Washington Healthcare Update

January 11, 2021

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This week in Washington: The 117th Congress will be in session on Jan. 21.


Proposed Rules

Final Rules/Guidance




CMS: 2022 Requests for Applications for the Value-Based Insurance Design (VBID) Model and its Hospice Benefit Component

On Jan. 8, the Centers for Medicare and Medicaid Services (CMS) announced that the Value-Based Insurance Design (VBID) Model team will host a webinar on Jan. 14, 2021, from 4-5 p.m. ET. During this webinar, presenters will provide a brief review of the recently released calendar year (CY) 2022 requests for applications (RFAs) for the VBID Model and the Hospice Benefit Component. This session will also offer attendees an opportunity to ask follow-up questions.

Please submit questions in advance by emailing the VBID mailbox at VBID@cms.hhs.gov.

CMS: MFAR to Be Formally Withdrawn

On Jan. 7, the Centers for Medicare and Medicaid (CMS) Administrator Seema Verma announced that CMS is withdrawing the Medicaid Fiscal Accountability Regulation (MFAR). She added that the 2020 year-end legislation that included supplemental pay transparency provisions would help achieve the proposed rule’s goals. However, the withdrawal notice did not appear to be on the Federal Register website as of her announcement.

CMS Adds to ACO, ESCO Resources with Resource Transformation Toolkit, Case Studies and Tip Sheet

On Jan. 6, the Centers for Medicare and Medicaid Services (CMS) announced the release of new resources highlighting strategies used by Medicare Accountable Care Organizations (ACOs) and End-Stage Renal Disease Seamless Care Organizations (ESCOs) in an effort to improve quality of care, lower health care costs and enhance beneficiary experience. These resources, posted on the ACO General Information web page, include:

  • A care transformation toolkit that describes ACO approaches to developing and implementing programs that transform the delivery of care and relate to telehealth, home visits and timely access to skilled nursing facilities. Find the toolkit here.
  • Four case studies that feature specific ACO and ESCO initiatives to:
  • A tip sheet that highlights strategies for enhancing education on home dialysis and for expanding the use of home dialysis. Find the tip sheet here.

CMS: Applications for MIPS Exceptions Due to COVID-19 Now Due Feb. 1

On Dec. 17, the Centers for Medicare and Medicaid Services (CMS) pushed back the deadline to Feb. 1 for doctors to apply for extreme and uncontrollable circumstances exceptions from the Merit-based Incentive Payment System to Feb. 1. CMS is reminding providers that that process can include a request to leave out one or more performance categories from their score due to the COVID-19 pandemic. However, the hardship application for the interoperability category would still have a Dec. 31 deadline.

Find more information here.

Proposed Rules

FDA Issues Draft Guide on Proprietary Naming of Non-Rx Drugs

On Dec. 11, the Food and Drug Administration (FDA) published a draft guidance that details how sponsors should select and screen proprietary names for nonprescription drugs. The new draft guidance, Best Practices in Developing Proprietary Names for Human Nonprescription Drug Products, makes naming recommendations for drugs that are switched from full-prescription and partial-prescription to nonprescription status. In the draft guide, FDA says drugs that switch from full-prescription to nonprescription status likely can keep the same name. However, drugs that are switched from partial-prescription to nonprescription status may need to have their names changed to avoid causing confusion among consumers.

Find the draft guidance here. Public comments are due by Feb. 8, 2021.

Final Rules/Guidance

CMS Issues Guidance to Address the Social Determinants of Health and Support State Value-Based Care Strategies

On Jan. 7, the Centers for Medicare and Medicaid Services (CMS) issued guidance to state health officials on the adoption of strategies that address the social determinants of health (SDOH) in Medicaid and the Children’s Health Insurance Program (CHIP). The purpose of the guidance is to further improve beneficiary health outcomes, reduce health disparities and lower overall costs in Medicaid and CHIP. The new guidance describes how states can leverage existing flexibilities under federal law to address adverse health outcomes that can be impacted by SDOH and supports states with designing programs, benefits and services that can more effectively improve population health and reduce cost.

Find the final guidance here.

CMS: States Have 6 Months After PHE to Drop Medicaid, CHIP Enrollees

On Dec. 22, the Centers for Medicare and Medicaid Services (CMS) issued guidance stating that states have up to six months after the COVID-19 public health emergency ends to begin kicking ineligible enrollees off Medicaid and Children’s Health Insurance Program rolls. The end of the COVID-19 public health emergency is currently set for Jan. 20, 2021, and the redetermination process will restart at the end of the month.

Find the guidance here.


Find a comprehensive look at “Courts and Healthcare Policy in 2020” here.

Appeals Court Clears Hospital Transparency Rule to Go Into Effect Jan. 1

On Dec. 29, the U.S. Court of Appeals for the District of Columbia Circuit ruled that the Department of Health and Human Services (HHS) could move forward with its hospital price transparency rule on Jan. 1, 2021. The final rule requires hospitals make public their standard charges for all items and services, including their gross charges and payer-specific negotiated charges. Hospitals will need to provide price transparency through a comprehensive machine-readable file with all items and services and a display of 300 shoppable services in a consumer-friendly format. The American Hospital Association is urging the incoming Biden administration not to enforce the rule for the duration of the COVID-19 public health emergency and to revise the rule.


GAO: Medicare Severe Wound Care – Spending Declines May Reflect Site of Care Changes; Limited Information Is Available on Quality

On Jan. 4, the Government Accountability Office (GAO) released a report on Medicare cost changes in caring for people immobilized by a health condition who may develop severe wounds, such as bedsores, that may require longer-term care. Some patients get wound care at costly long-term care hospitals, facilities that mostly admit patients with multiple serious conditions. Medicare began paying less to these hospitals for more stable patients in FY2016. Since then, these facilities have seen fewer patients with severe wounds, while facilities with lower costs, such as inpatient rehabilitation facilities, have seen more. There is not enough information to know if this affected quality of care, but Medicare spent less on severe wound care in FY2018 than in FY2016.

Find the full report here.

GAO: Defense Health Care – Efforts to Ensure Beneficiaries Access Specialty Care and Receive Timely and Effective Care

On Dec. 22, the Government Accountability Office (GAO) released a report on the likelihood that Department of Defense (DOD) health care beneficiaries will be able to access specialty care within three days after an urgent referral. The GAO analysis of 16,754 urgent referrals at military treatment facilities found that more than half met the three-day expectation and about 9 percent waited three weeks or longer. According to DOD, some longer waits were due to patient preference or pending lab results. In addition, the new electronic health record system that DOD implemented in 2017 has kept it from monitoring most (9 of 10) of the measures it uses for quality of care. DOD set a timeline for improvements underway to allow this monitoring.

Find the full report here.

If you have any questions, contact the following individuals atMcGuireWoods Consulting:

Stephanie Kennan, Senior Vice President
Mariam Eatedali, Research Associate

Founded in 1998,McGuireWoods Consulting LLC(MWC) is a full-service public affairs firm offering infrastructure andeconomic development, strategic communications & grassroots, and governmentrelations services. McGuireWoods Consulting is a subsidiary of theMcGuireWoods LLPlaw firm and has been named in The National Law Journal’s special annualreport, “The Influence 50,” for the past several years. In the most recentreport, McGuireWoods Consulting was ranked 15th of the 1,900 governmentrelations firms in Washington, D.C.

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