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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.

 

 

Federal Health Policy Update for Monday, August 30

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

Temporary Suspension of COVID-19 Data Reporting Requirements for Some Hospitals

  • The Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response has announced that federal hospital COVID-19 reporting requirements for the entire state of Louisiana and parts of Mississippi have been suspended for seven days in response to Hurricane Ida.  While hospitals in the affected areas may still report their data if they wish they are not required to do so and reporting for this period is not expected to be back-filled.  The office will continue to monitor the storm’s impact and this suspension could be extended or expanded to additional areas depending on conditions in the region.

Department of Health and Human Services

  • HHS has declared a state of public emergency in Louisiana and Mississippi because of the effects of Hurricane Ida.  See the HHS announcement for more about what this means.
  • HHS has issued guidance with essential information for states as they navigate the options available to advance COVID-19 vaccination and testing and the Medicaid program’s broader aim of providing health coverage for millions of eligible individuals.  To help states support families and communities and to continue to address health disparities, CMS is providing guidance to states about additional American Rescue Plan funding to promote the importance of COVID-19 vaccination for eligible children and adults enrolled in Medicaid.  Among the areas the new guidance addresses are COVID-19 testing in schools, coverage of habilitation services, enhancing access to COVID-19 vaccines, incentives for states to expand Medicaid, and reducing health disparities.  Learn more from this HHS news release, which includes links to several documents HHS has issued in support of this initiative.
  • HHS has established an Office of Climate Change and Health Equity in response to President Biden’s executive order calling for tackling the climate crisis at home and abroad.  The office is charged with:
    • Identifying communities with disproportionate exposures to climate hazards and vulnerable populations.
    • Addressing health disparities exacerbated by climate impacts to enhance community health resilience.
    • Promoting and translating research on public health benefits of multi-sectoral climate actions.
    • Assisting with regulatory efforts to reduce greenhouse gas emissions and criteria air pollution throughout the health care sector, including participating suppliers and providers.
    • Fostering innovation in climate adaptation and resilience for disadvantaged communities and vulnerable populations.
    • Providing expertise and coordination to the White House, Secretary of Health and Human Services, and federal agencies related to climate change and health equity deliverables and activities, including Executive Order implementation and reporting on health adaptation actions under the United Nations Framework Convention on Climate Change.
    • Promoting training opportunities to build the climate and health workforce and empower communities.
    • Exploring opportunities to partner with the philanthropic and private sectors to support innovative programming to address disparities and health sector transformation.
  • HHS’s Health Resources and Services Administration (HRSA) has extended the deadline for providers, FQHCs, and associations to apply for grants under its “Promoting Resilience and Mental Health Among Health Professional Workforce” program from August 30 to September 20.  $29 million in grant funding is available.  Learn more about the grants and the application process here.
  • HRSA has extended the deadline for applications for another public safety workforce resiliency training program from August 30 to September 20.  This program, which will award up to $68 million in grants, is part of a program to plan, develop, operate, or participate in health professions and nursing training activities using evidence-based or evidence-informed strategies, to reduce and address burnout, suicide, mental health conditions, and substance use disorders and promote resiliency among health care students, residents, professionals, paraprofessionals, trainees, public safety officers, and employers of such individuals in rural and underserved communities.  Learn more about the program and the grant opportunity here.
  • HRSA has awarded $10.7 million from the American Rescue Plan to expand pediatric mental health care access by integrating telehealth services into pediatric care.  Learn more about the programs funded by these resources and the recipients of this grant in this HHS announcement.
  • HRSA will publish a notice in the Federal Register announcing changes in the agency’s organization and operations.  See a pre-publication version of the notice here.

Centers for Medicare & Medicaid Services

COVID-19

Health Policy News

  • CMS has published the latest edition of MLN Connects, its online newsletter.  The latest edition has an article on revised ICD-10 code sets, an update on monoclonal antibodies, and more.  Find it here.
  • CMS announced that Accountable Care Organizations (ACOs) participating in the Medicare Shared Savings Program in 2020 earned performance payments (shared savings) totaling nearly $2.3 billion while saving Medicare approximately $1.9 billion.  Learn more about the performance of ACOs in the Medicare Shared Savings Program from this CMS news release,
  • CMS has announced three new major appointments:   Dr. Ellen Montz as Deputy Administrator and Director of the Center for Consumer Information and Insurance Oversight; Dr. Natalia Chalmers as its first-ever Chief Dental Officer in the Office of the Administrator; and Dara Corrigan as Deputy Administrator and Director of the Center for Program Integrity.  Learn more about the new officials and the positions to which they have been appointed in this CMS news release.

Food and Drug Administration

  • The FDA has approved a first-of-its-kind drug-free rehabilitation system intended to treat moderate to severe upper extremity motor deficits associated with chronic ischemic strokes.  Learn more about this new technology and its application in this FDA news release.

National Institutes of Health

  • The NIH has begun a clinical trial to assess the antibody response to an extra dose of an authorized or approved COVID-19 vaccine in people with autoimmune disease who did not respond to an original COVID-19 vaccine regimen.  The trial also will investigate whether pausing immunosuppressive therapy for autoimmune disease improves the antibody response to an extra dose of a COVID-19 vaccine in this population.  Learn more in this NIH news release.

Medicare Payment Advisory Commission (MedPAC)

  • MedPAC has submitted formal comments to CMS on that agency’s proposed end-stage renal disease (ESRD) prospective payment system for 2022.  Read its letter here.

Medicaid and CHIP Payment and Access Commission (MACPAC)

MACPAC has posted a fact sheet on Medicaid coverage of qualified residential treatment programs for children in foster care.

Stakeholder Event

MedPAC Meeting – September 2 and 3

MedPAC will hold its September public meetings remotely on Thursday, September 2 and Friday, September 3.  To register to view the Thursday, September 2 session (from 1:15 to 5:15 eastern) go here and to register to view the Friday, September 3 session (9:30 until noon eastern) go here.  To see the agenda for the two sessions and find supporting materials, go here.

 

 

Federal Health Policy Update for Wednesday, July 14

The following is the latest health policy news from the federal government as of 2:45 p.m. on Wednesday, July 14.  Some of the language used below is taken directly from government documents.

CMS – Proposed 2022 Medicare Physician Fee Schedule Rule

CMS has released its proposed Medicare physician fee schedule rule for 2022.  Highlights of the proposed rule, which is more than 1700 pages, include:

  • loosening current restrictions on the use of telehealth and expanding its use for behavioral health services;
  • expanding the reach of the Medicare Diabetes Prevention Program;
  • requiring clinicians to meet a higher performance threshold to receive incentives under the Quality Payment Program;
  • authorizing physician assistants to bill Medicare directly for the Part B services they provide; and
  • phasing out coinsurance for colorectal screening additional services.

In addition, CMS is soliciting stakeholder feedback on health equity data collection and on current Medicare payments for administering vaccines.

For further information about the proposed physician fee schedule rule, see the following resources:

CMS’s news release announcing the newly proposed rule

a CMS fact sheet

quality program update fact sheet

Medicare Diabetes Prevention Program update fact sheet

the proposed rule itself

Centers for Medicare & Medicaid Services

Health Policy News

  • CMS has published the latest edition of MLN Connects, its online weekly bulletin.  This week’s edition includes an article about cognitive assessment resources for providers, updated FY 2022 ICD-10-CMS codes, and opportunities for web-based training on aspects of Medicare billing.  For this and more, go here.
  • CMS has announced that it will open a National Coverage Determination (NCD) analysis through which it will review and determine whether Medicare will establish a national Medicare coverage policy for monoclonal antibodies targeting amyloid for the treatment of Alzheimer’s disease.  NCDs are program instructions developed by CMS to describe the nation-wide conditions for Medicare coverage for a specific item or service.  This NCD analysis will be applicable to national coverage considerations for aducanumab, which was recently approved by the FDA, as well as any future monoclonal antibodies that target amyloid for the treatment of Alzheimer’s disease.  As part of the NCD process, a 30-day public comment period began on July 12.  CMS will host two public listening sessions in July to provide an opportunity for public input.  Learn more from this CMS announcement.
  • CMS has announced that it will distribute $15 million in American Rescue Plan funding to provide community-based mobile crisis intervention services for those with Medicaid.  The $15 million funding opportunity is available to state Medicaid agencies, not providers, for planning grants to support developing these programs.
  • CMS’s Accountable Health Communities (AHC) Model assesses whether bridging the gap between clinical care and social services can reduce health care utilization and costs for Medicare and Medicaid beneficiaries.  In February 2021, CMS hosted its third annual AHC meeting virtually to convene 28 bridge organizations participating in the AHC model and key partners, including community service providers, state Medicaid agencies, and advisory board members.  Meeting participants collaborated and shared insights to sustain their screening, referral, and navigation strategies to address the health-related social needs of Medicare and Medicaid beneficiaries.  Learn more about their insights in the brief “Planning for Sustainability and Advancing Health Equity during the Public Health Emergency.

Provider Relief Fund

Department of Health and Human Services

Health Policy News

  • HHS has provided $398 million in American Rescue Plan money through the Small Rural Hospital Improvement Program to 1540 small rural hospitals for COVID-19 testing and mitigation.  See the HHS announcement here, including a list of how much was distributed to hospitals in each state.
  • HHS’s Health Resources and Services Administration (HRSA) has published a notice in the Federal Register announcing the availability of complete lists of all geographic areas, population groups, and facilities designated as primary medical care, dental health, and mental health professional shortage areas (HPSAs) as of April 30, 2021.  See the HRSA notice here and find the updated lists of HPSAs here.

Centers for Disease Control and Prevention

COVID-19

Food and Drug Administration

COVID-19

Please note that the vaccine’s FAQ and separate fact sheets translated into other languages have not yet been updated.

Medicaid and CHIP Payment and Access Commission (MACPAC)

Occupational Safety and Health Administration (OSHA)

Office of Management and Budget (OMB)

  • OMB has published its semi-annual work plan presenting its regulatory priorities in the coming months.  Among the HHS matters listed, in addition to those that occur regularly, are:
    • Streamlining the Medicaid and CHIP Application, Eligibility Determination, Enrollment, and Renewal Processes
    • Medicaid Drug Misclassification, Beneficiary Access Protection, and Drug Program Administration
    • Mandatory Medicaid and CHIP Core Set Reporting
    • Medicaid Managed Care Risk-Sharing Mechanisms
    • Temporary Federal Medical Assistance Percentage (FMAP) increase under the Families First Coronavirus Response Act

See the complete HHS list here.

Stakeholder Events

Thursday, July 15 – Centers for Disease Control

CDC National Call Series on COVID-19-Related Response Strategies

Thursday, July 15 at 2:00 – 3:00 pm ET Click here to join
CDC’s COVID-19 response team conducts a national call weekly to provide state, tribal, local, and territorial (STLT) partners with timely updates and opportunities for peer-to-peer learning and sharing of successful response strategies. Over the summer, these weekly COVID-19 community of practice webinars will focus on topics related to school readiness.

Monday, July 19 – National Emergency Management Association (NEMA)

Mission-Ready Packages Workshop for Resource Providers

Monday, July 19 at 1:00 pm ET  Click here for registration

NEMA is hosting a workshop on developing mission ready packages (MRPs). MRPs are specific response or recovery capabilities that have been created to ensure the skills, capabilities, and associated costs are bundled prior to an emergency or disaster for more efficient deployment. These workshop sessions are designed for resource providers. A resource provider is any organization that is able to deploy under the Emergency Management Assistance Compact (EMAC) and that has capabilities that might be needed during an emergency response. Previous knowledge of EMAC or MRPs is not required.

Tuesday, July 20 – Health Resources and Services Administration (HRSA)

Provider Relief Fund Reporting Requirements

Tuesday, July 20 at 3:00 pm ET

HRSA will host a recorded Reporting Technical Assistance session to provide technical assistance on reporting requirements for Provider Relief Fund recipients and stakeholders.  To register for the July 20 session go here.

Thursday, July 22 – HHS’s Health Sector Cybersecurity Coordination Center (HC3)
HC3
Cybersecurity Threat Briefing – Qbot/QakBot

Thursday, July 22 at 1:00 pm ET – Click here for registration

HC3 is holding its second July threat briefing, the topic will be “Qbot/QakBot.”  This webinar will provide actionable information on health sector cybersecurity threats and mitigations.  HC3 analysts will engage in discussions with participants on current threats and highlight best practices and mitigation tactics.

Wednesday, August 4 – Centers for Disease Control

Zoonoses and One Health Update (ZOHU) Call

Wednesday, August 4 at 2:00 – 3:00 pm ETClick here for more information

ZOHU Calls are one-hour monthly webinars that provide timely education on zoonotic and infectious diseases, One Health, antimicrobial resistance, food safety, vector-borne diseases, recent outbreaks, and related health threats at the animal-human-environment interface.

 

Federal Health Policy Update for Friday, July 9

The following is the latest health policy news from the federal government as of 2:45 p.m. on Friday, July 9.  Some of the language used below is taken directly from government documents.

White House

President Biden has issued an executive order “…to promote competition in the American economy, which will lower prices for families, increase wages for workers, and promote innovation and even faster economic growth.”  Among other things, the executive order calls for closer scrutiny of corporate consolidation, maintaining that such consolidation results in a “…lack of competition [that] drives up prices for consumers.  As fewer large players have controlled more of the market, mark-ups (charges over cost) have tripled.  Families are paying higher prices for necessities – things like prescription drugs, hearing aids, and internet service.”  The order also includes a provision that “… enforcement should focus in particular on labor markets, agricultural markets, healthcare markets (which includes prescription drugs, hospital consolidation, and insurance), and the tech sector.”

In a section on hospitals, the order notes that

Hospital consolidation has left many areas, especially rural communities, without good options for convenient and affordable healthcare service.  Thanks to unchecked mergers, the ten largest healthcare systems now control a quarter of the market.  Since 2010, 139 rural hospitals have shuttered, including a high of 19 last year, in the middle of a healthcare crisis.  Research shows that hospitals in consolidated markets charge far higher prices than hospitals in markets with several competitors.

It also

  • Underscores that hospital mergers can be harmful to patients and encourages the Justice Department and FTC to review and revise their merger guidelines to ensure patients are not harmed by such mergers.
  • Directs HHS to support existing hospital price transparency rules and to finish implementing bipartisan federal legislation to address surprise hospital billing.

Learn more from the White House fact sheet on the executive order, which addresses other aspects of health care as well.

Provider Relief Fund

  • The Provider Relief Fund’s “Reporting Requirements and Auditing” page has been updated with new information about Provider Relief Fund recipient reporting deadlines, requirements, and worksheets.  Find it here.
  • The Health Resources and Services Administration (HRSA) will host recorded Reporting Technical Assistance Sessions to provide technical assistance on reporting requirements for Provider Relief Fund recipients and stakeholders.  For the July 14 session at 3:00 p.m., go here to register and for the July 20 session at 3:00 go here to register.

Department of Health and Human Services

COVID-19

  • HHS has published notice of the extension of the designation issued on February 1, 2021 identifying health and medical resources necessary to respond to the spread of COVID-19 that are scarce or the supply of which would be threatened by excessive accumulation by people or entities not needing the excess supplies.  These designated materials are subject to the hoarding prevention measures authorized under Executive Order 13910 and section 102 of the Defense Production Act of 1950.  Learn more from the Federal Register notice.  The notice lists specific items that have had their “scarce” designation removed and others that have not.  The action took effect on July 1 and interested parties have until August 7 to submit comments.

Health Policy News

  • HHS has updated interoperability standards to support the collection and electronic exchange of data on sexual orientation, gender identity, and social determinants of health.  Learn more from HHS’s announcement about this development and from the United States Core Data for Interoperability version 2 (USCDI v2), a standardized set of health data classes and constituent data elements for nation-wide, interoperable health information exchange.
  • HHS’s Office of the Assistant Secretary for Preparedness and Response has shared a notice from the federal Cybersecurity and Infrastructure Security Agency and the FBI about how multiple managed service providers and their customers can protect themselves from recent supply-chain ransomware attacks leveraging a vulnerability in Kaseya VSA software.  Learn more here.
  • HHS’s Office of the Assistant Secretary for Preparedness and Response has developed an infectious disease surge annex tabletop exercise toolkit that can be used by health care coalitions to enhance operational area awareness and capability to effectively address the needs of patients seeking care following exposure to an infectious agent.  Health care coalitions are not required to use this template but it can be used to satisfy funding opportunity announcement requirements for the hospital preparedness program cooperative agreement.  Find the toolkit and links to other resources here.
  • The same HHS office has prepared a home care and hospice emergency operations plan that includes emergency operations plans specific to home care and hospice agencies.

Centers for Medicare & Medicaid Services

Health Policy News

  • CMS has published the latest edition of MLN Connects, its online weekly bulletin.  This week’s edition includes an updated FAQ about repayment of COVID-19 accelerated and advance payments, including information about how recoupment works and how it affects providers’ Medicare claims payment amounts.  For this and more, including articles on updated HCPCS codes for skilled nursing facilities and updated durable medical equipment, prosthetics, orthotics, and supplies, go here.
  • CMS has announced the appointment of Dr. Meena Seshamani, M.D., Ph.D. as Deputy Administrator and Director of Center for Medicare.  Dr. Seshamani most recently served as vice president of clinical care transformation at MedStar Health, where she conceptualized, designed, and implemented population health and value-based care initiatives and served on the senior leadership of a health system with 10 hospitals and more than 300 outpatient sites.  Prior to MedStar Health, she was director of the Office of Health Reform at HHS.  Dr. Seshamani received her B.A. with honors in business economics from Brown University, her M.D. from the University of Pennsylvania School of Medicine, and her Ph.D. in health economics from the University of Oxford.  Learn more from the CMS announcement of the appointment.
  • The CMS Center for Medicare and Medicaid Innovation’s Financial Alignment Initiative is designed to provide individuals dually enrolled in Medicare and Medicaid with a better care experience and to better align the financial incentives of the Medicare and Medicaid programs.  Through this initiative, CMS partners with states to test new models for their effectiveness in accomplishing these goals.  Now, the innovation center has posted evaluation and savings reports from participating states Washington, Colorado, Minnesota, New York, and Virginia.  Find those reports and other information about the program here.

COVID-19

Centers for Disease Control and Prevention

COVID-19

Americans who have been fully vaccinated do not need a booster shot at this time. FDA, CDC, and NIH are engaged in a science-based, rigorous process to consider whether or when a booster might be necessary. This process takes into account laboratory data, clinical trial data, and cohort data – which can include data from specific pharmaceutical companies, but does not rely on those data exclusively. We continue to review any new data as it becomes available and will keep the public informed. We are prepared for booster doses if and when the science demonstrates that they are needed.

Food and Drug Administration

COVID-19

  • The FDA has authorized the use, under the emergency use authorization for the Janssen COVID-19 vaccine, of an additional batch of vaccine drug substance manufactured at the Emergent facility.  Questions had been raised about the safety of the batch but the FDA has investigated and concluded it is safe.  See the FDA announcement of this decision here and the letter the FDA sent to JanssenBiotech explaining its decision.

Medicaid and CHIP Payment and Access Commission (MACPAC)

  • MACPAC has responded to the Office of Management and Budget request for information “Methods and Leading Practices for Advancing Equity and Support for Underserved Communities Through Government” with a letter that highlights opportunities for CMS and state agencies that jointly operate Medicaid and the State Children’s Health Insurance Program (CHIP) to document specific disparities in health care and develop new opportunities to improve access to and the quality of care beneficiaries receive.  The letter also outlines areas that could be addressed through subregulatory guidance, waiver opportunities, and technical assistance.  Learn more from the MACPAC letter to OMB.

National Institutes of Health

Stakeholder Events

Tuesday, July 13 – Food and Drug Administration

The FDA will host a webinar to share information and answer questions about its revocation of EUAs for non-NIOSH-approved respirators and decontamination systems.  It will present information about its June 30, 2021 “Update:  FDA No Longer Authorizes Use of Non-NIOSH-Approved or Decontaminated Disposable Respirators – Letter to Health Care Personnel and Facilities.”  To join the webinar:

Zoom Webinar Link: https://fda.zoomgov.com/j/1600971341?pwd=UTJMTlZmYzVScmNZamd2d2J4SU92Zz09

Webinar Passcode: $vrC6z

Dial: 833-568-8864
Webinar ID: 160 097 1341
Passcode: 292602

Tuesday, July 13 Office of the National Coordinator for Health Information Technology (ONC)
ONC Workshop: Advancing SDOH Data Use and Interoperability for Achieving Health Equity
Tuesday, July 13 at 10:00 am – 4:00 pm ET  Click here for connection information
This workshop will explore existing and emerging data standards, tools, approaches, policies, models, and interventions for advancing the use and interoperability of non-clinical health data for individual and community health improvement.  It will share varying perspectives of health policy-makers and health improvement implementers to highlight inventive solutions, share challenges, and offer ideas on data modernization to advance health equity.  The workshop offers introductory content as well as deep exploration of key topics as part of social determinants of health IT data use and interoperability including facilitated, expert stakeholder engagement.

Wednesday, July 14 and Tuesday, July 20 – Health Resources and Services Administration (HRSA)

HRSA will host recorded Reporting Technical Assistance Sessions to provide technical assistance on reporting requirements for Provider Relief Fund recipients and stakeholders.  For the July 14 session at 3:00 p.m. go here to register and for the July 20 session at 3:00 p.m. go here to register.

Federal Health Policy Update for Monday, June 28

The following is the latest health policy news from the federal government as of 2:30 p.m. on Monday, June 28.  Some of the language used below is taken directly from government documents.

Supreme Court Decision in Affordable Care Act Case

  • The Supreme Court has declined to hear an appeal of a case in which insurers unsuccessfully sued to recover reductions in their Affordable Care Act federal cost-sharing reduction payments.

White House

Department of Health and Human Services

COVID-19

  • HHS and the FDA have paused all distribution of bamlanivimab and etesevimab together and etesevimab alone, to pair with existing supply of bamlanivimab, on a national basis until further notice.  In addition, the FDA has recommended that health care providers nation-wide use alternative authorized monoclonal antibody therapies and not use bamlanivimab and etesevimab administered together at this time.  Learn more about why the agencies have taken this action and what they propose as alternatives from this message distributed by HHS’s Office of the Assistant Secretary for Preparedness and Response,
  • HHS’s Office of the Inspector General has published a report on the impact of COVID-19 on Medicare beneficiaries residing in nursing homes during 2020.  Learn more from the OIG’s announcement and summary of the report and from the OIG report “COVID-19 Had a Devastating Impact on Medicare Beneficiaries in Nursing Homes During 2020.”

Health Policy News

  • HHS and the CDC have awarded 59 jurisdictions with $200 million to bolster support for and enhance the disease intervention specialists workforce.  These awards represent the initial funding of a $1.13 billion investment being made over the next five years under the American Rescue Plan and will provide these jurisdictions, public health programs, and the CDC with support to expand and leverage the work of disease intervention specialists.  Learn more from the CDC’s announcement and find a list of the funding recipients here.

Centers for Medicare & Medicaid Services

COVID-19

  • CMS has provided guidance to state Medicaid programs about the circumstances under which health care facilities still operating under their emergency preparedness plans because of COVID-19 will temporarily remain exempt from participating in required full-scale emergency preparedness exercises and testing.  See the CMS guidance letter here.

Health Policy News

  • CMS has announced the appointment of Daniel Tsai as deputy administrator and director of its Center for Medicaid and CHIP Services.  Tsai comes from Massachusetts, where he served as the assistant secretary for MassHealth and state Medicaid director.  Learn more about Tsai and the agency he will help lead in this CMS news release.
  • CMS has released a Center for Medicaid and CHIP Services bulletin to introduce a series of tools and toolkits for states and CMS to use to improve the monitoring and oversight of managed care in Medicaid and the Children’s Health Insurance Program (CHIP) that will help improve beneficiaries’ access to care.  This bulletin also provides guidance setting the content and format of the Annual Managed Care Program Report required by CMS regulations and introduces additional resources and technical assistance toolkits that states can use to improve compliance with managed care standards and requirements.  Learn more from the new CMS bulletin.
  • CMS has published the latest edition of MLN Connects, its online publication.  For articles about updates of the hospital outpatient prospective payment system and the clinical laboratory fee schedule and more, go here.
  • CMS has updated its FAQ on its final rule on interoperability and patient access.  Find the information here.
  • CMS announced that it will provide $20 million in American Rescue Plan money to support state-based marketplaces to improve access to affordable, comprehensive health insurance coverage for consumers in their states.  States can apply for funding to help modernize or update their systems, programs, or technology to comply with federal marketplace requirements.  Learn more about the new funding from this CMS announcement.
  • CMS’s Center for Medicare and Medicaid Innovation has announced an anti-kickback safe harbor for CMS-sponsored model patient incentives under the agency’s Maternal Opioid Misuse Model.  Learn more here.

Centers for Disease Control and Prevention

COVID-19

Food and Drug Administration

COVID-19

Health Policy News

  • The FDA has approved the drug Pradaxa (dabigatran etexilate), the first oral blood thinning medication for children.  Learn more from this FDA news release.
  • The FDA has issued draft guidance encouraging industry to include patients with incurable cancers (when there is no potential for cure or for prolonged/near normal survival) in cancer clinical trials regardless of whether they have received existing alternative treatment options.  See the FDA announcement of this new policy and the draft guidance itself, which was published in the Federal Register.

Occupational Safety and Health Administration

  • OSHA has issued an emergency temporary standard to protect health care and health care support service workers from occupational exposure to COVID-19 in settings where people with COVID-19 are reasonably expected to be present.  Compliance with some of the new requirements is mandatory as of July 6 and compliance with the rest of the requirements is mandatory as of July 21.  Learn more from OSHA’s notice in the Federal Register.

National Institutes of Health

  • NIH director Francis S. Collins and other leaders have outlined their vision for a new science entity, the Advanced Research Projects Agency for Health, that was included in the president’s fiscal year 2022 budget with requested funding of $6.5 billion.  The purpose of the agency is to accelerate biomedical innovation and adoption of technologies and approaches to revolutionize health care and medicine.  Find the NIH announcement and a link to additional information about the agency here.
  • An NIH study published in the journal Science Translational Medicine concludes that “…there were 4.8 undiagnosed SARS-CoV-2 infections for every diagnosed case of COVID-19, and an estimated 16.8 million infections were undiagnosed by mid-July 2020 in the United States.”  Find the study here.

Medicare Payment Advisory Commission (MedPAC)

  • MedPAC has submitted formal comments to CMS about that agency’s proposed regulation describing how it plans to pay for acute-care hospital and long-term-care hospital inpatient care in FY 2022.  The MedPAC letter addresses limited parts of the proposed regulation.  Go here to see MedPAC’s letter to CMS.

Medicaid and CHIP Payment and Access Commission (MACPAC)

  • MACPAC has published a fact sheet with an updated analysis of physician acceptance of new Medicaid patients, including at the state level.  The analysis found that physicians were significantly less likely to accept new patients covered by Medicaid than patients with Medicare or private insurance, although acceptance varied by specialty and by state.  Learn more from the new MACPAC fact sheet “Physician Acceptance of New Medicaid Patients:  Findings from the National Electronic Health Records Survey.”
  • MACPAC has published an issue brief that describes how Medicaid programs can pay for certain housing-related services.  Learn more from the MACPAC issue brief “Medicaid’s Role in Housing.”

Government Accountability Office

Stakeholder Events

CMS – Coronavirus (COVID-19) Stakeholder Calls 

HHS’s “We Can Do This” campaign is a national initiative to build confidence in COVID-19 vaccines and get more people vaccinated.  This campaign offers tailored resources and toolkits for stakeholders to use to provide COVID-19 vaccine information to at-risk populations.  CMS is partnering with the campaign to offer several webinars to walk through each toolkit and its resources and train community organizations, local voices, and trusted leaders to use the campaign tools for vaccine outreach efforts to diverse communities.  Webinar dates and registration links are below:

  • Tuesday, June 29, 1:00-1:30 pm ET:  Faith-Based Toolkit – Register here
  • Thursday,  July 1, 1:00-2:00 pm ET:  Toolkits for Racial and Ethnic Minority Communities – Register here
  • Thursday, July 8, 1:00-1:30 pm ET:  Older Adults Toolkit – Register here

Wednesday, Thursday, and Friday, July 7, July 8, and July 9 CMS

CMS – Revisions to the Healthcare Common Procedure Coding System (HCPCS) Code Set

CMS will hold virtual meetings on July 7, 8, and 9, to discuss its preliminary coding recommendations for revisions of the HCPCS Level II code set.  For information about times, registration, submission of materials, signing up to speak, and submitting comments, click here.

Tuesday, July 13 Office of the National Coordinator for Health Information Technology (ONC)
ONC Workshop: Advancing SDOH Data Use and Interoperability for Achieving Health Equity
Tuesday, July 13 at 10:00 am – 4:00 pm ET  Click here for connection information
This workshop will explore existing and emerging data standards, tools, approaches, policies, models, and interventions for advancing the use and interoperability of non-clinical health data for individual and community health improvement.  It will share varying perspectives of health policy-makers and health improvement implementers to highlight inventive solutions, share challenges, and offer ideas on data modernization to advance health equity.  The workshop offers introductory content as well as deep exploration of key topics as part of social determinants of health IT data use and interoperability including facilitated, expert stakeholder engagement.

Federal Health Policy Update for Thursday, June 3

The following is the latest health policy news from the federal government as of 2:30 p.m. on Thursday, June 3.  Some of the language used below is taken directly from government documents.

White House

Health Policy News

  • Late last week the Biden administration released its proposed FY 2022 budget.  Most of the health care provisions had already been disclosed and discussed prior to the formal budget release.  For additional information about the proposed budget, see the following resources:

COVID-19

  • President Biden announced a “National Month of Action” to mobilize a drive to get 70 percent of U.S. adults at least one COVID-19 shot by July 4.  Throughout the month, national organizations, local government leaders, community-based and faith-based partners, businesses, employers, social media influencers, celebrities, athletes, colleges, young people, and thousands of volunteers across the nation will be asked to work together to get their communities vaccinated.  Learn more about the various facets of this campaign in this administration fact sheet.

Congress

  • Representative Frank Pallone, chair of the House Energy and Commerce Committee, and Senator Patty Murray, chair of the Senate Health, Education, Labor and Pensions Committee, have released a letter “…requesting information on design considerations for legislation to develop a public health insurance option” with a stated goal of “…establishing a federally administered public option… to work towards achieving universal coverage, while making health care simpler and more affordable for patients and families.”  The letter invites interested parties to respond to eight specific questions about such a public health insurance option, with written comments due by July 31.  Find the Pallone/Murray letter here.

Centers for Medicare & Medicaid Services

COVID-19

Health Policy News

  • CMS has posted the latest edition of its online publication MLN Connects.  Among items of interest in this edition are:
    • Medicare Shared Savings Program:  Submit Notice of Intent to Apply by June 7
    • Clinical Diagnostic Laboratories:  Key Dates for New & Reconsidered Test Codes
    • Clinical Diagnostic Laboratories:  Private Payor Rate-Based CLFS Resources
    • MACs Resume Medical Review on a Post-payment Basis
    • Improper Payment for Intensity-Modulated Radiation Therapy Planning Services
    • International Classification of Diseases, 10th Revision (ICD-10) and Other Coding Revisions to National Coverage Determination (NCDs) – October 2021
    • National Coverage Determination (NCD) 110.24:  Chimeric Antigen Receptor (CAR) T-cell Therapy
    • National Coverage Determination (NCD) 210.3:  Screening for Colorectal Cancer (CRC) – Blood-Based Biomarker Tests
    • National Coverage Determination (NCD) Removal
    • Quarterly Update for Clinical Laboratory Fee Schedule (CLFS) and Laboratory Services Subject to Reasonable Charge Payment

Go here for links to these and other items.

Department of Health and Human Services

COVID-19

  • HHS and its Health Resources and Services Administration (HRSA) have announced that $100 million in new funding is available through HRSA’s Rural Health Clinic Vaccine Confidence Program to support efforts to encourage residents of rural areas to receive COVID-19 vaccines.  Medicare-certified rural health clinics and organizations that own and operate such clinics are eligible for funding.  Learn more about the grant opportunity here.  Grant applications are due June 23.

Centers for Disease Control and Prevention

COVID-19

Food and Drug Administration

  • The FDA has recommended that health care workers and facilities transition away from crisis capacity personal protective equipment conservation strategies, such as using non-NIOSH-approved disposable respirators, including non-NIOSH-approved imported respirators such as KN95s.  This recommendation is in follow-up to an April 9, 2021 letter in which the FDA recommended a transition away from decontamination or bioburden-reduction systems for cleaning and disinfecting disposable respirators, which were being reused by health care personnel.  See the FDA’s new recommendation here and its April 9 letter here.

National Institutes of Health

COVID-19

  • The NIH announced that a new study has found that COVID-19 does not appear to pose a threat to the safety of the nation’s blood supply.  The analysis supports current donor screening guidelines, that do not require testing blood samples for COVID-19 but do require that donors be screened for physical symptoms of COVID-19 and for infections that occurred within 14 days of the blood donation.  The blood of donors with recent COVID-19 infections, or who develop infections after recent donations, cannot be used.  Learn more from this NIH news release.
  • The NIH has started a clinical trial in which adult volunteers who have been fully vaccinated against COVID-19 will receive booster doses of different COVID-19 vaccines to determine the safety and effectiveness of individuals receiving vaccines and boosters made by different pharmaceutical companies.  Learn more here.
  • The NIH announced that the experimental drug TEMPOL may be a promising oral antiviral treatment for COVID-19, as indicated by a study of cell cultures by NIH researchers.  Learn more from this NIH news release.

Health Policy News

  • The NIH has launched a clinical trial to assess the safety and effectiveness of an investigational influenza vaccine designed to provide long-lasting protection against multiple flu virus strains.  Healthy participants 18 to 50 years old will receive either a licensed seasonal influenza vaccine or the experimental vaccine that has been formulated to protect against multiple strains of influenza for much longer than one flu season.  Learn more here.

Congressional Research Service

  • The CRS has published a brief report on Medicaid’s money follows the person rebalancing demonstration program.  Find it here.

Medicaid and CHIP Payment and Access Commission

  • MACPAC has published an issue brief on Medicaid base and supplemental payments to hospitals that reviews each type of Medicaid hospital payment, with information on payment goals, payment amounts, and the relationship to other types of Medicaid payments.  It also provides examples showing how the use of supplemental payments varies by state and additional information about how state methods for financing Medicaid payments affect net hospital payments.  Find the report here.

Medicare Payment Advisory Commission

  • The GAO has appointed two new members to the MedPAC board:  Stacie B. Dusetzina, PhD, associate professor of health policy and an Ingram associate professor of cancer research at Vanderbilt University Medical Center in Nashville, Tennessee, andThe following is the latest health policy news from the federal government as of 2:30 p.m. on Thursday, June 3.  Some of the language used below is taken directly from government documents.

U.S. Equal Employment Opportunity Commission

Stakeholder Events

FEMA

Monday, June 7

FEMA’s National Exercise Division has developed exercise starter kits with sample documents to assist organizations with planning and conducting tabletop exercises aligning with the updated National Exercise Program 2021-2022 Principal’s Strategic Priorities.  FEMA will host webinars for whole community exercise practitioners.  The webinars will introduce the new exercise starter kits, providing stakeholders with an overview of the kits along with how to use them.  Visit the Homeland Security Exercise and Evaluation Program Webinar webpage to register.

FDA

Friday, June 11
Identification of Medicinal Products:  Path to Global Implementation
Monday, June 11 at 1:00 – 2:30 pm ET  Click here to learn more
The FDA will present updates on the identification of medicinal products standards development and implementation with an emphasis on international collaboration, pilot projects on substance, dosage form, and pharmaceutical identification.

Federal Health Policy Update for Thursday, May 27

The following is the latest health policy news from the federal government as of 2:45 p.m. on Thursday, May 27.  Some of the language used below is taken directly from government documents.

The White House

COVID-19

Medicaid and CHIP Payment and Access Commission

  • In a new issue brief, MACPAC describes the current use of health care provider taxes in Medicaid, the history and current state of the rules governing their use, and the potential effects of changes to these policies.

Centers for Medicare & Medicaid Services

Health Policy News

CMS has posted the latest edition of its online publication MLN Connects.  Among items of interest in this edition are:

  • Critical Care Evaluation & Management Services:  Comparative Billing Report in May
  • Medicare Shared Savings Program:  Submit Notice of Intent to Apply Beginning June 1
  • Submit Medicare GME Affiliation Agreements during COVID-19 PHE by January 1
  • Addition of the Shared System CWF to the Business Requirements for the Healthcare Common Procedure Coding System (HCPCS) codes U0002QW and 87635QW Mentioned in Change Request 11765
  • International Classification of Diseases, 10th Revision (ICD-10) and Other Coding Revisions to National Coverage Determination (NCDs) – July 2021
  • Quarterly Update to the Medicare Physician Fee Schedule Database (MPFSDB) – July 2021 Update
  • Complying with Medicare Signature Requirements – Revised
  • Medicare Diabetes Prevention & Diabetes Self-Management Training – Revised
  • Medicare Mental Health– Revised

Go here for links to these and other items.

Department of Health and Human Services

COVID-19

Health Policy News

Office of the Secretary
Dr. Stephen “Steve” Cha (he/him), Counselor to the Secretary, AHRQ/FDA/NIH
Melanie Fontes Rainer (she/her), Counselor to the Secretary, ACA/Marketplaces/OCR/CMMI
Steven Lopez (he/him), Counselor to the Secretary, Equity/OASH/HRSA/IHS
Ben Scott (he/him), Advance Representative
Josie Villanueva Prescott (she/her), Counselor to the Secretary, ACF/ACL
Dr. Mary Wakefield (she/her), Counselor to the Secretary
Laurence Wilson (he/him), Advance Representative

Office of the Deputy Secretary
Angela Botticella (she/her), Chief of Staff

Office of Intergovernmental and External Affairs
Molly Doris-Pierce (she/her), Special Assistant

Office of the Assistant Secretary for Legislation
Leslie Zelenko (she/her), Senior Advisor and Congressional Liaison

Office of the Assistant Secretary for Public Affairs
Kamara Jones (she/her), Deputy Assistant Secretary for Strategic Planning

Administration for Community Living
Dr. Anjali Forber-Pratt (she/her), Director, National Institute on Disability, Independent Living and Rehabilitation Research

Health Resources and Services Administration
Elaina Boutte (she/her), Special Assistant

Office of the Assistant Secretary for Health
Jessica “Jess” Swafford Marcella (she/her), Deputy Assistant Secretary for Population Affairs

Office of the Assistant Secretary for Planning and Evaluation
Dr. Tisamarie “Tisa” Sherry (she/her), Deputy Assistant Secretary for Planning and Evaluation (Office of Behavioral Health, Disability, and Aging Policy)

Centers for Disease Control and Prevention

COVID-19

Food and Drug Administration

COVID-19

Stakeholder Events

FEMA

Friday, May 28

Monday, June 7

FEMA’s National Exercise Division has developed exercise starter kits with sample documents to assist organizations with planning and conducting tabletop exercises aligning with the updated National Exercise Program 2021-2022 Principal’s Strategic Priorities.  FEMA will host webinars for whole community exercise practitioners.  The webinars will introduce the new exercise starter kits, providing stakeholders with an overview of the kits along with how to use them.  Visit the Homeland Security Exercise and Evaluation Program Webinar webpage to register.

CDC

Wednesday, June 2
Zoonoses and One Health Update (ZOHU) Call
Wednesday, June 2 at 2:00 – 3:00 pm ET   Click here to learn more
ZOHU Calls are one-hour monthly webinars that provide education on zoonotic and infectious diseases, One Health, antimicrobial resistance, food safety, vector-borne diseases, recent outbreaks, and related health threats at the animal-human-environment interface.

CDC

Thursday, June 3

CDC/Clinical Outreach and Communication Activity – “Long COVID”

The CDC will hold a one-hour call about its new interim guidance that provides a framework for health care providers in their initial assessment, evaluation, management, and follow-up of persons suspected of long COVID.  Go here for further information on the subject of the call and how to join it.

FDA

Friday, June 11
Identification of Medicinal Products:  Path to Global Implementation
Monday, June 11 at 1:00 – 2:30 pm ET  Click here to learn more
The FDA will present updates on the identification of medicinal products standards development and implementation with an emphasis on international collaboration, pilot projects on substance, dosage form, and pharmaceutical identification.

Internal Revenue Service

Federal Health Policy Update for Tuesday, April 27

The following is the latest health policy news from the federal government as of 3:00 p.m. on Tuesday, April 27.

The White House

COVID-19

Health Policy News

Congress

  • The New Democrat Coalition is a group of 94 mostly centrist Democrats working to bridge the gap between left and right on health care by offering proposals that seek to build on the policy infrastructure that currently exists rather than replacing it.  The coalition has written to President Biden with its list of policy recommendations that it asks him to incorporate into the American Families Plan.  Learn more about the New Democrat Coalition here and learn more about the health care policies it espouses in its recent letter to President Biden.
  • A group of 17 Democratic senators has written to President Biden asking him to pursue expansion of Medicare in his soon-to-be-unveiled American Families Plan.  Read that letter here.

Department of Health and Human Services

COVID-19

Health Policy News

  • HHS has announced the availability of $1 billion in American Rescue Plan money for Health Resources and Services Administration (HRSA)-Health Center Program-funded health centers to support major construction and renovation projects across the country.  Health centers that receive this funding will be able to use it for COVID-19-related capital needs and to construct new facilities, renovate and expand existing facilities, and purchase new equipment.  All of the nation’s nearly 1,400 HRSA-funded health centers will be eligible for these funds.  See the HHS announcement here and find information about submitting applications, which are due June 24, here.
  • HHS has released new buprenorphine practice guidelines that, among other things, remove a long-time requirement tied to training, which some practitioners have cited as a barrier to treating more people.  The order exempts eligible physicians, physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, and certified nurse midwives from federal certification requirements related to training, counseling, and other ancillary services that are part of the process for obtaining a waiver to treat up to 30 patients with buprenorphine.  For additional resources, consult:
  • HHS has published a request for information in the Federal Register about the development of a national public health strategy for the prevention and control of vector-borne diseases in humans.  The RFP solicits “…specific input regarding strategic goals, benchmarks, gaps, duplicative federally funded programs, and opportunities to enhance coordination data collection, research, and the development of diagnostics, treatments, vaccines and other related activities…” Submissions are due by June 11.  Go here to see the notice.
  • The administration has announced a new round of appointments to staff positions at HHS.  They are:

Office of the Secretary
Cynthia Palafox (she/her), Director of Scheduling and Advance
Karuna Seshasai (she/her), Executive Secretary
Alia Schechter (she/her), Special Assistant to the Secretary

Office of Intergovernmental and External Affairs
Carrie Pugh (she/her), Director of External Affairs

Office of the Assistant Secretary for Public Affairs
Tericka Lambert (she/her), Director of Digital Engagement

Office of the Assistant Secretary for Legislation
Rose Sullivan (she/her), Principal Deputy Assistant Secretary for Legislation

Office of the Assistant Secretary for Health
Arsenio Mataka (he/him), Senior Advisor for Health Equity and Climate

Administration for Children and Families
Kathryn “Kate” Wolff (she/her), Senior Advisor

Centers for Medicare and Medicaid Services
Hannah Katch (she/her), Senior Advisor

Food and Drug Administration
Erica Jefferson (she/her), Associate Commissioner for External Affairs

Food and Drug Administration

COVID-19

  • The FDA and CDC have lifted the pause on use of the Johnson & Johnson Janssen vaccine.  See the agencies’ joint news release announcing and explaining their decision.
  • The FDA has published a notice in the Federal Register about the authorization of emergency use of certain medical devices during the COVID-19 emergency.  The notice, found here, includes COVID-19 diagnostic tests.

Centers for Disease Control and Prevention

COVID-19

Medicaid and CHIP Payment and Access Commission

COVID-19

  • MACPAC has published a report on provider use of Medicaid retainer payments during the COVID-19 pandemic.  Retainer payments are temporary payments intended to preserve the financial viability of providers during disruptions in care, and unlike most other types of Medicaid payments, they are not tied to specific services used by a Medicaid enrollee.  During the COVID-19 pandemic, many states have used retainer payment authority as a source of relief for home and community-based providers experiencing decreases in utilization, temporary practice closures, or other circumstances that limit their ability to provide covered services to Medicaid beneficiaries.  See the MACPAC report here.

Stakeholder Events

Tuesday, April 27

FDA Webinar Series – Respirators and Other Personal Protective Equipment (PPE) for Health Care Personnel Use During the COVID-19 Pandemic
Tuesday, April 27 at 12:00 pm ET.  Click here for connection information.
The FDA hosts a webinar series to keep stakeholders informed about the latest resources and news related to PPE use during the COVID-19 pandemic.

Wednesday, April 28
FDA Virtual Town Hall SeriesCoronavirus (COVID-19) Test Development and Validation
Wednesday, April 28 at 12:15 pm ET.  Click here for connection information.
The FDA will host a virtual town hall for COVID-19 test developers.  The purpose of this event is to help answer technical questions about the development and validation of tests for COVID-19.

Thursday, April 29
FEMA National Business Emergency Operations Center Business & Infrastructure Conference Call
Thursday, April 29 at 3:00 pm ET.  Conference Dial-in:  800-619-3427, Participant PIN: 2725748.
This is a business and infrastructure partners call in alignment with President Biden’s plan to respond to COVID-19.  FEMA will work with other federal agencies to coordinate with state, tribal, and territorial authorities and private sector partners and others to assist, augment, and expedite vaccinations in the United States.

Wednesday, May 5
FDA Product-Specific Guidances:  Lighting the Development Pathway for Generic Drugs
Wednesday, May 5 at 9:00 am – 12:30 pm ET.  Click here for connection information.
The FDA will provide an overview of product-specific guidances, including how they are developed and revised and their role in facilitating generic drug development and generic drug application review.  The FDA will also discuss ways prospective and current generic drug applicants can use PSGs, including those for complex products, to improve the efficiency of generic drug development.

Wednesday, May 5
CDC Zoonoses and One Health Update (ZOHU) Call
Wednesday, May 5, at 2:00 pm – 3:00 pm ET.  Click here to learn more.
ZOHU calls are one-hour monthly webinars that provide education on zoonotic and infectious diseases, One Health, antimicrobial resistance, food safety, vector-borne diseases, recent outbreaks, and related health threats at the animal-human-environment interface.

Friday, May 7
FDA -Common Labeling Deficiencies and Tips for Generic Drug Applications
Friday, May 7 at 1:00pm – 2:00pm ET.  Click here for connection information.
The FDA will discuss the most common labeling mistakes found in abbreviated new drug applications (ANDAs) and how to avoid them and offer other labeling tips.  The FDA also will provide answers to common labeling questions asked by generic drug applicants.

Friday, May 12
Cybersecurity and Infrastructure Security Agency (CISA)
CISA 2021 Hurricane Webinar
Wednesday, May 12 at 10:30 am – 12:00pm ET.  Click here for registration.

This webinar will focus on providing awareness of CISA’s role and resources in hurricane preparedness and response activities associated with systems that make landfall on the continental U.S. or U.S. territories while in a COVID-19 environment.  It will also feature presentations from the NOAA Liaison to the National Operations Center and FEMA’s National Business Emergency Operations Center.

MACPAC Meets

The Medicaid and CHIP Payment and Access Commission met for two days last week in Washington, D.C.

The following is MACPAC’s own summary of the sessions.

MACPAC kicked off its April meeting with a review of a draft chapter for the June 2021 report to Congress and recommendations on addressing high-cost specialty drugs. Since 2017, the Commission has been working to identify potential models that could help states address the challenges of high prices. The presentation focused on drugs that have been approved by the U.S. Food and Drug Administration (FDA) under the accelerated approval pathway. Such approvals are based on whether the drug has an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit; however, unlike under the traditional pathway, the clinical benefit has yet to be verified.

On Friday, the Commission voted to approve two recommendations* that address Medicaid payment for such drugs. The recommendations would increase the rebates under the Medicaid Drug Rebate Program on accelerated approval drugs until these drugs have verified the clinical benefit. Once the FDA converts the drugs to traditional approval, the rebates would revert back to the standard amounts.

Commissioners then turned their attention to ways states can integrate care through Medicare Advantage dual eligible special needs plans (D-SNPs) using contract authority under the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA, P.L. 110-275). The draft chapter for the June report describes why MACPAC is focused on D-SNPs, MIPPA strategies available to states, state ability to use these strategies, and MACPAC’s plans for future work on specific strategies that if made mandatory could give further momentum to state efforts.

The Commission then discussed two additional draft chapters for the June 2021 report related to behavioral health services. Staff presented a draft chapter and recommendations on improving access to mental health services for adult Medicaid beneficiaries, followed by a draft chapter and recommendations on improving access to behavioral health services for children and youth.

Commissioners on Friday approved recommendations* that call on the Secretary of the U.S. Department of Health and Human Services to:

  • direct relevant agencies to issue joint subregulatory guidance that addresses how Medicaid and the State Children’s Health Insurance Program (CHIP) can be used to fund a crisis continuum for beneficiaries experiencing behavioral health crises;
  • direct a coordinated effort to provide education, technical assistance, and planning support to expand access to such services;
  • direct relevant agencies to issue joint subregulatory guidance that addresses the design and implementation of benefits for children and adolescents with significant mental health conditions covered by Medicaid and CHIP; and
  • direct a coordinated effort to provide education, technical assistance, and planning support to expand access to such services.

After a break on Thursday, Commissioners discussed a draft chapter for the June 2021 report to Congress on how electronic health records (EHRs) can be used to strengthen clinical integration and improve patient care.  Adoption of EHRs remains low among behavioral health providers. The chapter provides an overview of MACPAC’s work to date on clinical integration for behavioral and  physical health services, and discusses how data-sharing can improve the quality of care for beneficiaries with behavioral health conditions. It concludes by identifying ways to strengthen EHR uptake among Medicaid’s behavioral health providers.

Next, Commissioners reviewed a draft chapter on non-emergency medical transportation (NEMT). In recent years, policymakers at the state and federal levels have begun to re-examine this benefit. As part of a congressionally mandated request, MACPAC conducted a multi-pronged study of NEMT that will be published as a chapter in the June 2021 report to Congress. This presentation included the key findings of MACPAC’s study and an overview of the topics covered in the draft chapter.

On Friday, the day kicked off with a discussion of the challenges that states face in providing more care through home- and community-based services (HCBS). As of fiscal year (FY) 2018, HCBS spending as a percentage of long-term services and supports spending remained under 50 percent in 18 states and the District of Columbia. To understand why some states have made less progress in rebalancing, MACPAC contracted with RTI International and the Center for Healthcare Strategies. This presentation summarized the results of the work, as well as proposed policy considerations.

The Commission then heard a staff presentation on key Medicaid and CHIP managed care quality requirements, as well as quality improvement and measurement activities conducted by states, plans, and the Centers for Medicare & Medicaid Services. Staff also provided a summary of preliminary findings on state performance over time on selected core set measures and managed care plan performance on performance improvement projects, which suggest the effectiveness of these efforts is unclear. Staff and Commissioners identified potential areas for future MACPAC work related to quality of care in Medicaid and CHIP.

After the Commission voted on several recommendations, staff provided an update on the current state of Transformed Medicaid Statistical Information System (T-MSIS) data submissions and MACPAC’s work to validate and analyze the data. MACPAC found that data submissions have improved since 2016, but some challenges remain.

The meeting concluded with a panel discussion about Medicaid’s use of telehealth services, which expanded during the COVID-19 pandemic. Commissioners heard from Chethan Bachireddy, chief medical officer for the Virginia Department of Medical Assistance Services; Tracy Johnson, Medicaid director for the Colorado Department of Health Care Policy and Financing; and Sara Salek, chief medical officer for the Arizona Health Care Cost Containment System. Panelists described the use of telehealth during the pandemic, considerations for post-pandemic telehealth policies, and challenges to the use and adoption of telehealth in Medicaid and how these states are addressing them.

*All recommendations were approved as presented in draft.

Supporting the discussion were the following briefing papers:

  1. High-Cost Specialty Drugs Review of Draft Chapter and Recommendations
  2. Strategies for State Contracts with Dual Eligible Special Needs Plans
  3. Access to Mental Health Services for Adults: Draft Chapter and Recommendations
  4. Access to Behavioral Health Services for Children and Adolescents: Draft Chapter and Recommendations
  5. Electronic Health Records as a Tool for Integration of Behavioral Health Services
  6. Mandated Report: Non-Emergency Medical Transportation Benefit
  7. Progress on Rebalancing: Lessons from States
  8. Ensuring Medicaid and CHIP Quality
  9. Update on Transformed Medicaid Statistical Information System (T-MSIS)
  10. Panel Discussion: What States are Learning from Expanded Use of Telehealth

Because they serve so many Medicaid and CHIP patients – more than the typical hospital – MACPAC’s deliberations are especially important to private safety-net hospitals.

MACPAC is a non-partisan legislative branch agency that provides policy and data analysis and makes recommendations to Congress, the Secretary of the U.S. Department  of Health and Human Services, and the states on a wide variety of issues affecting Medicaid and the State Children’s Health Insurance Program.  Find its web site here.