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Washington DC Update 12/15/2020
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September is National Suicide Prevention Awareness Month. The Centers for Disease Control and Prevention (CDC) has created a new webpage for coping with stress in the difficult times resulting from the COVID-19 pandemic.

Greetings from Washington, DC
The big issues in DC right now are:

  • FDA authorization for emergency use of coronavirus vaccines – On Thursday, an FDA advisory committee recommended that the FDA grant “emergency use authorization” (EUA) of the vaccine developed by Pfizer for individuals age 16 and above. Next steps: the FDA decision about whether to grant the EUA; CDC recommendations for use of the vaccine; federal delivery of the vaccine to states; administration of the vaccine to those in the highest-priority categories as determined by each state, territory, and tribe. 

  • COVID-relief legislation – The two houses of Congress and the White House are negotiating on a package to provide assistance to individuals and businesses; there is no agreement yet on whether to provide assistance to states and localities, among other issues.

  • Surprise billing legislation – A bipartisan, House-Senate agreement has been reached on how to protect consumers from surprise medical bills, and will likely be included in a year-end appropriations/COVID-relief bill. 

  • Regulations and guidance The administration has issued and proposed regulations and guidance that would curtail Medicaid benefits and make it more difficult to administer Medicaid and other health programs.

  • Supreme Court decision to take up case about waivers for establishing work requirements for Medicaid beneficiaries.

  • President-Elect Biden’s selections for positions in his administration.
The Election & Transition
Biden Selects Health Officials

The president-elect has selected the following individuals for health-related positions in his administration (see Biden unveils health team with Becerra, Murthy, Walensky in top roles, The Hill, 12/07/20):

Secretary of Health and Human Services (HHS): California Attorney-General (AG), and former House Member, Xavier Becerra, who is known for being the leader of the group of Democratic attorneys-general who are defending the Affordable Care Act (ACA) in a lawsuit challenging the law’s constitutionality. There is some disagreement among observers about whether the HHS Secretary should have more substantive health-policy experience than Becerra possesses. See In Becerra, an HHS Nominee With Political Skill But No Front-Line Health Experience (Kaiser Health News, 12/08/20).  

Director of the Centers for Disease Control and Prevention (CDC): Rochelle Walensky, MD, who heads the infectious-diseases department at Massachusetts General Hospital and is a professor of medicine at Harvard Medical School. She has conducted research on HIV and AIDS, with an emphasis on equity and access to treatment. See Biden’s choice to run CDC is a respected specialist who is unafraid to speak her mind (Washington Post, 12/08/20).

Surgeon-General: Vivek Murthy, MD, who served in that position under President Obama. He will also serve as one of three leaders of a new coronavirus task force. See President-elect Biden announces coronavirus task force made up of physicians and health experts (Washington Post, 11/09/20).
Additional Steps in Selection of President
The Congressional Research Service (CRS), an arm of Congress, recently updated The Electoral College: A 2020 Presidential Election Timeline (Congressional Research Service, 10/22/20), which describes the steps taken between the election and inauguration to formally select the next president and vice-president. 

The most important dates and actions:  
  • Dec. 8, 2020 – If by this date (six days before electors vote), a state has settled any controversies over its electors pursuant to the state’s procedures, then the electoral votes cast by those electors will be considered conclusive when the votes are counted in Congress on January 6. This year, every state but Wisconsin has met this “safe harbor” deadline.

  • Dec. 14, 2020 State electors will meet in their respective states and D.C. to cast their votes for president and vice-president. 

  • Jan. 6, 2021 – The two houses of Congress will assemble in a joint session to count the electoral votes submitted by the states, with the vice-president presiding. If one ticket attains a majority of 270 or more electoral votes, the vice-president will declare the new president and vice-president. The process can be interrupted if a Senator and Representative together submit a written objection to any state’s electors. (But see “safe harbor” explanation, above.)

  • Jan. 20, 2021, at noon EST– The new President takes office and will be sworn in immediately after the Vice-President takes her (!) oath of office.
The Courts
Supreme Court Will Take Up Case on Waivers for Medicaid Work Requirements

On Nov. 10, the Supreme Court decided that it will hear a case about the administration’s approval of waivers to establish work requirements for certain populations as a condition of Medicaid eligibility. The Court will decide whether to affirm or overturn a unanimous US Court of Appeals decision invalidating Arkansas and New Hampshire waivers. That court ruled that the department’s approval of these waivers was “arbitrary and capricious” (thus violating the Administrative Procedure Act) because the department failed to consider whether the work requirements were consistent with Medicaid’s purpose of providing health insurance coverage. Thus, the case is about this particular waiver-approval process, rather than whether work requirements are themselves permitted under Medicaid law. See D.C. Circuit on Medicaid Work Requirements: Read the Statute (Blog of the Georgetown Center for Children and Families, 2/19/20).

The Supreme Court will likely hear oral arguments in the winter or early spring. In the meantime, however, the new administration could begin the process of rescinding the waiver approvals, thus making the case moot. See Supreme Court Will Hear Trump Administration Defend Controversial Medicaid Work Requirements (USA Today, 12/04/20). 
Coronavirus-Relief Legislation

The two houses of Congress and the White House are still negotiating legislation to provide relief to individuals and businesses harmed financially as a result of the coronavirus pandemic. The main issues in contention are: the overall cost of the financial relief package ($500 billion versus about $900 billion); whether to provide funds to states and localities (including for vaccine distribution); whether to provide entities with liability protection from COVID-related lawsuits; and whether to increase unemployment benefits and/or send a stimulus check to everyone. If an agreement is reached, it will likely be attached to a bill making appropriations for all federal departments and agencies for the remainder of the 2021 fiscal year, which is also under negotiation. The federal government is being funded now through a “continuing resolution” (CR) that expires Friday, Dec. 18. 

Things are developing by the minute, but as of this writing, Hill leaders press forward on Covid relief talks (Politico, 12/11/20).

Surprise on Surprise Medical Billing!

Members from both parties in the House and Senate have been hoping to include provisions in the year-end appropriations/COVID bill to protect consumers from “surprise” out-of-network medical bills, but one of the four House and Senate committees of jurisdiction disagreed with the other committees about how to do so. Three agreed on a policy favored by insurers, unions, and consumer groups; while one favored an approach backed by hospitals, doctors, and investors who own physician staffing companies. See Bipartisan fix for 'surprise' medical bills hits roadblock with powerful chairman (The Hill, 12/08/20).

BUT, this surprise just in: Committees reach bipartisan deal to protect patients from surprise medical bills (The Hill, 12/11/20, 4:54 pm). For the bill text and summaries, see Congressional Committee Leaders Announce Surprise Billing Agreement (Press Release, Energy & Commerce Republicans, 12/11/20).
Medicaid & CHIP
Recent Regulations and Guidance

NEW – Child Core Set for Medicaid and CHIP. 
On Nov. 19, the Centers for Medicare & Medicaid Services (CMS) released an Informational Bulletin that describes the 2021 updates to the core set of children’s health care quality measures (the Child Core Set) for Medicaid and the Children’s Health Insurance Program (CHIP) and the core set of health care quality measures for adults enrolled in Medicaid (the Adult Core Set).

NEW – HHS Issues Final “Good Guidance” Rule.
On Dec. 3, the administration issued the final version of the “Good Guidance” rule, which had been proposed in August 2020. (See HHS press release.) The rule is applicable to the entire Department of Health and Human Services (so will affect the ACA and other programs) (HHS) except the Food & Drug Administration. “Guidance documents” are a key way that HHS directs states about how to implement their Medicaid programs, and include State Medicaid Directors letters, FAQs, and Informational Bulletins. 

Among other things, the final rule requires that all guidance documents carry a disclaimer indicating that the guidance is not legally binding. To enhance transparency in program administration, all guidance documents will be in a single, searchable guidance repository from now on (at www.HHS.gov/Guidance).  
Any existing guidance documents not posted to the repository by January 6 will be considered rescinded. The National Health Law Program is working with other groups to identify which existing guidance documents have been posted in the repository to date.

NEW – Informational Bulletin on Medicaid and Children’s Health Insurance Program (CHIP) Renewal Requirements. On Dec. 4, CMS released an Informational Bulletin (a guidance document “without the force of law”) in order “to remind states about current federal regulations and expectations for completing redeterminations of eligibility for Medicaid and CHIP beneficiaries.” CMS notes that the Bulletin will serve as a resource for states as they return to their routine eligibility and enrollment operations after the COVID-19 Public Health Emergency.

NEW – Medicaid and CHIP Vaccination Coverage.
This new toolkit for states and territories is focused primarily on how vaccine administration will be covered, because CMS expects that the initial supply of COVID-19 vaccines will be federally purchased. See Updates to the Coverage and Reimbursement of COVID-19 Vaccines, Vaccine Administration and Cost Sharing under Medicaid, the Children’s Health Insurance Program, and Basic Health Program Toolkit (CMS, 11/23/20).

NEW – Notice of Benefit and Payment Parameters for 2022 Proposed Rule (issued 11/30/20) – See ACA section, below.
WORTH REPEATING: Medicaid MOE interim final rule. As explained in the Oct. 30 Washington Update, the administration issued an interim final rule with comment period (fact sheet) on Oct. 28 that, among other things, weakens the “maintenance of effort” (MOE) conditions states must meet to receive enhanced Medicaid funding during the pandemic. States now can get the enhanced federal funding even if they reduce benefits to a limited extent. Of note: EPSDT services no longer must be maintained during the pandemic for enrollees who would otherwise “age out” at 21.

Comments are due on Jan. 4, 2021. For information about how to comment, see the “Your Input Sought” section below.

WORTH REPEATING – Medicaid managed care final rule.
On Nov. 9, CMS issued a final rule governing state oversight of Medicaid and CHIP managed care organizations (MCOs). See Rule; Press Release; Fact Sheet; Nov. 9 Medicaid.gov Bulletin

Among other things, the rule relaxes requirements for network adequacy. Rather than continuing the current requirement that states set provider time and distance standards, the new rule requires states only to set a “quantitative network adequacy standard.”
Vaccine Approval and Distribution

FDA Advisory Committee makes recommendation on EUA. On Dec. 10, the Vaccines and Related Biological Products Advisory Committee (VRBPAC) of the US Food & Drug Administration (FDA), voted to recommend “emergency use authorization” (EUA) for the coronavirus vaccine developed by Pfizer and BioNTech. The committee voted 17 to 4, with one abstention, that the safety and efficacy of the vaccine outweigh the risks for use in individuals age 16 and older. Reportedly, those who voted ‘no’ did so because they did not believe there was sufficient safety information to recommend the vaccine for those under age 18.

See FDA panel endorses Pfizer's coronavirus vaccine (Fox News, 12/10/20); FDA advisory panel endorses Pfizer/BioNTech Covid-19 vaccine (STAT, 12/10/20) – detailed description of meeting; FDA Statement On Vaccines And Related Biological Products Advisory Committee Meeting (FDA, 12/11/20). The Advisory Committee will meet again on Dec. 17 to consider the EAU request for the Moderna vaccine.

FDA staff will decide whether to grant EUA.
Next, the FDA’s career professional staff will consider the input of the advisory committee and make a final determination about whether to grant EUA based on their evaluation of data on the safety, effectiveness, and manufacturing of the vaccine. The director of the FDA division that oversees has indicated that the FDA decision would come "days to a week" after the Advisory Committee’s Dec.10 meeting.

The federal government will distribute the vaccine to states.
The White House’s Operation Warp Speed plans to ship the vaccine to states within 24 hours after the FDA provides the authorization for its use.

The CDC’s ACIP recommends how to allocate the vaccine.
The CDC’s Advisory Committee on Immunization Practices (ACIP) will meet on Sunday, Dec. 13 to finalize the interim vaccine allocation recommendations that it developed during its November meeting. The interim recommendations call for health care personnel and residents of long-term care facilities to receive the vaccine first (Phase 1a); essential workers to receive it next (Phase 1b); and adults with high-risk medical conditions and adults age 65 and above to get it next (Phase 1c). (See p. 4 of the November meeting minutes for a graphic depiction of the phases.)

States, territories and tribes decide how to allocate the vaccines.  They are not required to follow the CDC's allocation recommendations, but most are expected to do so, with some variations.

For more details, see:

For more information on vaccines, see:
Affordable Care Act/ Private Insurance
NOTE: The “Good Guidance” and “SUNSET” rules mentioned above will also affect administration of the ACA.

Healthcare.Gov Open Enrollment Period ends Dec. 15

To purchase a 2021 plan, consumers in a state that uses the federal exchange, Healthcare.gov, can log in to www.HealthCare.gov or www.CuidadodeSalud.gov, or call 1-800-318-2596.

If someone does not enroll in a plan by December 15, they cannot get 2021 coverage unless they qualify for a Special Enrollment Period

Note for those affected by a disaster -- From Beyond the Basics: A change to the HealthCare.gov application implements the “FEMA SEP” [Special Enrollment Period] to allow consumers who lost qualifying coverage but missed their 60-day SEP window to enroll in Marketplace coverage. The FEMA SEP will last until 60 days after the end of the disaster declaration. See this Fact Sheet.

Notice of Benefit and Payment Parameters for 2022 Proposed Rule (issued 11/30/20)

On November 25, the Centers for Medicare and Medicaid Services (CMS) released the proposed 2022 “Notice of Benefit and Payment Parameters” (NBPP), which governs states, issuers, Exchanges, pharmacy benefit managers, direct enrollment entities, and the administrative appeals processes with respect to health insurance issuers and non-Federal governmental plan sponsors. See the CMS press release and the CMS fact sheet.

Comments are due on Dec. 30, and can be submitted via this page on Regulations.gov.
Other COVID Related News

HHS Launches Centralized Website for COVID-19 Clinical Trials

The portal is a one-stop resource to help members of the public and doctors find information about different stages of COVID-19 illness, NIH-supported COVID-19 prevention and treatment clinical trials, and locations to donate plasma.

The website provides clear and easy-to-understand information for:

The recording and slides from the webinar Supporting Children and Youth with Special Healthcare Needs During COVID-19 are available. Sponsored by Manatt Health, Family Voices, the American Academy of Pediatrics and Georgetown Center for Children and Families.

TRICARE and Military Health System
Tricare updates since the last Washington update:

TRICARE Young Adult (TYA) is available for purchase by certain family members under the age of 26 who have lost or will lose TRICARE eligibility due to age. Qualified adult children can purchase TYA coverage after regular TRICARE coverage ends at: 
  • Age 21
  • Age 23 (if enrolled in college full time or at a college graduation, whichever comes first)

See the TRICARE Young Adult Program Fact Sheet to learn more about who qualifies for TYA and how to purchase TYA coverage. [TRICARE wants to hear your feedback. Take the publications survey, and share your thoughts about this publication.]

For other TRICARE news and information, see the TRICARE Benefits Updates and TRICARE Publications.

To keep up with TRICARE and COVID-19 updates, sign up for email alerts.
Download the latest TRICARE East Region or TRICARE West Region newsletter at www.tricare.mil/publications.
Due December 18 – The Maternal and Child Health Bureau (MCHB), of the Health Resources and Services Administration (HRSA), is seeking input on the Maternal and Child Health Bureau Strategic Plan (PDF - 94 KB).

The agency is seeking input from a broad range of organizational and individual stakeholders, including maternal and child health service providers, states and localities, health service delivery and other community-based organizations, health care providers, researchers, community members, patients, consumers, families, caregivers, advocates, and other interested parties.
How to comment: Comments must be submitted by 11:59 p.m. ET on Friday, December 18, 2020, by emailing [email protected].

Due December 30 – The Centers for Medicare and Medicaid Services (CMS) issued its proposed Notice of Benefit and Payment Parameters (NBPP) for 2022. The annual NBPP governs how the Affordable Care Act is implemented by states, insurers, and others. 
See the CMS press release and the CMS fact sheet. Comments are due on Dec. 30, and can be submitted via this page on Regulations.gov.

Due January 4 – Comments on an interim final rule (Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency CMS-9912-IFC) with request for comments (IFC) regarding, among other things, the Medicaid maintenance-of-effort requirements for states receiving an enhanced federal match during the pandemic.

This rule replaces earlier guidance that required states to maintain all benefits for individuals enrolled in Medicaid on or after March 18, 2020, including EPSDT services for 21-year-olds who would otherwise age out of this benefit. Under this new final rule, states are permitted to reduce benefits and increase cost-sharing for Medicaid beneficiaries within certain parameters and still receive an enhanced federal match during the pandemic. Comments may be submitted via this page on Regulations.gov.

Family Voices Survey on Telehealth

As health care providers ramp up the use of telemedicine, Family Voices is interested in improving families’ access to and use of telehealth. We are asking families to complete a survey describing their access to telehealth, and their confidence in and concerns about virtual services. Take the anonymous survey in English or Español.
Wednesday, December 16, 4:00-5:00 ET
Alliance for Health Policy

Thursday, December 17, 2:00 ET
National Conference of State Legislatures

Friday, December 18, 1:00-2:30 ET 
TBI Technical Assistance and Resource Center

Wednesday, January 13, 2021, 1:00 ET
American Cancer Society Cancer Action Network
Pediatric Annals: Special Issue on Children with Medical Complexity (Nov. 2020; click on “Nov.” from the drop-down menu).

This special issue includes a guest editorial, Children with Medical Complexity, and articles on care coordination, partnering with families, and other topics. There is a cost to read full journal articles, but abstracts can be viewed without cost.
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Family Voices is a national organization and grassroots network of families and friends of children and youth with special health care needs and disabilities that promotes partnership with families--including those of cultural, linguistic and geographic diversity--in order to improve healthcare services and policies for children.