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Issue Brief

NABH Issue Brief: Details About 9th U.S. Circuit Court of Appeals Ruling to Overturn Wit v. United Behavioral Health Decision

In a blow to parity this week, a three-judge panel of the 9th U.S. Circuit Court of Appeals overturned a trial court’s Wit v. United Behavioral Health (UBH) decision, asserting that UBH’s interpretation that health insurance plans do not require consistency with generally accepted standards of care (GASC) “was not unreasonable.”

This NABH Issue Brief highlights brief background on the earlier decision from the trial court, as well as the main points of the three-judge panel’s reversal of that decision this week in its seven-page ruling:

  • The original Wit decision determined that patients’ health and safety are protected when clinicians provide services consistent with GASC that are established by not-for-profit, professional associations, rather than insurance companies whose financial incentives often conflict with what is best for patients.
  • The three-judge panel said it is “not unreasonable” for health insurers’ coverage determinations to be inconsistent with GASC; however, the trial court’s decision, including two 100-page decisions, described how UBH made medical coverage decisions based on financial interests.
  • In its ruling, the appellate court’s three-judge panel did not cite one holding or one fact that the trial court concluded, despite the trial court’s exhaustive trial findings.
  • The trial court’s decision explained UBH’s misrepresentation to regulators that UBH used American Society of Addiction Medicine (ASAM) criteria when, in fact, the company modified and ultimately undercut the actual ASAM criteria.
  • The appellate court’s three-judge panel ruled that UBH is not obligated to cover treatment consistent with GASC if the treatment is not a covered benefit; however, the plaintiffs did not argue that UBH was obligated to cover all services consistent with GASC. Instead, the plaintiffs argued that if services—such as outpatient, intensive outpatient, and residential treatment—are covered benefits, UBH must make medical necessity determinations that are consistent with GASC.

The deeply flawed ruling from the three-judge panel of the 9th U.S. Circuit Court of Appeals has the potential for worsening America’s mental health and addiction crises as the critical need for mental health and addiction treatment services continues to rise during the ongoing Covid-19 pandemic. NABH will continue to fight for true mental health addiction treatment parity and expanded access to care for all who need it.

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CMS Issues Guidance on Covid-19 Vaccination Requirements for Most Medicare- and Medicaid-Certified Providers

The Centers for Medicare & Medicaid Services (CMS) on Dec. 29 issued guidance regarding the Interim Final Rule (IFR) regarding Covid-19 vaccination requirements for healthcare staff that the agency published in early November.

In the Dec, 29 memo, CMS specified that this guidance does not apply to the following states that are still subject to preliminary injunctions that federal courts issued to block implementation of the IFR in those states: Alabama, Alaska, Arizona, Arkansas, Georgia, Idaho, Indiana, Iowa, Kansas, Kentucky, Louisiana, Mississippi, Missouri, Montana, Nebraska, New Hampshire, North Dakota, Ohio, Oklahoma, South Carolina, South Dakota, Texas, Utah, West Virginia, and Wyoming.

The new CMS guidance delineates the following deadlines and clarifications for requirements that most Medicare- and Medicaid-certified providers must meet in all other states:

Within 30 days after issuance of the guidance, healthcare facilities must:

  • Have policies and procedures developed and implemented to ensure all facility staff are vaccinated; and
  • 100% of staff have received at least one dose of Covid-19 vaccine, or have requested an exemption due to a disability or sincerely held religious beliefs, or must wait to receive the vaccine as the Centers for Disease Control and Prevention (CDC) recommends.
  • Facilities that fail to meet this requirement will receive notice of non-compliance, but those that are above 80% and have a plan to achieve 100% staff vaccination within 60 days will not be subject to additional enforcement action.

Within 60 days after the guidance has been issued, healthcare facilities must:

  • Have policies and procedures developed and implemented to ensure all facility staff are vaccinated; and
  • 100% of staff have received completed vaccine series or been granted an exemption due to a disability, or sincerely held religious beliefs, or must wait to receive the vaccine as the CDC recommends.
  • Facilities that fail to meet this requirement will receive notice of their non-compliance, but those that are above 90% and have a plan to achieve 100% staff vaccination within 30 days will not be subject to additional enforcement action.

Within 90 days of issuance of the guidance, facilities failing to maintain compliance with the 100% standard may be subject to enforcement action.

CMS also issued specific guidance for each healthcare facility type subject to the IFR, including hospitals and psychiatric residential treatment facilities (PRTFs). The guidance for hospitals and PRTFs appears to be the same. These more specific guidance documents note that “the requirements described above do not include the 14-day waiting period as identified by CDC for full vaccination. Rather, these requirements are considered met with the completed vaccine series (i.e., one dose of a single dose vaccine, or final dose of a multi-dose vaccine series).”

This guidance specifies that hospitals and PRTFs “must have a process for ensuring all staff have received at least a single-dose, or the first dose of a multi-dose Covid-19 vaccine series prior to providing any care, treatment, or other services for the facility and/or its patients.”

Hospitals and PRTFs “must also ensure those staff who are not yet fully vaccinated . . . adhere to additional precautions that are intended to mitigate the spread of Covid-19.” The guidance suggests a variety of actions or job modifications a facility can implement, including reassigning staff to remote work, mandatory routine Covid-19 testing in accordance with Occupational Safety and Health Administration (OSHA) and CDC guidelines, and requiring staff to wear N95 or higher-level respirators. CMS suggests similar actions for unvaccinated staff who are exempt from the vaccination requirements.

The guidance for hospitals and PRTFs clarifies that “[s]taff who exclusively provide telehealth or telemedicine services outside of the hospital setting” and “[s]taff who provide support services for the hospital that are preformed exclusively outside of the hospital setting” are exempt from the vaccination requirements. The guidance also notes, however, “that these individuals may be subject to other federal requirements for Covid-19 vaccination.”

In addition, the guidance notes that hospitals and PRTFs are not required to ensure that “one-off” vendors, volunteers, and professionals that provide infrequent, ad hoc, non-healthcare services (such as annual elevator inspections) are vaccinated.

Hospitals and PRTFs must track and securely document the following information:

  • Each staff member’s (including contractors, volunteers, and students) vaccination status including specific vaccine, date of each dose, and date of next scheduled dose as well as each staff’s role, assigned work area, and how they interact with patients;
  • Staff who have obtained any booster doses (including specific vaccine and date);
  • Staff granted an exemption (including type of exemption and supporting documentation including documentation signed and dated by a licensed practitioner for medical exemptions);
  • Staff for whom vaccination must be temporarily delayed (including date when staff can safely be vaccinated); and
  • Staff who telework full-time.

The CMS guidance also recommends that hospitals and PRTFs refer to the following CDC informational document when assessing requests for medical exemptions: Summary Document for Interim Clinical Considerations for Use of Covid-19 Vaccines Currently Authorized in the United States.

Regarding religious exemptions, the CMS guidance directs hospitals and PRTFs to the Equal Employment Opportunity Commission Compliance Manual on Religious Discrimination for information on evaluating and responding to such requests.

The guidance also discusses contingency plans that hospitals and PRTFs must have in place for staff who do not comply with these vaccination requirements, including those who qualify for an exemption. These plans can include actively seeking replacement staff or temporary vaccinated staff until permanent vaccinated replacements can be hired.

Surveyors will begin evaluating for compliance 30 days after this guidance was issued during full surveys for recertification or reaccreditation, federal initial surveys, or complaint surveys.

This guidance includes detailed instructions for surveyors, including levels of deficiency that may be assigned based on levels of staff vaccination and other factors including whether policies and procedures regarding staff Covid-19 vaccination have been developed and implemented by a facility.  In addition, the guidance specifies that surveyors may lower a citation level and/or enforcement action if they identify that prior to the survey that:

  • A hospital or PRTF “has no or has limited access to vaccine, and the hospital [or PRTF] has documented attempts to obtain vaccine access (e.g., contact with health departments and pharmacies)”; or
  • A hospital or PRTF “provides evidence that they have taken aggressive steps to have all staff vaccinated, such as advertising for new staff, hosting vaccine clinics, etc.”
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DEA Eases Regulations for Mobile Methadone

DEA Eases Regulations for Mobile Methadone

The Drug Enforcement Administration (DEA) on Feb. 26 proposed a regulation that revises the Controlled Substances Act (CSA) to permit narcotic treatment programs (NTPs)—opioid treatment programs, detoxification services that use methadone, and compounders— to operate mobile components, or mNTPs, without separate registrations.

The rule also proposes requirements related to security, recordkeeping, reporting, and inventory. The purpose of the rulemaking is to address the opioid epidemic by expanding access to methadone treatment, especially for residents of rural and underserved communities.

Background

Currently, each mobile component of an NTP must be separately registered, as the components dispense narcotic drugs regularly and therefore constitute a “principal place of business” or a “professional practice.” The CSA permits waivers to this requirement in instances that serve public health. The DEA had provided waivers on an ad hoc basis until a moratorium was implemented in 2007; after that, there was a subsequent decline in the number of operational mobile components.

The proposed rule obviates the need for ad hoc waivers by establishing mobile unit operations as a permissible “coincident activity” under the CSA with prior approval of a local DEA office.

Selected Summary of Requirements

  • Registration
    • Registrants notify the local DEA office in writing about intent to operate an mNTP and receive explicit written approval prior to operation.
    • The mNTP functions within the same states that the NTP is registered.
      • Practitioners maintain a DEA license in each state where they dispense controlled substances.
    • Vehicles possess valid county/city and state information on file at the NTP.
    • mNTPs are a controlled premise subject to administrative inspection; registrants provide licensing and registration to DEA at time of the inspection and before transportation of substances.
    • mNTPs may not serve as hospitals, long-term care facilities, emergency medical service vehicles, or patient transportation.
  • Security
    • Storage area must not be accessible from the outside of the mNTP vehicle.
    • Substances are secured in a locked safe:
      • with safeguards against forced entry, lock manipulation, and radiological attacks;
      • cemented to the floor or wall such that it cannot be readily removed;
      • equipped with an alarm system that can directly signal a protection company, local or State policy agency, or 24-hour registrant-operated control station, or other DEA Administrator approved protection.
    • Transportation personnel retain control over the controlled substances when transferring, traveling, and dispensing the substances.
    • mNTP is returned to registration location after operations are completed.
      • Substances are removed and secured within the registered NTP location.
      • Protocols allow for securing substances if the component is disabled.
      • Substances are removed and secured if the vehicle is taken to an automotive shop for repair.
    • For security breaches such as theft and loss, the NTP must abide by theft and loss reporting requirements.
    • NTPs follow state and federal regulations or whichever is more stringent and consults with State Opioid Treatment Authority to ensure compliance.
  • Other security controls
    • Ensure proper security measures and patient dosage, e.g., enrolled individuals wait in an area of the mNTP that is physically separated from the narcotic storage and dispensing area by a physical entrance.
      • If no seating is available, patient will wait outside of the mNTP.
    • mNTPs will abide by existing HHS standards for quantity of substances provided for unsupervised use.
    • Degree of security is at DEA discretion, based on factors including the location, number of patients, staff, and security guard.
    • Disposal of controlled substances is done consistent with all applicable laws and regulations.
    • Distribution and delivery of controlled substances to mNTP is only done at the registered location. Persons delivering narcotic drugs to mNTP may not:
      • Receive or deliver controlled substances to another mNTP or other entity while deployed outside the registered location.
      • Act as reverse distributors (or collectors).
  • Records and Reports
    • mNTP records are maintained in a paper dispensing log at the registered NTP, or
    • Use of automated/computerized system if the system:
      • maintains the same information as required for paper records;
      • has the capability to produce hard copies of the dispensing records;
      • the mNTP prints each day’s dispensing log which is initialed by individuals who dispense the medication;
      • produces accurate summary reports for any time frame requested by DEA in an investigation;
      • Hard copies of summaries are systematically organized at the NTP;
      • Computer generated information has off-site back-up;
      • DEA approves of the system.
    • mNTP maintain records for two years, or longer if required by the state.

Please contact Sarah Wattenberg, NABH’s director of quality and addiction services, at sarah@nabh.org, or 202.393.6700, ext. 114.

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MHLG Supports the Implementation of the National Suicide Hotline Improvement Act of 2018

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NABH Issue Brief: CMS Proposes Slight Payment Increase for PHPs and CMHCs in 2020

The Centers for Medicare and Medicaid Services (CMS) has proposed a hospital-based partial hospitalization program (PHP) payment rate of $228.20 for 2020, up from the 2019 rate of $220.86, in the Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System (OPPS/ASC) proposed rule the agency released on July 29.

CMS also proposed an increase for community mental health centers (CMHCs), which could see a payment rate of $124.59 in 2020 if the rule is made final. By comparison, CMHCs received a payment rate of $120.58 in 2019.

The rates set in the proposed CY 2020 rule are not based on the most recent average cost data from the PHP program, a deviation from CMS’ long-standing policy. When CMS calculated the average PHP program cost for the CY 2020 proposed rule, the agency found it had decreased by nearly 15 percent for CMHCs and 11 percent for hospitals-based PHPs.

After finding this decrease, CMS reviewed the data sets and found that a single provider in the CMHC set and a single provider in the hospital-based set had such dramatically lower-reported costs that it significantly skewed the average cost for both data sets.

Because the lower average costs were the result of single providers and could significantly reduce access for beneficiaries, CMS decided to use the CY 2019 cost average as a floor for both type of PHP rates in the CY 2020 rule. If not for this change, the rate for both types of PHPs would have been significantly lower than what CMS proposed in the rule.

It is important to note that CMS stressed that it does not intent to carry this policy forward: “To be clear, this policy would only apply for the CY 2020 rate setting,” the agency said in the rule.

CMS will accept comments on the CY 2020 proposed rule until September 27.

CY 2020 Rates
Level 1 Health and Behavior Services                                                         $28.59
Level 2 Health and Behavior Services                                                         $81.06
Level 3 Health and Behavior Services                                                         $130.27
Partial Hospitalization (3 or more services) for CMHCs                               $124.59
Partial Hospitalization (3 or more services) for Hospital-based PHPs         $228.20

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NABH Issue Brief: CMS Addresses OUD Treatment in OTPs and Office Settings in Proposed Rule

The Centers for Medicare and Medicaid Services (CMS) on Monday issued a proposed rule for establishing a Medicare Part B benefit and payment bundles for opioid use disorder (OUD) treatment services in opioid treatment program (OTP) settings and new HCPCS codes and bundled rates for office-based treatment of OUD.

OTP Bundled Payment

The proposal implements Section 2005 of the Substance Use Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities (SUPPORT) Act.

The rule proposes:

  • A definition of OUD treatment services and OTPs, including an explanation that services include access to all FDA-approved medications, counseling and therapy, and toxicology testing;
  • Enrollment policies that align with SAMHSA OTP regulation and that do not have additional conditions of participation;
  • Bundled payment methodologies that separate drug from non-drug treatment components, account for different medications and variable intensity of services, provide for service add-ons and partial- and full-billing for weekly episodes;
  • Use of audio-video communication technology; and
  • Zero beneficiary cost-sharing requirement for a time-limited period.
Office-based Care Bundled Payment

The agency also proposed a bundled payment for office-based OUD treatment services, to encourage the expansion of access to OUD care, including:

  • Coverage of OUD management, care coordination, psychotherapy, and counseling; medication to be billed and reimbursed under existing Medicare Part B or D; toxicology testing to be billed under Clinical Lab Fee Schedule;
  • Bundled payment methodologies that are based on monthly billing cycles to better align with office-based practices; one bundle for the initial month of treatment that is more service-intensive; and a second bundle for subsequent “maintenance months,” service add-on codes, and not restricted to addiction specialists;
  • Three new HCPCS codes to Category I of the list of Medicare telehealth services for office-based substance use disorder (SUD)/OUD services, permits a patient’s home as a telehealth originating site; and
  • No changes to cost-sharing.
Emergency Departments

Also of interest, the proposed rule requests information on emergency department practice patterns related to the initiation and use of MAT, and referral or follow-up care, for developing such bundles in future rulemaking.

Comments are due September 27, 2019. NABH has engaged a consulting firm to help analyze the proposed bundled payment methodology and payment rates, and the association will submit comments.

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