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Federal Health Policy Update for Wednesday, January 19

The following is the latest health policy news from the federal government as of 2:45 p.m. on Wednesday, January 19.  Some of the language used below is taken directly from government documents.

Public Health Emergency Declaration Renewed

  • HHS Secretary Xavier Becerra has renewed his department’s declaration of a public health emergency in response to the COVID-19 pandemic.  The renewal took effect on January 16 and extends the declaration for three months.  Find the declaration here.

Free COVID-19 Tests and Masks

  • Upon request, the federal government is now providing four free monthly home COVID-19 tests to every household.  Order those tests here.
  • The administration will make 400 million N95 respirators from the Strategic National Stockpile free to Americans. The N95 respirators will be available for the public to pick up at local pharmacies and health centers.  The masks will begin shipping this week and will start to become available late next week.  The notice is posted here.

White House

The White House has issued a fact sheet elaborating on several recent policy developments:

  • How individuals may get free COVID-19 tests delivered to their homes.
  • Additional information about the new requirement that health insurers must cover the cost of at-home COVID-19 tests.
  • The plan to provide more tests to schools.
  • Federal plans to establish more free testing sites and more surge testing sites.

Centers for Medicare & Medicaid Services

COVID-19

Health Policy Update

  • CMS has published a new edition of MLN Connects, its online newsletter with Medicare reimbursement information.  This latest edition includes articles on vaccine access in long-term-care facilities; the 2022 annual update of the clinical lab fee schedule and lab services subject to reasonable charge payment; new and expanded flexibilities for Rural Health Centers and Federally Qualified Health Centers during the COVID-19 public health emergency; changes in Rural Health Center payments that took effect on January 1; and more.  Learn more in this week’s MLN Connects.
  • CMS has published a quarterly update of the national correct coding initiative (NCCI) procedure-to-procedure edits, version 28.1, which takes effect on April 1, 2022.  Find the update here.
  • CMS’s Center for Medicare and Medicaid Innovation (CMMI) has published a list of 2022 participants in its Bundled Payments for Care Improvement Advanced (BPCI Advanced) Model, an advanced alternative payment model (APM) under its quality payment program.  Learn more about the program here and go here for a downloadable file with a list of the program’s 2022 participants.
  • CMMI has published the annual report for its Comprehensive ESRD Care Model.  Learn more about the model here and go here for the annual report for the program’s performance year five.

Department of Health and Human Services

Health Policy Update

  • HHS’s Office of the National Coordinator for Health Information Technology (ONC) has announced the publication of the Trusted Exchange Framework and the Common Agreement (TEFCA).  Entities will soon be able to apply and be designated as Qualified Health Information Networks (QHINs), which will connect to one another and enable their participants to engage in health information exchange across the country.  TEFCA supports multiple exchange purposes critical to improving health care and has the potential to benefit a wide variety of health care entities. This flexible structure should enable stakeholders – such as health information networks, ambulatory practices, hospitals, health centers, federal government agencies, public health agencies, and payers – to benefit from TEFCA through improved access to health information. Individuals also will be able to benefit from TEFCA and seek access to their health information through entities that offer individual access services.  Learn more about TEFCA from this HHS news release and from the TEFCA web page.  Interested parties also can go here for information about webinars that will offer an overview of the program and its implications.
  • HHS and its Health Resources and Services Administration (HRSA) have announced the availability of $13 million in funding to increase access to behavioral health care services and address health inequities in rural America, including through evidence-based, trauma-informed treatment for substance use disorder.  Eligible applicants include entities such as Rural Health Clinics, federally recognized tribes, tribal organizations, and community- and faith-based organizations.  Learn more about the funding from this HHS news release and HRSA’s grant opportunity notice.  Applications are due by April 19.
  • HHS’s Agency for Healthcare Research and Quality (AHRQ) invites nominations of individuals to serve as members of the U.S. Preventive Services Task Force.  Nominations are due March 15.  For further information, see this Federal Register notice.

Centers for Disease Control and Prevention

COVID-19

  • The CDC has updated its recommendations for isolation for people with COVID-19.  The updated guidance includes new recommendations for the duration of isolation for people with COVID-19 who are moderately or severely immunocompromised.  Find the updated guidance here.
  • The CDC has updated its consumer web page that describes the types of masks and respirators used to prevent the transmission of COVID-19.  The updated page describes the protection provided by available masks and respirators.  Find the updated page here.
  • The CDC has published research on racial and ethnic disparities in receipt of medications for the treatment of COVID-19 in the U.S. between March of 2020 and August of 2021.  Find the report here.

Health Policy Update

Food and Drug Administration

  • The FDA’s Center for Devices and Radiological Health has published its “Health of Women Program Strategic Plan.”  The plan presents a framework to further the FDA’s mission by protecting and promoting the health of women, strengthening regulatory science, and identifying and addressing current and emerging issues in medical device research and regulation for the health of all women.  To learn more about the plan, its purpose, and its priorities see this FDA statement and find the plan itself here.

FEMA

  • The administrator of the Federal Emergency Management Agency participated in a White House news briefing to outline steps FEMA is currently taking to support COVID-19 testing and health care providers serving large numbers of COVID-19 patients in the states.  Find a transcript of that briefing here.

Congressional Research Service

U.S. Preventive Services Task Force

  • The U.S. Preventive Services Task Force has invited public comment on its draft recommendations statement and draft evidence review on behavioral counseling to promote a healthy lifestyle in adults without cardiovascular risk factors.  While an independent, non-government body, the group was charged by the Affordable Care Act with making an annual report to Congress that identifies gaps in the evidence base for clinical preventive services and recommends priority areas that deserve further examination.  For information about the public comment period and links to the documents with the recommendations, go here.  Comments are due February 14.

Stakeholder Events

MACPAC – January 20-21

The Medicaid and CHIP Payment and Access Commission (MACPAC) will hold its next public meeting on January 20 and 21.  Go here for a meeting agenda and information about registering for the virtual meeting.

Federal Health Policy Update for Monday, November 15

The following is the latest health policy news from the federal government as of 2:45 p.m. on Monday, November 15.  Some of the language used below is taken directly from government documents.

The White House

Centers for Medicare & Medicaid Services – Final Guidance on Shared/Co-Located Hospital Spaces

  • In a memo to state survey agencies, CMS has published final guidance for the evaluation of compliance with the Medicare Conditions of Participation that address shared space and services for hospitals co-located with other hospitals or health care entities, updating guidance issued in May of 2019.  The revised guidance is shorter and less prescriptive and does not contain nearly as much detail as the 2019 draft.  Find it here.

Centers for Medicare & Medicaid Services

COVID-19

  • In a memo to state survey agencies, CMS has revised restrictions on nursing home visits, easing limits it introduced last year in an attempt to limit the spread of COVID-19.  Find the new guidance here.
  • A second CMS memo to state survey agencies on the subject of nursing homes suggests steps those agencies can take to address the backlog of facility complaint and recertification surveys that has amassed during the pandemic.  Find that memo here.

Health Policy Update

  • CMS has published the latest edition of MLN Connects, its online newsletter about Medicare reimbursement matters.  The new update has articles about CMS’s provider enrollment application fee for CY 2022, updates in the long-term hospital (LTCH) and inpatient rehabilitation facility (IRF) quality reporting programs for 2022, billing for durable medical equipment provided during inpatient stays, and more.  Go here to see the latest edition of MLN Connects.
  • CMS has released its Medicare Part A and Part B premiums for calendar year 2022.  The Part B increase is one of the largest in years, which CMS attributes to the possibility that it may be required to provide coverage for the use of the new Alzheimer’s treatment drug Aduhelm.  Learn more about 2022 Part A and Part B premiums and Medicare coverage changes in this CMS news release and an accompanying CMS fact sheet.
  • CMS has repealed a regulation adopted in January of this year titled “Medicare Program; Medicare Coverage of Innovative Technology (MCIT) and Definition of `Reasonable and Necessary’” that established faster access for Medicare beneficiaries to recently authorized medical devices designated as breakthroughs by the FDA.  See the repeal notice and read CMS’s rationale for its action in this Federal Register notice.

Centers for Disease Control and Prevention

Food and Drug Administration

  • HHS has withdrawn a policy that directed the FDA not to enforce pre-market review requirements for laboratory-developed tests.  The FDA also updated its policies regarding tests, including laboratory-developed tests, currently being offered prior to or without authorization as well as policies regarding the types of tests on which the FDA intends to focus its reviews in the future.  Go here to see the FDA announcement about this change and its future priorities and go here to read a statement from HHS Secretary Xavier Becerra outlining his rationale for the change.

National Institutes of Health

  • The NIH has enrolled the first participants in a study that will track up to 1000 children and young adults who previously tested positive for COVID-19 and evaluate the impact of COVID-19 on their physical and mental health over three years.  Learn more from this NIH announcement.

Medicaid and CHIP Payment and Access Commission (MACPAC)

  • In September of this year the Senate Finance Committee requested input on opportunities to enhance behavioral health care in the areas of strengthening the workforce; increasing integration, coordination, and access; ensuring parity between behavioral health and physical health care; furthering the use of telehealth; and improving access to behavioral health care for children and young people.  In its response to this request, MACPAC urges the committee to address the needs of adults and children enrolled in Medicaid and CHIP.  In addition, it stresses the need to address barriers to care that result in disparities in access to care and behavioral health outcomes for Black, Hispanic, and Asian American beneficiaries, people with disabilities, and those living in rural areas.  Go here to see MACPAC’s full response.

Stakeholder Events

CMS – Hospital/Quality Imitative Open Door Forum – November 17

CMS will hold a Hospital/Quality Initiative Open Door Forum on Wednesday, November 17 at 2:00 p.m. (eastern).  The forum will address a number of issues, including the CY 2022 hospital outpatient prospective payment system and ambulatory surgical center payment system final rule, outpatient payments, pass-through drugs and devices, ambulatory surgical center payments, hospital price transparency, and the Radiation Oncology Model.  This forum will be held by conference call.

To participate, dial 1-888-455-1397 and use conference passcode 8604468

HHS/Center for Medicare and Medicaid Innovation – November 18

On Thursday, November 18 HHS’s Center for Medicare and Medicaid Innovation will host a webinar listening session at 1:00 p.m. (eastern) as a follow-up to the release of its recently published document “Driving Health System Transformation – A Strategy for the CMS Innovation Center’s Second Decade.”  The listening session will be an opportunity for stakeholders to share with CMS leaders their perspectives on how to execute the agency’s strategic vision.  Register for the event and find more information here.

CDC/NIOSH – Mental Health of the Health Care Workforce – November 18

On Thursday, November 18 the CDC’s National Institute for Occupational Safety and Health (NIOSH) will host a virtual event with NIOSH director Dr. John Howard, Surgeon General Dr. Vivek Murthy, and other national experts from labor and medicine on the mental health of the nation’s critical health workforce.  Go here to learn more about the participants and the subjects they plan to address and go here to register to participate.

CDC – Antibiotic Prescribing and COVID-19 – November 18

The CDC will hold a webinar titled “What Clinicians, Pharmacists, and Public Health Partners Need to Know About Antibiotic Prescribing and COVID-19” on Wednesday, November 18 at 2:00 p.m. (eastern).  Go here for information about the webinar, the presenters, and how to participate.

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

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

Federal Health Policy Update for Wednesday, November 10

The following is the latest health policy news from the federal government as of 2:45 p.m. on Wednesday, November 10.  Some of the language used below is taken directly from government documents.

The White House

  • The White House announced that it will spend $785 million in American Rescue Plan funding to support community-based organizations building vaccine confidence across communities of color, rural areas, and low-income populations; bolster the efforts of Tribal communities leading the way in mitigating the spread of the virus; expand public health systems’ ability to respond to the needs of people with disabilities and older adults who have been among the highest risk for infection or death from COVID-19; and continue its mission to build a more diverse and sustainable public health workforce, including a new apprenticeship program that will train thousands of our COVID-19 community health workers and prepare them for long-term careers in public health.  Learn more from a White House fact sheet about the initiative.
  • The president has issued a memo to the secretary of the Department of Homeland Security and the administrator of the Federal Emergency Management Agency (FEMA) directing them to continue reimbursing states for 100 percent of the cost of using their national guard units in their response to the COVID-19 pandemic through April 1, 2022.  See that memo here.
  • The White House has posted a transcript of the November 10 press briefing given by its COVID-19 response team and public officials.  Go here for the slides presented during that briefing.

Provider Relief Fund:  Phase 3 Payment Reconsideration

  • The Health Resources and Services Administration (HRSA) is accepting requests for reconsideration from providers that believe their Provider Relief Fund Phase 3 payments were incorrectly calculated.  Providers may not revise or correct their submitted application and the reconsideration will address only the calculation itself and not objections to the calculation methodology.  Go here for further information.  The deadline for submitting requests for reconsideration of Phase 3 payments is this Friday, November 12.

Department of Health and Human Services

COVID-19

  • HHS will invest $650 million from the American Rescue Plan to strengthen manufacturing capacity for quick, high-quality diagnostic testing through rapid point-of-care molecular tests and improve Americans’ access to them.  HHS will use these funds to ramp up U.S. domestic manufacturing capacity.  Learn more from this HHS announcement.
  • HHS will spend $143.5 million in American Rescue Plan money to expand community-based efforts to conduct tailored local outreach about vaccines, build vaccine confidence, and address barriers to vaccination in their communities.  The funding will support two programs in which award recipients will develop regional and local partnerships to reach unvaccinated individuals, including pregnant women and people from underserved and high-risk communities, to help bolster COVID-19 vaccination efforts.  Learn more from this HHS news release.  Much of the funding has already been awarded but $10 million is still available, to be awarded on a competitive basis.  Learn more from this HHS funding notice.  Applications are due December 10.

Health Policy News

  • HHS’s Office on Women’s Health has announced that more than 200 hospitals are participating in the HHS Perinatal Improvement Collaborative, which will focus on improving maternal and infant health outcomes by reducing disparities.  Including hospitals from all 50 states, the collaborative will be the first to evaluate how pregnancy affects overall population health by linking inpatient data of newborns to their mothers.  Learn more about the program and find a list of the participating hospitals in this HHS announcement.

HHS/Center for Medicare and Medicaid Innovation

Next Thursday, November 18, the CMS Innovation Center (CMMI) will host a webinar listening session at 1 p.m. (eastern).  Register for that webinar and find more information here.

CMMI has requested stakeholder input on three specific questions and NASH intends to submit responses on behalf of its members.  To do so, we need to hear from you.  Please review the CMMI questions below and send us your written responses no later than the close of business this Friday, November 12.  If you prefer to share your responses to these questions via phone, we will be happy to schedule a call with you.

Questions from CMMI

  1. What is the greatest obstacle to participating in a CMS Innovation Center or other value-based, accountable care model, and how do you recommend the CMS Innovation Center alleviate this obstacle?
  2. CMS is currently exploring quicker, more actionable data, learning collaboratives, and payment and regulatory flexibilities. What else could the CMS Innovation Center do to support clinicians and help them be successful in models?
  3. How can CMMI better incorporate patient needs and goals into models? How should the impacts of value-based care on patients be measured?

NASH staff will compile member responses and submit them to CMMI prior to next week’s listening session.

Centers for Medicare & Medicaid Services

COVID-19

  • Last week CMS held a webinar to explain the new federal regulation that mandates COVID-19 vaccines for all health care workers and others employed by provider organizations regulated under Medicare’s conditions of participation.  Learn more about the regulation from this video of the webinar and the slides presented during the event.  CMS also has posted an infographic about the requirement.
  • The Surgeon General has released a new community toolkit to help individuals, health care professionals and administrators, teachers, school administrators, librarians, and faith leaders to understand, identify, and stop the spread health misinformation in their communities.  Learn more from this HHS announcement and go here to see the toolkit.

Centers for Disease Control and Prevention

Medicaid and CHIP Payment and Access Commission (MACPAC)

Stakeholder Events

HHS – Monoclonals and More:  Issues and Opportunities with Early COVID-19 Treatment Options – November 12

HHS’s Office of the Assistant Secretary for Preparedness and Response will hold a webinar on COVID-19 treatment with monoclonal antibodies on Friday, November 12 at 12:30 p.m. during which it will address some of the most current recommendations for use of monoclonal antibodies, upcoming therapies, and the challenges and opportunities that new therapies may pose in conjunction with monoclonal antibodies and other treatments (e.g., prioritization and distribution).  Speakers also will highlight operational principles for a scaled strategy for use of these therapeutics in a scarce resource situation.  For more information about the webinar and to register, go here.

CMS – COVID-19 Vaccines and Rural Communities – November 15

CMS will hold a webinar on COVID-19 vaccines and rural communities for its community providers and partners working in rural areas.  Go here for further information about the webinar and to register to participate.

CDC – Antibiotic Prescribing and COVID-19 – November 18

The CDC will hold a webinar titled “What Clinicians, Pharmacists, and Public Health Partners Need to Know About Antibiotic Prescribing and COVID-19” on Wednesday, November 18 at 2:00 p.m. (eastern).  Go here for information about the webinar, the presenters, and how to participate.

Federal Health Policy Update for Monday, October 25

The following is the latest health policy news from the federal government as of 2:30 p.m. on Monday, October 25.  Some of the language used below is taken directly from government documents.

NASH Advocacy:  MedPAC and Safety-Net Hospitals

On the heels of a recent meeting of the Medicare Payment Advisory Commission (MedPAC) during which commission members discussed the challenges inherent in attempting to identify safety-net hospitals, NASH has written to the agency to suggest that it consider a different approach to addressing that matter.  In the letter, NASH suggests that MedPAC urge Medicare to look not at individual hospitals and what kinds of patients they serve but to focus instead on vulnerable communities and then to identify the hospitals that are caring for meaningful proportions of the residents of those communities.  Go here to see NASH’s letter to MedPAC.  In response to this letter, MedPAC scheduled a meeting with NASH to discuss this concept.

NASH Advocacy:  Surprise Billing Regulation

Representatives Suozzi (D-NY), Wenstrup (R-OH), Ruiz (D-CA), and Bucshon (R-IL) are leading a bi-partisan congressional sign-on letter to HHS Secretary Becerra and others, urging the administration to revise the Surprise Billing, Part II interim final rule’s (IFR) implementation of the independent dispute resolution (IDR) process.

The letter states that

…we urge you to revise the IFR to align with the law as written by specifying that the certified IDR entity should not default to the median in-network rate and should instead consider all of the factors outlined in the statute without disproportionately weighting one factor.

NASH is listed among the supporters of this letter.

Action required:  NASH members should contact their House members today to ask them to sign on to the Suozzi-Wenstrup-Ruiz-Bucshon letter to support the successful implementation of Congress’s surprise billing ban.  The deadline for representatives to sign onto the letter is this Friday, October 29.

If you would like more information about the letter or if you need contact information for your representatives, contact Kate Finkelstein.

Provider Relief Fund:  Deadline for Submission is Tuesday, October 26

  • The Health Resources and Services Administration (HRSA) will accept applications for $25.5 billion in health care relief funds until October 26.  Go here for further information.
  • HRSA has modified some of the terms for applying for assistanceAll applicants must complete the first step of the application process (i.e., submitting their Tax Identification Number (TIN) and associated information for Internal Revenue Service (IRS) validation no later than October 26, 2021 at 11:59 PM EST.  The required IRS validation that occurs after completion of the first step may take a few days.  If an applicant submits their TIN for validation by the October 26, 2021 deadline and that TIN is subsequently validated by the IRS, the applicant will have until November 3, 2021 at 11:59 PM EST to complete and submit their application.
  • The Provider Relief Fund FAQ has been updated with seven modified or new questions on pages 4, 9, 10 (two questions), 37, and 58 (two questions); all are dated 10/20/2021.  Entities that have received Provider Relief Funds in the past and/or intend to apply for Phase 4 funds should review these changes carefully.

The White House

  • In anticipation of the FDA’s independent advisory committee meeting on October 26 and the CDC’s independent advisory committee meeting on November 2-3, the administration has unveiled a plan to ensure that if a vaccine is authorized for children ages 5-11 it is quickly distributed and made conveniently and equitably available to families across the country.  Learn more from this White House fact sheet.
  • The White House has posted transcripts of the October 20 and October 22 press briefings given by its COVID-19 response team and public officials.

Centers for Medicare & Medicaid Services

Health Policy News

  • CMS has issued guidance to states about the statutory requirement for them to cover COVID-19-related treatment without cost-sharing in Medicaid and CHIP for many seniors, low-income adults, pregnant women, children, and people with disabilities who receive health coverage through these programs.  This coverage includes care for conditions that could complicate the treatment of COVID-19 in patients who are presumed positive for the virus or have been diagnosed with COVID-19.  Find a news release about the guidance here and find the guidance itself here.
  • CMS has posted a new edition of MLN Connects, its online newsletter.  This latest edition includes features on new/modifications of the place of service codes for telehealth, a prescriber’s guide to Medicare prescription drug opioid policies, and more.  Go here to find these and other items.
  • In a separate, special edition of MLN Connects, CMS presents new Medicare rates and billing information for Moderna and Johnson & Johnson booster vaccines.
  • The CMS Innovation Center has published a document that shares its strategic direction for the coming years.  Driving Health System Transformation – A Strategy for the CMS Innovation Center’s Second Decade reviews the lessons the agency has learned over the past ten years and lays out its objectives for the next ten.  Find it here.
  • CMS’s Center for Medicare and Medicaid Innovation has posted the fourth evaluation report and performance year 5 (2020) financial and quality results for its Next Generation ACO Model.  Find the report by going here and scrolling down to “Performance Year 5 (2020 (XLS).”
  • CMS’s “Medicare & You” handbook is now available in Chinese, Korean, and Vietnamese.  Go here for the agency’s announcement and links to the new handbooks.

Department of Health and Human Services

Health Policy News

  • HHS is awarding $797.5 million in American Rescue Plan funding to support survivors of domestic violence and sexual assault and their children.  The funds will cover COVID-19 testing, vaccines, mobile health units, and other support for domestic violence services programs and increase support for sexual assault service providers and culturally specific services.  Learn more about the new spending and how it will be distributed in this HHS news release and additional program resources.
  • HHS proposes repealing two final rules:  “Department of Health and Human Services Good Guidance Practices,” published in the Federal Register on December 7, 2020; and “Department of Health and Human Services Transparency and Fairness in Civil Administrative Enforcement Actions,” published in the Federal Register of January 14, 2021, maintaining that “…they create unnecessary hurdles that hinder the Department’s ability to issue guidance, bring enforcement actions, and take other appropriate actions that advance the Department’s mission.”  Learn more about the rules that would be repealed and HHS’s rationale for doing so in this Federal Register notice.

Centers for Disease Control and Prevention

  • The CDC has taken a series of actions to address COVID-19 booster vaccines, deciding that:
    • The use of a single booster dose of the Moderna COVID-19 vaccine that may be administered at least six months after completion of the primary series to individuals 65 years of age and older; 18 through 64 years of age at high risk of severe COVID-19; and 18 through 64 years of age with frequent institutional or occupational exposure to COVID-19.
    • The use of a single booster dose of the Johnson & Johnson vaccine may be administered at least two months after completion of the single-dose primary regimen to individuals 18 years of age and older.
    • Each of the available COVID-19 vaccines may be use as a booster dose in eligible individuals following completion of primary vaccination with a different available COVID-19 vaccine.  This is now being referred to by many as “mixing and matching.”
    • A single booster dose of the Pfizer vaccine may be administered at least six months after completion of the primary series to individuals 18 through 64 years of age with frequent institutional or occupational exposure to COVID-19.

Stakeholder Events

CDC – Information about Recent Updates to CDC’s Recommendations for COVID-19 Boosters – October 26

On Tuesday, October 26 the CDC will provide an overview for clinicians of the most recent recommendations for administering COVID-19 booster vaccines and updates about the latest recommendations and clinical considerations for administering those boosters.  Go here for further information about the webinar and how to participate.

CDC – Pediatric COVID-19 Vaccines – November 4

The CDC will hold a webinar on Thursday, November 4 to provide an overview of its recommendations and clinical considerations for administering COVID-19 vaccines to children between the ages of five and eleven years old.  Go here for further information about the webinar and how to participate.

HHS – Monoclonals and More:  Issues and Opportunities with Early COVID-19 Treatment Options – November 12

HHS’s Office of the Assistant Secretary for Preparedness and Response will hold a webinar on COVID-19 treatment with monoclonal antibodies on Friday, November 12 at 12:30 p.m. during which it will address some of the most current recommendations for use of monoclonal antibodies, upcoming therapies, and the challenges and opportunities that new therapies may pose in conjunction with monoclonal antibodies and other treatments (e.g., prioritization and distribution).  Speakers also will highlight operational principles for a scaled strategy for use of these therapeutics in a scarce resource situation.  For more information about the webinar and to register, go here.

Innovation Center Unveils Blueprint

The CMS Innovation Center has published a document that shares its strategic direction for the coming years.

Driving Health System Transformation – A Strategy for the CMS Innovation Center’s Second Decade reviews the lessons the agency has learned over the past ten years and lays out its objectives for the next ten:

  • Drive Accountable Care – increase the number of people in a care relationship for quality and total cost of care.
  • Advance Health Equity – embed health equity in every aspect of CMS Innovation Center models and increase focus on underserved populations.
  • Support Care Innovation – leverage a range of supports that enable integrated, person-centered care such as actionable, practice-specific data, technology, dissemination of best practices, peer-to-peer learning collaborations, and payment flexibilities.
  • Improve Access by Addressing Affordability – pursue strategies to address health care prices, affordability, and reduce unnecessary or duplicative care.
  • Partner to Achieve System Transformation – align policies and priorities across CMS and aggressively engage payers, purchasers, providers, states, and beneficiaries to improve quality, to achieve equitable outcomes, and to reduce health care costs.

In addition, the document summarizes the lessons the CMS Innovation Center has learned over the past ten years, outlines future approaches to assessing the agency’s impact, and presents an implementation strategy for the coming years.

Learn more about what the CMS Innovation Center has in mind for providers, payers, and patients in the agency’s new document Driving Health System Transformation – A Strategy for the CMS Innovation Center’s Second Decade and find a summary of the document here.

Changes Coming in Innovation Center Payment Models

Future Medicare payment models will probably feature less risk for participants and a greater emphasis on health equity.

At least that is the vision shared by Centers for Medicare & Medicaid Services chief operating officer Jon Blum during a recent conference.

While not backing away from including risk in future value-based purchasing models, CMS and the Center for Medicare and Medicaid Innovation Center will probably propose fewer full-risk models, which the agency fears favor wealthier providers that can afford to shoulder more risk to begin with, and a greater focus on reporting race and ethnicity data among future model participants as the federal government works to close equity gaps.

In addition, CMMI will probably simplify its array of payment models and have fewer tracks within those models.

Learn more about the directions CMMI envisions moving with its Medicare alternative pay models in the near future in the Fierce Healthcare article “CMS official:  Don’t expect a lot of fully risk-based payment models going forward.”

New Health Care Leaders Share Priorities

New leaders at the Centers for Medicare & Medicaid Services and the Center for Medicare and Medicaid Innovation are quickly making their priorities known to health care industry stakeholders.

For new CMS administrator Chiquita Brooks-LaSure, her priority is coverage.  She has declared that “Our focus is going to be on making sure regulations and policies are going to be focused on improving coverage,” and while she hopes that states that have not yet expanded their Medicaid programs will take advantage of current federal incentives to do so, there is another path to coverage:  “…the public option or other coverage certainly would be a strategy to make sure people in those states have coverage.”

For new CMMI director Liz Fowler, one of her stated objectives is to make more value-based payment models mandatory rather than voluntary, noting that “What we have learned from CMMI models over the past 20 years is that voluntary models [are] subject to risk selection, which has a negative impact on the ability to generate system-level savings.”  To that end, Fowler said she and CMMI are exploring more mandatory models.

Learn more about the directions new federal health care leaders hope to take their operations in the Kaiser Health News article “Expanding Insurance Coverage is Top Priority for New Medicare-Medicaid Chief” and the Fierce Healthcare article “CMMI director:  expect more mandatory value-based care payment models.”

“Oh Say Can We See?”: Ways & Means Leaders Seek CMMI Transparency

The chairman and ranking member of the House Ways and Means Committee have written to CMS administrator Seema Verma to ask her to address the lack of transparency in the Center for Medicare and Medicaid Innovation.

In the bipartisan letter, committee chairman Richard Neal (D-MA) and ranking member Kevin Brady (R-TX) note that “…Congress established CMMI to test different innovative delivery system and payment models to improve quality and reduce costs for Medicare and Medicaid beneficiaries” but observe that “…significant policy changes made unilaterally by the executive branch without sufficient transparency could yield unintended negative consequences for beneficiaries and the health care community.

Their request:

We strongly urge the Agency to provide more sunshine in this process, all allow Congress, beneficiaries, and stakeholders greater opportunity to provide feedback into the policies that CMMI tests that affect millions of Americans with Medicare.

The letter also poses a series of questions about CMMI’s current endeavors.

Learn more from the letter from Representatives Neal and Brady to CMS administrator Seema Verma.

Medicaid Birthing Model Improves Outcomes

A federal program to improve birth outcomes among Medicaid-covered women has produced positive results:  lower rates of pre-term births, fewer low birthweight babies, fewer C-sections, lower delivery costs, and lower first-year health care spending.

The “Strong Start for Mothers and Newborns” program was a four-year initiative established by the Affordable Care Act and developed by the U.S. Department of Health and Human Services’ Center for Medicare and Medicaid Innovation to employ patient education, nutrition, exercise, preparation for childbirth, breast-feeding, and family planning rather than strictly medical interventions and was delivered through three evidence-based prenatal care models:  Birth Centers, Group Prenatal Care, and Maternity Care Homes.

The program, operated in 219 separate sites in 32 states, served participants with especially challenging socio-economic risk factors:  unemployment, lack of a high school degree or GED, food insecurity, transportation challenges, chronic health problems, and previous poor birth outcomes.  The objective of the program was to find ways to overcome these social determinants of health and produce better birth outcomes and now, a new, independent evaluation has found that it did.

Learn more about Strong Start for Mothers and Newborns and what it has produced in the official program evaluation document.

Administration Moving Away From Value Pay?

First, new Medicare programs for lump-sums payments for cardiac care and joint replacements were scaled back.

Then, additional doctors were exempted from a new payment system that would have paid them more for the results they produce than for the quantity of care they provide.

Next, the Department of Health and Human Services presented a document outlining a new direction for its Center for Medicare and Medicaid Innovation.

And it announced that it was seeking input from doctors on payment policy.

All suggest that if the Trump administration is not moving away for paying for quality rather than quantity it is at least considering pursuing value in different ways.

What ways?  A recent article in the New York Times looked at these recent changes and presented the views of experts on where the administration may be going with Medicare payment policy.  Go here to see that article.