Weekly Health Care Policy Update – August 13, 2021

August 20, 2021

In this update: 

  • Administration
    • Biden Administration Announces Updates on COVID-19 Response 
      • Military Vaccine Mandate
      • FDA Recommends Booster Shots for the Immunocompromised
  • Legislative
    • Senate Passes Bipartisan Infrastructure Bill Including Resumption of Sequester Cuts
    • Senate Democrats Pass FY 2022 Budget Resolution
  • Regulatory
    • CMS Ends Work Requirements for Medicaid in Ohio, South Carolina, and Utah
    • CMS Leaders Publish Ten-Year Vision for CMMI
    • CMS Proposes to Rescind Part B Most-Favored Nation Rule
    • CMS Ends Work Requirements for Medicaid in Ohio, South Carolina, and Utah
    • CMS Solicits Medicaid MCOs for Pilot on COVID-19 Vaccination Data-Sharing for Dual Eligibles
    • CMS Announces Increased Enrollment in Exchanges and Medicaid
    • HRSA Issues Additional FY 2022 FQHC Service Area Competition
  • Other
    • OIG Reports that Almost All Medicaid MCOs Meet MLR Targets
    • GAO Releases Report on Nursing Home Staffing Levels and Potential Reductions in Readmissions
    • Telehealth Utilization Stabilizes in May 2021
    • Census Bureau Releases Data for Redistricting
    • U.S. Overdose Deaths Rise to Record Level
  • Congressional Hearings
  • New York State
    • Governor Cuomo Announces Resignation, Lieutenant Governor Kathy Hochul to Take Office
    • DOH Seeks Stakeholder Feedback Regarding the Development of Children’s Waiver Renewal
    • OPWDD Releases Memorandum Regarding Care Planning and Service Options
    • DOH Updates Nursing Home Cohorting FAQs

Administration Updates

Biden Administration Announces Updates on COVID-19 Response
This week, the Biden Administration announced new updates on the COVID-19 response: 

  • Military Vaccine Mandate: On August 9th, the Pentagon announced that members of the U.S. military will be required to get the COVID-19 vaccine by mid-September, or upon full authorization by the Food and Drug Administration (FDA), whichever is sooner. Pentagon leadership noted that vaccination is “a key force protection and readiness issue.”
  • FDA Recommends Booster Shots for the Immunocompromised: On August 12th, the FDA amended the Emergency Use Authorizations (EUAs) of the Pfizer-BioNTech and Moderna COVID-19 vaccines to allow individuals 12 and older who have undergone solid organ transplantation, or who have a similar level of immunocompromise, to receive a third dose. The approval comes after the recommendation of a Centers for Disease Control and Prevention (CDC) advisory panel in July. Roughly 2.7 percent of U.S. adults are immunocompromised, and a Johns Hopkins study showed that a third dose increased antibody levels in this population.

Legislative Updates

Senate Passes Bipartisan Infrastructure Bill Including Resumption of Sequester Cuts
On August 10th, the Senate passed the “Bipartisan Infrastructure Investment and Jobs Act” in a 69-30 vote. The nearly $1 trillion package, with $550 billion of new spending, includes various physical infrastructure investments, many of which were included in President Biden’s American Jobs Plan. These include, among others, new funding for roads, bridges, public transit, investments in the electric grid and broadband infrastructure. 
 
As discussed in previous weeks, the Act does not contain new health care spending, but is partially paid for with two health care policies. First, the bill would resume the 2% sequester reduction to all Medicare payments through 2031. These payment cuts were paused last year as part of COVID-19 relief legislation. In addition, the Act includes a three-year delay in a rule finalized during the end of the Trump administration that would eliminate the safe harbor for Part D drug rebate payments and replace it with a safe harbor for point-of-sale discounts. The rule was originally scheduled to take effect in 2022, but the Biden administration delayed it until 2023. The Senate bill imposes an additional three-year delay. 

The bill now goes to the House of Representatives, where Speaker Nancy Pelosi has stated that it will only be passed in tandem with a larger reconciliation bill (as described below). A fact sheet by the White House is available here.
 
Senate Democrats Pass FY 2022 Budget Resolution
On August 10th, the Senate passed a budget resolution for federal fiscal year (FY) 2022 on a party-line vote. The resolution outlines Senate Democrats’ policy priorities in a variety of areas including health care, education, housing, tax reform, labor, and energy. It also includes reconciliation instructions which begin the process required to negotiate potential passage of other proposals contained in President Biden’s Build Back Better agenda, also known as the remaining parts of the American Jobs Plan and American Families Plan. Under the terms of the budget resolution, the reconciliation bill may contain up to $3.5 trillion in spending, and at least half that amount must be offset with revenue increases or spending reductions in other areas. While reconciliation instructions are not specific policy recommendations, they direct committees to make investments in health care areas, including:

  • Expanding Medicare benefits to include dental, hearing, and vision, and lowering the eligibility age;
  • Graduate Medical Education investments to address the health care provider shortage;
  • Lowering prescription drug prices;
  • Home and community-based services for seniors and people with disabilities;
  • Health equity (maternal, behavior, and racial justice);
  • Extension of enhanced Affordable Care Act premium tax credits; and
  • Filling the Medicaid coverage gap in non-expansion states.

The reconciliation instructions also mention savings from health care but do not detail what policies that may entail, although the proposals around drug pricing are expected to be a part. The White House released a fact sheet outlining some plans around drug pricing, including allowing Medicare to negotiate drug prices, penalizing increases above inflation, capping Medicare out-of-pocket drug expenses, and other provisions, which is available here. The White House has also released a separate fact sheet outlining its remaining general priorities for the Build Back Better agenda, which is available here.

Senate committees will now begin to debate details of the reconciliation package, with a deadline of September 15th to complete the final legislation. At that time, the bill will hit the Senate floor again for additional amendment consideration.

Regulatory Updates

CMS Leaders Publish Ten-Year Vision for CMMI
On August 12th, Health Affairs published a blog post attributed jointly to incoming CMS leadership establishing a “vision for the next 10 years” of the Centers for Medicare and Medicaid Innovation (CMMI). The authors include CMS Administrator Chiquita Brooks-LaSure, CMMI Director Liz Fowler, Center for Medicare Director Meena Seshamani, and Center for Medicaid and CHIP Director Daniel Tsai. The post focuses in large part on how CMMI will “make equity a centerpiece of every model,” including an increased focus on the Medicaid population and partnerships with state Medicaid agencies. It sets five “strategic objectives” for CMMI models going forward, and describes certain steps CMS intends to take, including:

  • Reviewing how current models meet the needs of underserved populations and where this could be strengthened; 
  • Prioritizing new models based on their ability to meet CMMI’s refreshed objectives;
  • Committing to greater transparency and accessibility to CMMI data;
  • Soliciting beneficiary and patient input earlier in model development; and
  • Ensuring strong partnerships between CMMI, the Center for Medicare, and the Center for Medicaid.

The full post is available here.

CMS Proposes to Rescind Part B Most-Favored Nation Rule
On August 6th, the Centers for Medicare and Medicaid Services (CMS) announced a proposed rule to rescind the Most Favored Nation (MFN) interim final rule. This rule, issued at the end of the Trump Administration, had a stated effective date of January 1, 2021, but its implementation was stopped by a federal judge, citing concerns about the process CMS used to finalize the rule. The rule would have linked reimbursement for certain Part B drugs to prices in other high-income countries, and led to a significant backlash from stakeholders.

Comments on the proposed rule to rescind the MFN model are due October 12, 2021.

CMS Ends Work Requirements for Medicaid in Ohio, South Carolina, and Utah
On August 10th, Centers for Medicare & Medicaid Service (CMS) Administrator Chiquita Brooks-LaSure sent letters to health officials in Ohio, South Carolina, and Utah informing them that state requirements for Medicaid enrollees to work, volunteer, or attend training in order to access health coverage would no longer be permissible. The letters cite “significant coverage losses and harm to beneficiaries” associated with the requirements, as well as CMS’s authority to “withdraw waivers or expenditure authorities” as part of its oversight of demonstration projects to “ensure that they are currently likely to assist in promoting the objectives of Medicaid.” CMS also cited the significant impact of the COVID-19 pandemic on beneficiaries–such as mental health challenges, an increase in substance abuse, and child care shortages–as reasons that low-income Medicaid beneficiaries need access to coverage and care without “the initial and continued eligibility obstacle” of work requirements.

CMS Solicits Medicaid MCOs for Pilot on COVID-19 Vaccination Data-Sharing for Dual Eligibles
On August 9th, CMS released a solicitation for Medicaid managed care organizations (MCOs) interested in participating in a pilot project to receive access to Medicare COVID-19 vaccination data for their dual eligible enrollees. Currently, COVID-19 vaccinations for dual eligibles are paid 100% by Medicare fee-for-service, so that the dual eligible’s Medicaid MCO may have no knowledge of the claim. Through the solicitation, CMS will select up to 20 Medicaid MCOs to receive updated COVID-19 vaccination data on a weekly basis, to be used for operational purposes, such as care coordination, case management, and population-based activities to improve health. The pilot will last approximately six months, after which CMS will assess the feasibility of expanding this functionality nationwide.

Responses are due by August 30th. The solicitation is available here.

CMS Announces Increased Enrollment in Exchanges and Medicaid
On August 10th, the Centers for Medicare and Medicaid Services (CMS) announced that more than 2.5 million Americans have gained health coverage during the Special Enrollment Period ending August 15th. This number includes a 64% increase in enrollment in the last week of July. CMS also released data showing that nearly 81.7 million people are now receiving coverage through Medicaid and the Children’s Health Insurance program (CHIP) as of March 2021, a record high. In addition, the American Rescue Plan’s increased subsidies have provided families with an average savings of $40 per person per month on premiums. Over one-third of customers have found coverage for $10 or less per month, and the median plan deductible has fallen by nearly 90%.

HRSA Issues Additional FY 2022 FQHC Service Area Competition
On August 5th, the Health Resources and Services Administration (HRSA) posted a new Service Area Competition (SAC) opportunity for fiscal year (FY) 2022. Through the SAC, organizations may apply to participate in the Federally Qualified Health Center (FQHC) program by taking over a grant in an existing service area. FQHCs are typically approved for a three-year period and, if they seek to renew, must reapply to the SAC. For this opportunity, there are additional SACs open in Brooklyn, the Bronx, Manhattan, and Queens.

Applications are due October 4th. More information is available here.

Other Updates

OIG Reports that Almost All Medicaid MCOs Meet MLR Targets
On August 6th, the HHS Office of the Inspector General (OIG) released a report showing that 91% of Medicaid managed care plans met state-set minimum medical loss ratio (MLR) requirements. To date, 34 states have established MLRs for Medicaid managed care plans for annual reporting periods ending in 2017, 2018, or 2019. Most of these plans (92%) also achieved MLRs that met or exceeded the federal MLR standard of 85% regardless of whether theri state had established minimum MLR requirements. Of 39 plans that failed to meet their state-set minimum MLR, 19 owed a total of $198 million to states that required plans to return money when MLRs were not met. In a future report, HHS OIG will assess states’ oversight of their Medicaid managed care plans’ compliance with MLR reporting requirements as well as the completeness of MLR data that plans report to states.

GAO Releases Report on Nursing Home Staffing Levels and Potential Reductions in Readmissions
On August 9th, the Government Accountability Office (GAO) released a report “Medicare: Additional Reporting on Key Staffing Information and Stronger Payment Incentives Needed for Skilled Nursing Facilities.” In the report, GAO estimates that Medicare spent $5 billion on potentially preventable critical incidents, mostly consisting of rehospitalizations within 30 days of SNF admission, in 2018. If facilities had reduced actual readmission rates to risk-adjusted rates, Medicare could have saved $426 million.

GAO found that while 99 percent of facilities met the federally required minimum standard of having a registered nurse on site eight hours a day, significantly fewer met higher recommended staffing levels. Only half of SNFs met the CMS case-mix staffing measures used to set staffing ratings, while only one-quarter frequently met staffing thresholds for minimum RN and total nurse staffing that a CMS staffing study identified as needed to avoid quality problems. GAO also found that average RN staffing hours decreased about 40 percent on weekends. GAO noted that CMS’s current ability under the SNF Value-Based Purchasing program to cut SNF payments by up to 2 percent based on readmission rates does not sufficiently compensate for increased costs from readmissions. 

Telehealth Utilization Stabilizes in May 2021
On August 9th, FAIR Health published its Monthly Telehealth Regional Tracker, showing that telehealth claims for the privately-insured population rose 2 percent nationally from April to May 2021, after falling as a percentage of all medical claims each month from February to April. For the first time, substance use disorders joined the top five telehealth diagnoses nationally in May, while mental health claims remained the most frequent telehealth claim. Claims for infections and acute respiratory diseases also rose in frequency for May, as the third and fourth most common reason for telehealth visits.

Census Bureau Releases Data for Redistricting
On August 12th, the Census Bureau released the data states will use to redraw congressional district lines. As a reminder, New York lost one seat during reapportionment, leaving the delegation with 26 seats in the House of Representatives. This year, for the first time, an Independent Redistricting Commission will create a plan to redraw district lines. The 10-member commission must submit its plan to the State Legislature by January 1, 2022. Legislative approval of the plan requires a two-thirds vote in both the Senate and the Assembly.

U.S. Overdose Deaths Rise to Record Level
On August 11th, the CDC released a report showing there were 95,000 overdose deaths in the U.S. last year, the highest level ever recorded. The provisional data, which may be revised, noted that overdose deaths increased by 31% from January 2020 through January 2021 compared to the previous 12 months. Overdose deaths were on the rise before the pandemic, reversing a trend of declining deaths from late 2017 through mid-2019.

Congressional Hearings

The House is in recess through August 30th. The Senate is not holding major health care-related hearings next week.

New York State Updates

Governor Cuomo Announces Resignation, Lieutenant Governor Kathy Hochul to Take Office
On August 10th, Governor Cuomo announced his decision to resign effective August 24th. As of that date, Lieutenant Governor Kathy Hochul will become the 57th Governor of New York. Hochul, who has held the position of Lieutenant Governor since 2015, is a lawyer by training who also has experience working as a staffer in Congress and in the New York State Assembly. Hochul served as a member of the House of Representatives from 2011 to 2013, representing the 26th congressional district, which at the time encompassed traditionally conservative areas in the suburbs of Buffalo, including Genesee, Livingston, and Wyoming Counties.

Hochul has stated that she will make an address laying out her administration’s vision shortly after taking office, and has not yet issued specific statements regarding policy issues, including health care. While in Congress, she voted against repeal of the Affordable Care Act. She also currently serves as co-chair of the New York State Heroin and Opioid Task Force.

During and after the transition, SPG will continue to provide updates and analysis regarding staff appointments, policy announcements, and other issues.

DOH Seeks Stakeholder Feedback Regarding the Development of Children’s Waiver Renewal
On August 12th, the New York State Department of Health (DOH) announced a series of stakeholder feedback sessions regarding the 1915(c) Children’s Waiver renewal, which is due on April 1, 2022. The renewal process provides an opportunity for the State to evaluate what is working well and what requires improvement with regards to service delivery, processes, and requirements. These sessions will allow key stakeholders to share suggestions and solutions to improve services under the Children’s Waiver and the experience for children, youth, and families.

Sessions will be held for the following stakeholders on the below dates/times:

  • Health Homes and Care Management Agencies: September 14th from 10am-11am (here)
  • C-YES and Medicaid Managed Care Plans: September 14th from 11:30am-12:30pm (here)
  • HCBS Providers: September 14th 1pm-2pm (here)
  • MRT Children’s Subcommittee Members and Advocates: September 15th 10am-11am (here)

DOH will also accept written feedback, which may be sent to BH.Transition@health.ny.gov.

OPWDD Releases Memorandum Regarding Care Planning and Service Options
On August 2nd, in preparation for the end of COVID-19 flexibilities and the return to in-person service delivery, the Office for People with Developmental Disabilities (OPWDD) released a memorandum (available here) to providers and Care Coordination Organizations (CCOs) outlining the person-centered care planning discussions and activities that will be required for individuals who have had Life Plan service and support changes. These discussions and activities must take place between July 1, 2021 and six months after the end of the federal COVID-19 Public Health Emergency in order to:

  • Assist the individual to make informed choices on post-pandemic service and support options, in conjunction with the care planning team, and update the Life Plan accordingly;
  • Coordinate required service access processes for the individual with providers and the Developmental Disabilities Regional Offices (DDROs) to facilitate the desired post-pandemic service and support options; and 
  • Follow-up and monitor service delivery to ensure implementation of the Life Plan in accordance with the individual’s needs and goals and that the individual is satisfied with service delivery and progress towards desired outcomes.

DOH Updates Nursing Home Cohorting FAQs
On August 6th, DOH released revised guidance (available here) regarding the policies and procedures for nursing home cohorting. The revised guidance replaces previous guidance issued in May 2020 and includes updated information regarding cohorting procedures for residents and staff based on vaccination status. Specifically, the guidance clarifies that outbreak testing should be completed on both vaccinated and unvaccinated residents and staff, and resident cohorting should be based on SARS-CoV-2 diagnostic testing results (i.e., positive cohort, negative cohort, and unknown cohort). Residents who have a confirmed COVID-19 infection should be placed in the positive cohort regardless of vaccination status.

Questions may be submitted to icp@health.ny.gov or covidnursinghomeinfo@health.ny.gov.