In this update:
- Biden Administration Announces Updates on COVID-19 Response
- White House Releases Report on Pandemic Supply Chain Disruptions
- Biden Taps Obama Administration Officials for CMS Leadership Roles
- HCP-LAN Creates Health Equity Advisory Team
- CMS Issues 2021 Navigator Notice of Funding Opportunity
- HHS Report Finds 31 Million Americans Gained Coverage through ACA
- CMS Releases New User Guide to Health-Related Social Needs Screening Tool
- Treasury Updates State and Local Aid FAQs
- OMB Review Update on Surprise Billing and Other Rules
- FDA Approves Biogen Alzheimer’s Therapy; Advisory Committee Members Resign
- Mortality Disparities Increased Between Rural and Urban Populations
- FAIR Health Report Shows Telehealth Usage Continues to Fall
- PwC Projects 6.5 Percent Medical Cost Trend in 2022
- Congressional Hearings
- New York State Legislature Passes Several Health Care Bills Prior to End of Session
- CMS Approves OPWDD Comprehensive HCBS Waiver Amendment
- DFS Issues Emergency Amendment Clarifying that Telehealth Includes Audio-Only Visits
- OMH and OASAS Announce Statewide and Regional Reopening Forums
Administration Updates
Biden Administration Announces Updates on COVID-19 Response
This week, the Biden Administration announced new updates on the COVID-19 response:
- On June 9th, the Centers for Medicare & Medicaid Services (CMS) announced an additional payment for administering in-home COVID-19 vaccinations to Medicare beneficiaries. Medicare will pay an additional $35 per dose for COVID-19 vaccine administration when performed in a beneficiary’s home, increasing the total payment amount to $75 per dose ($150 for a two-dose vaccine). More information is available here.
- On June 8th, Andy Slavitt, the lead White House advisor on the COVID-19 response, announced that June 9th would be his last day in the temporary position. His departure was expected this month, as special government appointments may not exceed 130 days.
- On June 10th, President Biden announced that the Administration will buy 500 million doses of Pfizer’s COVID-19 vaccine to donate to 92 low-income and lower-middle-income nations in need. The U.S. will work through COVAX, the World Health Organization’s initiative to share global vaccine doses, to distribute this supply. The Administration has committed to 200 million doses going out this year, and 300 million distributed in the first half of next year, at a cost of about $3.5 billion, including $1.5 billion appropriated in the American Rescue Plan (ARP). This supply is in addition to the 80 million doses that the Administration announced it would distribute last month. Biden stated that the G7 nations will make a further announcement on their commitment today (June 11th).
White House Releases Report on Pandemic Supply Chain Disruptions
On June 8th, the White House released a report on supply chain disruptions in certain industries caused or exacerbated by the COVID-19 pandemic. The report, which was ordered by President Biden in Executive Order 14017, is entitled “Building Resilient Supply Chains, Revitalizing American Manufacturing, and Fostering Broad-Based Growth.” The Department of Health and Human Services’s (HHS) section, which focuses on pharmaceuticals, recommends that the U.S. boost domestic production of pharmaceuticals and their ingredients, build emergency capacity, and increase the surveillance and shortage prevention activities of the Food and Drug Administration (FDA). The report recommends that Congress should provide HHS with new authorities to track production by facility, track ingredient sourcing, and require sources to be identified on pharmaceutical labels. It also recommends that a public-private consortium work to stabilize supplies for up to 100 drugs from the FDA’s essential medicine list. This would include working with allies across the globe to reinforce the global supply chain. The Association for Accessible Medicines and the American Pharmacists Association expressed support for the recommendations in the report.
Biden Taps Obama Administration Officials for CMS Leadership Roles
This week, the Biden administration tapped two former Obama administration officials to serve in leadership positions at CMS, although neither has yet been formally announced:
- Erin Richardson, formerly a lobbyist at the Federation of American Hospitals, will serve as Chief of Staff to CMS Administrator Chiquita Brooks-LaSure. She previously worked at the White House Domestic Policy Council during the Obama Administration and on the House Ways and Means Committee.
- Jon Blum will serve as the new principal deputy commissioner at CMS, a position he also held during the Obama Administration. Most recently, Blum was Vice President and Managing Principal for Medicare at Health Management Associates.
Regulatory Updates
HCP-LAN Creates Health Equity Advisory Team
On June 10th, the CMS Health Care Payment Learning & Action Network (LAN) launched a new Health Equity Advisory Team (HEAT). The LAN was launched by CMS in March 2015 to provide a forum for public and private stakeholders to collaborate on shifting from fee-for-service to value-based alternative payment models (APMs). LAN’s goal is to accelerate the percentage of payments tied to quality and value across all market segments, including by conducting national measurements of APM adoption rates. The HEAT’s mission will be to “help identify and prioritize opportunities to advance health equity through APMs, to influence design principles and to inform LAN priorities and initiatives.” It will focus on improving outcomes and access and reducing disparities. The HEAT will be co-chaired by Dr. Marshall Chin, Professor of Healthcare Ethics at the University of Chicago, and Dr. Karen Dale, Market President of AmeriHealth Caritas in Washington, DC.
The full HEAT membership can be found here.
CMS Issues 2021 Navigator Notice of Funding Opportunity
On June 7th, CMS issued the 2021 Navigator Notice of Funding Opportunity (NOFO). This NOFO makes $80 million in funding available for Navigators, which are entities that help consumers select insurance plans in the individual market, in states with federally-facilitated exchanges (i.e., using HealthCare.gov for their marketplace), during the 2022 plan year. This is the largest allocation CMS has made available for Navigator grants to date. CMS encourages applications from Navigators focused on education, outreach, and enrollment efforts to serve underserved and diverse communities.
The NOFO can be viewed here.
HHS Report Finds 31 Million Americans Gained Coverage through ACA
On June 5th, HHS released a report showing that 31 million Americans have gained health insurance coverage through the Affordable Care Act (ACA), including 11.3 million people enrolled in the ACA marketplaces, 14.8 million individuals newly eligible for Medicaid, 1 million individuals enrolled in the ACA’s Basic Health Plan, and nearly 4 million Americans who were previously eligible for Medicaid but who gained coverage with the help of enhanced outreach efforts. Overall, the number of nonelderly uninsured adults decreased by 41 percent, falling from 48.2 million to 28.2 million, between 2010 and 2016.
The report can be found here.
CMS Releases New User Guide to Health-Related Social Needs Screening Tool
On June 7th, CMS released a new user guide to help health care or social service providers participating in the Accountable Health Communities (AHC) Model use the Health-Related Social Needs (HRSN) Screening Tool. The HRSN Tool is a short screening tool for social determinants of health needs, meant as a quick, universal tool to assess areas including food insecurity, housing instability, and lack of access to transportation. The new user guide provides information on the AHC model and the AHC HRSN screening tool and also includes information on how to use the screening tool outside the AHC model. Finally, the guide offers best practices from AHC model participants meant to inform efforts to conduct universal HRSN screening in a wide range of clinical settings.
The user guide is available here; the Screening Tool is available here.
Treasury Updates State and Local Aid FAQs
On June 10th, the Department of the Treasury posted additional updates to its FAQ document on the use of Coronavirus State and Local Fiscal Recovery Funds. Some relevant updates include:
- State and local governments may use funds to establish a public jobs program, among a broad range of assistance to unemployed or underemployed workers.
- State and local governments may use unaudited financials if audited data is unavailable to calculate revenue loss. They may also use a cash, accrual, or modified accrual basis of accounting as long as they are consistent.
- Although state and local governments may not use funds to reimburse costs they incur before March 3, 2021, this start date does not apply to downstream beneficiaries. For example, premium pay may be provided to frontline workers for work provided before March 3rd, as long as the state or local government does not incur the cost of such premium pay before that date.
The updated FAQs are available here.
OMB Review Update on Surprise Billing and Other Rules
On June 8th, the Office of Management and Budget (OMB) received an interim final rule for review from HHS entitled “Requirements Related to Surprise Billing; Part I.” The rule will be published in the Federal Register once OMB review is complete. Other rules still under review at OMB include:
- A proposed rule on “Updating Payment Parameters and Improving Health Insurance Markets for 2022 and Beyond”;
- The 2022 final rule for the Basic Health Program;
- The 2022 proposed rule for the Hospital Outpatient Prospective Payment System (PPS);
- The 2022 proposed rule for the Home Health PPS; and
- A proposed rule on “2022 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B.”
Other Updates
FDA Approves Biogen Alzheimer’s Therapy; Advisory Committee Members Resign
On June 7th, the FDA granted Biogen an “accelerated approval” for its Alzheimer’s therapy, Aduhelm (also known as aducanumab). It is the first approval for a new Alzheimer’s drug in nearly two decades. In November, the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee reviewed the drug, with 10 of 11 panelists agreeing that the evidence did not support that the drug was effective for Alzheimer’s treatment (the 11thmember was “uncertain”). Three members of the Advisory Committee have now resigned as a result of the decision, voicing sharp criticism of the FDA’s choices.
Mortality Disparities Increased Between Rural and Urban Populations
On June 8th, JAMApublished a Research Letter which found growing disparities in age-adjusted mortality rates between rural and urban populations. Though mortality rates have fallen in both areas overall since 1999, the gap in mortality rates between urban and rural communities has grown 172% over the past 20 years. In 2019, the mortality rate in U.S. urban areas was 665 deaths per 100,000, while it was 834 deaths per 100,000 in rural areas. Overall, Black Americans had the highest mortality rates in both urban and rural areas, but white Americans achieved the smallest gain in improving mortality rates.
FAIR Health Report Shows Telehealth Usage Continues to Fall
On June 8th, FAIR Health released a new edition of its Monthly Telehealth Regional Tracker, showing that telehealth utilization in the privately-insured population continued to fall from February to March 2021. Telehealth claims fell 5.1% nationally as a percentage of all medical claims, from 5.9% of all claims in February to 5.6% of all claims in March. Two additional trends were seen in the data: 1) psychotherapeutic/psychiatric codes replaced evaluation and management (E&M) codes in the top five telehealth procedure codes; and 2) hypertension, as well as some joint and soft tissue diseases, dropped in the rankings of telehealth diagnoses in some regions, while developmental disorders remained steady or rose in the rankings.
PwC Projects 6.5 Percent Medical Cost Trend in 2022
On June 9th, PricewaterhouseCoopers’ (PwC) Health Research Institute published predicted medical cost trends for 2022. PwC projects a 6.5% medical cost trend for 2022, which is slightly lower than the 7.0% PwC projected for 2021, but higher than the trend was for 2016 through 2020. In general, PwC forecasts health care spending to return to its pre-pandemic baseline, though the 2022 estimate includes adjustments for persistent effects of the pandemic. PwC expects spending increases to be driven by increased utilization and spending from care delayed during the pandemic, investments to better prepare for future pandemics, and investments in digital tools that will strengthen patient relationships and drive utilization. Spending increases would be partly offset by consumer use of lower-cost sites of care, which accelerated during the pandemic, and changes providers made during the pandemic to lower their operating costs, including remote work and process automation.
PwC’s report can be found here.
Congressional Hearings
Tuesday, June 15th:
- At 10am, the Senate Finance Committee will hold a hearing to examine mental health care in the United States, with a focus on addressing root causes and identifying policy solutions. More information is available here.
- At 10:30am, the House Energy and Commerce Subcommittee on Health will hold a hearing entitled “Booster Shot: Enhancing Public Health Through Vaccine Legislation.” More information is available here.
Wednesday, June 16th:
- At 9am, the House Education and Labor Committee will hold a hearing to examine the policies and priorities of HHS. More information is available here.
- At 10am, the Senate Finance Committee will hold a hearing to examine the President’s FY 2022 Budget Proposal. More information is available here.
- The Senate Committee on Health, Education, Labor, and Pensions (HELP) will hold a committee hearing to examine the nominations of Miriam Delphin-Rittmon as HHS Assistant Secretary for Mental Health and Substance Use and Dawn O’Connell as HHS Assistant Secretary for Preparedness and Response (ASPR). The hearing time has yet to be announced. More information is available here.
Thursday, June 17th:
- At 9:30am, the Senate Committee on Aging will hold a hearing entitled “21st Century Caregiving: Supporting Workers, Family Caregivers, Seniors and People with Disabilities.” More information is available here.
New York State Updates
New York State Legislature Passes Several Health Care Bills Prior to End of Session
Prior to the close of the annual session, the New York State (NYS) Legislature passed the below health care-related bills. Passed bills will now be delivered to the Governor to be signed or vetoed.
- Assembly Bill A7504-A/Senate Bill S6431 extends for an additional year certain exemptions from professional licensure requirements for individuals employed as mental health practitioners, psychologists, and social workers in licensed programs, such as Office of Mental Health (OMH) licensed Article 31 clinics. This exemption would otherwise be currently set to expire on June 24, 2021.
- Assembly Bill A6395-B/Senate Bill S7194 creates an Opioid Settlement Fund comprising all funds received by NYS as a result of a settlement or judgment in litigation against opioid manufacturers or related companies. Such funds should supplement and not supplant or replace existing state funding. The Opioid Settlement Fund will be monitored by the Office of Addiction Services and Supports (OASAS) and other state agencies to ensure that funding is expended for appropriate substance use disorder purposes.
- Assembly Bill A0108-B/Senate Bill S1168-A requires hospitals to establish and maintain a clinical staffing committee no later than January 1, 2022. At least half of the members of the committee must be registered nurses (RNs), licensed practical nurses (LPNs), and ancillary members of the frontline team currently providing or supporting direct patient care. The committee will be responsible for developing and overseeing an annual clinical staffing plan, which will include patient-to-nurse ratios or specific guidelines for how many patients are assigned to each nurse. The committee will also be responsible for responding to complaints regarding violations of the adopted staffing plan or staffing variations.
- Assembly Bill A7119/Senate Bill S6346 requires the Commissioner of Health to establish staffing standards for nursing home minimum staffing levels and impose civil penalties for nursing homes that fail to adhere to the minimum standards. Beginning January 1, 2022, nursing homes would be required to maintain daily average staffing hours equal to 3.5 hours of care per resident per day by a certified nurse aide (CNA), a licensed nurse, or nurse aide, provided that no less than 2.2 hours of care per resident per day be provided by a CNA or nurse aide, and no less than 1.1 hours of care per resident per day shall be provided by a licensed nurse.
- Senate Bill S2521-B (note: the equivalent Assembly Bill A3470-B has not yet been passed at the time of this writing) requires health care providers to notify patients at least seven days in advance if the patient will be subject to a facility fee. The notice must include the amount of the fee, the purpose of the fee, whether the patient’s insurance plan will pay the fee, and how to apply for financial assistance if the patient is uninsured.
CMS Approves OPWDD Comprehensive HCBS Waiver Amendment
On June 8th, the Office for People with Developmental Disabilities (OPWDD) announced that CMS approved a new amendment, Amendment 06, to its 1915(c) Comprehensive Home and Community Based Services (HCBS) Waiver. Effective July 1st, the Amendment includes the following changes, including several changes that make permanent certain provisions that were temporarily adopted through Appendix K waivers to address the COVID-19 emergency:
- Allows telehealth service delivery for the provision of Day Habilitation, Prevocational Services, Respite, Pathway to Employment, Support Brokerage, Community Habilitation, and Supported Employment.
- Revises the service description for Community Habilitation to allow it to be delivered within certified residences on weekdays before 3pm, and, where appropriate, via telehealth. The provision of Community Habilitation in the certified residential setting may be authorized when:
- The person is unable to participate in another HCBS habilitation service outside the residence due to their health status;
- The person chooses this mode of service delivery;
- The person has regular opportunities for community integration activities; and
- The provision of this service does not tend to isolate the person.
- Revises the Intensive Respite service definition to allow individuals who live in certified settings to access Intensive Respite from a Crisis Services for Individuals with Intellectual and/or Developmental Disabilities (CSIDD) Resource Center. During the individual’s stay, the time spent in Respite will be counted towards the available retainer day limit and paid at 50 percent of the provider’s residential rate. Residents of certified settings continue to be ineligible for Intensive Respite delivered outside of a CSIDD Resource Center and all other categories of Respite.
Implementation of the telehealth and Community Habilitation provisions will take effect following the end date of the OPWDD COVID-19 Appendix K authority. Based on feedback received during the public comment process, OPWDD added safeguards to ensure appropriate delivery of the telehealth and Community Habilitation provisions, including confirmation that individuals receive an informed choice to receive remote supports and/or Community Habilitation services in their residence.
The final Amendment omits a provision from the draft proposal to implement, by October 2021: (1) a new overnight Respite reimbursement methodology; (2) the use of the Coordinated Assessment System (CAS) to determine funding for individuals identified with high needs; and (3) new Personal Resource Account (PRA) calculations. These proposals are no longer contained in the Amendment and appear to be delayed indefinitely. OPWDD noted that stakeholders raised concerns during the public comment period regarding CAS implementation and that it plans to work to address these concerns.
OPWDD also noted other topics were raised during public comment. Those pertaining to the COVID-19 response will be addressed in further edits to the OPWDD Appendix K and OPWDD policy. Otherwise, topics were raised including:
- Lack of funding for HCBS Waivers services during school hours;
- Recommendations to combine existing service models and creation of new services such as Social Adult Day Care, housing supports, and Assistive Technology supports;
- Request to expand funding services for people with higher needs and additional funding for telehealth service delivery; and
- Recommendation to reinstitute the monthly approach for paying property costs for site-based day services.
OPWDD stated that addressing these topics would require additional collaboration and public input between stakeholders and the State.
The approved Amendment is available here.
DFS Issues Emergency Amendment Clarifying that Telehealth Includes Audio-Only Visits
On June 4th, the New York State Department of Financial Services (DFS) adopted on an emergency basis an amendment (available here) to Insurance Regulation 62 (11 NYCRR 52). The amendment includes the following clarifications:
- The definition of telehealth includes audio-only visits.
- An insurer may engage in reasonable fraud, waste, and abuse detection efforts, including to prevent payments for services that do not warrant a separate billable encounter.
DFS expects every insurance plan to reimburse a provider offering telehealth services for audio-only visits when medically necessary.
OMH and OASAS Announce Statewide and Regional Reopening Forums
OMH and OASAS are hosting several focus groups to better understand behavioral health (BH) providers’ needs and experiences during the transition to a post-COVID-19 environment. OMH and OASAS seek to understand what challenges and successes that BH providers have faced and are facing during this period.
On June 18th from 3:30pm-5pm, OMH and OASAS will host a statewide reopening forum for children and family behavioral health providers. Registration is available here.
OMH and OASAS will also host the below regional reopening forums for all behavioral health providers: