The following LPG Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from November 16 - November 22. 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 November 16, Dr. Anthony Fauci suggested that Trump’s refusal to concede the presidential election and allow President-elect Joe Biden to begin transition measures could harm the federal COVID-19 response and delay COVID-19 vaccine delivery. The Biden’s COVID-19 advisory team agreed that the inability to officially transition is harming the incoming administration’s preparedness planning. Health and Human Services (HHS) Secretary Alex Azar said the delay would not complicate distribution efforts because most of that work is done by career officials who would remain on board regardless of administration.
On November 19, Biden and his transition team met with the National Governors Association to talk about the COVID-19 response at the state level.
On November 19, Biden pledged to fully fund the National Guard's COVID-19 relief efforts in all states. Most states are currently funding 25% of the National Guard's actions in their states, including running testing sites, staff hospitals, conducting contact tracing, and other work.
On November 19, the Associated Press declared Biden the winner in Georgia, after the state conducted a hand-recount of all ballots.
As of November 22, the General Services Administration (GSA) has yet to recognize Biden as the next president and has not signed a letter of ascertainment to give the Biden team $6.3 million in transition funding and access to agency officials and information. The Biden team is raising money in order to make up for the lack of public funding.
Biden announced a series of White House appointments this week, including:
Mike Donilon as Senior Adviser to the President;
Steve Ricchetti as Counselor to the President;
Former campaign manager Jen O’Malley Dillon as Deputy Chief of Staff;
The Biden campaign general counsel Dana Remus as Counsel to the president;
Julissa Reynoso Pantaleon as Dr. Jill Biden’s Chief of Staff;
Rep. Cedric Richmond (D-LA) as Senior Adviser to the President and Director of the White House Office of Public Engagement;
Biden-Harris campaign Deputy Campaign Manager Julie Chavez Rodriguez as Director of the White House Office of Intergovernmental Affairs;
Biden campaign’s Chief of Staff Julie Annie Tomasini as Director of Oval Office Operations;
Louisa Terrell as Director of the White House Office of Legislative Affairs;
Carlos Elizondo as White House Social Secretary; and
Mala Adiga as Policy Director for Dr. Jill Biden.
NON-CORONAVIRUS LEGISLATIVE UPDATE
House
On November 16, House Judiciary Chair Jerry Nadler (D-NY) and Oversight Chairwoman Carolyn Maloney (D-NY) raised concern to Office of Management and Budget (OMB) Acting Director Russell Vought and Office of Information and Regulatory Affairs Administrator Paul Ray regarding “midnight rules,” warning that Congress would not have adequate time to review last-minute regulations.
The House passed a series of health care bills, including:
H.R. 4499, the NIMHD Research Endowment Revitalization Act of 2020, that would allow the Director of the National Institute on Minority Health and Health Disparities to facilitate minority health disparities research;
H.R. 5668, the MODERN Labeling Act of 2020, that would modernize the labeling of certain generic drugs;
H.R. 4712, the Fairness in Orphan Drug Exclusivity Act, that would reduce limitations on exclusive approval or licensure of orphan drugs;
H.R. 2466, the State Opioid Response Grant Authorization Act of 2020, that would extend the State Opioid Response Grants program through Fiscal Year (FY) 2026 at a rate of $1.5 billion per year; and
H.R. 2281, the Easy MAT for Opioid Addiction Act, that would allow practitioners to prescribe up to a three-day supply (instead of one day) of buprenorphine to a patient suffering from substance abuse disorder before the patient enrolls in treatment.
On November 18, Speaker Nancy Pelosi (D-CA) and Republican Leader Kevin McCarthy (R-CA) were both reelected to their leadership positions for next Congress.
On November 18, Energy & Commerce Ranking Member Greg Walden (R-OR), Health Subcommittee Ranking Member Michael Burgess (R-TX), and Oversight & Investigations Subcommittee Ranking Member Brett Guthrie (R-KY) requested information from the Centers for Disease Control and Prevention (CDC) to determine the BioSafety Level-3 and Animal BSL-3 laboratory capacity relating to COVID-19 research in developing vaccines, therapeutics, and diagnostics.
On November 19, Oversight Committee Chairwoman Maloney, Appropriations Chairwoman Nita Lowey (D-NY), Rep. Gerry Connolly (D-VA), and Rep. Mike Quigley (D-IL) requested for GSA Administrator Emily Murphy to brief them on why the GSA has not granted the Biden team access to agency officials and transition funds. The letter also warns that top GSA officials may be required to testify at a public hearing.
Bicameral negotiations continue over the 2021 omnibus spending package.
Senate
The Senate will return from recess on November 30.
NON-CORONAVIRUS REGULATORY UPDATE
On November 16, the Centers for Medicare & Medicaid Services (CMS) announced the Extreme and Uncontrollable Circumstances Policy, to allow Merit-based Incentive Payment System (MIPS) eligible clinicians, groups, and virtual groups to submit an application requesting reweighting of one or more MIPS performance categories to 0% if they've been affected by COVID-19. Applications are due December 31.
On November 16, the Food & Drug Administration (FDA) released guidance entitled Investigational COVID-19 Convalescent Plasma Guidance for Industry. This guidance details that the FDA will not enforce certain requirements under the convalescent plasma Emergency Use Authorization (EUA) until February 28, as part of an effort to meet the immediate need for plasma to treat hospitalized patients with COVID-19.
On November 16, HHS released the annual Agency Financial Report. The report found that the Medicare Fee-For-Service (FFS) improper payment rate declined to 6.27%, compared to 7.25% in 2019, resulting in an estimated $15 billion reduction of Medicare FFS improper payments since 2016. A fact sheet is available here. A summary of this decreased rate is available here.
On November 17, CMS announced it will be retiring the original Compare Tools on December 1, as Medicare.gov’s Care Compare replaced the original tool.
On November 17, the HHS Office of the Assistant Secretary for Health issued a Request for Information to identify technological advances, like artificial intelligence, with the greatest potential to improve health outcomes for aging Americans.
On November 17, HHS issued a final rule entitled the Regulatory Clean Up Initiative. The rule will allow HHS to utilize artificial intelligence tools to identify locations in the Code of Federal Regulations that warrant corrections.
On November 17, CMS recognized 1,092 nursing homes that had 50% or more of their staff complete CMS COVID-19 training, which represents 12.5% of the one million nursing home staff in the country.
On November 18, CMS updated certain research-ready Transformed Medicaid Statistical Information System data files, which provides for a more robust and evolving collection of Medicaid and Children’s Health Insurance Program (CHIP) data. A fact sheet is available here.
On November 19, Senate Finance Committee Ranking Member Ron Wyden (D-OR) requested information from UnitedHealth about the management of mental health and substance use disorder (SUD) benefits after a series of lawsuits surfaced over coverage denials.
On November 19, the FDA hosted a meeting on the Reauthorization of the Biosimilar User Fee Act for fiscal years (FY) 2023 through 2027.
On November 19, the CDC released guidance advising Americans not to travel for Thanksgiving and limit gatherings to people within the same household.
On November 19, the CMS Center for Medicare and Medicaid Innovation (CMMI) announced the Request for Application for the Value in Opioid Use Disorder Treatment (ViT) Initiative, an initiative to increase access to opioid use disorder (OUD) treatment services to eligible Medicare FFS beneficiaries, including those dually eligible for Medicare and Medicaid. ViT is a four-year demonstration that creates two new payments to participating providers, in addition to the OUD treatment services Medicare currently covers: a per beneficiary per month care management fee and a performance-based incentive payment two new payments to participating providers.
On November 19, CMS announced that 803,741 people selected plans through HealthCare.gov during the second week of enrollment, including 170,284 new enrollees. 1,622,106 total people have selected plans through HealthCare.gov since enrollment opened on November 1.
On November 20, OIG issued a final rule entitled Removal of Safe Harbor Protection for Rebates to Plans or Pharmacy Benefit Managers (PBMs) Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection. This rule excludes rebates on prescription drugs paid by manufacturers to PBMs and Part D plans from safe harbor protection under the anti-kickback statute. The rule also creates a new safe harbor protecting discounts reflected in the price of the drug at the pharmacy counter, and a new safe harbor for fixed-fee services arrangements between manufacturers and PBMs. The rule is effective on January 19, 2021, with the exception of the revision to exclude manufacturer rebates from safe harbor protection, which is effective on January 1, 2022. This rule is expected to be challenged in court.
On November 20, CMS released an interim final rule with comment period entitled the Most Favored Nation (MFN) Model for Medicare Part B drugs. The MFN Model is a mandatory, nationwide model that will test paying no more for high-cost Part B drugs than the lowest price that drug manufacturers receive in other similar countries. The model will operate from January 1, 2021, to December 31, 2027. The CMS Office of the Actuary estimates that the MFN Model will result in overall savings of $85.5 billion in Part B spending. The rule is effective immediately, however, there is a comment period that ends on January 20, 2021. A fact sheet for the rule is available here. A summary of the rule is available here. The rule is likely to be challenged in court.
On November 20, CMS finalized a final rule entitled Medicare Program: Modernizing and Clarifying the Physician Self-Referral Regulations. The rule advances value-based arrangements among physicians, hospitals, and other providers by creating pathways for compliance with the law and regulations through the establishment of new exceptions. The rule also finalizes clarifications of important terms and definitions under the law, the applicability of existing exceptions, and other policies that will make these rules more transparent and ease compliance burden. The rule will be effective on January 19, 2021. A fact sheet for the rule is available here. A summary of the rule is available here.
On November 20, OIG issued the final rule entitled Revisions to the Safe Harbors Under the Anti-Kickback Statute and Beneficiary Inducements Civil Monetary Penalties Rules Regarding Beneficiary Inducement. This rule aims to reduce regulatory barriers to care coordination and accelerate the transformation of the health care system into one that better pays for value and promotes care coordination. A fact sheet for the rule is available here. A summary of the rule is available here.
On November 20, CMS finalized a final rule entitled Organ Procurement Organization (OPO) Conditions for Coverage Final Rule: Revisions to Outcome Measures for OPOs CMS-3380-F. The rule aims to increase the supply of organs available for transplant by requiring that the organizations responsible for organ procurement be transparent in their performance, highlighting the best and worst performers, and requiring them to compete on their ability to successfully facilitate transplants. The rule will be implemented on August 1, 2022. A fact sheet for the rule is available here.
On November 20, HHS issued a notice entitled Termination of the FDA’s Unapproved Drug Initiative; Request for Information Regarding Drugs Potentially Generally Recognized as Safe and Effective. This notice withdrawals guidance documents issued as part of the Unapproved Drugs Initiative. A FAQ regarding this notice is available here.
On November 20, CMMI announced the first cohort of Primary Care First participants, including the 916 primary care practices and 37 regional partnerships with commercial, State, and Medicare Advantage (MA) plans. Primary Care First is a voluntary, five-year alternative payment model rewarding value and quality through an innovative payment model to support delivery of advanced primary care. The Primary Care First Payment Model Option will begin on January 1, 2021.
On November 20, the HHS ASPE released a report entitled Medicare FFS Part B and International Drug Prices: A Comparison of the Top 50 Drugs. The report found that Medicare FFS pays at least twice as much as comparable Organization for Economic Co-operation and Development countries for the top-selling prescription drugs in Part B.
On November 20, the HHS Office of the Assistant Secretary for Planning and Evaluation (ASPE) released a report entitled Medicare Part B Drugs: Trends in Spending and Utilization, 2006-2017. The report found that Medicare Part B FFS drug spending per enrollee grew more than twice as high as Part D (per enrollee annual spending growth of 3.4%) and nearly three times as high as the nation overall (per capita annual spending growth of 2.9% for the National Health Expenditures retail drug spending) between 2006 and 2017.
On November 20, HHS issued a Request for Information entitled Vaccines National Strategic Plan.The draft Vaccine Plan may be reviewed here.
NON-CORONAVIRUS WHITE HOUSE UPDATE
None of note.
CORONAVIRUS UPDATE
Legislative
On November 19, the Senate Homeland Security & Governmental Affairs Committee held a hearing entitled Early Outpatient Treatment: An Essential Part of a COVID-19 Solution. Chairman Ron Johnson (R-WI) voiced his support for further exploration of COVID-19 therapies and treatments and posed the question of “why has there been such resistance to low cost, off-the-shelf therapies that might stop the progression on COVID-19 and help keep people out of hospitals and intensive care?” Ranking Member Gary Peters (D-MI) called attention to COVID-19 misinformation and disinformation and supported data transparency surrounding COVID-19 therapies and vaccines. Witnesses included: Peter McCullough, M.D., Vice Chief of Internal Medicine, Baylor University Medical Center; Harvey Risch, M.D., Professor of Epidemiology, Yale University; George Fareed, M.D., Medical Director and Family Medicine Specialist, Pioneers Medical Center; and Ashish Jha, M.D., Dean of the School of Public Health, Brown University.
On November 19, the House Financial Services Housing, Community Development and Insurance Subcommittee held a hearing entitled Insuring against a Pandemic: Challenges and Solutions for Policyholders and Insurers. Chairman WM. Lacy Clay (D-MO) highlighted the conflict between small businesses, insurance companies, and patients navigating health insurance during COVID-19. Witnesses included: Ann Cantrell, Owner, Annie’s Blue Ribbon General Store, on behalf of the National Retail Federation; John Doyle, President & Chief Executive Officer, Marsh; Brian Kuhlmann, Chief Corporate Counsel, Shelter Insurance, on behalf of APCIA and NAMIC; Michelle Melendez McLaughlin, Chief Underwriting Officer, Chubb North America; and R.J. Lehmann, Executive Editor and Senior Fellow, International Center for Law and Economics.
Sens. Chuck Grassley (R-IA), Rick Scott (R-FL), and Kelly Loeffler (-R-GA) and Reps. Ed Perlmutter (D-CO), Dan Newhouse (R-WA), Doug Lamborn (R-CO), and Don Young (R-AK) tested positive for COVID-19 this week.
Regulatory
On November 16, Assistant Secretary for Health Admiral Brett Giroir announced that the FDA will review EUAs of tests developed by labs. This reverses a previous decision by Secretary Azar that the FDA did not have the authority to require and regulate laboratory-developed tests.
On November 16, HHS announced the agency would send 7 million of Abbott Laboratories’ BinaxNOW rapid antigen COVID-19 tests to states, hospice providers, and for other uses as part of the HHS’s effort to deploy 150 million rapid tests in 2020.
On November 17, HHS cancelled the $15 million COVID-19 ad campaign with Atlas Research to “defeat despair,” after conducting an internal review of the campaign.
On November 18, the FDA committed to publicly disclose reviews of data and other information for emergency drug authorizations.
On November 18, CMS released an alert to nursing home staff, residents, and visitors to follow COVID-19 guidelines for visitation, including remaining six feet apart from individuals, wearing a face covering, and limiting the number of visitors in the nursing home at any one time.
On November 18, Operation Warp Speed (OWS) chief operating officer Gen. Gustave Perna announced that every state will have access to some doses of a COVID-19 vaccine within 24 hours after authorization.
On November 19, HHS announced a partnership with Cue Health to deploy its rapid point-of-care molecular COVID-19 test in Alaska, Florida, Louisiana, New Jersey, and Texas.
On November 19, the FDA issued an EUA to Lilly for the janus kinase inhibitor, baricitinib, in combination with remdesivir, for the treatment of hospitalized COVID-19 patients that require supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation.
On November 20, the FDA issued a notice entitled Authorization of Emergency Use of Certain Medical Devices during COVID-19; Availability. This notice issued and reissued EUAs for COVID-19 molecular diagnostic and antigen tests, excluding multianalyte tests.
On November 20, the FDA issued draft guidance entitled Cross Labeling Oncology Drugs in Combination Drug Regimens. This guidance includes recommendations for information to include in labeling for oncology drugs approved for use in combination drug regimens.
On November 20, the FDA issued draft guidance entitled Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the Biologics Price Competition and Innovation Act of 2009; Draft Guidance for Industry; Availability. This guidance informs applicants of the agency’s interpretation of statutory requirements for the development of biosimilars.
On November 20, the FDA issued draft guidance entitled Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability. This guidance includes recommendations on the design of bioequivalence studies to support abbreviated new drug applications.
White House
On November 16, the White House Coronavirus Task Force released guidance for states navigating COVID-19, emphasizing the use of rapid tests in hotspots, even for those without COVID-19 symptoms.
Other
On November 16, Moderna announced that the company’s COVID-19 mRNA-based vaccine candidate, mRNA-1273, was over 94.5% effective in preventing COVID-19, based on interim efficacy analysis. Moderna expects to file for EUA within the next few weeks.
On November 17, the FDA issued an EUA for Lucira Health’s All-In-One Test Kit test for the first at-home rapid COVID-19 molecular diagnostic self-test. Lucira predicts that the test will be available nationally through health care providers by spring 2021. Assistant Secretary Giroir commented that 50,000 to 100,000 tests will be available per month, initially.
On November 17, Johnson & Johnson predicted that the company’s Phase III COVID-19 vaccine trial will achieve 60,000 person enrollment by the end of the year and will seek an EUA for the company’s COVID-19 vaccine candidate by February or earlier.
On November 17, Roche completed early tests of the company’s ability to manufacture large quantities of Regeneron's REGN-COV2 COVID-19 antibody treatment. Roche is waiting for the FDA to authorize REGN-COV2 to begin manufacturing.
On November 17, the American Hospital Association, the American Medical Association, and the American Nurses Association urged the Trump administration to work with the Biden Administration and share real-time COVID-19 data and information, including supplies of therapeutics, testing supplies, personal protective equipment, ventilators, hospital bed capacity, the capacity of the Strategic National Stockpile, the assets from OWS, and distribution plans for therapeutics and vaccines.
On November 17, Quest Diagnostics announced that the increase in COVID-19 cases and testing across the country may cause testing delays.
On November 18, Pfizer announced that the company’s COVID-19 mRNA-based vaccine candidate, BNT162b2, was over 95% effective in preventing COVID-19, based on final efficacy analysis. For adults over 65, efficacy was over 94%. On November 20, Pfizer announced that the company submitted their mRNA COVID-19 vaccine, BNT162b2, to the FDA for EUA. The FDA’s independent vaccine advisory committee announced they will meet on December 10 to review Pfizer’s vaccine and provide FDA advice on safety and effectiveness data submitted as part of the EUA request.
Earlier, on November 17, Pfizer announced the launchd of a pilot delivery program for their vaccine in Rhode Island, Texas, New Mexico, and Tennessee to inform the company of effective distribution methods. The states will not receive the COVID-19 vaccine earlier than other states.
On November 19, AstraZeneca published interim analysis of the Phase II COVID-19 vaccine trial data in the Lancet, finding that older adults showed strong immune responses to the company’s vaccine, ChAdOx1 nCoV-19, and were less likely to experience common side effects than younger clinical trial participants.
On November 19, the World Health Organization (WHO) Guideline Development Group advisedagainst using remdesivir for the treatment of COVID-19, due to the lack of significant evidence from previous WHO clinical trials and other research supporting remdesivir as an effective COVID-19 treatment.
On November 19, HHS awarded Siemens Healthineers a $12 million contract to support domestic production of two COVID-19 antigen tests, in addition to the $13 million contract the company received on November 2.
Some governors imposed new COVID-19 restrictions, as a new wave of COVID-19 cases and deaths sweep the nation going into the holiday season. Michigan Governor Gretchen Whitmer (D) implemented restrictions, including temporarily ending in-person dining, organized sports, and high school and college classes. California Governor Gavin Newsom (D) announced the state will be under a limited stay-at-home order and imposed a statewide curfew. Governors in Ohio, Maryland, and Illinois imposed restrictions on business hours and crowd sizes. Michigan Governor Gretchen Whitmer (D), Ohio Governor Mike DeWine (R), Wisconsin Governor Tony Evers (D), Minnesota Governor Tim Walz (D), Illinois Governor J.B. Pritzker (D), Indiana Governor Eric Holcomb (R), and Kentucky Governor Andy Beshear (D) published an op-ed urging people to stay home and avoid large gatherings for Thanksgiving.
As of November 20, the U.S. had 12,207,237 confirmed COVID-19 cases resulting in 256,671 deaths, according to the Johns Hopkins University & Medicine Coronavirus Resource Center. COVID-19 is now the third leading cause of death in the U.S., according to Scientific American.
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
HHS Notice of Benefit and Payment Parameters for 2022 (CMS-9914); Proposed Rule; Received 11/3/20
CY 2021 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates (CMS-1736); Final Rule; Received 11/5/20
CY 2021 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS-1734); Final Rule; Received 11/6/20
REPORTS
HHS Office of Inspector General (OIG)
On November 16, OIG released a Special Fraud Alert: Speaker Programs, warning the pharmaceutical industry against using “speaker programs,” classifying them as a form of kickbacks to providers.
On November 17, OIG released a report entitled In Selected States, 67 of 100 Health Centers Did Not Use Their Health Resources and Services Administration (HRSA) Access Increases in Mental Health and Substance Abuse Services Grant Funding in Accordance With Federal Requirements. The report found that most health centers did not use their Access Increases in Mental Health and Substance Abuse Services (AIMS) grant funding in accordance with Federal requirements and grant terms. OIG recommended that HRSA improve monitoring of how health centers meet targets for future grant funding opportunities and charge expenditures to their HRSA grants and require the health centers to refund unallowable and improperly allocated costs to the Federal Government. A summary of the report is available here.
On November 17, OIG released a report entitled Comparison of Average Sales Prices and Average Manufacturer Prices: Results for the Second Quarter of 2020. The report found that in the second quarter of 2020, seven Part B drugs codes met CMS's price substitution criteria by exceeding the 5% threshold for two consecutive quarters or three of the previous four quarters. OIG provided the seven drug codes to CMS for its review and recommended that CMS review the information to determine whether to pursue price substitutions that would limit excessive payments for Part B drugs. A summary of the report is available here.
On November 18, OIG released a report entitled Hospitals Did Not Comply With Medicare Requirements for Reporting Cardiac Device Credits. The report found that for half of the Medicare claims OIG reviewed, hospitals did not comply with Medicare reporting requirements for manufacturer credits for recalled or prematurely failed cardiac medical devices, resulting in $33 million in potential overpayments. OIG recommended that CMS recover identified Medicare overpayments, and instruct Medicare contractors to implement a postpayment review process, among other recommendations. A summary of the report is available here.
On November 18, OIG released a report entitled Cahaba Government Benefits Administrators (GBA), LLC, Claimed Some Unallowable Medicare Postretirement Benefit Costs Through Its Incurred Cost Proposals. The report found that Cahaba GBA claimed $4.3 million unallowable Medicare postretirement benefit (PRB) costs for CYs 2014 through 2016 due to Cahaba GBA incorrectly calculating allocable PRB costs using the accrual method instead of the pay-as-you-go method. OIG recommended that Cahaba GBA work with CMS to ensure that its final settlement of contract costs reflects a decrease in Medicare PRB costs. A summary of the report is available here.
On November 19, OIG released a report entitled Ohio Made Capitation Payments to Managed Care Organizations for Medicaid Beneficiaries With Concurrent Eligibility in Another State. The report found that Ohio made some capitation payments on behalf of beneficiaries who should not have been eligible for Medicaid benefits in Ohio because they were concurrently eligible and residing in another State, resulting in $5.9 million improper payments. OIG recommended that Ohio develop or enhance current procedures to identify beneficiaries with concurrent eligibility in another State and ensure that procedures are in place for county caseworkers to timely review and terminate eligibility for beneficiaries who were identified as concurrently eligible in another State. A summary of the report is available here.
On November 19, OIG released a report entitled Medicare Hospital Provider Compliance Audit: Edward W. Sparrow Hospital. The report found that Edward W. Sparrow Hospital did not fully comply with Medicare billing requirements for all claims, resulting in an estimated $550,917 in overpayments. OIG recommended that the hospital identify, report, and return any overpayments and strengthen its controls to ensure full compliance with Medicare requirements. A summary of the report is available here.
On November 20, OIG released a report entitled Medicare Home Health Agency Provider Compliance Audit: The Palace at Home. The report found that Palace at Home incorrectly billed Medicare for services provided to beneficiaries who were not homebound, services provided to beneficiaries who did not require skilled services, and claims that it assigned with incorrect Health Insurance Prospective Payment System codes, resulting in an estimated $731,304 in overpayments. OIG recommended that Palace at Home identify, report, and return any overpayments and strengthen its procedures to ensure full compliance with requirements for billing home health services. A summary of the report is available here.
Government Accountability Office (GAO)
On November 17, the GAO released a report entitled COVID-19: Federal Efforts Accelerate Vaccine and Therapeutic Development, but More Transparency Needed on EUAs. The report found that as of October 15, 2020, OWS publicly announced financial support for the development or manufacturing of six COVID-19 vaccine candidates, totaling more than $10 billion, and the development of therapeutics, including a $450 million award to manufacture a monoclonal antibody treatment. The report also outlined the FDA’s process of approving COVID-19 vaccines. GAO recommended that the FDA should identify ways to uniformly disclose to the public the information from its scientific review of safety and effectiveness data, when issuing EUAs for therapeutics and vaccines. A summary of the report is available here.
On November 18, the GAO released a report entitled Comparative Effectiveness Research: Patient-Centered Outcomes Research Institute (PCORI) and HHS Continue Activities and Plan New Efforts. The report found that PCORI and HHS allocated $3.6 billion for clinical effectiveness research (CER) activities and program support during FY 2010 - 2019 from the Patient Centered Outcomes Research Trust Fund. GAO found that PCORI met its performance targets. A summary of the report is available here.
On November 19, the GAO released a report entitled Defense Production Act: Opportunities Exist to Increase Transparency and Identify Future Actions to Mitigate Medical Supply Chain Issues. The report found that Federal agencies used the Defense Production Act (DPA) to help address medical supply shortages from COVID-19 including 43 contracts and agreements valued at about $3.9 billion where agencies placed priority ratings on or funded domestic production expansion projects for COVID-19 medical supplies. GAO recommended that HHS identify how DPA and similar actions will be used to increase domestic production of essential medical supplies as part of efforts to reduce reliance on foreign manufacturers. A summary of the report is available here.
On November 20, the GAO released a report entitled Biomedical Research: the National Institutes of Health (NIH) Should Publicly Report More Information about the Licensing of Its Intellectual Property. The report found that the NIH had 93 patents that contributed to the successful development of 34 drugs approved by the FDA and brought to market, including vaccines and treatments for cancer. GAO recommended that NIH provide more information to the public about the licensing of its intellectual property. A summary of the report is available here.
UPCOMING HEARINGS
Senate
None of note.
House
None of note.
OTHER HEALTH POLICY NEWS
On November 16, America’s Health Insurance Plans elected new board members including Independence Health Group Gregory Deavens; Gateway Health Cain Hayes; UPMC Health Plan Diane Holder; SCAN Group Sachin Jain; Aflac Virgil Miller; CareSource Erhardt Preitauer; Cambia Health Solutions Jared Short; and AmeriHealth Caritas Family of Companies Paul Tufano. Humana CEO Bruce Broussard will chair the board.
On November 16, the National Association of County and City Health Officials released a transition document for the Biden-Harris Administration and the 117th Congress, including policy recommendations. The Association called for additional COVID-19 funding for local governments and national COVID-19 response guidance.
On November 16, Mylan and Upjohn, the legacy division of Pfizer, merged and launched Viatris.
On November 17, Amazon launched Amazon Pharmacy, allowing customers to order medications online using their health insurance and giving Prime members discounts on drugs.
On November 17, the PhRMA released industry-wide principles on clinical trial diversity. The principles include protecting research participants, changing the conduct of clinical trials, ensuring objectivity in research, providing information about clinical trials, expanding access to investigational drugs, and commitment to enhancing diversity in clinical trial participation.
On November 17, U.S. Bankruptcy Court Judge Robert Drain approved the $8.34 billion Purdue Pharma opioid settlement. The settlement included transforming Purdue into a corporate trust run for the benefit of the public, which many states opposed.
On November 18, the Better Medicare Alliance released a report entitled Review of Contract Year 2021 MA supplemental healthcare benefit offerings. The report found that the number of MA plans offering at least one of five expanded supplemental benefits increased 64% in 2021, compared to 2020.
On November 18, the Council of Informed Drug Spending Analysis released a report entitled High Drug Prices: Costing Millions of Lives and Billions of Dollars. The report found that allowing Medicare to negotiate lower drug prices could prevent 94,000 seniors’ deaths annually and save $475.9 billion.
On November 19, Get America Covered launched a campaign to encourage people to wear masks and enroll in ACA Marketplace plans. 15 states, and a variety of consumer groups and providers joined the coalition.
On November 19, 19 health associations and physician groups urged Congressional leadership to freeze the qualifying participant thresholds for advanced alternative payment models (APMs) for 2021 and 2022, to incentivize providers to join advanced APMs and prevent providers from dropping out of the programs. The Medicare Access and CHIP Reauthorization Act of 2015 requires clinicians to receive at least 75% of Medicare Part B payments or see at least 50% of Medicare beneficiaries in order to receive a 5% bonus on part B Medicare claims through the advanced model in 2021.