human Nonprescription Drug Products; Draft Guidance for Industry; 2016-1296
On December 2, OMB received a notice from the Indian Health Service entitled Calendar Year 2021 Reimbursement Rates.
CORONAVIRUS UPDATE
Legislative
On November 1, Pelosi and Treasury Secretary Steven Mnuchin restarted relief package talks. Pelosi and Senate Minority Leader Chuck Schumer (D-NY) reportedly offered Senate Majority Leader Mitch McConnell (R-KY) and House Minority Leader Kevin McCarthy (R-CA) a $1.3 trillion deal that was quickly shot down. On December 4, Pelosi and McConnell suggested combining the $1.4 trillion omnibus spending package with COVID-19 relief.
On December 1, Sens. Joe Manchin (D-WV), Mitt Romney (R-UT), Susan Collins (R-ME), Lisa Murkowski (R-AK), Bill Cassidy (R-LA), Mark Warner (D-VA), Jeanne Shaheen (D-NH), Angus King (I-ME), and Maggie Hassan (D-NH), and Members of the House Problem Solvers Caucus introduced an $908 billion bicameral, bipartisan relief package. The package allows states to develop their own liability reforms and protect businesses in the meantime. The package also includes:
$160 billion in state and local aid;
$180 billion in additional unemployment insurance;
$288 billion for small businesses;
$82 billion for schools;
$45 billion for transportation; and
$300 a week in federal unemployment benefits for four months.
On December 1, Sens. Schumer, Wyden, Sherrod Brown (D-OH), and Michael Bennet (D-CO) introduced the American Worker Holiday Relief Act, to extend aid programs created under the CARES Act. The bill would give unemployed workers an additional $600 weekly in unemployment insurance benefits through October 2021 and retroactive payments for every week of unemployment since September.
Multiple Senate leaders, including McConnell, Schumer, and Senate Finance Chair Chuck Grassley (R-IA) urged Congress to pass a bipartisan COVID-19 relief package. Majority Leader McConnell reintroduced a $569 billion GOP Targeted Relief Package which includes:
$332.7 billion for the Paycheck Protection Program and other small business relief;
$105 billion for education;
$31 billion for the development of vaccines and testing strategies and distribution;
$16 billion for contact tracing, testing, and surveillance in states
$20 billion for farm relief;
Liability protections for hospitals; small and large businesses; schools; colleges and universities; religious, philanthropic and other nonprofit institutions; and local government agencies;
1-month extension of Pandemic Unemployment Assistance and Pandemic Emergency Unemployment Compensation;
Encouraging partnerships with the medical product supply chain to increase manufacturing and stockpiling capacity for the Strategic National Stockpile; and
A series of tax provisions.
Reps. Austin Scott (R-GA) and Robert Aderholt (R-AL) tested positive for COVID-19 this week.
Regulatory
On December 1, the CDC Advisory Committee for Immunization Practices voted 13-1 to recommend that health care workers and residents of long-term care facilities should be the first to receive a COVID-19 vaccine, once one is authorized. Recommendations are not legally binding but states creating vaccination plans are looking to the committee for recommendations.
On December 1, Operation Warp Speed Chief Moncef Slaoui predicted that 100 million people could receive a COVID-19 vaccine by the end of February and that there will be enough COVID-19 vaccine produced to immunize every American over the next six months.
On December 1, the Small Business Administration published the names of employers that received money under the Paycheck Protection Program and Economic Injury Disaster Loan program.
On December 1, the Department of Transportation announced that all of its necessary regulatory measures have been taken for the safe, rapid, mass transportation of a COVID-19 vaccine.
On December 1, HHS announced that all tribal health programs and Urban Indian Organizations chose their preferred method for receiving the vaccine, either receiving the vaccine through the Indian Health Service (IHS) or their respective state.
On December 2, the CDC issued new guidance decreasing the quarantine time from 14 days to 10 days for people exposed to COVID-19 who do not have symptoms. The CDC recommends that if a person tests negative, he/she should quarantine for seven days.
On December 2, the Biomedical Advanced Research and Development Authority (BARDA) and Moderna announced the company’s intent to conduct a COVID-19 vaccine trial with teenagers between the ages of 12 and 18.
On December 2, HHS purchased 650,000 additional doses of Lilly's antibody drug bamlanivimab for $813 million to treat mild to moderate cases of COVID-19 in patients at high risk for progressing to severe cases or hospitalization.
On December 2, the Department of Defense announced the use of vaccination kits and COVID-19 vaccination record cards for patients to track which COVID-19 vaccine they receive and when, in addition to vaccination clinics reporting to state immunization registries.
On December 3, CMS announced the agency is exercising enforcement discretion for billing by Skilled Nursing Facilities (SNFs) to facilitate COVID-19 vaccines administration. CMS will allow Medicare-enrolled immunizers to bill directly and receive direct reimbursement from the Medicare program for vaccinating Medicare Part A SNF residents. A FAQ is available here.
On December 3, HHS issued an amendment to the Declaration under the Public Readiness and Emergency Preparedness (PREP) Act. The amendment authorizes telehealth providers to order “Covered Countermeasures”, including ordering diagnostic tests, and expands and clarifies immunity under the PREP Act, including covering more providers who could administer COVID-19 vaccines. A summary of the amendment is available here.
On December 4, the CDC issued guidance advising state and local officials to impose mask mandates for indoor settings. This is the first time the CDC is recommending universal mask-wearing.
The FDA Vaccines and Related Biological Products Advisory Committee will hold a meeting to discuss the Emergency Use Authorization (EUA) of the Pfizer COVID-19 vaccine in individuals 16 years of age and older on December 10.
White House
In a report dated November 29, the White House Coronavirus Task Force released reports warning governors that “the COVID risk to all Americans is at a historic high” and states virus-mitigation efforts and restrictions are not strong enough. The Task Force’s report classified 47 states and the District of Columbia were in the red zone for new cases, with more than 100 new cases per 100,000 residents in the week prior, and 39 states were in the red zone for deaths, with more than more than two new deaths per 100,000 residents in the week prior. The Task Force also urged states to conduct more rapid testing.
On November 30, Vice President Mike Pence told governors that COVID-19 vaccine distribution could begin the week of December 14, following the FDA Vaccines and Related Biological Products Advisory Committee discussion of Pfizer’s vaccine.
On November 30, Scott Atlas resigned from his position as Special Advisor to the President on COVID-19. Atlas was brought into the White House in August 2020.
On December 3, President Trump extended federal funding for the National Guard’s COVID-19 work in states past the current December 31 deadline. Federal Emergency Management Agency (FEMA) will fund 100% of the National Guard forces in Florida and Texas until December 31. FEMA will continue to fund 75% of the National Guard’s efforts in all states, including Florida and Texas, through March 31, 2021.
The White House will host a meeting entitled the COVID-19 Vaccine Summit on December 8 with drug industry and distribution representatives, governors, and federal officials.
Other
On November 30, Moderna filed for an EUA of its mRNA COVID-19 vaccine, mRNA-1273. Moderna also announced that mRNA-1273, was 94.1% effective in preventing COVID-19, based on interim efficacy analysis.
On November 30, Novavax delayed the company’s U.S. and Mexico Phase III trial. Novavax announced it has completed enrollment in the company’s U.K Phase III trial and South Africa Phase 2b efficacy trial.
On November 30, the Association of American Medical Colleges called for medical schools, teaching hospitals, and health systems to prepare their Crisis Standards of Care (CSC), due to surging COVID-19 cases and hospitalizations. CSCs were implemented earlier in the COVID-19 PHE and in response to natural disasters and other health emergencies.
On December 1, Gov. Andrew Cuomo (D) and a coalition of advocacy groups urged HHS Secretary Alex Azar to better fund states and ensure patient privacy for the federal COVID-19 vaccination program. The letter calls for more funding to support states' efforts to distribute the vaccine to minority and low-income communities and to adjust the current data sharing agreement to better protect identification data from being shared with multiple federal agencies, which may dissuade people from taking the vaccine.
On December 1, American Hospital Association, American Medical Association, and American Nurses Association published an open letter supporting rigorous scientific and regulatory processes for COVID-19 vaccines, establishing safe and effective processes for administering vaccines, and making vaccine information transparent.
On December 1, the Kaiser Family Foundation released a brief entitled How have health spending and utilization changed during the coronavirus pandemic? The brief found that health services revenue have fallen 2.4% in 2020, compared to 2019. A summary is available here.
On December 2, 60 health advocacy organizations launched the COVID-19 Vaccine Education and Equity Project to advocate for the regulatory review process, raise awareness around the COVID-19 vaccine, target vulnerable communities with education efforts, and ensure the equitable access of vaccines.
On December 2, the U.K. authorized Pfizer’s COVID-19 vaccine, becoming the first country to authorize the vaccine and the first Western country to authorize a COVID-19 vaccine. The U.K. Health Secretary Matt Hancock said the National Health Service could begin vaccinating “priority groups,” including health care workers and the elderly, early next week. National Institute of Allergy and Infectious Diseases Director Anthony Fauci called the country’s authorization rushed, compared to the FDA’s approval process that is conducting an independent data review.
On December 2, Russian President Vladimir Putin announced the Russian Health Agency will begin large-scale COVID-19 vaccination as early as next week, beginning with health care workers and teachers.
On December 2, a study released in Health Affairs entitled Increased Intensity Of PCR Testing Reduced COVID-19 Transmission Within Countries During The First Pandemic Wave, found that increased testing and isolation are the most effective and least costly policy for controlling COVID-19. The study also suggested that the World Health Organization and other testing benchmarks are insufficient for COVID-19 control.
On December 3, the Commonwealth Fund published a report entitled How Prepared Are States to Vaccinate the Public Against COVID-19? Learning from Influenza and H1N1 Vaccination Programs. The report emphasized the importance of achieving high rates of COVID-19 vaccination uptake, especially in minority populations; that vaccination strategies should aim for higher COVID-19 vaccine adherence than typical influenza vaccination; and the importance of ensuring equitable availability across states.
On December 3, former Presidents Barack Obama, George W. Bush, and Bill Clinton indicated their willingness to take a COVID-19 vaccine on camera, if deemed safe.
On December 3, a study published in the New England Journal of Medicine entitled Durability of Responses after SARS-CoV-2 mRNA-1273 Vaccination, found that during a small study of the Phase I trial, vaccine participants who received Moderna’s COVID-19 vaccine had higher levels of antibodies three months after vaccination than those who recovered from COVID-19 infections.
On December 3, Pfizer predicted that the company will have half as many of the 100 million COVID-19 vaccines by the end of 2020, due to supply chain issues. Pfizer expects to ship 1.3 billion doses in 2021, as originally planned.
On December 4, Lilly and UnitedHealth announced a partnership to study the efficacy of Lilly’s COVID-19 monoclonal antibody treatment, bamlanivimab, in high-risk individuals.
On December 4, the World Health Organization (WHO) released a report entitled Behavioural considerations for acceptance and uptake of COVID-19 vaccines: WHO technical advisory group on behavioural insights and sciences for health, meeting report, 15 October 2020. The report identified behavioral factors that vaccine acceptance and uptake, including: environmental factors, such as cost and vaccination location; social influences, such as social norms and endorsements from trusted sources; and motivation, such as building trust and emphasizing social benefits.
On December 4, Ellume submitted its over-the-counter, at-home COVID-19 antigen test for EUA. The company projects it will manufacture 100,000 tests a day beginning in January and have the capacity to produce 1 million per day by mid-2021.
As of December 6, the U.S. had 14,639,724 confirmed COVID-19 cases resulting in 281,628 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
Reducing Provider and Patient Burden, and Promoting Patients' Electronic Access to Health Information (CMS-9123); Proposed Rule; Received 11/30/20
HHS-IHS
Calendar Year 2021 Reimbursement Rates; Notice; Received 12/2/20
REPORTS
HHS Office of Inspector General (OIG)
On December 2, OIG released its Semiannual Report to Congress. The report highlights more than $4 billion in expected recoveries identified fiscal year (FY) 2020. OIG also reported 624 criminal actions against individuals or entities that engaged in crimes that affected HHS programs and 791 civil actions, which include false claims and unjust-enrichment lawsuits filed in federal district court, civil monetary penalty settlements, and administrative recoveries related to provider self-disclosure matters, in 2020. A summary of the report is available here.
On December 2, OIG released a report entitled Nebraska Claimed Almost All Medicaid Payments for Targeted Case Management Services in Accordance With Federal Requirements but Claimed Some Unallowable Duplicate Payments. The report found that Nebraska claimed almost all Federal Medicaid reimbursement for Targeted Case Management services during FYs 2016 through 2018 in accordance with Federal and State requirements. Though, there were a handful of unallowable claims due to duplicate monthly payments, resulting in $22,484 in overpayments. OIG recommended that Nebraska refund overpayments and implement the necessary Medicaid Management Information System edits to prevent and detect duplicate payments. A summary of the report is available here.
Government Accountability Office
On November 30, the GAO released a report entitled COVID-19: Urgent Actions Needed to Better Ensure an Effective Federal Response. The report found that the COVID-19 pandemic has resulted in loss of life and substantial damage to the global economy, stability, and security. GAO made 11 recommendations, including for:
HHS and FEMA to implement GAO’s previous September 2020 recommendations;
FDA to identify ways to uniformly disclose information from its scientific review of safety and effectiveness data when issuing EUAs for therapeutics and vaccines;
HHS to ensure that CDC clearly discloses the scientific rationale for any change to testing guidelines at the time the changes made;
CMS to quickly develop a plan that further details how it intends to respond to and implement, as appropriate, the commission’s recommendations; and
Department of Labor to revise its weekly news releases to clarify that in the current unemployment environment, the numbers it reports for weeks of unemployment claimed do not accurately estimate the number of unique individuals claiming benefits, and pursue options to report the actual number of distinct individuals claiming benefits, such as by collecting these already available data from states.
A summary of the report is available here.
On November 30, the GAO released a report entitled Artificial Intelligence in Health Care: Benefits and Challenges of Technologies to Augment Patient Care. The report found that Artificial Intelligence (AI) tools have shown promise for augmenting patient care from a clinical and administrative perspective. GAO identified a number of challenges, including data access, bias, scaling and integration, lack of transparency, privacy, and uncertainty over liability. GAO developed six policy options to address these challenges or enhance the benefits of AI tools, including encouraging interdisciplinary collaboration between developers and health care providers; developing or expanding high-quality data access mechanisms; encouraging relevant stakeholders and experts to establish best practices for development, implementation, and use of AI technologies; creating opportunities for more workers to develop interdisciplinary skills; and collaborating with relevant stakeholders to clarify appropriate oversight mechanisms. A summary of the report is available here.
UPCOMING HEARINGS
Senate
Homeland Security & Governmental Affairs Committee
December 8, 10:00 a.m., Senate Dirksen Building
Early Outpatient Treatment: An Essential Part of a COVID-19 Solution, Part II
Witnesses include: Jane Orient, M.D., Executive Director, Association of American Physicians and Surgeons; Pierre Kory, M.D., Associate Professor of Medicine, St. Luke's Aurora Medical Center; Jean-Jacques Rajter, M.D., Pulmonologist, Broward Health Medical Center; and Ramin Oskoui, M.D., Vice President of Medica Staff, Sibley Memorial Hospital, Chief Executive Officer, Foxhall Cardiology
Commerce, Science, & Transportation, Transportation and Safety Subcommittee
December 10, 9:30 a.m., 253 Russell Senate Office Building
The Logistics of Transporting a COVID-19 Vaccine
Witnesses include: Rachel Levine, Secretary of Health, Pennsylvania, President, Association of State and Territorial Health Officers; Richard Smith, Regional President, Americas, Executive Vice President, FedEx Express; Wesley Wheeler, President, Global Healthcare, United Parcel Service
House
House Oversight and Reform Committee
December 8, 10:00 a.m., virtual
Purdue Pharma's Role in the Opioid Epidemic
Witnesses include: Mortimer Sackler, Controlling share of Purdue Pharma, Richard Sackler, Controlling share of Purdue Pharma; David Sackler, Controlling share of Purdue Pharma; Kathe Sackler, Controlling share of Purdue Pharma; and Craig Landau, President, CEO, Purdue Pharma
OTHER HEALTH POLICY NEWS
On November 30, DeepMind’s AI system, AlphaFold, was recognized as a solution to the “protein folding problem,” which could accelerate the ability for scientists and researchers to understand diseases and develop new drugs.
On November 30, Google Cloud launched the Healthcare Interoperability Readiness Program to help providers and payers advance data interoperability and make sure data is secure, reliable, compliant to federal guidance that is coming into effect on January 1.
On December 1, Fair Health’s Monthly tracker revealed that the use of telehealth saw a 16.5% drop from August to September, though telehealth usage is still above 2019 levels.
On December 4, the Pharmaceutical Research and Manufacturers of America (PhRMA) filed a lawsuit to halt the enforcement of CMS’ “Most Favored Nation Rule,” which would link Medicare Part B reimbursement for medicines to lower prices paid by other countries. PhRMA accuses CMS of exceeding its statutory authority and claims that the rule violates Administrative Procedure Act procedural safeguards and will harm patients, providers, manufacturers, and the public. BIO also filed a lawsuit against the agency, calling for the rule to be rejected.