Last week, McDermott+Consulting launched an election 2024 resource page, where you can find a 2024 health policy outlook and other insights into the November election. While regulations aren’t necessarily top-of-mind when thinking about the election, an election year’s potential effects on the Administration’s regulatory agenda cannot be overlooked (in other words, yes, regs are always very important!) Watch for a regulatory calendar and other information about pertinent regulations on the resource page coming soon.

In the meantime, my colleague Leigh Feldman and I want to highlight some of the patient-centered regs and initiatives the Biden Administration has already pushed out this year that reflect some of its top priorities. In our view, these regs and initiatives that focus on improving patient access to services and behavioral and reproductive health set the tone for the Administration’s potential actions in the weeks and months ahead.

Also, we must call out Tuesday’s Politico “Pulse,” which highlighted regs to watch out for this year (great minds think alike!)

Medicare Advantage and Other Private Payer Reforms

The Centers for Medicare & Medicaid Services (CMS) released a long-awaited final reg last week that requires certain private payers (including Medicare Advantage health plans) to automate their prior authorization processes and establish other application program interfaces to help improve the exchange of information among payers, patients and providers. For more details on this major reg, see our recent +Insight.

This reg builds on other actions that the Administration has taken regarding prior authorization. Last year, CMS finalized the contract year (CY) 2024 Medicare Advantage (MA) and Part D reg, which prohibited MA plans from denying coverage for services covered by traditional Medicare. CMS required that prior authorization approvals remain valid for patients’ entire episode of care as long as the care is medically necessary. The reg also required health plans to establish a utilization management committee to review policies annually and ensure consistency with traditional Medicare’s national and local coverage determinations and guidelines.

Other CMS regulatory actions last year tried to address what CMS believes to be questionable marketing practices by private health plans. For example, in the same CY 2024 MA and Part D reg mentioned above, CMS prohibited MA plans from putting out advertisements that do not mention a specific plan name or that use the Medicare name, CMS logo, and products or information issued by the federal government, including the Medicare card, in a misleading way. As described in this Regs & Eggs blog post, CMS proposed in the CY 2025 MA and Part D proposed reg to limit the amount that third-party agents and brokers can be paid by MA plans. CMS also proposed to prohibit contract terms that allow “marketing middlemen” to receive bonuses based on the number of beneficiaries that enroll in certain MA plans.

Reproductive Health

Promoting maternal and reproductive health is a big priority for the Administration – especially as the presidential election nears. The White House announced new actions regarding reproductive care earlier this week, marking the 51st anniversary of Roe v. Wade. The US Department of Health and Human Services (HHS), including CMS, is creating a comprehensive plan to educate all patients about their rights and help ensure that hospitals meet their obligations under the Emergency Medical Treatment and Labor Act (EMTALA). As part of the comprehensive plan, CMS published new informational resources to help individuals understand their rights under EMTALA. CMS also plans to partner with hospital and provider associations to disseminate training materials on providers’ obligations under EMTALA. HHS will convene these associations to discuss best practices and challenges related to EMTALA compliance and will establish a dedicated team of HHS experts who will increase the Department’s capacity to support hospitals in complying with federal requirements under EMTALA.

It is important to note that HHS is not creating any new EMTALA requirements or issuing new guidance. Rather, these efforts are meant to help reinforce existing guidance and requirements, since HHS and CMS have noted provider and patient confusion. Part of the confusion may stem from the fact that CMS’s July 11, 2022, EMTALA guidance related to emergency reproductive services has been challenged in federal court. This 2022 guidance sought to reaffirm physicians’ legal obligations under EMTALA, specifically stating that if a physician believes that an abortion needs to be performed to stabilize a patient with an emergency medical condition, the physician must provide the treatment regardless of any state law that may prohibit abortions. The Supreme Court of the United States is set to hear the case regarding this guidance in April.

In addition to the Administration’s new initiatives, CMS will accept applications later this year for a new model to be tested by the CMS Innovation Center, called the Transforming Maternal Health (TMaH) Model. The TMaH Model focuses exclusively on improving maternal healthcare for people enrolled in Medicaid and the Children’s Health Insurance Program (CHIP). The model aims to support participating state Medicaid agencies in developing a whole-person approach to pregnancy, childbirth and postpartum care that addresses the physical, mental health and social needs experienced during pregnancy. The model’s stated goal is to reduce disparities in access and treatment. CMS will release a Notice of Funding Opportunity for state Medicaid agencies in spring 2024, and applications will be due in summer 2024.

Behavioral Health

Speaking of Innovation Center models, CMS recently announced a new model. The Innovation in Behavioral Health (IBH) Model will test approaches to improve the quality of care and health outcomes for people with moderate-to-severe mental health conditions and/or substance use disorders. The model will connect patients with the physical, behavioral and social supports necessary to manage their care. Practice participants in the model will be community-based behavioral health organizations and providers, including community mental health centers, opioid treatment programs, safety net providers, and public and private practices, where individuals can receive outpatient mental health and/or substance use disorder services. CMS will release a Notice of Funding Opportunity for the IBH Model in spring 2024, and the model will launch in fall 2024. CMS anticipates that the model will operate for eight years in up to eight states. Additional information can be found on the Innovation Center’s IBH Model page, in CMS’s fact sheet and in this FAQ document.

These are only some of the regs and initiatives launched by the Administration so far this year – and we expect related policies and other initiatives to be released in the very near future:

Medicaid and MA Reforms

• A Few Medicaid Final Regs. According to the Unified Agenda, CMS will release the Medicaid and CHIP Managed Care Access, Finance, and Quality final reg and the Streamlining the Medicaid, CHIP, and BHP Application, Eligibility Determination, Enrollment, and Renewal Processes final reg in the next few months. These rules are at the Office of Management and Budget (OMB) for final clearance. The May 2023 Managed Care Access, Finance, and Quality proposed reg proposed to make transparency-related updates to state directed payments. It would also require states to submit an annual payment analysis that compared managed care plans’ payment rates for routine primary care services, obstetrical and gynecological services, and outpatient mental health and substance use disorder services as a proportion of Medicare’s payment rates. The other reg, proposed in September 2022, aims to remove barriers and facilitate enrollment of new applicants, particularly those dually eligible for Medicare and Medicaid.

CMS also plans to finalize the Ensuring Access to Medicaid Services reg. This reg aims to standardize data and monitoring and create new opportunities for states to promote active beneficiary engagement in their Medicaid programs, with the goal of improving access to care. The rule has a particular focus on home and community-based services (HCBS), including direct care worker compensation requirements, grievance process development, critical incident reporting definitions and HCBS quality reporting. Notably, the proposed reg would require that at least 80% of Medicaid payments for certain personal care, homemaker and home health aide services be spent on compensation for direct care workers.

• CY 2025 MA and Part D Final Reg. This reg, also in OMB clearance, will likely finalize the MA marketing reforms that we discussed above.

Prescription Drug Prices

• Prices Negotiated Under the Inflation Reduction Act. This year will be pivotal for implementing the Medicare Part D drug price negotiation provisions of the Inflation Reduction Act. CMS is expected to publish final prices in September 2024 following negotiations with makers of the first 10 drugs selected under law.

Behavioral Health and Substance Abuse

• Confidentiality of Substance Use Disorder Patient Records. This final reg will implement provisions of the CARES Act aimed at better harmonizing regulatory confidentiality requirements with certain permissions and requirements of the Health Insurance Portability and Accountability Act (HIPAA).
• Medications for the Treatment of Opioid Use Disorder. This final reg may permanently expand the COVID-19 public health emergency flexibilities for opioid Treatment Programs (OTPs), allowing OTP providers to continue prescribing buprenorphine to patients via telehealth for the treatment of opioid use disorder. It is important not to confuse this reg with other rulemaking that the US Drug Enforcement Administration will likely take up later this year regarding the ability of non-OTP providers (i.e., all providers outside of OTPs) to prescribe buprenorphine via telehealth beyond 2024.

Reproductive Care

• HIPAA Privacy Rule to Support Reproductive Health Care Privacy. HHS may soon finalize a reg proposed in April 2023 that would limit uses and disclosures of personal health information for certain purposes where the use or disclosure of information is about reproductive healthcare that is lawful under the circumstances in which such healthcare is provided.

Innovation Center Models

• A Possible Mandatory Model on Increasing Access to Organ Transplants. A proposed reg entitled Alternative Payment Model Updates; Increasing Organ Transplant Access (IOTA) Model, is in OMB clearance. The CMS Innovation Center has stated that it plans to release models that require participation, and this may be an example of that, since only mandatory models require CMS to go through rulemaking. More to come from us regarding the Innovation Center in coming weeks.

Stay tuned for updates on all these regs and initiatives!

Until next week, this is Jeffrey (and Leigh) saying, enjoy reading regs with your eggs.

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