Licensing and Regulatory Updates

The Michigan Department of Licensing and Regulatory Affairs (LARA) recently published updated rules related to hospitals. Those updates include the following:

  • Final EMS Life Support Agencies and Medical Control Rule: The final rule, effective May 19, 2023, discontinues the Certificate of Need of air ambulance services and updates the medical care requirements for air ambulance services.
  • Final Center Fill Pharmacies Rule: The final rule, effective May 19, 2023, updates record timelines for keeping prescriptions on file and defining central fill and shared pharmacy services.
  • Draft Board of Nursing – General Rules: The latest Board of Nursing draft rules address the NCLEX examination, clarify nursing education program requirements and continuing education, and modify the nurse professional fund scholarship program requirements.

Members with questions should contact Renée Smiddy at the MHA.

Public Health Emergency Michigan Provider Licensing Guidance

The U.S. Department of Health and Human Services is set to end the federal Public Health Emergency May 11. At that time, the special privileges and exemptions Michigan extended to licensed healthcare facilities and providers during the pandemic will be discontinued. Beginning May 12, all healthcare providers and health facilities operating in Michigan must have the appropriate license(s) and permit(s) required under Michigan and federal law.

Impacted by this notice are emergency certificate of need approvals granted to hospitals and health systems for additional licensed beds.

The Michigan Department of Licensing and Regulatory Affairs (LARA) expressed to the MHA a willingness to work with healthcare providers to minimize any interruptions in the delivery of care by healthcare providers and within their facilities.

LARA’s Bureau of Community and Health Systems (BCHS) issues state licenses for various health facilities, agencies and programs. The BCHS webpage contains information on how to apply for a State of Michigan health facility license or permit. Members with questions about health facility license may contact the BCHS.

LARA’s Bureau of Professional Licensing (BPL) issues state licenses for health professionals. The BPL webpage contains information on how to apply for a State of Michigan health professional license. Members with questions about health professional licensure may contact the BPL.

Members with further questions about licensure and the ending of the PHE may contact Laura Appel at the MHA.

Implicit Bias Trainings Available to Meet LARA Requirement

The Department of Licensing and Regulatory Affairs revised Public Health Code – General Rules to allow asynchronous teleconferences or webinars as acceptable modality of training as part of the implicit bias training standards for all professions licensed or registered under the Public Health Code.

The Michigan Health Council (MHC) is offering five virtual one-hour implicit bias fulfilling the training requirement, with modules outlining implicit bias recognition and remediation, myth-busting race, poverty and the social determinants of health, understanding sex and gender identity, and the case for inclusion. Registration for this training is available for $35 per person. The MHC will continue to offer two-hour hybrid and live education trainings priced between $74 and $150.

Members may contact Kristin Sewell at the MHC for pricing and availability.

DEA Change in X-Waiver Requirement

President Biden approved the elimination of the DATA Waiver (X-Wavier) requirement and several other prescribing practice changes when he signed Dec. 29 the Consolidated Appropriations Act, 2023. Changes to prescribing practices include:

  • No longer requiring the X-Waiver to treat patients with buprenorphine for opioid use disorder.
  • Removing any limits or caps on the number of patients a prescriber may treat with buprenorphine for opioid use disorder.
  • Only requiring a standard Drug Enforcement Administration registration number for all prescriptions for buprenorphine moving forward.
  • Maintaining existing state laws or regulations that may be applicable.
  • Introducing new training requirements for all prescribers that are expected to take effect June 21, 2023. These requirements have not yet been made clear, but do not impact the elimination of the X-Waiver.

Biden held an event at the White House Jan. 24 celebrating the policy change as a bipartisan success that will increase access to medication for opioid use disorder. The additional barriers the X-Waiver presented deterred providers from offering these services and a similar license was never required for prescribing other controlled substances like opioids.

Current laws and regulations in Michigan have not changed because of the changes to federal X-Waiver requirements, but the Michigan Department of Licensing and Regulatory Affairs (LARA) is in the process of revising substance use disorder (SUD) rules that would no longer require a SUD program license for buprenorphine providers. The Michigan Public Health code currently states:

  • A substance use disorder services program license is required if a prescriber is providing buprenorphine treatment to more than 100 individuals OR is providing methadone treatment.
  • No license is needed if a prescriber is administering buprenorphine treatment to less than 100 individuals at a time.

Michigan’s current rules and regulations regarding prescribing buprenorphine are available on the LARA Substance Abuse Program Licensure webpage.

Members will be updated once the revised SUD rules are approved by the Michigan Joint Committee on Administrative Rules. Updated federal information will be available on the Substance Abuse and Mental Health Services Administration website.

Members with questions should contact the MHA Keystone Center.

LARA Updates Implicit Bias Training Rules

The Michigan Department of Licensing and Regulatory Affairs (LARA) recently released the final draft of the Public Health Code – General Rules to allow asynchronous teleconference or webinars as acceptable modality of training as part of the implicit bias training standards. Webinars and asynchronous teleconference were previously prohibited because they didn’t allow for interaction between students and the instructor. These rules will be filed with the Joint Committee on Administrative Rules and become effective March 23, 2023

Under the updated rules, individuals applying to renew their license will be allowed to satisfy the implicit bias training standard through webinars offered by acceptable sponsors. Another positive rule change is the allowance of implicit bias training to satisfy other training or continuing education requirements.

Members with questions should contact Renée Smiddy at the MHA.

Rural Emergency Hospital Legislation Passed in Michigan

The legislation needed for hospitals to begin converting to Rural Emergency Hospitals (REH) in Michigan was sent to the Governor’s desk Dec. 6 for final approval. Due to limited session days left, the language to allow for REH licensure in Michigan was officially included in Senate Bill (SB) 183. After the REH amendments were adopted, SB 183 passed with overwhelming support in both the State House and Senate.

The MHA has been actively working with the Michigan Department of Health and Human Services, the Michigan Department of Licensing and Regulatory Affairs (LARA) and the Whitmer administration’s legal team on REH licensure during the legislative process and have received positive indications of the administration’s support for SB 183.

Member hospitals considering conversion to an REH are encouraged to review the final rules by the Centers for Medicare and Medicaid Services (CMS). Some key changes outlined in the final rule include:

  • Clarification that REHs can operate provider-based rural health clinics (RHCs) and that REHs are considered hospitals with less than 50 beds for purposes of the payment limit exception. Provider-based RHCs will maintain their excepted status upon a hospital’s REH conversion.
  • A roughly $4,000 per month increase in monthly facility payments due to a misstep in the methodology that the National Rural Health Association (NRHA) highlighted in the MHA comment on the proposed rule.
  • The CMS agreed with the NRHA that one-lane federal highways should be excluded from the definition of primary roads. Primary roads are now defined as state or federal highways with two or more lanes in either direction.

Additionally, the CMS has released initial information on the application process. There will also be an application process at the state level through LARA. This application is still in development.

Members considering converting to the REH designation should contact Lauren LaPine at the MHA for support in navigating this process.

 

 

 

 

 

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“The Labor Department reported that the U.S. added 528,000 jobs in July including 69,600 in healthcare. The unemployment rate fell to 3.5%, June job openings were down to 10.7 million from 11.3 million in May and government officials announced that the economy has now recouped the 22 million jobs lost in the pandemic.

But the more sobering news is that inflation has negated the workforce’ 5.1% wage gain in the last year and 1 in 5 workers is looking for employment elsewhere for higher pay and better benefits. And it’s even worse in the healthcare delivery workforce—the hospitals, long-term care facilities, clinics and ancillary service providers where 12 million work. During the COVID-19 pandemic, hospital employee turnover increased to 19.5%–five times higher than the general workforce. And today, 45% of physicians report burnout—double the rate pre-pandemic.”

Paul Keckley, August 8, 2022


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Member Feedback Requested on Rural Emergency Hospital Proposed Rule

The Centers for Medicare & Medicaid Services (CMS) released a proposed rule June 30 that would establish conditions of participation (CoPs) that Rural Emergency Hospitals (REHs) must meet to participate in the Medicare and Medicaid programs. This proposed rule also includes changes to the Critical Access Hospital CoPs. Proposed payment and enrollment policies, quality measure specifications and quality reporting requirements for REHs will be included in future rulemaking. The CMS also modifies the provider agreement regulations to include REHs. The public comment period will end Aug. 29.

The MHA has been working closely with the Michigan Department of Health and Human Services (MDHHS) and the Michigan Department of Licensing and Regulatory Affairs (LARA) over the past few months to develop the licensure criteria and conversion process for eligible facilities in Michigan to convert to an REH after Jan. 1, 2023. The MHA will develop a comment letter in response to the proposed rule and share a draft with small/rural members prior to submission. To include input from Michigan hospitals eligible to convert to an REH in its comments, the MHA has created a brief survey to collect critical feedback that should be submitted by Aug. 1. Members with questions or concerns are encouraged to contact Lauren LaPine at the MHA.

Michigan Legislators Act on Healthcare Bills

capitol building

capitol buildingSeveral bills impacting hospitals were acted upon during the week of May 9. Bills to plan for new funding from the national opioid settlement and to allow for certain out-of-state prescriptions were sent to the governor. In the Senate, testimony was taken on a bill to create a new license for dieticians and nutritionists and a bill to register certain medical labs in Michigan, and legislation to allow for certain visitors in healthcare facilities was reported to the House for further consideration.

On the House floor, the final votes were held on legislation to help guide Michigan’s use of new funding from the $26 billion national opioid settlement. Senate Bills (SBs) 993, 994 and 995 would create a new restricted fund for the state to house the settlement dollars, establish a new advisory commission appointed by the Legislature and governor to oversee spending, and prohibit future civil lawsuits related to claims covered by this fund. The bills now head to the governor’s desk for signature into law.

The Senate passed an MHA-supported bill related to out-of-state prescriptions. SB 166, introduced by Sen. Curt VanderWall (R-Ludington), would allow pharmacies to fill noncontrolled substance prescriptions written by licensed, out-of-state physician assistants and advanced practice registered nurses. SB 166 was also sent to the governor for signature.

The full Senate approved and reported to the House SB 450, which would ensure that visitors of cognitively impaired patients are permitted in healthcare facilities. Introduced by Sen. Jim Stamas (R-Midland), the bill would prohibit the director of the Michigan Department of Health and Human Services (MDHHS) or a local health officer from issuing an order that prohibits a patient representative from visiting a cognitively impaired individual in a healthcare facility. As written, the legislation does not prevent a healthcare facility from implementing reasonable safety measures for visitors and will still allow for facilities to limit the number of representatives per patient. The MHA is neutral on the bill and will continue to monitor any action taken in the House.

Further testimony was held in the Senate Health Policy and Human Services Committee on SB 614, which would create a new license for both dieticians and nutritionists in Michigan. Under the current language, a single license would be used for both professions. There was no vote held on SB 614, as the bill sponsor Sen. Michael MacDonald (R-Macomb Township) is working to address concerns from the Michigan Department of Licensing and Regulatory Affairs on the implementation of the dual licensure. The MHA supports SB 614 and looks forward to working with the stakeholders on potential improvements.

Questions on these issues or other state legislation related to healthcare can be directed to Adam Carlson at the MHA.