The following LPG Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from November 23 - November 28. 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 23, the General Services Administration (GSA) recognized President-elect Joe Biden as the “apparent winner” of the presidential election. The Biden team may now receive $6.3 million in transition funding and contact federal agencies to plan staffing.
On November 25, the Biden transition team began meeting with Operation Warp Speed (OWS) officials to discuss COVID-19 vaccine distribution plans.
On November 25, Reps. Alexandria Ocasio-Cortez (D-NY), Ilhan Omar (D-MN), Rashida Tlaib (D-MI) and the Justice Democrats coalition signed a petition against nominating Biden’s former chief of staff Bruce Reed for the position of Office of Management and Budget (OMB) Director out of their concern that Reed is a “deficit hawk,” specifically criticizing his support for Social Security and Medicare cuts.
Biden announced a series of White House senior staff appointments this week, including:
Reema Dodin as Deputy Director of the White House Office of Legislative Affairs. Dodin served as Deputy Chief of Staff and Floor Director to the Senate Democratic Whip Richard Durbin (D-IL); and
Shuwanza Goff as Deputy Director of the White House Office of Legislative Affairs. Goff served as Floor Director for the House of Representatives under House Majority Leader Steny Hoyer (D-MD).
Biden also announced a series of White House nominations, including:
Tony Blinken for Secretary of State;
Jake Sullivan for National Security adviser;
Avril Haines for Director of National Intelligence;
Alejandro Mayorkas for Department of Homeland Security Secretary;
Linda Thomas-Greenfield for U.S. Ambassador to the United Nations;
John Kerry for Special Presidential Envoy on Climate; and
Janet Yellen and Treasury Secretary.
NON-CORONAVIRUS LEGISLATIVE UPDATE
House
On November 24, House Oversight and Reform Committee Chair Carolyn Maloney (D-NY) asked Purdue Pharma President and Chief Executive Officer Craig Landau to testify regarding the role of Purdue Pharma and certain members of the Sackler family in contributing to the opioid epidemic.
The House will return from recess on December 2. Leader Hoyer recommended that members remain in Washington to consider COVID relief and government funding legislation, among other policies.
Senate
The Senate will return from recess on November 30.
NON-CORONAVIRUS REGULATORY UPDATE
On November 23, the Food & Drug Administration (FDA) launched the Orphan Drug Designation Portal, allowing the electronic submission of new orphan drug designation requests through a cloud-based online submission portal to provide drug developers with enhanced, direct communication with the FDA.
On November 23, Health and Human Services (HHS) issued a request for information entitled Effective and Innovative Approaches/Best Practices in Health Care in Response to the COVID-19 Pandemic.
On November 23, OMB received a notice from the FDA entitled Best Practices in Developing Proprietary Names for Human Nonprescription Drug Products; Draft Guidance for Industry; 2016-1296.
On November 23, OMB received a notice from the FDA entitled Best Practices in Developing Proprietary Names for Human Prescription Drug Products; Guidance for Industry; Availability.
On November 24, the OMB received a final rule from the Health Resources & Services Administration entitled Implementation of Executive Order 13937, Executive Order on Access to Affordable Life-saving Medications.
On November 24, the Centers for Medicare & Medicaid Services (CMS) issued a final rule entitled Amendments to the HHS-operated Risk Adjustment Data Validation (HHS-RADV) under the Patient Protection and Affordable Care Act’s (ACA) HHS-operated Risk Adjustment Program. The program provides payments to insurers that cover high-risk, high-cost individuals. Payments are funded through charges to insurers that cover lower-risk enrollees. HHS-RADV works to verify that data, which is submitted by insurers, is accurate and complete based on their members’ risks. Under the rule, CMS updated the error-rate calculation and application of HHS-RADV results. A summary of the rule is available here.
On November 24, HHS issued a policy statement entitled Policy on Redundant, Overlapping, or Inconsistent Regulations.
On November 25, the OMB received a proposed rule from HHS entitled Department of Health and Human Services Promoting the Rule of Law Through Transparency and Fairness in Civil Administrative Enforcement and Adjudication.
On November 25, CMS announced that 758,421 people selected plans through HealthCare.gov during the third week of enrollment, including 177,644 new enrollees. Thus far, 2,380,527 enrollees have selected plans through HealthCare.gov since enrollment opened on November 1.
On November 25, CMS 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. A fact sheet is available here. A summary is available here.
NON-CORONAVIRUS WHITE HOUSE UPDATE
None of note.
CORONAVIRUS UPDATE
Legislative
On November 23, Rep. Cheri Bustos (D-IL) urged President Trump to restore 100% federally funding for the National Guard’s COVID-19 efforts in the states.
Reps. Bryan Steil (R-WI) and Joe Courtney (D-CT) tested positive for COVID-19 this week.
Regulatory
On November 23, the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices held a meeting discussing planning for COVID-19 vaccine distribution, including prioritizing health care workers and people living in long-term care facilities to receive the first doses of a COVID-19 vaccine. The committee also published a report entitled Immunization Practices’ Ethical Principles for Allocating Initial Supplies of COVID-19 Vaccine. This report details the principles for ethically allocating COVID-19 vaccines, including: maximizing benefits and minimizing harms, promoting justice, mitigating health inequities, and promoting transparency.
On November 23, the HHS distributed 30,000 doses of Regeneron’s COVID-19 monoclonal antibody combination to states with the highest numbers of confirmed cases and hospitalizations, as part of the 300,000 doses the government purchased.
On November 23, HHS and the Department of Defense jointly awarded $11.6 million to Puritan Medical Products Company to expand the domestic production capacity of nasal swabs used for the COVID-19 cartridge-based molecular testing system.
On November 24, HHS Secretary Alex Azar announced that 6.4 million COVID-19 vaccine doses will be immediately distributed through OWS, once approved by the FDA for Emergency Use Authorization (EUA). Azar also noted that states will determine how to prioritize COVID-19 vaccines, predicting that there will be variation in distribution plans across states. Vaccine allocations will be made based on states’ total populations rather that COVID-positive caseload.
On November 25, the FDA published a notice for the Vaccines and Related Biological Products Advisory Committee meeting on December 10. The meeting will discuss the EUA of the Pfizer COVID-19 vaccine in individuals 16 years of age and older.
On November 25, CMS announced additional flexibilities expanding its Hospitals Without Walls program by allowing health care services to be provided outside a hospital setting. These flexibilities include allowances for safe hospital care for eligible patients in their homes, updating staffing flexibility designed to allow Ambulatory Surgical Centers to provide inpatient care when needed, and building on previous actions to expand the availability of telehealth.
White House
None of note.
Other
On November 23, The Ad Council, National Governors Association, and the COVID Collaborative launched a $50 million education campaign to encourage mask wearing, promote awareness of the COVID-19 vaccines, and reach marginalized communities.
On November 23, AstraZeneca announced that its COVID-19 vaccine candidate, AZD1222, was 90% effective in preventing COVID-19 when given as a half dose, followed by a full dose at least one month apart, and another dosing regimen showed 62% efficacy when given as two full doses at least one month apart, based on interim efficacy analysis. AstraZeneca will submit preliminary data to the FDA as part of an EUA and predict that the company will have 200 million doses by the end of 2020. On November 24, OWS announced plans to review the dosing error that resulted in participants receiving a half dose, then one month later receiving a full dose that proved 90% effective.
On November 23, the Lancet named members of the COVID Commission Task Force on the Origins of SARS-CoV-2. Members include: Peter Daszak M.D., John Amuasi M.D., Danielle Anderson, Isabella Eckerle M.D., Hume Field, Gerald Keusch M.D., Dato’ Sai Kit Lam, Malik Peiris, Stanley Perlman M.D., Linda Saif, and Supaporn Wacharapluesadee.
On November 23, Moderna Chief Medical Officer Tal Zaks predicted that children could receive COVID-19 vaccines by the middle of next year. Moderna has not initiated COVID-19 vaccine testing with children yet.
On November 23, NPR announced the results of an investigation into the Strategic National Stockpile (SNS) finding that the SNS still lacks critical supplies, including gloves, masks, and other supplies due to budget shortfalls, a lack of domestic manufacturing, global supply chain disruptions, and overwhelming demand.
On November 23, Merck announced a $425 million deal to purchase OncoImmune for the company’s COVID-19 treatment for hospitalized patients with severe and critical Covid-19.
On November 24, the Russian Direct Investment Fund announced that the country’s COVID-19 vaccine candidate, Sputnik V, was 95% effective in preventing COVID-19, based on a second interim analysis, and will be free for all Russian citizens. The cost for one of two required doses of the Sputnik V vaccine will be less than $10 for international markets.
On November 24, over 100 activists, public health experts, and political figures urged President-elect Biden to guarantee all COVID-19 vaccines are sold at affordable prices, ensure a fair and equitable global distribution plan, and ensure transparency and accountability over COVID-19 vaccine funding.
On November 25, the World Health Organization called for more information and data transparency on AstraZeneca’s COVID-19 vaccine.
As of November 28, the U.S. had 13,216,193 confirmed COVID-19 cases resulting in 265,097 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
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 23, OIG released a report entitled Medicare Hospice Provider Compliance Audit: Hospice Compassus, Inc., of Payson, Arizona. The report found that Payson did not always comply with Medicare requirements by claiming Medicare reimbursement for hospice services for ineligible beneficiaries, undocumented services, and at a reimbursement rate associated with a level of care higher than what the associated beneficiary required, resulting in an estimated $1.8 million in improper reimbursement. OIG recommended that Payson exercise reasonable diligence to identify, report, and return overpayments and strengthen its procedures to ensure that hospice services comply with Medicare requirements. A summary of the report is available here.
On November 23, OIG released a report entitled Opioid Treatment Programs Reported Challenges Encountered During the COVID-19 Pandemic and Actions Taken To Address Them. The report found that opioid treatment programs (OTPs) reported a variety of challenges during the pandemic and actions they have taken to address those challenges, while ensuring the continuity of needed services and protecting the health and safety of their patients and staff. A summary of the report is available here.
On November 24, OIG released a report entitled U.S. Department of Health and Human Services Met the Requirements of the Digital Accountability and Transparency Act of 2014, With Areas That Require Improvement. The report found that HHS complied with the reporting requirements of the DATA Act as stipulated by OMB, Council of the Inspectors General on Integrity and Efficiency, and the Department of Treasury. OIG also found that there are access controls, configuration management, segregation of duties, and interface controls deficiencies. OIG recommended that HHS focus its efforts on resolving issues related to its IT system controls, fully implementing interface controls by updating the governance for different environments to be compliant, and continue to progress toward producing high-quality data; remediating deficiencies in financial, procurement and grant-related systems; and better automating DATA Act data collection and submission processes. A summary of the report is available here.
On November 27, OIG released a report entitled Florida Received Unallowable Medicaid Reimbursement for School-Based Services. The report found that Florida did not always claim Federal Medicaid reimbursement for school-based services in accordance with Federal and State requirements, resulting in an estimated $1.4 million in unallowable costs. OIG recommended that Florida work with CMS to review Medicaid claims for school-based services and refund any overpayments, and improve its policies and procedures to ensure that it is adequately monitoring school-based service claims to ensure compliance with Federal and State requirements. A summary of the report is available here.
UPCOMING HEARINGS
Senate
None of note.
House
None of note.
OTHER HEALTH POLICY NEWS
On November 23, the Kaiser Family Foundation (KFF) released a report entitled Insurer Participation on the ACA Marketplaces, 2014-2021. The report found that 30 insurers are entering the ACA individual market across 20 states and an additional 61 insurers are expanding their service area within states they already operated. KFF also estimated that there will be an average of 5 insurers per state in 2021.
On November 23, AdventHealth announced it was partnering with Berg to find the best treatments for COVID-19 patients through integrating AdventHealth’s patient data with Berg’s proprietary artificial-intelligence-enabled Interrogative Biology platform.
On November 23, Florida Governor Ron DeSantis asked HHS to allow the state to import prescription drugs from Canada, allowing certain providers to buy certain pharmaceuticals from Canadian suppliers, with the potential to save taxpayers at least $289 billion.
On November 23, the Pharmaceutical Research and Manufacturers of America (PhRMA) initiated litigation in the U.S. District Court for the District of Columbia, challenging the 2019 FDA rule entitled Importation of Prescription Drugs that would allow pharmacists and wholesalers to import certain prescription drugs from Canada into the U.S. PhRMA challenged the rule due to potential safety concerns from the rule allowing the importation of drugs without drug manufacturers’ authorization or oversight and the lack of evidence supporting that the proposal would result in significant cost savings.
On November 24, the Department of Justice imposed a criminal fine of $3.54 billion and an additional $2 billion in criminal forfeiture to Purdue Pharma. Purdue pleaded guilty to conspiring to defraud the U.S. and violation the anti-kickback statute, including: impeding the lawful function of the Drug Enforcement Administration and providing misleading information to the agency as a way to boost company manufacturing quotas; paying doctors through a speakers program to induce them to write more prescriptions; and admitting to paying an electronic medical records company to refer, recommend, and arrange for the ordering of Purdue’s extended release opioid products.