Weekly Health Care Policy Update – December 3, 2021

December 10, 2021

In this update: 

  • Covid-19 Updates
    • White House Announces Plans to Combat Covid-19 Given Winter, Omicron
    • CDC Recommends Booster Shots for All Adults
    • Federal Judge Halts Health Care Worker Vaccine Mandate
    • FDA Panel Narrowly Backs Covid-19 Pill
    • Pfizer Seeks Booster Authorization for 16- and 17-Year-Olds
  • Legislative
    • Congress Passes Stopgap Funding Deal
  • Regulatory
    • Innovation Center to Hold Roundtable on Health Equity Strategy
    • CMS Removes Seriously Ill Population Component of Primary Care First Model
    • HRSA Announces Dental Training Grant Programs; NHSC Loan Repayment Application Deadline Extended
    • HHS Seeks Public Comments to Advance Equity and Reduce Disparities in Organ Transplantation 
    • HHS Announces $35 Million for Telehealth in the Title X Family Planning Program
    • Labor Department Launches Initiative to Protect Professional Caregiver Wages and Rights 
    • HHS Launches Website for Aligning Health Care Industry Security Approaches Program
    • OSHA Extends Comment Period on Employer Vaccination or Testing Requirement
  • Other
    • SCOTUS Hears Oral Arguments in DSH Case
    • SCOTUS Hears Oral Arguments in 340B Case
    • SCOTUS Hears Oral Arguments in Mississippi Abortion Case
    • Biden Releases New HIV/AIDS Strategy
  • Congressional Hearings
  • New York State Updates
    • Governor Hochul Declares State Disaster Emergency as a Result of Increased Covid-19 Transmission
    • OMH Issues Emergency/Proposed Rule on Telehealth Expansion
    • CMS Approves New York State SPA to Establish Community-Based Mental Health Services Under the Rehabilitative Option
    • DFS Proposes Regulation to Protect Consumers Against Health Care Provider Directory Misinformation
    • NY State of Health Announces Care at Home Pilot Program
    • OASAS Issues Emergency/Proposed Rules on Telehealth Flexibilities, LGBTQ Optional Endorsement, Patient Rights, and Chemical Dependence Service Provisions 
    • DOH Adopts Regulations Establishing Medicaid Payment Standards for the ET3 Model
    • DOH Webinar on Electronic Visit Verification for Home Health Care Services

COVID-19 Updates

White House Announces Plans to Combat Covid-19 Given Winter, Omicron
On December 2nd, the White House announced a new plan to combat Covid-19 as the nation heads into colder conditions and deals with the Omicron and Delta variants. The plan includes a number of actions, such as: 

  • A focus on increasing uptake of booster vaccines for all adults and initial vaccination for children to ensure schools can stay open;
  • Expanding access to “free” at home testing, covered by insurance without cost-sharing for those with private insurance, and provided by the government for the uninsured;
  • Strengthening public health protocols for international travel, including pre-departure testing and extending mask requirements;
  • Asking businesses to move forward with vaccination or testing requirements;
  • Deploying federal rapid response teams to assist states with rising cases;
  • Ensuring equitable access to Covid-19 treatments, including those still under FDA review;
  • Continuing the U.S. commitment to a global vaccination strategy; and
  • Accelerating the development of new vaccines and boosters in the event they are required for Omicron.

A White House statement on the plan is available here. 
 
CDC Recommends Booster Shots for All Adults
 On November 29th, the Centers for Disease Control and Prevention (CDC) updated its guidance to recommend booster shots for everyone ages 18 and older. For those who originally received an mRNA vaccine, the CDC recommends a booster at least six months after completing a primary Covid-19 vaccination series, with any authorized Covid-19 vaccine. For those who originally received a Johnson & Johnson vaccine, the CDC recommends a booster at least two months after receiving a primary Covid-19 vaccination, with any authorized Covid-19 vaccine.
 
Federal Judge Halts Health Care Worker Vaccine Mandate
On November 30th, a federal judge halted the enforcement of President Biden’s vaccine mandate for health care workers. The interim final rule, issued by the Centers for Medicare and Medicaid Services (CMS) earlier in November, effectively mandated Covid-19 vaccinations for health care employees by making compliance a condition of participation in the Medicare and Medicaid programs. The rule requires employees to receive a first vaccination dose by December 6th and to be fully immunized by January 4th. Fourteen states sued, and Judge Terry Doughty of the U.S. District Court for the Western District of Louisiana issued a preliminary injunction, writing that “it is not clear that even an act of Congress mandating a vaccine would be constitutional.” The ruling adds to a similar order issued by a Missouri federal court on November 29th that only applied to 10 states. It is likely to be appealed.
 
FDA Panel Narrowly Backs Covid-19 Pill
 On November 30th, a Food and Drug Administration (FDA) advisory panel voted 13-10 to recommend full authorization of molnupiravir, the first at-home drug to treat Covid-19, which is already authorized for emergency use. The drug, co-created by Merck and Ridgeback Pharmaceuticals, was recommended for adults with mild-to-moderate Covid-19 who face the greatest risk of serious illness. In its final study results, Merck reported that the drug reduced hospitalization and death by 30% among infected adults, compared to placebo. Molnupiravir has not been tested against the Omicron variant. Vaccinated patients were not part of this study, and use in that population was not recommended. The panel also called on the FDA to recommend extra precaution when prescribing the drug to anyone who might be pregnant, including pregnancy tests for women of child-bearing age. The FDA is not bound by the recommendation of the panel, and will make its own decision in the coming weeks.
 
Pfizer Seeks Booster Authorization for 16- and 17-Year-Olds
On November 30th, Pfizer asked the FDA to authorize booster shots for 16- and 17-year olds. The vaccine was fully authorized for everyone over 16 in August, but only those 18 and older are eligible for the booster. According to CDC data, 2.3 million 16- and 17-year-olds are over six months out from the end of their two-dose vaccine series, which will grow to 3 million by the end of the year. The FDA is expected to act within a week.

Legislative Update

Congress Passes Stopgap Funding Deal
On December 2nd, Congress passed a continuing resolution that will fund the government for an additional 11 weeks, averting a government shutdown that would have begun at midnight on December 4th. Passage in the Senate was slowed by a vote on an amendment from Senators Marshall (R-KS) and Lee (R-UT) to cut funding to enforce the Biden Administration’s vaccine mandates. By a vote of 48-50, the amendment was not accepted. President Biden is expected to sign the bill shortly.  
 
Congress still has a handful of key items on its short-term agenda. These include raising the debt limit ceiling (by December 15th), statutory PAYGO rules which will dictate across-the-board spending cuts as a result of the American Rescue Plan, a 2% spending cut for all Medicare services, an expiring 3.75% increase to physician pay, and several tax extender policies. 
 
A summary of the 11-week spending bill can be found here.

Regulatory Updates

Innovation Center to Hold Roundtable on Health Equity Strategy
On Wednesday, December 8th, from 1:30-3:00pm ET, the CMS Innovation Center (CMMI) will hold a roundtable discussion on how the Center can “execute on its strategic objective to Advance Health Equity.” This roundtable serves as a follow-up to the recent release of CMMI’s strategic vision white paper that set a number of goals for 2030 entitled “Driving Health System Transformation: A Strategy for the CMS Innovation Center’s Second Decade.” The roundtable will address the following questions: 

  1. What approaches or interventions should the CMS Innovation Center prioritize when building models to eliminate health inequities?
  2. CMS is currently exploring options for expanding collection of self-reported demographic and social needs data. What could the CMS Innovation Center do to support collection of self-reported data? What are successful approaches for such collection?
  3. What are the most significant obstacles for safety net providers who want to participate in a CMS Innovation Center or another value-based, accountable care model, and how do you recommend the CMS Innovation Center help these providers overcome these obstacles?

Webinar registration can be found here. The white paper can be found here.

CMS Removes Seriously Ill Population Component of Primary Care First Model
On November 30th, CMS announced that it will not move forward with the Seriously Ill Population (SIP) Component of the Primary Care First (PCF) Model. The SIP Component was intended to allow advanced primary care practices to coordinate care for high-need, seriously ill beneficiaries. However, CMS has determined that the outreach method as designed, which would have identified and attributed eligible beneficiaries to participants, will not result in sufficient beneficiary uptake to allow for adequate evaluation of the model. The Innovation Center will look for additional ways to reach this population, either through existing or new models.

HRSA Announces Dental Training Grant Programs; NHSC Loan Repayment Application Deadline Extended
On November 22nd, the Health Resources and Services Administration (HRSA) announced the opportunity to apply for two dental training programs:

  • The Predoctoral Training in General, Pediatric, and Public Health Dentistry and Dental Hygiene Program: This program will award up to $300,000 per year to up to 15 applicants to operate approved professional training programs that emphasize training for public health dentistry. Applicants may propose to develop a new program, which must be accredited by July 1, 2023.
  • The Dental Clinician Educator Career Development Program: This program will award up to $187,500 per year to eight recipients to applicants to support the academic career development of dental faculty. It will implement a collaborative project between dentistry departments and primary care departments to support faculty that teach the integration of oral health into primary care.

Applicants for these programs may include private nonprofit hospitals or other public or private nonprofit entities as determined by HRSA. Applications for the Predoctoral Training program are due February 7, 2022; applications for the Career Development Program are due February 14, 2022. Contracts will last for five years, starting July 2022.
 
Two of HRSA’s major loan repayment programs, the National Health Service Corps (NHSC) and the Nurse Corps, are also currently open for applications. The NHSC helps clinicians pay off loan debt in exchange for working in a facility in a Health Professional Shortage Area (HPSA). The Nurse Corps funds loan repayment for nurses who work in facilities with critical nursing shortages.
 
The NHSC application deadline for 2022 has been extended to February 3, 2022, while the Nurse Corps deadline is January 13, 2022. More information on the NHSC is available here. More information on the Nurse Corps is available here.
 
HHS Seeks Public Comments to Advance Equity and Reduce Disparities in Organ Transplantation 
On December 1st, CMS issued a Request for Information (RFI) to solicit feedback on proposals to improve the organ transplantation system and enhance quality of life for those living with organ failure. CMS seeks ideas for “systemwide improvements,” which may be implemented through future rulemaking that would adjust the Conditions of Participation for Medicare and Medicaid. Potential areas for suggestions include activities that would: 

  • Increase organ donation;
  • Improve transplants;
  • Enhance the quality of care in dialysis facilities;
  • Increase access to dialysis services; and
  • Advance equity in organ donation and transplantation.

In particular, CMS seeks input regarding health and safety standards for transplant programs, End Stage Renal Disease (ESRD) facilities, and Organ Procurement Organization (OPO) operations. CMS is also emphasizing the opportunity for feedback from donors, recipients, and their families. as well as specific ideas on advancing equity within the organ transplant system. Feedback will be used to inform potential changes and future rulemaking.
 
The RFI is available here. Comments are due February 1, 2022.

HHS Announces $35 Million for Telehealth in the Title X Family Planning Program
On November 23rd, the Department of Health and Human Services announced the availability of $35 million in American Rescue Plan (ARP) funding to enhance and expand the telehealth infrastructure and capacity of Title X family planning providers. HHS will award 60 one-time grants to active Title X grantees to help expand their capacity to provide telehealth services, increase their community’s access to family planning services, and support national efforts to achieve health equity.
 
Applicants can begin the application process here; applications are due February 3, 2022. This is the third of three Title X funding opportunities which have been released recently. SPG has prepared a brief summary of all three opportunities, which is available here.
 
Labor Department Launches Initiative to Protect Professional Caregiver Wages and Rights
On November 23rd, the Department of Labor (DOL) announced an education, outreach, and enforcement initiative to ensure that professional caregivers are paid their rightful wages and are given all protections afforded to them by law. The initiative will focus on educating essential care workers about their rights to minimum wage and overtime pay, and about how to file a complaint if they believe their rights have been violated. The initiative will also target misclassification of workers as independent contractors, which can deprive workers of earned ages and other protections. DOL’s Wage and Hour Division will also step up enforcement to encourage employer compliance and reduce violations.
 
The DOL press release is available here.
 
HHS Launches Website for Aligning Health Care Industry Security Approaches Program
On December 1st, HHS launched a website for the 405(d) Aligning Health Care Industry Security Approaches Program. This program was established in response to the Cybersecurity Act of 2015, which requires HHS to convene a task force to align industry approaches to cybersecurity through a voluntary common set of practices and methodologies. The website provides various security resources, including the cornerstone publication containing recommended practices, entitled “Health Industry Cybersecurity Practices: Managing Threats and Protecting Patients.”
 
The website is available here.
 
OSHA Extends Comment Period on Employer Vaccination or Testing Requirement
On November 30th, the Department of Labor’s Occupational Safety and Health Administration (OSHA) announced it was extending the comment deadline on its workplace vaccine requirement until January 19, 2022. The emergency temporary standard was originally released on November 5th. OSHA indicated it would extend the comment deadline by 45 days to give stakeholders additional time to collect information and data necessary to comment. OSHA had previously paused implementation of the standard, which was intended to take effect January 4, 2022, due to a court order and pending litigation.
 
An announcement from OSHA regarding the comment extension is available here.

Other Updates

SCOTUS Hears Oral Arguments in DSH Case
On November 29th, the Supreme Court heard oral arguments in a case brought by Empire Health Foundation challenging changes made by CMS to the formula for calculating disproportionate share hospital (DSH) payments. In 2005, CMS modified a portion of the DSH payment formula, and this modification was challenged by several hospitals that claimed the change underpaid them. During oral arguments, justices appeared skeptical that CMS appropriately interpreted the Medicare statute when it changed the DSH formula in 2005. However, this skepticism may be at least partially a response to the statute’s lack of clarity. While several justices emphasized the need for precision in interpreting the statutory language, they also repeatedly expressed exasperation with inconsistencies in the statute and in CMS’ regulatory interpretation of the statute, as well as procedural mistakes CMS made in the rulemaking process. A decision in this case is expected before the end of the Court’s term in July.
 
SCOTUS Hears Oral Arguments in 340B Case
On November 30th, the Supreme Court heard oral arguments in the 340B Drug Pricing Program case brought by the American Hospital Association, the Association of American Medical Colleges, and other provider groups. The plaintiffs have asked the Court to reverse a nearly 30% cut in 340B reimbursements initiated by CMS in 2018, arguing that the government made the changes without adequate data from hospitals. The cuts resulted in a $1.6 billion reduction in reimbursement over the first year. Donald Verrilli, counsel for the providers, argued that Congress did not authorize the methodology actually used by CMS, which varied reimbursement rates between 340B and non-340B hospitals without conducting a cost study. The government argued that the cuts are permissible under the law, as is the varied reimbursement rates. The justices seemed to universally question the government’s attorney, Christopher Michel, on this logic, but a decision will not be released until sometime next year.
 
SCOTUS Hears Oral Arguments in Mississippi Abortion Case
On December 1st, the Supreme Court heard oral arguments in the case of a 2018 Mississippi law that bans most abortions after 15 weeks, except in cases of medical emergencies or severe fetal abnormality. Lower courts have blocked the law thus far. The Court’s more conservative justices seemed sympathetic to the law, with Justices Thomas, Alito, Gorsuch, and Kavanaugh going even further, suggesting they could overturn Roe on the grounds that it was wrongly decided. Justice Kavanaugh referenced other previous decisions where the Court overruled long-standing precedents, such as on segregation and gay marriage. Chief Justice Roberts seemed to stop short of looking to overrule Roe, while still upholding the Mississippi law. A decision is not expected until late June or early July.
 
Biden Releases New HIV/AIDS Strategy
On December 1st, World AIDS Day, President Biden unveiled a new HIV/AIDS strategy to guide his administration’s work to reduce new cases, increase access to treatment and support services, and eliminate inequitable access to treatment and support. The strategy articulates a new vision for the U.S. in the effort to eliminate HIV by 2030 and includes a strong emphasis on eliminating health disparities, calling racism “a serious public health threat that directly affects the well-being of millions of Americans.” Broadly, the strategy’s goals are: 

  1. Prevent new HIV infections;
  2. Improve HIV-related health outcomes of people with HIV;
  3. Reduce HIV-related disparities and health inequities; and
  4. Achieve integrated, coordinated efforts that address the HIV epidemic among all partners and interested parties.

The HIV/AIDS Strategy may be found here, and a fact sheet from the White House may be found here.

Congressional Hearings

Past Hearings:

  • On December 1st, the House Financial Services Committee held a hearing on the oversight of the Treasury Department’s and Federal Reserve’s pandemic response. A webcast of the hearing is available here.
  • On December 2nd, the House Energy and Commerce Subcommittee on Health held a hearing entitled “The Overdose Crisis: Interagency Proposal to Combat Illicit Fentanyl-Related Substances.” A webcast of the hearing is available here.

Wednesday, December 8th:

  • At 10am, the House Agriculture Subcommittee on Nutrition, Oversight, and Department Operations will hold a hearing to review the nutrition distribution programs of the U.S. Department of Agriculture (USDA). More information is available here.
  • At 10:30am, the House Energy and Commerce Subcommittee on Health will hold a hearing entitled “The Future of Biomedicine: Translating Biomedical Research into Personalized Health Care.” More information is available here.
  • At 11am, the House Select Committee on Economic Disparity and Fairness in Growth will hold a hearing entitled “Growing our Economy by Investing in Families: How Supporting Family Caregiving Expands Economic Opportunity and Benefits All Americans.” More information is available here.

New York State Updates

Governor Hochul Declares State Disaster Emergency as a Result of Increased Covid-19 Transmission
On November 26th, Governor Hochul issued an Executive Order (available here) declaring a disaster emergency in New York State through January 15, 2022 as a result of increased Covid-19 transmission rates and hospital admissions. The Order implements the State’s Comprehensive Emergency Management Plan and the “Surge and Flex” system, which allows the Department of Health (DOH) to limit non-essential elective procedures at health systems with limited capacity. Limited capacity is defined as having below 10% staffed bed capacity available, or as otherwise determined by DOH. As of December 1st, 56 hospitals statewide met this threshold, including 19 in the NYC metro area, although some are likely to avoid the requirement due to shifting among other facilities within a health system. The new protocols will begin on December 3rd and will be reassessed based on the latest Covid-19 data on January 15, 2022.

The Order also waives certain State Finance Law provisions around procurement to expedite purchasing of pandemic-related supplies. These provisions will expire December 26th unless further extended. 
 
The Governor’s press release is available here.

OMH Issues Emergency/Proposed Rule on Telehealth Expansion
On December 1st, OMH issued an emergency/proposed rule in the State Register (available here) revising Part 596 of Title 14 of the New York Codes, Rules, and Regulations (NYCRR) that regulates the provision of services via telehealth. The proposed regulations include the following changes, among others: 

  • Allow for the provision of telephonic (audio-only) services;
  • Allow any authorized provider to deliver mental health services under their scope of practice;
  • Expand the definitions of originating and distant sites;
  • Remove the required in-person initial assessment;
  • Remove additional requirements for Personalized Recovery Oriented Services (PROS) and Assertive Community Treatment (ACT) programs; and
  • Strengthen language around consent and recipient preference.

The proposed regulations are available here. SPG’s summary of the regulations is available here. Public comment may be submitted to regs@omh.ny.gov through January 30, 2022. The emergency rule will expire February 12, 2022.
 
CMS Approves New York State SPA to Establish Community-Based Mental Health Services Under the Rehabilitative Option
On November 23rd, the Centers for Medicare and Medicaid Services (CMS) approved New York State’s State Plan Amendment (SPA) to establish outpatient mental health services under the rehabilitative services benefit. This amendment allows Medicaid to reimburse outpatient mental health services when provided in a community setting or in an individual’s place of residence. Outpatient mental health services include: 

  • Assessments/screening;
  • Treatment planning;
  • Counseling/therapy;
  • Medication treatment;
  • Psychiatric consultation;
  • Testing services;
  • Health monitoring;
  • Screening, Brief Intervention, and Referral to Treatment (SBIRT);
  • Complex care management;
  • Peer/family peer recovery support; and
  • Crisis intervention.

Ambulatory Patient Group (APG) reimbursement for all Office of Mental Health (OMH) community-based mental health rehabilitative services will be effective March 1, 2021.
 
The SPA is available here. The CMS approval letter is available here.  
 
DFS Proposes Regulation to Protect Consumers Against Health Care Provider Directory Misinformation
On November 24th, the New York State Department of Financial Services (DFS) issued a proposed regulation to protect consumers against health care provider directory misinformation. The proposed regulation would protect consumers against out-of-network charges when: 

  • A provider is incorrectly listed as in-network in the insurer’s provider directory;
  • An insurer provides incorrect information about a provider’s network participation status in response to a request from a consumer; and
  • An insurer fails to provide network status information in writing to a consumer within one business day of the consumer’s request for such information by telephone.

Under the proposed regulation, consumers would pay no more than their in-network cost-sharing when they receive services from an out-of-network provider based on provider directory misinformation. The proposed regulation is consistent with the federal No Surprises Act requirements, which will be effective January 1, 2022.
 
The DFS press release is available here. The proposed regulation is available here.
 
NY State of Health Announces Care at Home Pilot Program
On November 22nd, NY State of Health, the State’s health plan exchange marketplace, announced a new pilot program call “NY State of Health, Care at Home.” A recommendation from the Medicaid Redesign Team (MRT) II, the pilot program will help New Yorkers connect with home care professionals from licensed home care services agencies (LHCSAs) for the provision of private pay home care services for themselves or their loved ones. The pilot program is initially launching in Nassau, Suffolk, and Westchester counties, with the intention to expand the program statewide in the future.  
 
More information is available here.
 
OASAS Issues Emergency/Proposed Rules on Telehealth Flexibilities, LGBTQ Optional Endorsement, Patient Rights, and Chemical Dependence Service Provisions
On November 24th, the Office of Addiction Services and Supports (OASAS) issued an emergency/proposed rule in the State Register (available here) amending Part 830 of Title 14 of NYCRR to continue telehealth flexibilities allowed during the New York State Disaster Emergency and to make those flexibilities permanent in alignment with the proposed regulations released by OMH. The emergency/proposed rule also adds an optional LGBTQ endorsement to develop a distinction for OASAS-certified programs meeting additional criteria for the provision of LGBTQ-affirming care.
 
The proposed regulations are available here. Public comment may be submitted to kelly.grace@oasas.ny.gov through January 16, 2022. The emergency rule will expire February 5, 2022.
 
OASAS has also published proposed amendments to: 

  • Part 800 Chemical Dependence Service Provisions (available here), including a new section addressing “Access to Treatment.” Public comment may be submitted to kelly.grace@oasas.ny. 
  • Part 815 Patient Rights (available here), which includes various changes related to patient rights and provider requirements for developing policies and procedures. Public comment may be submitted to carmelita.cruz@oasas.ny.gov.

DOH Adopts Regulations Establishing Medicaid Payment Standards for the ET3 Model
On November 24th, DOH posted a Notice of Adoption in the State Register (available here) of regulations that establish Medicaid payment standards for emergency ambulance providers participating in an Emergency Triage, Treat, and Transport (ET3) model. This model is a Medicare demonstration program that provides an alternative to hospital emergency department care for Medicaid beneficiaries otherwise transported to the hospital.
 
The regulations are available here.
 
DOH Webinar on Electronic Visit Verification for Home Health Care Services
On December 8th at 11am, DOH will host a webinar on Electronic Visit Verification (EVV) for the upcoming home health care services (HHCS) EVV implementation. During the webinar, DOH will provide a high-level overview of EVV and information on the inclusion of HHCS, which will be subject to EVV requirements beginning on January 1, 2023.
 
Registration for the webinar is available here. DOH has posted a draft list of applicable HHCS billing codes subject to EVV (available here) and providers are invited to review the draft list and provide feedback to DOH via EVVHelp@health.ny.gov by December 15th. After reviewing feedback, DOH will publish a finalized list of EVV-applicable billing codes.