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Health Policy Update for Wednesday, April 14

The following is the latest health policy news from the federal government as of 2:45 p.m. on Wednesday, April 14.

Temporary Halt to Use of the Johnson & Johnson Janssen Vaccine

  • The White House held a press briefing on Tuesday, April 13 during which the White House press secretary, its COVID-19 response coordinator, and Dr. Anthony Fauci discussed the decision to halt administration of the Johnson & Johnson (Janssen) vaccine until its safety can be further examined.  Learn more from a transcript of that briefing.
  • Representatives of the FDA and CDC briefed the news media on the situation involving the Johnson & Johnson vaccine.  Listen to that briefing here.
  • The FDA and CDC issued a joint statement noting some adverse effects from the Johnson & Johnson COVID-19 vaccine and explaining that

CDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday to further review these cases and assess their potential significance. FDA will review that analysis as it also investigates these cases. Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution.

Congress – Medicare Sequestration Legislation

COVID-19

  • The House has passed a bill to extend the moratorium on the two percent Medicare sequestration cut that has been delayed throughout the pandemic; this latest delay would extend to December 31, 2021.   President Biden is expected to sign the bill and then CMS will begin processing the claims it has been holding since April 1 in anticipation of the bill’s passage.  Those claims will be paid without the two percent sequestration deduction.

The White House

COVID-19

Centers for Medicare & Medicaid Services

COVID-19

  • CMS is terminating some of its COVID-19 waivers for health care providers that apply to long-term-care settings.  Find the terminated waivers, marked in red with “terminated effective,” followed by a May 9 or May 10, 2021 date, on pages 18 and 19 of its compendium of COVID-19 emergency blanket waivers.

Health Policy News

  • CMS has extended the deadline for interested parties to apply to participate in its Primary Care First Cohort 2 to May 21, 2021 and the deadline for payer applications has been extended to June 18, 2021.  Learn more from the following resources:

Department of Health and Human Services

COVID-19

  • HHS’s Office for Civil Rights, Administration for Community Living, and Office of the Assistant Secretary for Planning and Evaluation have published several new resources to help states, vaccination providers, and others’ COVID-19 response activities improve access to vaccines for people with disabilities and older adults.  These resources clarify legal requirements, illustrate some of the barriers to vaccine access faced by people with disabilities and older people, and offer strategies for ensuring accessibility.  These resources include:
  • New guidance from the Office for Civil Rights outlining legal standards under federal civil rights laws prohibiting disability discrimination and providing examples of the application of legal standards in the context of COVID-19 vaccine programs and how to implement them.
  • An Office of Civil Rights fact sheet presenting specific steps that those involved in the planning and distribution of vaccines to combat the COVID-19 pandemic may wish to consider to promote compliance with disability rights laws and provide access to vaccination programs for people with disabilities.
  • The Administration for Community Living has compiled strategies and best practices for helping older adults and people with disabilities gain access to COVID-19 vaccines.
  • Learn more about these activities and other relevant resources from these agencies in the HHS news release announcing this initiative.

Health Policy News

  • HHS marked Black Maternal Health Week by announcing actions to expand access to continuous health care coverage and access to preventive care in rural areas to improve maternal health outcomes.  HHS also announced that Illinois will be the first state to provide continuity of full Medicaid benefit coverage for mothers by offering extended eligibility for a woman during the entire first year after delivery.  In addition, HHS announced a Notice of Funding Opportunity that will make $12 million available over four years for a Rural Maternity and Obstetrics Management Strategies program that will enable awardees to test models to address unmet needs for their target population, with applicants required to focus on populations that have historically suffered from poorer health outcomes, health disparities, and other inequities.  Three award recipients will each receive up to $1 million annually for up to four years to test models to address unmet needs for their target population.  Learn more from the following resources:
  • HRSA is seeking nominations of qualified candidates for consideration for appointment as members of the Advisory Committee on Training in Primary Care Medicine and Dentistry.  Nominations are due September 30.  See the HRSA notice here.

Food and Drug Administration

COVID-19

Government Accountability Office

COVID-19

  • The GAO has published a new report titled “Efforts to Increase Vaccine Availability and Perspectives on Initial Implementation.”  Find a brief summary of the report here and the entire report here.

Health Policy Update for Tuesday, March 30

The following is the latest health policy news from the federal government as of 3:30 p.m. on Tuesday, March 30.

Medicare Sequestration

  • In anticipation of possible congressional action to extend the two percent sequester reduction suspension, CMS has instructed the Medicare Administrative Contractors (MACs) to hold all claims with dates of service on or after April 1, 2021 for a short period without affecting providers’ cash flow.  This will minimize the volume of claims the MACs must reprocess if Congress extends the suspension.  The MACs will automatically reprocess any claims paid with the reduction applied if necessary.  NASH has been a strong proponent of extending the suspension of the Medicare sequester.

The White House

COVID-19

  • The White House has posted a fact sheet explaining that President Biden will announce that 90 percent of the adult U.S. population will be eligible for vaccination and 90 percent will have a vaccination site within five miles of their home by April 19.  The key elements of the plan are:
  • Expanding vaccines to 20,000 more local pharmacies, bringing the total to nearly 40,000 pharmacies across the country by April 19.
  • Launching a new effort to get the most vulnerable and at-risk seniors and people with disabilities vaccinated.
  • Expanding the number of mass vaccination centers across the country.
  • The White House has posted a transcript of the March 29 press briefing provided by its COVID-19 response team and public health officials.

Department of Health and Human Services

COVID-19

  • HHS, the CDC, and the Administration for Community Living (ACL) will spend nearly $100 million to help increase vaccinations among older adults and people with disabilities.  With funding from the CDC, the ACL will award nearly $93 million in grants to aging and disability networks in every state and territory.  This effort will include an additional $5 million in funding for national hotlines to help older adults and people with disabilities register for vaccinations and to connect them with local disability and aging agencies that can provide services and supports necessary to obtain them.  Learn more from HHS’s announcement of this initiative.

Health Policy News

  • HHS’s Substance Abuse and Mental Health Services Administration (SAMHSA) is accepting applications for FY 2021 screening, brief intervention, and referral-to-treatment grants.  The purpose of this program is to implement screening, brief intervention, and referral-to-treatment services for children, adolescents, and/or adults in primary care and community health settings with a focus on screening for underage drinking, opioid use, and other substance use.  Eligible applicants include public and private non-profit health care or behavioral health care systems such as hospital systems, pediatric health care providers, children’s hospitals, and community health or behavioral health centers, HMOs, PPOs, and FQHC systems.  Applications are due April 19.  Learn more from the SAMHSA announcement.
  • HHS’s Center for Medicare and Medicaid Innovation has announced that its request for applications to participate in an aspect of its Community Health Access and Rural Transformation (CHART) Model designed to involve 20 rural-focused accountable care organizations will be delayed from April of 2021 to the spring of 2022.  Learn more here.

Centers for Medicare & Medicaid Services

COVID-19

  • CMS has issued section 1135 waivers to Texas, Nevada, and Kentucky.  1135 waivers give states greater flexibility to serve their Medicaid beneficiaries during the COVID-19 public health emergency.

Health Policy News

  • In a message to state survey agencies, CMS announced that it has lifted the previously extended 30-day survey suspension for hospitals.  Survey activity will resume in accordance with previous non-long-term-care guidance.  Under the suspension, surveys had been limited to immediate jeopardy complaint allegations posing imminent danger to patients at the hospital, non-compliance with Medicare hospital conditions of participation, and matters requiring immediate action to be taken to protect the health and safety of patients.  Hospital recertification surveys were suspended except for a subset of hospital re-accreditation surveys under guidance provided to the accrediting organizations.  Hospital enforcement actions for deficiencies that did not represent immediate jeopardy had their termination date extended for at least 30 days.  CMS is now lifting the 30-day limitations imposed for hospital surveys as of March 23, 2021.  Among the resumed activities are reviews of non-immediate jeopardy hospital complaints, hospital plans of correction, desk reviews, on-site reviews, and work on open enforcement cases.  Learn more in this CMS memo to state survey agencies.

Centers for Disease Control and Prevention

COVID-19

National Institutes of Health

COVID-19

  • In a preliminary NIH study of recovered COVID-19 patients, researchers found that T-cells in those patients recognize most COVID-19 variants and offer some protection against those variants.  This suggests that vaccines may offer similar protection.  The NIH notes that additional research is needed.  Learn more here.

Federal Emergency Management Agency

COVID-19

  • FEMA announced that it has amended 58 COVID-19-related disaster declarations to increase FEMA’s share of the eligible costs associated addressing the disaster activities covered by the declarations from 75 percent to 100 percent.  See FEMA’s announcement here.
  • FEMA announced that it will provide financial assistance for COVID-19-related funeral expenses incurred after January 20, 2020.  Go here for information about eligibility and applications.

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.

House to Consider Extending Medicare Sequester Delay

The moratorium on the two percent sequestration of Medicare payments could be extended under a bill the House may consider this week.

If adopted, the bill would extend the sequester delay for nine months, providing financial relief that many health care providers seek as they continue to deal with the financial challenges posed by COVID-19.

The sequester delay was implemented early in the pandemic as a means of providing additional Medicare revenue to hospitals and other health care providers at a time when many people were delaying seeking medical attention out of fear of contracting COVID-19.

Without action by Congress, the current delay of the Medicare sequester will expire at the end of March.

NASH has urged Congress to extend the Medicare sequestration delay on a number of occasions, doing so most recently in this March 4 message.

Learn more about the latest effort to extend the Medicare sequester delay in the Fierce Healthcare article “House to vote later this week on bill to delay Medicare sequestration payment cuts.”