RISE summarizes recent regulatory-related headlines.

Avalere examines possible changes in the final MA RADV rule

The Center for Medicare & Medicaid Services (CMS) intends to publish a final Risk Adjustment Data Validation (RADV) rule by February 1. The agency has postponed publication of the final rule twice because of its focus on the COVID-19 public health emergency.

RELATED: CMS postpones RADV rule for another three months

In a new blog post, Avalere experts explore the potential policy changes that could impact Medicare Advantage (MA) 2024 bids, plan benefit design, and operations. Among the key questions: Will CMS move forward with its controversial plans to eliminate the Fee-For-Service (FFS) adjuster used in the risk adjustment model calculation? Will the changes to RADV policy be applied retroactively? Will CMS move forward with its methodology for sampling and extrapolation?

“Finalizing the rule as proposed has the potential to create disruption for plans and providers, which may, in turn, affect premiums and benefits for MA enrollees,” the Avalere team wrote. “Given the stakes, plans are likely to take legal action to prevent implementation of the rule. While CMS and industry agree on the need for a program to ensure payment integrity, the policy issues are complex, and implementation of proposed changes would likely present numerous challenges.”

Indeed, this week, during the J.P. Morgan Healthcare Conference, Humana’s Chief Financial Officer Susan Diamond indicated that if CMS moves forward with removing the FFS adjuster, MA organizations will likely sue the administration, Modern Healthcare reported

If the final rule includes any of the main components of the proposal it will have significant financial implications for all MA payers as well as providers who care for MA members, wrote Philip Legendy, an attorney with Ballard Spahr, adding that once finalized, MA organizations should expect increased RADV audit activity.

ACA marketplace: 16M sign up for coverage but millions more still eligible for premium-free plans

The Centers for Medicare & Medicaid Services (CMS) on Wednesday announced that nearly 16 million people have signed up for affordable health coverage in the Affordable Care Act (ACA) marketplaces since the start of the open enrollment period. The record-breaking enrollment represents a 13 percent increase over last year, including more than three million people new to the marketplaces. Open enrollment continues through January 15.

Meanwhile, a new Kaiser Family Foundation report finds that about five million uninsured people could get ACA marketplace coverage without a monthly premium if they enroll by the January 15 deadline. In most states, tax credits are available to help eligible low- and middle-income people afford coverage. Those tax credits would offset the full monthly premium for the lowest cost plan or plans for millions of uninsured residents, the analysis finds.

Free or nearly-free premium silver plans with low deductibles are available to all marketplace subsidy-eligible enrollees with incomes up to 150 percent of poverty ($20,385 for individuals or $41,625 for families of four enrolling in 2023). In some cases, there could be an extra charge usually of no more than a few dollars per month–for non-essential benefits covered by the plan.

KFF researchers said that in some parts of the country, people with incomes above 150 percent of poverty can also get free or nearly free silver plans, with somewhat less generous cost-sharing reductions. For example, a 40-year-old making $25,000 per year (184 percent of poverty) could get a free or nearly free silver plan with a smaller cost-sharing reduction in about eight percent of counties, excluding counties where individuals are eligible for Medicaid or Basic Health Program plans. Less generous bronze plans with higher deductibles are often available without a premium at even higher incomes.

State Medicaid programs aim to keep telehealth for behavioral health services

Two new KFF analyses examine how state Medicaid programs have used telehealth to increase access to behavioral health care during the pandemic and the strategies they are using to address workforce shortages in behavioral health.

The studies come as the 2022 Bipartisan Safer Communities Act legislation requires the federal government to issue telehealth guidance by the end of 2023, and the omnibus spending bill that Congress passed last month included several provisions affecting behavioral health telehealth and workforce issues. They include requirements or funding related to provider directories, crisis services, virtual peer mental health supports, increases in new psychiatry residency positions, and expansions in access to providers who prescribe certain medications for opioid use disorder.

Both new analyses draw their findings from KFF’s Behavioral Health Survey of state Medicaid programs, fielded as a supplement to the organization’s annual budget survey of Medicaid officials.

The first study finds that states’ expansion of telehealth has taken a variety of forms, including the addition of audio-only coverage of behavioral health services; the expansion of the types of behavioral health services that can be delivered via telehealth (e.g., group therapy or medication-assisted treatment); and the expansion of provider types that may be reimbursed for telehealth delivery of behavioral health services (e.g., marriage and family therapists, addiction specialists, and peer specialists).

States reported high use of telehealth for behavioral health care across all or most populations served by Medicaid. Some states found that utilization was higher in rural areas, among younger enrollees, or among white individuals. Although utilization has declined from peak levels, it remains higher than before the pandemic. Most states report that they are likely to keep many of the pandemic-driven telehealth policy expansions in place.

Even as the pandemic exacerbated mental health and substance use issues among the public, documented workforce challenges raise barriers to care in Medicaid and beyond. Nearly half of the US population–47 percent, or 158 million people–live in a mental health workforce shortage area.

Workforce challenges are widespread and go beyond Medicaid, but shortages may be worsened in Medicaid, particularly given low participation rates among mental health providers.

The second KFF analysis finds that some state Medicaid programs are implementing strategies to address the behavioral health workforce shortage, including:

  • Increasing provider reimbursement rates—two-thirds of responding states reported rate increases, which may encourage providers to participate in Medicaid.
  • Extending the workforce by reimbursing for new provider types, loosening restrictions on in-person requirements, and targeting outreach to recruit new providers.
  • Reducing administrative burdens through steps that may include streamlining documentation, centralizing enrollment processes, and asking providers for their thoughts on Medicaid’s administrative process.
  • Providing incentives to encourage provider participation through the adoption of measures such as prompt payment policies and loan repayment.

COVID PHE extended for another 90 days

The Department of Health and Human Services has extended the COVID-19 public health emergency (PHE) for another 90 days.

HHS Secretary Xavier Becerra on Wednesday renewed the PHE on January 11 due to the continued consequences of COVID-19. The extension of the PHE will allow providers and health plans to take advantage of flexibilities put in place to address the pandemic, such as telehealth and coverage for vaccines, testing, and antiviral treatments.

HHS first declared COVID-19 was a PHE on January 17, 2020, when the pandemic began, and it has been renewed each quarter since then. The government said it will provide states with 60 days’ notice before it terminates the PHE.

HHS sets timeline for Medicare drug price negotiations

HHS has announced key dates for the first year of the Medicare Drug Price Negotiation Program under the Inflation Reduction Act.

HHS will begin the process of negotiating lower prescription prices this year, with the first negotiated prices going into effect in 2026.

In an announcement, HHS Secretary Xavier Becerra released the plan for how the department and CMS will implement Medicare drug price negotiation under the Inflation Reduction Act. CMS has also released a memo that lists opportunities for members of the public, people with Medicare and consumer advocates, pharmaceutical manufacturers, Medicare Advantage and Part D plans, health care providers and pharmacies, and other interested parties.

The landmark law provides HHS with the opportunity for the first time ever to negotiate directly with drug manufacturers for prices of prescription drugs on behalf of Medicare, starting with a selection of 10 high-cost Medicare Part D drugs. The key dates for implementation of drug price negotiations are:

By September 1, 2023: CMS will publish the first 10 Medicare Part D drugs selected for the Medicare Drug Price Negotiation Program.

By September 1, 2024: CMS will announce the negotiated maximum fair prices for these drugs with prices in effect starting January 1, 2026.

In future years, CMS will select for negotiation 15 more Part D drugs for 2027, 15 more Part B or Part D drugs for 2028, and 20 more Part B or Part D drugs for each year after that, as outlined in the Inflation Reduction Act.