Federal Health Policy Update for Tuesday, June 15

The following is the latest health policy news from the federal government as of 3:30 p.m. on Tuesday, June 15.  Some of the language used below is taken directly from government documents.

NASH Advocacy

  • Reduced hospital admissions as a result of people deferring needed medical care during the pandemic could jeopardize safety-net hospitals’ continued eligibility for the section 340B prescription drug program.  Two bills currently in Congress, H.R. 3203 and S. 773, would protect safety-net hospitals and others from this one-year anomaly and NASH has written to members of Congress asking them to co-sponsor and support those bills.  See NASH’s letter to members of Congress.

Provider Relief Fund

  • Late last week HHS announced that it has increased the amount of time providers will have to report information and extended key deadlines for expending Provider Relief Fund payments for recipients that received payments after June 30, 2020.  The revised reporting requirements will be applicable to providers that received one or more payments exceeding, in the aggregate, $10,000 during a single payment-received period from the Provider Relief Fund General Distributions, Targeted Distributions, and/or Skilled Nursing Facility and Nursing Home Infection Control Distributions.  For additional information, see the following resources:

HHS also has updated its Provider Relief Fund FAQ to reflect those changes.  The changes in the FAQ, which address how much time fund recipients have to spend their grants, how they must report on their spending, how audits will be conducted, and how certain data elements in the reporting requirements are defined, can be found within the document on pages 8, 14, 16, 22-25, and 40.  HHS also has updated the FAQ section of the Provider Relief Fund web site and the reporting requirements and auditing section of that site to reflect these changes.

Department of Health and Human Services

COVID-19

  • HHS announced that it has provided $424.7 million in funding from the American Rescue Plan to more than 4200 Rural Health Clinics (RHCs) for COVID-19 testing and mitigation.  Later this summer HHS will issue up to $35.3 million in additional funding to RHCs that meet eligibility requirements.  Funding is based on how many certified clinic sites RHCs operate and is $100,000 for each clinic site.  RHCs will use the money to maintain and increase COVID-19 testing, expand access to testing for rural residents, and broaden efforts to mitigate the spread of the virus in ways tailored to local communities.  See HHS’s announcement about the funding.
  • HHS’s Office of the Secretary for Preparedness and Response has published a document titled “Innovations in COVID-19 Patient Surge Management” that offers brief case studies on how four different jurisdictions handled major increases in COVID-19 cases.

Health Policy News

  • HHS’s Office of the Secretary for Preparedness and Response has published a new table-top exercise toolkit to help emergency planners create an interactive, discussion-based exercise focusing on the effects on health care coalitions and health care facilities of large numbers of patients seeking care following exposure to an infectious agent.  Find the toolkit here.

Centers for Disease Control and Prevention

COVID-19

Food and Drug Administration

  • The FDA announced that it has authorized the use of a limited supply of Johnson & Johnson COVID-19 vaccine manufactured at a plant that is not yet an authorized manufacturing facility.  At the same time, it concluded that some vaccine materials manufactured in that same plant may not be used for COVID-19 vaccines.  In addition, the FDA has extended the expiration date for the refrigerated Johnson & Johnson vaccine after reviewing information submitted by the company.  Learn more from this FDA news release.
  • In a new episode of the FDA Office of Minority Health and Health Equity Forum Podcast, Rear Admiral Richardae Araojo discusses FDA’s emergency use authorization process with Rear Admiral Denise Hinton, the FDA’s chief scientist.  Go here for a transcript of the discussion and to find a link to the podcast itself.

National Institutes of Health

  • The NIH reports that results from a Phase 3 clinical trial show that the Novavax investigational vaccine demonstrated 90.4 percent efficacy in preventing symptomatic COVID-19 disease.  The vaccine showed 100 percent protection against moderate and severe disease.  In people at high risk of developing complications from COVID-19 the vaccine showed 91 percent efficacy in preventing symptomatic COVID-19 disease.  Learn more from the NIH news release.
  • The NIH announced that a new antibody testing study examining samples originally collected through its “All of Us” research program found evidence of COVID-19 infections in five states earlier than had initially been reported.  The results expand on findings from a CDC study that suggested that SARS-CoV-2, the virus that causes COVID-19, was present in the U.S. as far back as December of 2019.  See the NIH news release here.

Medicare Payment Advisory Commission (MedPAC)

  • MedPAC has released its annual report to Congress.  The report includes:
  • Mandatory reports that evaluate the skilled nursing facility value-based purchasing program; assess the impact of recent changes in Medicare’s clinical laboratory fee schedule payment rates; and examine the relationship between clinician services and other Medicare services.
  • Reports requested by Congress on private equity and Medicare and Medicare beneficiaries’ access to care in rural areas (an interim report).
  • Additional reports on rebalancing Medicare Advantage benchmark policy; streamlining CMS’s portfolio of alternative payment models; revising Medicare’s indirect medical education payments to better reflect teaching hospitals’ costs; Medicare vaccine coverage and payment; and improving Medicare’s policies for separately payable drugs in the hospital outpatient prospective payment system.

Learn more from MedPAC’s announcement about its June report and find the report itself here.

Medicaid and CHIP Payment and Access Commission (MACPAC)

  • MACPAC has sent its annual report to Congress.  The report addresses high-cost specialty drugs in the Medicaid program; access to mental health services for those enrolled in Medicaid and the State Children’s Health Insurance Program (CHIP); integration of physical and behavioral health care through electronic health records; Medicaid’s non-emergency transportation benefit; and state strategies for integrating care for people who are dually eligible for Medicaid and Medicare.  See MACPAC’s announcement about its report here and find the report itself here.

National Association of Medicaid Directors

  • The National Association of Medicaid Directors has published “Medicaid Forward,” which it describes as identifying “…opportunities for action to address immediate and long-term challenges for children’s health emerging from the COVID crisis across communities.  The report is amplified by real-world examples of states that have implemented the strategies outlined in the framework.”

Government Accountability Office

  • The Medicare Access and CHIP Reauthorization Act of 2015 established the Physician-Focused Payment Model Technical Advisory Committee to provide comments and recommendations to HHSSHH on physician payment models and gave the Comptroller General responsibility for appointing its members.  GAO is now accepting nominations of individuals to serve on this committee.  Letters of nomination and resumes should be submitted no later than July 16.  Learn more from this notice published in the Federal Register.

Stakeholder Events

Wednesday, June 16 – FDA

Virtual Town Hall Series – Coronavirus (COVID-19) Test Development and Validation
Wednesday, June 16 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 town hall is to help answer technical questions about the development and validation of tests for COVID-19.

Wednesday and Thursday, June 16 and June 17 – FEMA

COVID-19 Pandemic Operational Guidance Webinars
Wednesday, June 16 at 7:00 at 8:00 pm ET  Click here for connection information

FEMA is offering a series of webinars throughout the month of June to further educate people on its pandemic operational guidance.  The webinar will cover information included in COVID-19 Pandemic Operational Guidance: All Hazards Incident Response and Recovery, a document aimed at helping emergency managers plan for disaster response and recovery while adhering to public health guidelines to prevent the spread of COVID-19.  This is webinar is also being offered on Thursday, June 17 at 1:00 – 2:00 PM.

Thursday, June 17 – U.S. Health Sector Cybersecurity Coordination Center (HC3)
HC3 Cybersecurity Threat Briefing on Threat Hunting
Thursday, June 17 at 1:00 pm ET  Click here to learn more
HHS’s HC3 program invites stakeholders to join its second cybersecurity threat briefings in June; the topic will be “Threat Hunting.”  This initiative will provide actionable information on health sector cybersecurity threats and mitigations.  HC3 analysts will present relevant cybersecurity topics, engage in discussions with participants on current threats, and highlight best practices and mitigation tactics.

Thursday, June 17 – CDC
Evaluating and Caring for Patients with Post-COVID Conditions
Thursday, June 17 at 2:00 – 3:00 pm ET  Click here to learn more

During this CDC Clinician Outreach and Communication Activity (COCA) Call, clinicians will learn about the CDC’s new interim guidance that provides a framework for health care providers in their initial assessment, evaluation, management, and follow-up of persons with possible post-COVID conditions. Post-COVID conditions refer to the wide range of physical and mental health consequences experienced by some patients that are present four or more weeks after COVID-19 infection, including by patients who had initial mild or asymptomatic acute infection.

Friday, June 18 – Office of the National Coordinator for Health Information Technology (ONC)
ONC Workshop: Advancing Social Determinants of Health Data Use and Interoperability for Achieving Health Equity
Friday, June 18 at 10:00 am – 4:30 pm ET  Click here to learn more
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 enable varying perspectives of health policy-makers and health improvement implementers to highlight inventive solutions, share challenges, and review 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.

Tuesday, June 22 – FDA
FDA Drug Topics: Overview of Risk Evaluation and Mitigation Strategies (REMS) for Health Care Providers
Tuesday, June 22 at 1:00 – 2:15 pm ET  Click here to learn more
This webinar will provide an overview of REMS and discuss how REMS safety requirements affect prescribers, dispensers, and patients.  Participants should gain an understanding of the REMS authorities, how REMS are implemented, and the entities that provide oversite and support.  REMS is a drug safety program that the FDA can require for certain medications with serious safety concerns to help ensure that the benefits of the medication outweigh its risks.

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.

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:

  • Thursday, June 17 1:00-1:30 pm ET: Rural Toolkit – Register here
  • Tuesday, June 22, 1:00-1:30 pm ET: Spanish Language Toolkits – Registration TBD*
  • Thursday June 24, 1:00-1:30 pm ET: Healthcare workers Toolkit – Registration TBD
  • Tuesday, June 29, 1:00-1:30 pm ET: Faith-Based Toolkits – Registration TBD
  • Thursday, July 1, 1:00-2:00 pm ET: Toolkits for Racial and Ethnic Minority Communities – Registration TBD
  • Thursday, July 8, 1:00-1:30 pm ET: Older Adults Toolkit – Registration TBD

Go here for registration information for the remaining dates.

NASH Seeks Congress’s Help With 340B

Changing hospital admissions experiences in the past year resulting from the COVID-19 pandemic could jeopardize some safety-net hospitals’ continued eligibility for the section 340B prescription drug discount program and NASH is asking for Congress’s help to prevent this.

COVID-19 led to a reduction of hospitals admissions as people deferred addressing their medical problems out of fear of contracting the virus.  These reduced admissions, a one-year anomaly, could affect safety-net hospitals’ ability to continue participating in the 340B program, which is an essential tool for  helping hospitals provide low-cost prescription drugs to low-income patients in the communities they serve.

For this reason, NASH has asked members of Congress to co-sponsor and support H.R. 3203 and S. 773, which would protect hospitals from losing eligibility for the 340B program based on one year of once-in-a-lifetime admissions pattern changes.  See NASH’s message to members of Congress.

Hospitals Lower on Resources Less Likely to Help Patients See Health Data

Hospitals with fewer resources are less likely to offer app-based approaches that enable their patients to see their medical data, according to the Office of the National Coordinator for Health Information Technology, the federal agency that oversees such matters.

While patient access to their data has increased markedly in recent years, investment in the technology to make this possible has not been even across different types of hospitals:  smaller hospitals are less likely to be able to afford such investments than larger hospitals, rural and critical access hospitals are less likely to be able to afford such investments than suburban and urban hospitals, and independent hospitals are less likely to be able to afford such investments than those affiliated with health systems.

The National Alliance of Safety-Net Hospitals has long pointed out that many private safety-net hospitals, with their greater numbers of public insured and uninsured patients, lack the resources for such investments in comparison to other hospitals that serve larger proportions of privately insured patients for whom they are paid more appropriately for the care they provide.  The disparity in the adequacy of public and private reimbursement, NASH maintains, has contributed to hindered a disparity in hospital resources that has hindered the efforts to safety-net hospitals to do more to help their patients gain access to their own medical data.

Learn more about the role that access to resources plays in hospitals’ ability to enable their patients to view their personal medical data in the Fierce Healthcare article “Low-resource hospitals behind the curve on app-based data access for patients, ONC says.”

Federal Health Policy Update for Wednesday, May 19

The following is the latest health policy news from the federal government as of 2:15 p.m. on Wednesday, May 19.  Some of the language used below is taken directly from government documents.

NASH Advocacy

  • NASH has written to all members of Congress urging them to contact Health and Human Services Secretary Xavier Becerra about directing more of its remaining CARES Act Provider Relief Fund money to private safety-net hospitals to help them serve their diverse, predominantly low-income communities during the COVID-19 emergency.  Go here to see NASH’s message to Congress.

The White House

COVID-19

Centers for Medicare & Medicaid Services

Health Policy News

Go here for links to these and other items.

Department of Health and Human Services

COVID-19

  • HHS’s Substance Abuse and Mental Health Services Administration (SAMHSA) is distributing $3 billion in American Rescue Plan funding for its mental health and substance use block grant programs.  The Community Mental Health Services Block Grant Program and Substance Abuse Prevention and Treatment Block Grant Program are distributing $1.5 billion each to states and territories to help communities addressing mental health and substance use needs during the COVID-19 pandemic.  Learn more from HHS’s news release announcing the funding.
  • HHS’s Office of the Inspector General has updated its work plan for COVID-19-related audits, evaluations, and inspections scheduled for May.
  • In conjunction with the California Justice Department and the U.S. Attorney’s Office for the Eastern District of California, HHS’s Office of the Inspector General has issued a news release advising the public that they should not be asked by providers to pay for COVID-19 vaccines and reminding providers that they may not attempt to charge or bill consumers for administering those vaccines.  See the news release here.
  • HHS’s Office of the Assistant Secretary for Preparedness and Response has published information about the challenges of providing hospice care amid the COVID-19 pandemic and about providing home care during the public health emergency.

Health Policy News

Senate Finance Committee Hearing

The Senate Finance Committee held a hearing today on COVID-19 flexibilities.

  • Go here to read the opening statement of the committee chair, Senator Ron Wyden (D-OR) and go here to read the opening statement of the committee’s ranking minority member, Senator Mike Crapo (R-ID).
  • Go here to see the testimony of individuals who appeared at the hearing.
  • The Medicare Payment Advisory Commission has submitted a written statement to the committee.  The MedPAC statement notes that “While many of these actions have been helpful in addressing the short-term issues presented by the pandemic, continuing those changes indefinitely would have drawbacks.  Therefore, policymakers should be cautious about extending them beyond the duration of the public health emergency (PHE) or other scheduled expiration date.”  The statement pays particular attention to telehealth and post-acute care.  Go here to see the MedPAC submission “Temporary modifications of Medicare policies in response to the coronavirus public health emergency.”
  • The Government Accountability Office has submitted a report to the Senate Finance Committee on the same subject.  The GAO notes that it undertook this work, titled “Medicare and Medicaid:  COVID-19 Program Flexibilities and Considerations for Their Continuation,” because of a CARES Act provision that calls for the agency to “… conduct monitoring and oversight of the federal government’s response to the COVID-19 pandemic.”  Find the GAO submission here.

Centers for Disease Control and Prevention

COVID-19

Food and Drug Administration

COVID-19

National Institutes of Health

COVID-19

National Academy of Medicine

FEMA

Government Accountability Office

Safety-Net Hospitals Need More COVID Aid, NASH Tells Congress

The federal government should direct more of its remaining CARES Act Provider Relief Fund money to private safety-net hospitals, the National Association of Safety-Net Hospitals told members of Congress in a message delivered yesterday.

While the Provider Relief Fund has been a lifesaver for safety-net hospitals, NASH noted, the formula for distributing money put high-volume Medicaid hospitals at a disadvantage compared to the typical community hospital while separate distributions of the CARES Act money specifically for safety-net providers missed many such hospitals entirely

Last week NASH wrote to Health and Human Services Secretary Xavier Becerra to bring this situation to his attention and seek his assistance, and in its Monday message to members of Congress, NASH asked those members to convey to Secretary Becerra their support for greater aid to private safety-net hospitals in future Provider Relief Fund distributions.

See NASH’s message to members of Congress.

NASH Seeks Changes in Provider Relief Fund Distributions

Concerned that some private safety-net hospitals have not received Provider Relief Fund Phase 3 distributions and that others have not received adequate grants, the National Alliance of Safety-Net Hospitals has written to Health and Human Services Secretary Xavier Becerra to ask for changes in HHS’s approach to the CARES Act grants intended to help hospitals absorb the additional expenses they have incurred and the revenue they have lost as a result of the COVID-19 emergency.

Specifically, NASH urged HHS to:

  • Review the eligibility criteria and methodology for determining Provider Relief Fund grants to ensure that they reach true safety-net hospitals, and in particular those that serve especially large numbers of Medicaid patients.
  • Recalculate Phase 3 grants in a way that better reflects the true financial obstacles safety-net hospitals have faced throughout the COVID-19 emergency.
  • Apply more appropriate criteria and a better methodology for calculating payments in future Provider Relief Fund distributions.

Learn more from NASH’s letter to HHS Secretary Becerra.

Federal Health Policy Update for Friday, May 14

The following is the latest health policy news from the federal government as of 2:30 p.m. on Friday, May 14.  Some of the language used below is taken directly from government documents.

NASH Advocacy

  • NASH has written to Health and Human Services Secretary Xavier Becerra to urge his department to apply more appropriate criteria and a better methodology for calculating payments in all future Provider Relief Fund distributions.  Learn more from NASH’s letter to HHS Secretary Becerra.

The CDC and Mask Guidance

The White House

COVID-19

Centers for Medicare & Medicaid Services

COVID-19

  • CMS has released data highlighting the continued impact of the COVID-19 emergency on Medicaid and Children’s Health Insurance Program (CHIP) beneficiaries and their utilization of health care services.  The data show that from March through October 2020, beneficiaries skipped millions of primary, preventive, and mental health care visits due to COVID-19 in comparison to the same time period in 2019.  Although utilization rates for some treatments have rebounded to pre-pandemic levels, mental health services show the slowest rebound.  Learn more from the following resources:

Health Policy News

  • CMS has issued guidance to states on how they can receive enhanced American Rescue Plan funding to increase access to home and community-based services (HCBS) for Medicaid beneficiaries.  This guidance seeks to assist states with leveraging federal resources to increase health equity in Medicaid beneficiaries’ access to HCBS, positive health outcomes, and community integration.  Those resources include a one-year increase of 10 percent in federal Medicaid matching money for such expenditures.  The guidance was issued to states through a CMS letter to state Medicaid directors.  Go here to see CMS’s announcement about the enhanced HCBS funding and go here to see the CMS letter to state Medicaid directors.

Centers for Disease Control and Prevention

COVID-19

FEMA

Medicaid Coverage “Cliff” Poses Threat to Low-Income Medicare Beneficiaries

Nearly one-third of Medicare beneficiaries do not meet the criteria for Medicaid eligibility but have so little income that they are unlikely to be able to afford their share of their Medicare costs, such as co-pays and deductibles.

This is known as the “Medicaid coverage cliff,” and because they care for so many low-income seniors, the Medicaid coverage cliff poses a bigger threat to private safety-net hospitals, and to the patients they serve, than it does to the typical community hospital.

Becker’s Hospital Review, drawing from a recent study published in the journal Health Affairs, takes a brief look at what the Medicaid cliff is and how it may affect the well-being of those affected by this cliff.  Learn more in the Becker’s Hospital Review article “5 things to know about the Medicaid coverage ‘cliff’.”

Federal Health Policy Update for Friday, March 26

Beginning this week, NASH is expanding its regular updates to encompass a broader scope of federal health policy endeavors to include other matters of importance to providers.  Feel free to share this newsletter with others in your organization or to send us the email addresses of those you think might be interested and we will send it directly to them.

The following is the latest such information from the federal government as of 2:30 p.m. on Friday, March 26.

NASH Advocacy

The Senate voted 90-2 to extend the moratorium on the two percent sequester of Medicare payments through the end of 2021.  The House will take up the bill when it returns to Washington, DC in mid-April.  The current moratorium will expire on March 31, but CMS is expected to use its authority to hold Medicare payments for up to 14 days to give the House time to pass the legislation.  NASH sent a thank you note to all 90 senators who voted for the bill.

The White House

COVID-19

Department of Health and Human Services

COVID-19

Centers for Medicare & Medicaid Services

COVID-19

Health Policy News

  • CMS has posted the latest edition of MLN Connects, its online publication with the latest information about Medicare reimbursement policy.  The following is the table of contents of the March 25 edition, with links to the individual articles:

News

Compliance

Claims, Pricers, & Codes

MLN Matters® Articles

Centers for Disease Control and Prevention

COVID-19

Food and Drug Administration

COVID-19

  • The FDA announced that “Given the sustained increase in [COVID-19] viral variants in the United States that are resistant to bamlanivimab administered alone, and the availability of other authorized monoclonal antibody therapies that are expected to retain activity to these variants, the U.S. Government, in coordination with Eli Lilly and Company, will stop the distribution of bamlanivimab alone starting today, March 24, 2021.”  Using the other monoclonal antibody therapies, the FDA reasons, will increase the likelihood of successful treatment against COVID-19 variants.  Go here to see the FDA’s announcement and explanation and for links to resources that describe the available monoclonal antibodies and their differences in greater detail.

NASH Asks HHS for Provider Relief Fund Grants

Phase 3 distributions of Provider Relief Fund grants are long overdue and sorely needed by private safety-net hospitals, the National Alliance of Safety-Net Hospitals has declared in a letter to new Department of Health and Human Services Secretary Xavier Becerra.

NASH’s letter to Becerra notes that the COVID-19 emergency has posed a special challenge to private safety-net hospitals and that in too many cases, those safety-net hospitals have not received appropriate support from the CARES Act’s Provider Relief Fund.  In its letter, NASH asks Secretary Becerra to direct HHS staff to distribute the more than $20 billion remaining in the Provider Relief Fund as soon as possible and to make safety-net hospitals a priority in that distribution.

Learn more from NASH’s letter to Secretary Becerra.