Government Affairs Regulatory Changes & Guidance Updates

 

Regulatory Changes & Guidance Updates -

February 28, 2023

MaineHealth Government Affairs’ Regulatory Changes & Guidance Updates is an internal

newsletter that will be distributed weekly including highlights, policy changes, and other

pertinent announcements from the state and federal governments. Please note that any formal

submissions to the state or federal government on behalf of MaineHealth are coordinated by the

Government Affairs Team. If you would like to submit comments or respond to any of the

announcements shared through these weekly updates, please email

Katie.Harris@mainehealth.org for guidance.

COVID-19 Regulatory Weekly Highlights

Federal

  • CMS released updated fact sheets on coronavirus waivers and flexibilities on 2/24/23.
  • CMS released an updated COVID-19 Medicaid & CHIP Service Utilization Data Snapshot.
  • The FDA announced it's convening a virtual meeting on April 25 to hear patient perspectives on the impact long Covid has on their daily lives and what factors are important to them to inform future drug development.
  • The FDA authorized for emergency use the first over-the-counter test to detect both flu and SARS-CoV-2, the virus that causes COVID-19. The Lucira COVID-19 & Flu Home Test provides results from self-collected nasal swab samples in about 30 minutes


State

State & Federal Rulemaking

  • CMS issued a proposed rule implementing changes to Medicaid’s hospital-specific Disproportionate Share Hospital cap calculations for state Medicaid programs under the Consolidated Appropriations Act of 2021.
  • The DEA proposed to reinstate requirements that patients have in-person visits with doctors to get prescriptions for certain medications that the agency had waived during the Covid pandemic.
  • The Maine BMV proposed routine technical changes to a rule - Ch. 3 Physical, Emotional and Mental Competence to Operate a Motor Vehicle. The comment deadline is March 24, 2023.


To comment on any proposed rules, please contact Katie.Harris@mainehealth.org.

State Programs & Announcements

Federal Programs & Announcements

  • Acute care hospitals, physician group practices and Medicare accountable care organizations may apply through May 31 to participate in the Bundled Payments for Care Improvement Advanced Model for two years beginning in January, CMS announced. For more information, see the CMS fact sheet and register to attend a March 9 webinar on the CMS request for applications.
  • Effective Feb. 27, certified independent dispute resolution entities will resume issuing payment determinations for payment disputes involving out-of-network services and items furnished before Oct. 25, 2022, CMS announced. CMS has posted guidance for certified IDRs issuing payment determinations for items and services furnished before Oct. 25, 2022.
  • The CDC advised clinicians to report extensively drug-resistant strains of Shigella infections to their state or local health department, and educate patients and communities at increased risk.
  • GE Healthcare expects supplies of its iohexol and iodixanol intraveneous contrast media products for computed tomography imaging to return to normal in the next few weeks. Customers can check this webpage weekly for an update on stock available. A COVID-19 lockdown in China last year temporarily shut down the company’s production facility for iodinated contrast media, prompting global shortages of the two products.
  • Nonprofit hospitals and health systems and other eligible entities can apply until April 14 for up to $2.5 million from the Agency for Healthcare Research and Quality to support evidence-based interventions to prevent, diagnose and treat substance use disorders in primary care; and until April 21 for up to $2.5 million to support evidence-based interventions to accelerate health equity in health care delivery systems, among other funding opportunities. For details, see the agency’s request for applications.
  • Experts from the AHA, CMS and HRSA are hosting a webinar on what rural hospital leaders need to know about Rural Emergency Hospital enrollment, the conversion process and conditions of participation, as well as answer questions.
  • CMS released a bulletin reiterating certain federal requirements with respect to health care-related taxes. Specifically, the guidance focuses on health care-related tax programs that include arrangements in which providers or an intermediary redistribute some or all of the collected funds to the provider paying the tax.

Know someone who would like to be added to this distribution list?

Email Emily (Kovalesky) Birch at emily.birch@mainehealth.org

Please do not hesitate to reach out with any questions to Katie.Harris@mainehealth.org!

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