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Tags Posts tagged with "Waiver"

Waiver

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The Centers for Medicare & Medicaid Services (CMS) has approved the Office of Long-Term Living’s (OLTL) Community HealthChoices (CHC) Waiver amendment that transfers oversight of Financial Management Services (FMS) from an OLTL-held contract to an administrative function of the CHC-MCOs and revises waiver performance measure AA-5. The amendment became effective on July 1, 2022.

The current approved CHC 1915(c) Waiver document with the FMS amendment can be viewed here. The link can be found under the heading “Community HealthChoices 1915(b) Managed Care and 1915(c) Home and Community-Based Waivers.”

Questions about the CHC Waiver amendment should be sent via email.

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The Pennsylvania Department of State (DOS) has reversed course and extended its waiver allowing for an initial prescription of buprenorphine without an in-person physical exam. DOS had announced previously that the waiver would expire on June 30, 2022; however, DOS’s waiver will now continue until the last day of the federal public health emergency declaration, unless the exemptions are ended sooner by the Substance Abuse and Mental Health Services Administration (SAMHSA) or the US Drug Enforcement Administration (DEA).

On Sept. 4, 2020, DOS issued a waiver suspending the State Board of Medicine’s regulation at 49 Pa. Code § 16.92(b)(1), which requires an initial physical examination of a patient prior to prescribing buprenorphine for the treatment of opioid use disorder. This waiver was sought specifically to complement the Department of Drug and Alcohol Programs’ (DDAP) suspension of 28 Pa. Code § 715.9(a)(4) and “relates to Federal exemptions granted under the Federal public health emergency (PHE) declaration,” specifically the exemptions granted by the federal Substance Abuse and Mental Health Services Administration (SAMHSA) and the U.S. Drug Enforcement Agency (DEA).

Therefore, in accordance with section 2102-F(a.3) of the Pennsylvania Administrative Code of 1929 (amended by Act 14 of 2022), the Department of State’s waiver will continue until the last day of the federal public health emergency declaration, unless the exemptions are ended sooner by SAMHSA or the DEA. This waiver will not expire on June 30, 2022. More information about the federal public health emergency can be found here.

It is important to note that, to be considered within the acceptable and prevailing standard of care, the physician/prescriber must be following the applicable SAMHSA/DEA guidelines.

Pennsylvania has not received notification that the PHE will be terminated on July 15. The commonwealth expects the PHE to be extended again. If this occurs, this waiver and others tied to or related to the PHE will be extended until mid-October 2022.

Additional information:

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ODP Bulletin 00-22-02, effective June 2, 2022, is to establish the process for requesting a waiver of a regulatory requirement. This bulletin applies to entities seeking to be licensed or are currently licensed under one or more of the following chapters:

  • 55 Pa. Code Chapter 2380 (relating to Adult Training Facilities);
  • 55 Pa. Code Chapter 2390 (relating to Vocational Facilities);
  • 55 Pa. Code Chapter 6400 (relating to Community Homes for Individuals with an Intellectual Disability or Autism);
  • 55 Pa. Code Chapter 6500 (relating to Life Sharing Homes); and
  • Providers of home and community-based services (HCBS) for individuals with an intellectual disability or autism subject to 55 Pa. Code Chapter 6100 (relating to Services for Individuals with an Intellectual Disability or Autism).

Licensees and ODP-enrolled providers are expected to comply with all applicable regulations. However, the Department recognizes that there are occasions where compliance with a regulation impedes the licensee’s or ODP-enrolled provider’s ability to provide services to an individual. As a result, the Department permits licensees and ODP-enrolled providers to request that a section, subsection, paragraph, or subparagraph of a regulation not apply when it is in the best interest of an individual or group of individuals who receive services from the licensee or ODP enrolled provider.

Not all regulations can be waived. Section 6100.43(a) prohibits waivers of the following regulations:

  • Sections 6100.1–6100.3 (relating to General Provisions);
  • Sections 6100.41–6100.56 (relating to General Requirements);
  • Sections 6100.181–6100.186 (relating to Individual Rights); and
  • Sections 6100.341–6100.350 (relating to Restrictive Procedures).

Additionally, section 6500.12(7) prohibits waivers of sections 6500.1–6500.4 (relating to General Provisions). While Chapters 2380, 2390, and 6400 do not address waivers of regulation, waivers for these chapters are at the discretion of the Department and can be requested pursuant to 1 Pa. Code section 35.18.

Providers should utilize the Office of Developmental Programs’ form “Request for Regulatory Waiver.”

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ODP Announcement 22-059 informs readers that the Office of Developmental Programs (ODP) is pleased to announce that an amendment to the AAW was submitted to CMS on May 9, 2022. The submitted AAW includes modifications that were made as a result of public comment. The AAW amendment includes the following substantive changes:

  • Adding reserved waiver capacity for individuals who are discharged from a state center. Reserved waiver capacity is also being added for participants who have been incarcerated for more than six consecutive months;
  • Aligning provider qualifications in the AAW with the Consolidated, Community Living, and Person/Family Directed Support (P/FDS) waivers, whenever possible;
  • Allowing relatives to deliver the Life Sharing component of the Residential Habilitation service;
  • Requiring that agencies that provide Residential Habilitation/Life Sharing must be qualified and enrolled to provide Residential Habilitation/Life Sharing in the Consolidated or Community Living waivers;
  • Increasing the annual fiscal limit in the transportation service to $5,000 per participant’s ISP year;
  • Allowing one of the four required monitoring conducted by the Supports Coordinator each year to be conducted remotely;
  • Adding a new service, Remote Supports; and
  • Delivering direct services using remote technology.

The requirements in the AAW will become effective when Appendix K flexibilities expire, six months after the expiration of the federal COVID-19 public health emergency.

Please note that aligning the Assistive Technology service, where possible, with the Consolidated, Community Living, and P/FDS waivers includes adding generators for the participant’s primary residence.

The full AAW application, as well as a record of substantive changes, is available here.

CMS has 90 days to review the amendment, and changes may occur to the content based upon discussion with CMS during the approval process. The proposed effective date of July 1, 2022, is also subject to change. ODP will inform all stakeholders when CMS has officially approved the AAW and will make the approved waiver available at that time.

Questions about this communication should be directed via email.

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ODP Announcement 22-039 describes actions the Administrative Entities (AEs) and Supports Coordination Organizations (SCOs) must take when an Office of Developmental Programs’ (ODP) waiver or base participant is admitted to a Nursing Facility (NF) to ensure a coordinated transition to Long-Term Care (LTC) services and prevent service interruptions.

When an ODP waiver participant (Adult Autism, Consolidated, Community Living, or Person/Family Directed Support) is identified for NF admission, he or she will transition from the ODP waiver to Community Health Choices (CHC) for their Long-Term Services and Supports (LTSS). Nursing services are started the day of admission into the NF, ensuring health and safety. The individual must begin to receive CHC services on the day he or she is admitted to the NF. Individuals cannot be dually enrolled in CHC and an ODP waiver. The AE, county MH/ID program, and/or SC will assist the individual in transitioning to the NF and move the participant into reserved capacity for their ODP waiver.

Enrollment in an ODP waiver or base services in HCSIS prevents the CHC from enrolling the individual in LTSS in eCIS; therefore, the AE must end date the waiver or base enrollment in HCSIS prior to the CHC enrollment date in eCIS/CIS to avoid overlap.

Please review the announcement for further guidance.

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With Senate Bill 1019 passed into law as Act 14, the Department of Drug and Alcohol’s (DDAP) regulatory suspensions are also extended. These regulatory suspensions are “related to federal exemptions granted under the federal public health emergency declaration” until “the last day federal exemptions granted under the federal public health emergency declaration are authorized.” In addition to three DDAP regulatory suspensions, one additional regulation from the Department of State, also relevant to the field, is included in the chart below and also remains suspended.

Statute/Regulation Statute/Regulation Purpose

Waiver Benefit/Explanation

28 Pa. Code § 715.16(e)

 Prohibits narcotic treatment programs (NTPs — methadone clinics) from permitting a patient to receive more than a 2-week take-home supply of medication In response to COVID-19, SAMHSA is allowing up to 28 days of take-home medications for patients on stable dosages, if the physician deems appropriate.
28 Pa. Code § 715.9(a)(4) Requires NTPs to make a face-to-face determination before admission to treatment, for those clients who will receive buprenorphine treatment. In response to COVID-19, SAMHSA is allowing initial evaluations for a patient who will be treated with buprenorphine to be completed via telehealth.
28 Pa. Code § 715.6(d) Requires NTPs to have narcotic treatment physician services onsite. In response to COVID-19, SAMHSA is allowing initial evaluations for a patient who will be treated with buprenorphine to be completed via telehealth.
49 Pa. Code § 16.92(b)(1)

(Department of State)

 Before a patient can be prescribed any controlled substance in Pennsylvania, a person licensed to practice medicine and surgery in the commonwealth, or otherwise licensed or regulated by the State Board of Medicine, must take an initial medical history and conduct an initial physical examination, unless emergency circumstances justify otherwise.

In response to COVID-19, the Department of State suspended the initial medical history and physical examination requirement specifically for the treatment of opioid-use disorder with buprenorphine.

 

In November 2021, the Substance Abuse and Mental Health Services Administration (SAMHSA) announced that the methadone take-home flexibilities will be extended for one year after the eventual expiration of the federal COVID-19 Public Health Emergency. DDAP has submitted its written concurrence with this exemption. SAMHSA has also indicated that they are currently considering mechanisms to make this flexibility permanent. Narcotic treatment programs do not need to do anything additional at this time to continue taking advantage of this flexibility.

Similarly, the U.S. Drug Enforcement Administration (DEA) also announced last week that they are currently working to make their teleprescribing regulations permanent. DDAP will continue to provide additional information and guidance as it becomes available.

If you have any further questions, please contact the Bureau of Program Licensure at (717) 783-8675 or via email.

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