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Federal Health Policy Update for Wednesday, December 1

The following is the latest health policy news from the federal government as of 3:00 p.m. on Wednesday, December 1.  Some of the language used below is taken directly from government documents.

Omicron Variant

  • The CDC has confirmed the first case of the COVID-19 omicron variant on U.S. soil.  Learn more from this CDC news release.

Health Care Employee Vaccine Mandate

COVID-19

  • A federal court has issued a preliminary injunction blocking enforcement of the federal government’s requirement that health care workers receive COVID-19 vaccines by December 6.  Find the court’s ruling here.  The ultimate ruling will be made by a higher court.

No Surprises Act

  • CMS has released a series of documents addressing implementation of the No Surprises Act, the surprise medical billing law that takes effect on January 1.  Go here for a link to a zip file of those documents.
  • A reminder:  stakeholder comments on the most recent regulation implementing the No Surprises Act are due this coming Monday, December 6,

The White House

Centers for Medicare & Medicaid Services

COVID-19

  • CMS has issued guidance to inform Medicare Part D sponsors of permissible flexibilities during the COVID-19 public health emergency related to oral antiviral drug(s) for COVID-19 if such drug(s) become available under FDA emergency use authorization and are procured by the federal government.  Find that guidance here.
  • CMS has updated its compendium of Medicare emergency declaration blanket waivers for health care providers with two changes:  one, on page 21, addresses requirements for individuals employed as directors of food and nutrition services in long-term-care facilities and another, on page 33, alters Medicare ground ambulance data collection reporting requirements.  Find the revised blanket waivers document here.

Health Policy Update

  • CMS has published a request for public comments on potential changes in the requirements that transplant programs, organ procurement organizations, and end-stage renal disease facilities must meet to participate in the Medicare and Medicaid programs.  Learn more about what CMS seeks in this Federal Register notice.  Stakeholder comments are due in 60 days.
  • CMS has announced that it will not move forward with the Seriously Ill Population component of its Primary Care First Model.  That component was designed to have advanced primary care practices coordinate care for high-need, seriously ill beneficiaries.  After review, CMS concluded that the program’s outreach methodology was unlikely to result in sufficient beneficiary participation to allow for model evaluation.  Learn more from this CMS announcement.
  • CMS has published two documents addressing Medicaid and CHIP in the post-COVID-19 world:  “Strategies States and the U.S. Territories Can Adopt to Maintain Coverage of Eligible Individuals as They Return to Normal Operations” and “Connecting Kids to Coverage: State Outreach, Enrollment and Retention Strategies.”
  • CMS has posted the latest edition of MLN Connects, its online publication addressing Medicare payment matters.  This edition includes items on new 2022 web pricers for inpatient prospective payment system hospitals, inpatient rehabilitation facilities, and long-term-care hospitals; information about the 2022 physician fee schedule rule; news about telehealth originating site facility payments; information about disproportionate share hospital (DSH) payments; and more.  Go here for the new MLN Connects.

Department of Health and Human Services

Health Policy Update

  • HHS has launched a website for the HHS 405(d) Aligning Health Care Industry Security Approaches Program.  The purpose of the site is to provide the health care and public health sectors “…with useful, impactful, and vetted resources, products, videos, and tools that help raise awareness and provide cybersecurity practices, which drive behavioral change and move toward consistency in mitigating the most relevant cybersecurity threats to the sector.”  The website features health care-focused resources such as cybersecurity posters and infographics, installments of a bi-monthly newsletter, webinar recordings, and threat-specific products to support cybersecurity awareness and training.  Learn more from this HHS news release and go here to find the new site.

Centers for Disease Control and Prevention

Food and Drug Administration

  • The FDA has updated its guidance on the use of the monoclonal antibodies amlanivimab and etesevimab when administered together, expanding their authorized use to all U.S. states and territories.  Find that guidance here.
  • The FDA has issued emergency use authorization for the emergency use of the unapproved monoclonal antibody product sotrovimab for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients with positive results of direct COVID-19 viral testing who are at high risk for progression to severe COVID-19, including hospitalization or death.  Go here for an FDA fact sheet on the drug’s use.
  • The FDA has issued a statement outlining its efforts to investigate and address the potential impact of the COVID-19 omicron variant.  Find that statement here.

Stakeholder Events

CMMI – The Value-Based Insurance Design Health Equity Business Case for Medicare Advantage Organizations – December 2

The Center for Medicare and Medicaid Innovation (CMMI) is sponsoring a series of webinars for current and potential Medicare Advantage Organization participants in its Value-Based Insurance Design Model.  The first webinar in the series will provide an overview of the model’s health equity incubation sessions effort, articulate a business case for Medicare Advantage organizations to leverage Value-Based Insurance Design Model components to address health inequities in their member populations, and provide specific guidance and clarification on the full extent of health equity-focused flexibilities that fall under the model’s waiver authority.  The first webinar will be held on Thursday, December 2 at 2:30 p.m. (eastern).  Go here for more information about the webinar and to register to participate.

Center for Medicare and Medicaid Innovation – Roundtable on Health Equity Strategy – December 8

CMMI will hold a roundtable event on Wednesday, December 8 at 1:30 p.m. (eastern) to discuss how it can carry out its strategic objective of advancing health equity.  The agency also invites written comments on the subject.  For further information about the roundtable and to register to participate, go here.

CDC – Molecular Approaches for Clinical and Public Health Applications to Detect Influenza and COVID-19 Viruses – December 9

The CDC will hold a webinar on Thursday, December 9 to share with clinicians information about molecular approaches for clinical and public health applications to detect the influenza virus and COVID-19.  Go here to learn more about the webinar and how to participate.

MEDPAC – commission meeting – December 9-10

Members of the Medicare Payment Advisory Committee will meet virtually on December 9 and 10.  Information about how to join the meeting will be forthcoming; when it is, that information will be posted here.

Federal Health Policy Update for Tuesday, September 21

The following is the latest health policy news from the federal government as of 2:45 p.m. on Tuesday, September 21.  Some of the language used below is taken directly from government documents.

NASH Advocacy

  • NASH has submitted formal comments to CMS on the agency’s proposed outpatient prospective payment system regulation for calendar year 2022.  Writing from the perspective of private community safety-net hospitals, NASH addresses proposals and request for information about health equity, the section 340B prescription drug discount program, hospital price transparency requirements, proposed changes in Medicare’s inpatient-only procedures list, and the extension of provider flexibilities introduced in response to the COVID-19 public health emergency.  See NASH’s comment letter here.
  • In July the newly formed Congressional Social Determinants of Health Caucus invited stakeholders to respond to a series of questions designed to help the caucus learn more about social determinants of health and what Congress might do to address them more effectively.  Go here to read NASH’s response to the caucus’s questionnaire.

Provider Relief Fund

  • HHS has updated its Provider Relief Fund reporting portal’s frequently asked questions.  Find the updated FAQ here.
  • HHS has published a Provider Relief Fund reporting portal user guide.  Find the guide here.

The White House

Department of Health and Human Services

COVID-19

  • The federal government has responded to recent increases in COVID-19 cases by assuming control of the distribution of monoclonal antibodies used to treat the virus.  Learn more from the announcement of this new approach.  Federal officials also explain the new policy, why they are pursuing it, and how it will work in this video of a web event.

Health Policy News

  • HHS has extended the open enrollment period for people seeking health insurance on the federally facilitated marketplace and has extended the scope of services provided by navigators for that marketplace.  The department also has authorized state marketplaces to set their own open enrollment dates.  Learn more from this HHS news release.
  • HHS and its Health Resources and Services Administration (HRSA) have awarded $48 million to 271 HRSA-supported health centers in 26 states, Puerto Rico, and the District of Columbia to expand HIV prevention and treatment, outreach, and care coordination services.  To learn more about the awards, how the money will be used, and the award recipients, see this HHS announcement.
  • HHS and HRSA have awarded $350 million in grants to every state to support safe pregnancies and healthy babies.  Funding will be used expand home visiting services to families most in need, increase access to doulas, address health disparities in infant deaths, and improve data reporting on maternal mortality.  The money is being awarded through the Maternal, Infant, Early Childhood Home Visiting Program, the Healthy Start Initiative, and the State Systems Developmental Initiative.  To learn more about how HHS intends for the money to be spent, how much money is being allocated through these programs, and how much money individual recipients will receive, see this HHS announcement.
  • HRSA has announced the availability of funding to support continued access to comprehensive, culturally competent, high-quality primary health care services for communities and populations currently served by its Health Center Program.  Eligible organizations include domestic public or non-profit private entities that propose to serve an announced service area and its associated population(s) to ensure continued access to affordable, quality primary health care services.  Learn more from this HRSA announcement.

Centers for Medicare & Medicaid Services

COVID-19

Health Policy News

  • The latest edition of the CMS online publication MLN Connects includes Medicare’s quarterly provider quality compliance newsletter and information about annual HPSA updates, flu vaccine payment allowances, updated clinical lab fees, and more.  Find the September 16 edition of MLN Connects here.
  • CMS has posted a pre-publication version of a final rule that sets forth revised 2022 user fee rates for issuers offering qualified health plans (QHPs) through Federally-facilitated Exchanges and State-based Exchanges on the federal platform; repeals separate billing requirements related to the collection of separate payments for the portion of QHP premiums attributable to coverage for certain abortion services; expands the annual open enrollment period and Navigator duties; implements a new monthly special enrollment period for qualified individuals or enrollees, or the dependents of a qualified individual or enrollee, who are eligible for advance payments of the premium tax credit (APTC) and whose household income does not exceed 150 percent of the federal poverty level, available during periods of time during which APTC benefits are available such that certain applicable taxpayers’ applicable percentage is set at zero, such as during tax years 2021 and 2022 under the section 9661 of the American Rescue Plan Act of 2021; repeals the recent establishment of a Direct Enrollment option for Exchanges; and modifies regulations and policies related to section 1332 waivers.  Find the document here.
  • CMS has published three FAQs that explain that the agency will not take enforcement action against certain payers for the payer-to-payer data exchange provision of the May 2020 Interoperability and Patient Access final rule until future rulemaking is finalized.  CMS’s decision to exercise enforcement discretion for the payer-to-payer policy until future rulemaking occurs does not affect any other existing regulatory requirements and implementation timelines outlined in the final rule.  Go here to see the announcement and find links to the FAQs.
  • CMS has proposed repealing the Medicare Coverage of Innovative Technology and Definition of ‘”Reasonable and Necessary” final rule, which was published on January 14, 2021 and is scheduled to take effect on December 15.  The repealed rule was a response to concerns that breakthrough technologies were not being made available to the Medicare population in a timely manner but CMS now believes more care must be taken before authorizing the use of such technologies for Medicare patients.  Find the proposed rule here.
  • CMS has published its Inpatient Rehabilitation Facility Patient Assessment Instrument (IRF-PAI) Quarterly Q&As December 2020 document so inpatient rehabilitation facility (IRF) providers have the benefit of clarifications to existing guidance.
  • CMS has published the Long-Term-Care Hospital (LTCH) CARE Data Set Quarterly Q&As, September 2021, Consolidated September 2020 to September 2021 document so LTCH providers have the benefit of the clarifications to existing guidance.
  • CMS has awarded $15 million in planning grants to 20 states to support expanding community-based mobile crisis intervention services for Medicaid beneficiaries.  Learn more about the services the grants will underwrite and find a list of grant recipients in this CMS announcement.

Centers for Disease Control and Prevention

Food and Drug Administration

  • The FDA has revised its emergency use authorization (EUA) for the monoclonal antibodies bamlanivimab and etesevimab, administered together, to include emergency use as post-exposure prophylaxis (prevention) for COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) who are at high risk for progression to severe COVID-19, including hospitalization or death.  In this revision of the EUA, bamlanivimab and etesevimab, administered together, are authorized for use after exposure to the virus and are not authorized for pre-exposure prophylaxis to prevent COVID-19 before being exposed to the COVID-10 virus.  Learn more from the FDA announcement, the revised EUA, and this fact sheet for providers.
  • The FDA has updated its enforcement policy for masks, barrier face coverings, face shields, surgical masks, and respirators during the COVID-19 public health emergency.  Find the updated policy here.

National Institutes of Health

  • The NIH has awarded $470 million to build a national study population of diverse research volunteers and support large-scale studies on the long-term effects of COVID-19.  Learn more from this NIH news release.

Stakeholder Events

MACPAC – September meetings – September 23 and 24

The Medicaid and CHIP Payment and Access Commission (MACPAC) will hold its scheduled September meeting of commissioners on Thursday, September 23 and Friday, 24 to discuss federal Medicaid and CHIP policies.  The meetings will be held virtually.  Find the meeting agenda here and go here to register to view the sessions.

CDC – Evaluating and Supporting Patients Presenting With Fatigue Following COVID-19 – September 30

The CDC will hold a webinar on evaluating and supporting patients who present with fatigue following treatment for COVID-19.  The webinar will be held on Thursday, September 30 at 2:00 p.m. (eastern).  For further information on the subjects the webinar will cover, those who will be participating in the event, and how to join the webinar, go here.

FDA – Workshop Addressing Response to the Opioid Crisis – October 13

The FDA will hold a workshop titled “Reconsidering Mandatory Opioid Prescriber Education Through a Risk Evaluation and Mitigation Strategy (REMS)” to give stakeholders an opportunity to provide input on aspects of the current opioid crisis that could be mitigated in a measurable way by requiring mandatory prescriber education as part of a REMS effort.  The public workshop will be held on October 13 from 1 p.m. to 5 p.m. (eastern) and October 14 from 1 p.m. to 4:00 p.m.  For information about participating in the workshop or submitting comments or materials, see this Federal Register notice.

 

Federal Health Policy Update for Thursday, September 9

The following is the latest health policy news from the federal government as of 2:30 p.m. on Thursday, September 9.  Some of the language used below is taken directly from government documents.

The White House

Congress

  • Democrats on the House Energy and Commerce Committee today introduced their contribution to their party’s anticipated $3.5 trillion dollar spending bill.  Their portion of the reconciliation bill addresses expanding Medicaid in non-expansion states, reducing prescription drug prices, increasing federal spending on home-based care, and more.  Find their summary of their proposals here.

Provider Relief Fund

  • HHS’s Human Resources and Services Administration (HRSA) has published a notice explaining how Provider Relief Fund payments can be used for a wide variety of direct and indirect costs of recruiting and retaining personnel during the COVID-19 emergency.  Find the notice here.
  • With the next deadline for health care providers to report on their use of Provider Relief Fund grants coming up on September 30, HRSA will hold an “office hours” web event on Friday, September 10 at 1:00 (eastern) to address issues involving Provider Relief Fund reporting and auditing requirements.  For information about how to join the event and more about reporting and auditing requirements, go here.

Department of Health and Human Services

COVID-19

  • HHS Secretary Xavier Becerra has released a new plan to reduce prescription drug prices.  One of the key policies in this effort is legislation that would enable the Secretary of HHS to negotiate Medicare Part B and Part D drug prices directly with pharmaceutical companies and make those prices available to other purchasers.  Learn more about this plan from the HHS announcement, an HHS fact sheet, and the full plan.
  • The Office of the Assistant Secretary for Preparedness and Response has announced a new Notice of Funding Opportunity to establish Partnership(s) for Enhanced Efforts To Strengthen The Nation’s Healthcare And Public Health Preparedness, Response, And Recovery To Disasters And Other Emergencies.  This program seeks to fund up to seven new cooperative agreements to enable the agency’s broad collaboration with public health and health care sectors and emergency management services to ensure that local governments, communities, private sector entities, non-governmental organizations, academia, and individuals can optimally coordinate their respective national health security roles and responsibilities to achieve community health resilience and strengthen health care, public health, and emergency management systems in preparation of, response to, and recovery from disasters and other emergencies.  $20 million in grants will be awarded, with a maximum grant of $4 million.  The deadline for applications is September 22.
  • HHS’s Office of the Assistant Secretary for Planning and Readiness has updated its information on planning considerations for the administration of monoclonal antibodies.  Find the updated information here.
  • The Office of the Assistant Secretary for Planning and Readiness has published guidance to hospitals on how to address a surge of patients with behavioral health challenges during the COVID-19 pandemic.
  • HHS’s Office of the Inspector General has published a report that describes the complex care needs of beneficiaries hospitalized with COVID-19.  The report focuses on surges in COVID-19 hospitalizations in six localities and builds upon prior OIG work that describes the extent to which hospitals have been strained by COVID-19.  Find the report here.
  • Another report by HHS’s OIG found that the COVID-19 case and death data submitted by nursing homes to the federal government is incomplete and inaccurate despite CMS’s efforts to require such data reporting weekly.  Find the report here.

Centers for Medicare & Medicaid Services

Health Policy News

  • CMS has posted two new editions of MLN Connects, its online newsletter.  Subjects addressed in the September 2 edition include changes in Medicare provider enrollment processes, information about CMS’s planned implementation of its ambulance prior authorization model, the hospice quality reporting program, and more.  Go here to see the September 2 edition of MLN Connects.
  • The September 9 edition of MLN Connects includes information about a payment update on outpatient clinic visit services at excepted off-campus provider-based departments, the Medicare fee-for-service response to the COVID-19 emergency, skilled nursing facility consolidated billing web-based training, and more.  Find the September 9 edition of MLN Connects here.
  • CMS is distributing $452 million in federal funding to support 13 states’ efforts to improve access to affordable, comprehensive health insurance coverage through section 1332 state-based reinsurance waivers.  As a result of changes made in the American Rescue Plan Act of 2021, residents in states implementing reinsurance waivers may have access to more affordable health insurance coverage.  States also will have more pass-through funding to implement their waiver.  Learn more about the funding, how it will be used, and which states will receive it in this HHS news release.
  • CMS’s Center for Medicare and Medicaid Innovation has posted the annual report for its Comprehensive Care for Joint Replacement Model.  Go here to see the annual report and here for more information about and resources for the program.

Centers for Disease Control and Prevention

Food and Drug Administration

  • The FDA has revised its guidance on the authorized use of the monoclonal antibodies bamlanivimab and etesevimab when administered together.  The Emergency Use Authorization now authorizes the use of bamlanivimab and etesevimab, administered together, only in states, territories, and U.S. jurisdictions in which recent data shows the combined frequency of variants resistant to bamlanivimab and etesevimab administered together is less than or equal to five percent.  The FDA has posted a list of states, territories, and U.S. jurisdictions in which bamlanivimab and etesevimab administered together are currently authorized and a list of states, territories, and U.S. jurisdictions in which bamlanivimab and etesevimab administered together, are not currently authorized and will periodically update both lists as new data becomes available.
  • The FDA has posted a letter to veterinarians and retailers informing them of the danger of treating people for COVID-19 with animal ivermectin.
  • The FDA’s Vaccines and Related Biological Products Advisory Committee will meet on September 17 to discuss the Pfizer-BioNTech supplemental Biologics License Application for administration of a third (booster) dose of the Pfizer vaccine to individuals 16 years of age and older.  Learn more here.

National Institutes of Health

  • An investigational HIV vaccine tested in a clinical trial co-sponsored by the NIH posed no safety concerns but did not provide sufficient protection against HIV infection among women, according to a preliminary analysis of the study data.  Learn more from this NIH news release.

Medicare Payment Advisory Commission (MedPAC)

  • MedPAC has written to CMS to convey its views on CMS’s proposed physician fee schedule and changes to Medicare Part B regulation.  Find its letter here.
  • MedPAC’s commissioners met last week for two days to discuss Medicare payment issues.  During the meetings MedPAC addressed the following issues:
    • The effects of the COVID-19 emergency and considerations on MedPAC’s 2022 assessment of Medicare payment adequacy.
    • Potential reforms of the Part D low-income premium subsidy.
    • A report on designing a value incentive program for post-acute care.
    • A report on the impact of Bipartisan Budget Act of 2018 changes to the home health prospective payment system.

For briefs and presentations on these subjects go here; for a transcript of the MedPAC meetings go here.

Medicaid and CHIP Payment and Access Commission (MACPAC)

American Medical Association

  • The AMA has announced eight new CPT codes for COVID-19 vaccine administration.  Learn more from this AMA notice.
  • The AMA has issued its annual update of CPT codes.  The update includes 405 editorial changes, including 249 new codes, 63 deletions, and 93 revisions.  Learn more from this AMA news release.

Stakeholder Event

FDA – Workshop Addressing Response to the Opioid Crisis – October 13

The FDA will hold a workshop entitled “Reconsidering Mandatory Opioid Prescriber Education Through a Risk Evaluation and Mitigation Strategy (REMS)” to give stakeholders an opportunity to provide input on aspects of the current opioid crisis that could be mitigated in a measurable way by requiring mandatory prescriber education as part of a REMS effort.  The public workshop will be held on October 13 from 1 p.m. to 5 p.m. (eastern) and October 14 from 1 p.m. to 4:05 p.m.  For information about participating in the workshop or submitting comments or materials, see this Federal Register notice.