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


  • 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  • CMS has repealed a regulation adopted in January of this year titled “Medicare Program; Medicare Coverage of Innovative Technology (MCIT) and Definition of `Reasonable and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.

More Hospitals Gain Than Lose in FY 2020 Value-Based Purchasing Program

Medicare’s value-based purchasing program will reward more hospitals than it will penalize in FY 2020 through its value-based purchasing program.

The program, in which 2700 hospitals are scored in four domains – clinical outcomes, safety, person and community engagement, and efficiency and cost reduction – will distribute $1.9 billion in bonus payments to 1500 hospitals.

Bonus payment average 0.6 percent, with a high of 2.93 percent.  Penalties average -0.39 percent, with a high of -1.72 percent.

Overall, rural hospitals performed better in the safety, person and community engagement, and efficiency and cost reduction categories and had a higher average score nation-wide while urban hospitals produced better clinical outcomes.  Smaller hospitals performed better in safety, person and community engagement, and efficiency and cost reduction.

Hospitals can find a link to their own adjustments here.

Learn more about how Medicare’s value-based purchasing program works and how hospitals will fare in FY 2020 in this CMS fact sheet.

Stark Changes Coming to Facilitate Value Care?

At a Washington, D.C. conference, Centers for Medicare & Medicaid Services Administrator Seema Verma announced that changes coming in Stark law requirements will enable Medicare to make better use of value-based purchasing in its reimbursement system.

In addition to addressing cybersecurity and electronic health record system issues, changes in the anti-self-referral law will seek to facilitate better coordination of care for Medicare patients.  Verma explained the underlying rationale for the anticipated changes, noting that

…in a system where we’re transitioning and trying to pay for value, where the provider is ideally taking on some risk for outcomes and cost overruns, we don’t have nearly as much of a need to interfere with who’s getting paid for what service.

Learn more from the Fierce Healthcare article “Verma promises hospital industry ‘significant’ Stark Law changes later this year.”

Safety-Net Hospitals Struggle in Medicare Joint Replacement Model

Non-safety-net hospitals are outperforming safety-net hospitals in the Comprehensive Care for Joint Replacement model introduced in 2016.

According to a new study published in Health Affairs,

…in comparison to non-safety-net hospitals, 42 percent fewer safety-net hospitals qualified for rewards based on their quality and spending performance (33 percent of safety-net hospitals qualified, compared to 57 percent of non-safety-net hospitals), and safety-net hospitals’ rewards per episode were 39 percent smaller ($456 compared to $743). Continuation of this performance trend could place safety-net hospitals at increased risk of penalties in future years.

What might be done to address this disparity?  The study suggests that

Medicare and hospital strategies such as those that reward high-quality care for vulnerable patients could enable safety-net hospitals to compete effectively in CJR.

Learn more in the Health Affairs article Performance of Safety-Net Hospitals in Year 1 of the Comprehensive Care for Joint Replacement Model.


Medicaid APMs Moving in New Directions

For the most part, states’ use of alternative payment models in their Medicaid programs so far have focused on the work done by primary and acute-care providers.  Now, a number of states are starting to extend their use of APMs in other areas, including:

  • behavioral health providers
  • safety-net providers
  • long-term care providers

Because safety-net hospitals serve so many more Medicaid patients than the typical hospital, they are more likely to be affected by this trend in the coming years.

For a look at what states are doing to drive value in Medicaid payments in these new areas, see the Commonwealth Fund article “The Next Generation of Paying for Value in Medicaid,” which can be found here.