The following LPG Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from January 11 - January 16. 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 11, President-elect Joe Biden received his second dose of Pfizer’s COVID-19 vaccine.
On January 12, the Biden Administration indicated that it will appoint temporary agency heads until Cabinet nominees are confirmed and agency heads are sworn in, including Janet Woodcock as Acting Food & Drug Administration (FDA) Commissioner. Liz Richter is expected to be the Acting Administrator at the Centers for Medicare & Medicaid Services (CMS).
On January 13, Operation Warp Speed (OWS) Chief Adviser Moncef Slaoui submitted his resignation and will stay in his role for 30 days into the new administration to help with the transition. Former FDA Commissioner David Kessler will replace Slaoui.
On January 14, Biden released his $1.9 trillion COVID-19 relief plan entitled theAmerican Rescue Plan. Biden called for Congress to quickly pass the package. The plan includes:
$415 billion to improve the federal COVID-19 response, including $20 billion for vaccinations, $50 billion for testing, and $30 billion for supplies and protective gear;
An additional $1,400 direct payment for most Americans;
$350 billion for first responders and other essential workers;
$130 billion for schools to reopen;
Enhanced unemployment benefits; and
A number of requirements on employers including a $15 per hour minimum wage, mandatory leave and hazard pay, and COBRA subsidies.
On January 15, Biden detailed the incoming Administration's vaccine plan, including administering 100 million shots in his first 100 days in office; invoking the Defense Production Act to increase production of equipment needed to distribute the vaccines; increasing vaccine distribution in lower-income neighborhoods; enlisting the Federal Emergency Management Agency to set up 100 vaccine centers within a month of his inauguration; and other provisions to expand access to COVID-19 vaccines.
On January 16, it was reported that Biden will issue a number of Executive Orders after taking office, including those that would mandate masks on federal property and expand access to health care.
Biden announced a series of appointments and nominations this week, including:
Andy Slavitt for Senior Adviser to COVID Response Coordinator Jeff Zients,
David Cohen for Central Intelligence Agency (CIA) Deputy Director, and
Shalanda Young for Office of Management and Budget (OMB) Deputy Director.
NON-CORONAVIRUS LEGISLATIVE UPDATE
On January 12, the House approved the resolution 223-205 calling for Vice President Pence to invoke the 25th Amendment and remove Trump from office. The resolution does not have legal power and is largely symbolic. In response, Pence said he will not invoke the 25th Amendment to remove Trump from office.
On January 13, the House passed H. Res. 24, the Articles of Impeachment for President Trump 232-197, for inciting violent protestors to storm the Capitol last week. All Democrats and 10 Republicans voted in favor of impeachment. Senate Majority Leader Mitch McConnell (R-KY) stated that the Senate calendar would not allow for an impeachment trial until after Biden is in office. It is expected that the Senate will hold the impeachment trial shortly after Biden is sworn in, likely spitting floor time with legislative business and consideration of Biden’s nominees. Trump is the only president in U.S. history to be impeached twice.
Senate
On January 13, incoming Finance Committee Chair Ron Wyden (D-OR) indicated that he will push the committee to consider legislation allowing the Department of Health & Human Services (HHS) to directly negotiate the price of prescription drugs in Medicare and the bipartisan drug pricing legislation he previously sponsored. Sen. Wyden also expressed interest in expanding Affordable Care Act (ACA) coverage and reversing some Trump administration rules that weakened the ACA.
On January 12, Incoming Budget Committee Chair Sen. Bernie Sanders (I-VT) pledged to use the budget reconciliation process to pass additional COVID-19 relief, including direct checks and additional state funding for vaccine distribution and administration.
House
The Ways & Means Committee will add Reps. Stacey Plaskett (D-USVI), Kevin Hern (R-OK), Carol Miller (R-WV), and Lloyd Smucker (R-PA) in the 117th Congress.
The Energy & Commerce Committee will add Reps. Angie Craig (D-MN), Lizzie Fletcher (D-TX), Kathleen Rice (D-NY), Kim Schrier (D-WA), Lori Trahan (D-MA), John Curtis (R-UT), John Joyce, MD (R-PA), Kelly Armstrong (R-ND), Dan Crenshaw (R-TX), Debbie Lesko (R-AZ), Gary Palmer (R-AL), Greg Pence (R-IN), and Neal Dunn (R-FL) as new members of the committee. Democratic subcommittee assignments can be found here.
NON-CORONAVIRUS REGULATORY UPDATE
On January 11, the Health Resources and Services Administration (HRSA) awarded$8 million to the Telehealth Broadband Pilot program, to assess the broadband capacity available to rural health care providers and patient communities to improve their access to telehealth services. The Alaska Native Tribal Health Consortium National Telehealth Technology Assessment Resource Center was awarded $6.5 million and the University of Arkansas Telehealth-Focused Rural Health Research Center was awarded $1.5 million.
On January 11, FDA Commissioner Stephen Hahn announced that Mark Raza would act as FDA Chief Counsel replacing Stacy Cline Amin who recently resigned. HHS Secretary Alex Azar then announced James Lawrence as the acting FDA Chief Counsel. Raza will likely only hold the job until Biden's inauguration.
On January 11, CMS launched an online form entitled CMS 1135 Waiver / Flexibility Request and Inquiry Form to help standardize “Section 1135” waiver requests and other Public Health Emergency-related inquiries.
On January 11, the FDA released a report entitled 2021 Advancing Regulatory Science at FDA: Focus Areas of Regulatory Science. The report identified strategic initiatives to support Public Health Emergency Preparedness and Response, including increasing choice and competition through innovation, unleashing the power of data, and empowering patients and consumers.
On January 12, HRSA published a study in JAMA Network finding that the rates of pregnant women diagnosed with opioid use disorder and of babies born with withdrawal symptoms increased from 2010 to 2017. The study also found that rural, white, and Medicaid populations have the highest rates of maternal opioid-related diagnoses and neonatal abstinence syndrome.
On January 12, CMS issued a final rule entitled Medicare Coverage of Innovative Technology and Definition of Reasonable and Necessary. The rule establishes the Medicare Coverage of Innovative Technology (MCIT) pathway aimed at providing beneficiaries faster access to “breakthrough” devices. The MCIT pathway allows four years of national Medicare coverage starting on the date of FDA market authorization or a manufacturer chosen date within two years thereafter. The rule also implements regulatory criteria to be used in making “reasonable and necessary” Medicare coverage determinations for items and services under Part A and Part B. The rule is effective March 15, 2021. A fact sheet on the rule is available here. A summary of the rule is available here.
On January 12, CMS released the final weekly enrollment snapshot showing that 8,251,703 people, including 1,884,174 new enrollees, selected individual market plans through the Marketplaces using the federal platform during the 2021 Open Enrollment Period
On January 12, HHS issued a final rule entitled HHS Transparency and Fairness in Civil Administrative Enforcement Actions. According to HHS, this rule will help to ensure that regulated parties receive fair notice of laws and regulations they are subject to and have an opportunity to contest an agency determination prior to the agency taking an action that has a legal consequence. The rule is effective January 12, 2021.
On January 13, the Centers for Disease Control and Prevention (CDC) announcednew requirements that all international travelers entering the U.S. must show a negative COVID-19 test, effective January 26.
On January 13, CMS released a report entitled Putting Patients First: CMS’ Record of Accomplishment from 2017-2020, highlighting CMS’ accomplishments over the last four years, including responding to the COVID-19 pandemic and furthering CMS’ 2017 Four Core Goals, including empowering patients and doctors, ushering in a new era of state flexibility and local leadership, developing innovative approaches, and improving the CMS customer service experience.
On January 13, CMS Administrator Seema Verma confirmed that the Trump Administration’s $200 drug-discount cards for Medicare beneficiaries will not be issued, due to legal and logistical issues that delayed plans.
On January 13, the FDA released a report entitled COVID-19 Pandemic Recovery and Preparedness Plan Initiative. The initiative identified three major themes to strengthen the FDA’s COVID-19 response and build its resilience to respond to future emergencies, including (1) accelerating the immediate COVID-19 response with the goals of increasing effectiveness, efficiency and transparency; (2) selectively sustaining and scaling innovations; and (3) enhancing future pandemic preparedness to build the agency’s resilience to prepare and respond to future pandemics.
On January 14, HHS issued a notice entitled Announcement of Practice Guidelines for the Administration of Buprenorphine for Treating Opioid Use Disorder. The guidance eliminates the requirement that physicians registered to prescribe controlled substances obtain a “X” waiver” before being allowed to prescribe buprenorphine to 30 or fewer patients.
On January 14, HHS issued a final rule entitled Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2022; Updates to State Innovation Waiver (Section 1332 Waiver) Implementing Regulations. The rule finalizes provisions for the annual Notice of Benefit and Payment Parameters for 2022 and aims to reduce consumer costs, empower states to develop their own plans, accelerate innovation, and clarify program requirements. The rule would also allow all states to drop their ACA exchanges and turn over enrollment to private web brokers and agents, like Georgia. CMS set user fees for qualified health plans to 2.25% of the premium for 2022, a decrease from 3%, and fees for state-based exchanges that use HealthCare.gov to 1.75%, a decrease from 2.25%. The rule is effective March 15, 2021. A fact sheet on the final rule is available here. A summary of the final rule is available here.
On January 14, CMS’ Center for Medicare and Medicaid Innovation (CMMI) released the Manufacturer Request for Application (RFA) for participation in the CY2022 Part D Senior Savings Model (the “Insulin Model”). The RFA must be submitted by January 27, 2021 to participate in the CY2022 Model. Manufacturers who were approved to participate in the CY2021 model year do not have to reapply for CY2022 participation. CMS will make available to Part D sponsors the list of manufacturers participating in the CY2022 Model by the end of February 2021.
On January 15, CMS issued a final rule entitled Contract Year 2022 Policy and Technical Changes to the Medicare Advantage (MA) Program, Medicare Prescription Drug Benefit Program, Medicaid Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly. The rule advances the agency’s efforts to strengthen and modernize the MA and Part D prescription drug programs. The rule is estimated to save $75.4 million over ten years from reduced prescription drug spending. The rule is effective March 20, 2021. A fact sheet on the final rule is available here. A summary of the final rule is available here.
On January 15, CMS issued a final rule entitled Reducing Provider and Patient Burden by Improving Prior Authorization Processes, and Promoting Patients’ Electronic Access to Health Information for Medicaid Managed Care Plans, State Medicaid Agencies, CHIP Agencies and CHIP Managed Care Entities, and Issuers of Qualified Health Plans on the Federally-facilitated Exchanges; Health Information Technology Standards and Implementation Specifications, also known as the CMS Interoperability and Prior Authorization. The rule aims to build on interoperability efforts, empower patients, and reduce costs and burden by promoting secure electronic access to health data. The rule also aims to give providers more time to focus on their patients and provide higher quality care. The rule is effective March 20, 2021, and the majority of the provisions will be implemented on January 1, 2023 (with certain exceptions). A fact sheet on the final rule is available here. A summary of the rule is available here.
On January 15, CMS published the CY2022 MA and Part D Rate Announcement, finalizing MA and Part D payment methodologies for CY 2022. This Rate Announcement addresses comments received on Parts I and II of the CY 2022 Advance Notice, published on September 14 and October 30, 2020, respectively. According to CMS, the final policies described in the Rate Announcement are expected to increase per-capita plan payments by 4.08%, on average. A fact sheet on the Rate Announcement is available here. A summary is available here.
On January 15, HHS Secretary Azar and CMS Administrator Verma each submitted resignation letters, indicating that they will leave their post effective January 20. Azar’s resignation letter can be found here and Verma’s resignation letter can be found here.
The FDA will host meetings entitled Interim Assessment of the Program for Enhanced Review Transparency and Communication in the Biosimilar User Fee Acton January 27and Prescription Drug User Fee Act of 2017; Electronic Submissions and Data Standards on April 7.
NON-CORONAVIRUS WHITE HOUSE UPDATE
On January 11, OMB designated HHS as a Quality Service Management Office to transform the Federal grants management process by driving the standardization and modernization of systems to increase efficiency and reduce burden for grant applicants and recipients, and for the federal workforce.
CORONAVIRUS UPDATE
Legislative
On January 11, 45 Senate Democrats expressed concerns to HHS Secretary Azar, regarding the current pace and planning of COVID-19 vaccine distribution and administration and called for better coordination between the federal government and states.
On January 11, Rep. Bonnie Watson Coleman (D-NJ), Rep. Pramila Jayapal (D-WA), Rep. Adriano Espaillat (D-NY), and Rep. Brad Schneider (D-IL) tested positive for COVID-19. The representatives attributed their diagnoses to sheltering in place with other lawmakers during last week's attack on the Capitol, with Jayapal pointing to Republican colleagues who refused to wear masks while lawmakers and aides were in close proximity.
On January 13, Sen. Elizabeth Warren (D-MA) called for Biden to pursue executive action to improve the nation's COVID-19 response. Warren supported improving transparency and encouraging oversight of pandemic response efforts, addressing the pandemic’s disproportionate impact on vulnerable populations, rectifying supply chain challenges, and restoring integrity to politicized pandemic response efforts.
Regulatory
On January 11, HHS launched an online COVID-19 outpatient treatment locator to assist healthcare providers and patients in finding potential locations for treatment with monoclonal antibody therapeutics.
On January 12, to accelerate vaccine administration, HHS and OWS changed guidance on distributing COVID-19 vaccines, including releasing previously held back doses, urging states to vaccinate older adults and other priority groups, and distributing doses based on states’ 65 and over populations and how quickly they are administering shots in two weeks. Previously, OWS based weekly vaccine shipments on a state’s adult population. On January 15, it was reported that states will not receive increased shipments of vaccines because there are no federal reserve of doses.
On January 12, the CDC released a study finding that European countries that moved early to restrict gatherings and keep their citizens at home saw fewer COVID-19 deaths through the end of June.
On January 12, HHS purchased 1.25 million additional doses of the Regeneron COVID-19 antibody cocktail of casirivimab and imdevimab for $2.63 billion to treat non-hospitalized, high-risk COVID-19 patients.
The CDC identified the U.K. COVID-19 variant B.1.1.7, in California, Colorado, Florida, Georgia, New York, Connecticut, Pennsylvania, Florida, Connecticut, and Texas. Researchers in Ohio discovered two new variants of COVID-19 in the U.S. that may be more contagious. There have been other COVID-19 variants detected in the U.K., South Africa, and Brazil.
As of January 15, over 12 million people have received the first dose of COVID-19 vaccines and 31 million doses have been distributed, according to the CDC COVID Data Tracker.
White House
On January 14, OMB released a $27.4 billion rescission package for Congress to consider. The package includes $4 billion in funding cuts to GAVI, a public-private partnership promoting global vaccination, $13 million in funding cuts for the National Institutes of Health, and other proposed cuts to global health efforts. The package is unlikely to gain any traction in Congress.
Other
On January 11, Moderna Chief Medical Officer Tal Zaks warned against giving patients half doses of the company’s COVID-19 vaccine due to the lack of data supporting the efficacy for half the dose. Moderna also announced that immunity from its COVID-19 vaccine should last at least a year.
On January 11, Pfizer announced plans to increase the company’s COVID-19 vaccine production estimate from 1 billion to 2 billion doses for 2021 due to global demand.
On January 11, Michigan Governor Gretchen Whitmer (D) requested permission from HHS Secretary Azar for Michigan to purchase up to 100,000 doses of COVID-19 vaccine directly from Pfizer.
On January 12, a Brazil Phase III clinical trial of the Chinese-sponsored COVID-19 vaccine by Sinovac found the vaccine to be 50.38% effective, significantly lower than the efficacy of 78% efficacy earlier results found.
On January 13, Johnson & Johnson (J&J) published Interim Phase I/IIa data in the New England Journal of Medicine, finding that its single-dose COVID-19 vaccine, JNJ-78436735 provided an immune response that lasted for at least 71 days, within 57 days of receiving the vaccine. J&J predicts it will have Phase III data in late January 2021 and will apply for EUA following positive results in March. The company is rumored to have fallen behind on production of its COVID-19 vaccine, which could put it two months behind its schedule to deliver 12 million doses by the end of February. J&J declined to confirm the delay.
On January 13, the Rockefeller Foundation expanded its COVID-19 testing alliance with states and territories by $30 million, expanding its testing stockpile managed by Fisher Scientific.
On January 14, GoodRx released a report entitled ‘Vaccine Deserts’ Threaten to Prolong COVID-19 Vaccine Rollout and Widen Disparities. The report found that 177 counties in the U.S. have zero pharmacies, affecting 635,000 residents, making access to COVID-19 difficult. The report called for the use of mass vaccination sites, and additional infrastructure in rural and less populated counties
As of January 16, the U.S. had 23,743,788 confirmed COVID-19 cases resulting in 395,650 deaths, according to the Johns Hopkins University & Medicine Coronavirus Resource Center.
RULES AT THE WHITE HOUSE OMB
Pending Review
HHS-CMS
Conditions for Coverage for End-Stage Renal Disease Facilities-Third Party Payments (CMS-3337-P); Received 6/6/19
Strengthening Oversight of Accrediting Organizations (AO) and Preventing AO Conflict of Interest, and Related Provisions (CMS-3367); Proposed Rule; Received 2/18/20
Revisions to Medicare Part A Enrollments (CMS-4194) Proposed Rule; Received 9/9/20
HHS-IHS
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 13, OIG released a report entitled Independent Attestation Review: Centers for Disease Control and Prevention Fiscal Year (FY) 2020 Detailed Accounting Report, Performance Summary Report for National Drug Control Activities, Budget Formulation Compliance Report, and Accompanying Required Assertions. The report reviewed the CDC Office of National Drug Control Policy (ONDCP) Detailed Accounting Report, Performance Summary Report, and Budget Formulation Compliance Report and found that all reports complied with federal requirements. A summary of the report is available here.
On January 13, OIG released a report entitled Independent Attestation Review: Health Resources and Services Administration FY 2020 Detailed Accounting Report, Performance Summary Report for National Drug Control Activities, Budget Formulation Compliance Report, and Accompanying Required Assertions. The report reviewed the HRSA ONDCP Detailed Accounting Report, Performance Summary Report, and Budget Formulation Compliance Report. OIG found that that HRSA incorrectly asserted that its reported drug obligations were only actual obligations, resulting in a deviation from the ONDCP Compliance Reviews Circular. Besides this issue, OIG found that all other reports complied with federal requirements. A summary of the report is available here.
On January 13, OIG released a report entitled Independent Attestation Review: National Institutes of Health FY 2020 Detailed Accounting Report, Performance Summary Report for National Drug Control Activities, Budget Formulation Compliance Report, and Accompanying Required Assertions. The report reviewed the NIH ONDCP Detailed Accounting Report, Performance Summary Report, and Budget Formulation Compliance Report and found that all reports complied with federal requirements. A summary of the report is available here.
On January 13, OIG released a report entitled Independent Attestation Review: Indian Health Service FY 2020 Detailed Accounting Report, Performance Summary Report for National Drug Control Activities, Budget Formulation Compliance Report, and Accompanying Required Assertions. The report reviewed the Indian Health Service ONDCP Detailed Accounting Report, Performance Summary Report, and Budget Formulation Compliance Report and found that all reports complied with federal requirements. A summary of the report is available here.
On January 15, OIG released a report entitled Medicare Home Health Agency Provider Compliance Audit: Southeastern Home Health Services. The report found that Southeastern did not comply with all Medicare billing requirements for home health claims, resulting in an estimated $1.8 million in overpayments for services provided in calendar years 2015 and 2016. OIG found that Southeastern 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 were assigned with incorrect Health Insurance Prospective Payment System (HIPPS) codes. OIG recommended that Southeastern identify, report, and return the overpayments; and strengthen procedures to ensure that the homebound statuses of Medicare beneficiaries are verified and continually monitored and the specific factors qualifying beneficiaries as homebound are documented, beneficiaries are receiving only reasonable and necessary skilled services, and the correct HIPPS payment codes are billed. A summary of the report is available here.
Congressional Budget Office (CBO)
On January 11, the CBO released a report entitled Monthly Budget Review: December 2020. The report indicated that the federal budget deficit was $572 billion in the first quarter of FY2021, $215 billion more than the deficit during FY2020. CBO estimated that revenues were stable and from October through December but outlays were 18% higher than FY2020. A summary of the report is available here.
On January 13, the CBO released a report entitled Final Sequestration Report for FY 2021. CBO estimated that appropriations enacted for FY2020 did not exceed statutory caps on discretionary funding and a sequestration will not be required for FY2021. A summary of the report is available here.
Government Accountability Office (GAO)
On January 14, the GAO released a report entitled Prescription Drugs: Department of Veterans Affairs (VA) Paid About Half as Much as Medicare Part D for Selected Drugs in 2017. The report found that the VA paid on average, 54% less for brand-name and generic prescription drugs in 2017 than Medicare Part D. GAO found that 233 of the 399 drugs in the sample were at least 50% cheaper in VA than in Medicare, and 106 drugs were at least 75% cheaper. GAO identified several key program features that may contribute to the price differential between VA and Medicare Part D, including the VA’s ability to negotiate prices as a single integrated health system with a formulary and the VA’s access to discounts defined in law. A summary of the report is available here.
On January 14, the GAO released a report entitled Medicaid: Data Completeness and Accuracy Have Improved, Though Not All Standards Have Been Met. The report found that the completeness and accuracy of Transformed Medicaid Statistical Information System (T-MSIS) data have improved, in both priority items and analytic files. GAO found that these assessments highlight areas where data do not meet the agency's standards. GAO has made at least 13 recommendations for improving T-MSIS data and expediting their use for program oversight. GAO advised that implementing these recommendations would help CMS strengthen program oversight through improved T-MSIS data. A summary of the report is available here.
Congressional Research Service (CRS)
On January 11, the CRS published a report entitled Funding for COVID-19 Vaccines: An Overview. This report identified that the CDC received $6.5 billion to prevent, prepare for, and respond to coronavirus, domestically and internationally in FY 2020 and will received $8.75 billion in FY 2021 to plan, prepare for, promote, distribute, administer, monitor, and track coronavirus vaccines to ensure broad-based distribution, access, and vaccine coverage.
UPCOMING HEARINGS
Senate
Homeland Security and Governmental Affairs Committee
Hearing on Nomination of Alejandro Mayorkas as Homeland Security Secretary
January 19, 10 a.m. 342 Dirksen Senate Office Building
Finance Committee
Hearing on the Nomination of Janet Yellen as Treasury Secretary
January 19, 10 a.m. 106 Dirksen Senate Office Building
Foreign Relations Committee
Hearing on the Nomination of Antony Blinken as Secretary of State.
January 19, 2 p.m. 301 Russell Senate Office Building
Armed Services Committee
Hearing on the Nomination of Lloyd Austin as Defense Secretary
January 19, 3 p.m
House
None of note.
OTHER HEALTH POLICY NEWS
On January 14-15, MedPAC held a public meeting on the following topics:
Assessing payment adequacy and updating payments:
Hospital inpatient and outpatient services;
Physician and other health professional services;
Ambulatory surgical center services, outpatient dialysis services, and hospice services;
Skilled nursing facility (SNF) services, home health agency services, inpatient rehabilitation facility services, and long-term care hospital services;
Mandated report: Expanding the post-acute transfer policy to hospice;
CMMI's development and implementation of alternative payment models;
Telehealth in Medicare after the public health emergency;
Part D;
Mandated report on the SNF value-based purchasing program and proposed replacement; and
Medicare's vaccine coverage and payment policies.
On January 11, 48 State Attorney Generals, including HHS Secretary nominee Xavier Becerra, urged FDA Commissioner Hahn to update the agency’s current actions and information on work to combat the opioid epidemic.
On January 12, the Pharmaceutical Care Management Association filed suit in the U.S. District of Columbia District against the Trump Administration’s drug “Rebate Rule” on substantive and procedural grounds, including that the OIG did not comply with Administrative Procedure Act notice-and-comment rulemaking requirements.
On January 12, AstraZeneca, Lilly, and Sanofi filed lawsuits over the HHS OIG advisory opinion from December 30, concluding that drug manufacturers are required to provide 340B discounts when contract pharmacies are acting as agents of 340B covered entities. The companies argue that the 340B statute does not require manufacturers to recognize any contract pharmacies, and that the opinion didn’t follow proper procedure and exceeded HHS’ statutory authority
On January 13, Patients for Affordable Drugs released a report entitled A Closer Look: The January 2021 Drug Price Increases. The report identified that 636 drugs saw price increases in the first week of January, with prices increasing on average 4.99%.
On January 14, over 100 health advocacy groups urged the incoming Biden administration to address the opioid crisis and substance abuse, including re-orienting the Office of National Drug Control Policy, funding syringe services programs and other harm reduction providers, improving coordination and programming support for syringe services programs and other harm reduction providers across HHS agencies, permanently extending the Substance Abuse and Mental Health Services Administration/Drug Enforcement Administration COVID-19 accommodations for methadone and buprenorphine access, directing the FDA to make at least one formulation of naloxone available over-the-counter, and incentivizing states to provide access to medication for addiction treatment.
On January 14, Planned Parenthood Southeast and the Feminist Women’s Health Center filed a lawsuit to overturn the Georgia waiver that would get rid of HealthCare.Gov and outsource the sale of individual market plans to private brokers.
On January 14, the American Hospital Association announced it will pause all political contributions to politicians that voted against certifying the Electoral College votes. On January 15, America's Essential Hospitals also froze political donations.