Regulatory roundup: Proposed rule would expand birth control coverage under ACA; Humana sues to reverse 2025 Medicare Advantage Star ratings; and more

RISE summarizes recent regulatory-related headlines.

Proposed rule would expand birth control coverage under ACA

A new proposed rule issued Monday would require most health insurers and group plans to cover over-the-counter contraceptives for free.

The Centers for Medicare & Medicaid Services (CMS) said that if finalized as proposed, the rule would allow consumers more choices of covered contraceptives and reinforces the responsibility of plans and issuers to cover Food and Drug Administration (FDA)-approved, -cleared, and -granted birth control methods without cost sharing. The proposed rule was issued in response to reports that many plans and issuers continue to impose barriers to contraceptive coverage.

“From day one, the Biden-Harris Administration has made clear that every woman should have access to the health care she needs. That includes contraception and other family planning services,” said Department of Health and Human Services (HHS) Secretary Xavier Becerra in the announcement. “The proposed rule we announce today would expand access to birth control at no additional cost for millions of consumers. Bottom line: women should have control over their personal health care decisions. And issuers and providers have an obligation to comply with the law.”

In addition to contraception coverage, the proposed rule builds on previous guidance and would require health plans and issuers to provide an easily accessible, transparent, and sufficiently expedient exceptions process for all recommended preventive services. An exceptions process is crucial for people who face limits on medically necessary care or coverage and would ensure they can access all medically necessary, recommended preventive services, including contraception, as well as certain immunizations, screenings, and other critical services for infants, children, and adolescents, CMS said.

For more information, see the CMS fact sheet.  

Humana sues to reverse 2025 Medicare Advantage Star ratings

Humana, along with the Americans for Beneficiary Choice, a trade association based in Dallas, Texas, is suing the Centers for Medicare & Medicaid Services (CMS) over its latest Star ratings. The lawsuit, filed in Northern District of Texas on Friday, asks a federal judge to set aside Humana’s 2025 Medicare Advantage Star rating and recalculate its score.

The lawsuit claims that under CMS’ 2025 Star Ratings calculations, more than one dozen Humana Medicare Advantage contracts were near the cut point from 3.5 Stars to 4.0 Stars or the cut point from 4.0 Stars to 4.5 Stars. Humana believes these contracts would have received higher Star Ratings had the cut points been correctly calculated. However, the insurer says CMS would not allow it to validate, and therefore could not fully challenge, the calculations because the agency denied the company access to the data necessary for doing so. The refusal to disclose the information is “arbitrary, capricious, and unlawful,” the lawsuit said.

RELATED: 2025 Medicare Advantage Star ratings fallout: Humana’s stock drops, UnitedHealthcare sues CMS

In an October 10 announcement about the 2025 Star ratings, CMS said that the changes in measure-level cut points for 2025 ratings were due to the removal of extreme outliers on the lower level of performance; an increase in some measure cut points due to performance returning to pre-pandemic levels; a more compressed distribution of scores; a large number of high-scoring contracts for some measures, such as breast cancer screening; and an increase in scores for contract at the lower end of the distribution for some measures, such as colorectal cancer screening, which pushed cut points higher for those measures.   

Humana isn’t the only insurer suing over the quality scores. UnitedHealthcare argues its drop in Star ratings is due to an arbitrary and capricious assessment of how its call center handled a single phone call from a CMS test caller that lasted less than 10 minutes. And Bloomberg Law reports that HMO Louisiana, a subsidiary of Blue Cross Blue Shield of Louisiana, filed a lawsuit in U.S. District Court in Washington, D.C., last week, claiming that CMS’ methods to calculate its Star ratings was “arbitrary and unlawful.”

RELATED: CMS recalculates all 2024 MA Star ratings

Last year insurers were successful in their lawsuits against CMS Star ratings. CMS recalculated 2024 Medicare Advantage Star ratings to address the application of Tukey outlier deletion and guardrails after courts agreed with SCAN Health  and Elevance Health that the agency improperly calculated the scores.

Feds report IRA saved Medicare enrollees $1B in first half of 2024

New data shows that in the first half of 2024, nearly 1.5 million people with Medicare Part D  hit the new cap on out-of-pocket costs created by the Inflation Reduction Act, according to the Department of Health and Human Services (HHS), through the Office of Assistant Secretary for Planning and Evaluation (ASPE). The result: Savings of close to $1 billion in out-of-pocket prescription drug costs.

The Biden-Harris Administration said in an announcement that because of the Inflation Reduction Act, some people with high drug costs have their out-of-pocket drug costs capped at around $3,500 in 2024. Next year that cap will be lowered to $2,000 for everyone with Medicare Part D. The report shows that if the $2,000 cap had been in effect this year, 4.6 million enrollees would have hit the cap by June 30 and would not have to pay any more out-of-pocket costs for the rest of the year.

Prior to the Inflation Reduction Act, there was no limit to the amount of out-of-pocket drug costs Medicare enrollees might pay for their medication. As a result, out-of-pocket costs for people with Medicare who do not qualify for the low-income subsidy program and need the most expensive drugs could total $60,000 per year or more.

Key findings from the report include:

  • Nearly 1.5 million Part D enrollees hit the cap by June 30, 2024, and will have no out-of-pocket costs for the remainder of the year.
  • More than 500,000 people with Medicare Part D who do not qualify for financial subsidies based on income saved a total of $979 million, with average savings of $1,802 per enrollee for the first half of 2024 – with additional savings expected over the remainder of 2024.
  • California, Florida, New York, and Texas had the highest number of people hitting the cap by midyear among all states.
  • Younger enrollees, American Indian and Alaska Natives, and African Americans hit the cap at higher rates compared to other enrollees.

CMS reports success in actions to prevent fraudulent agent, broker activity in ACA market

CMS said it has seen a dramatic drop in complaints since it has taken actions to crackdown on agent and broker fraudulent behavior in Federally-facilitated Marketplaces and State-based Exchanges that operate on the federal Affordable Care Act (ACA) platform.

RELATED: Biden administration tightens broker access to healthcare.gov to thwart rogue sign-ups

Since changes went into effect in July, CMS said that:

  • Casework associated with consumer reports of unauthorized plan changes has dropped by approximately 30 percent, and the overall number of plan changes associated with an agent or broker has decreased by nearly 70 percent.
  • Changes to agent or broker commission information have decreased roughly 90 percent, which means commissions for helping a consumer have been made exclusively through the Marketplace Call Center, HealthCare.gov, or an approved Classic Direct Enrollment or Enhanced Direct Enrollment partner website with a consumer pathway.

CMS also said that from January to August, the agency received 90,863 complaints that consumers had their marketplace plan changed without their consent. CMS has resolved nearly all of them (90,376 or 99.45 percent) and says it is committed to addressing new and unresolved cases. CMS said it’s currently resolving these cases within approximately 16 calendar days of receipt. 

The report also finds that from January to August, CMS received183,553 complaints that consumers were enrolled in marketplace coverage without their consent. The agency has resolved 183,095 or 99.75 percent of these complaints. CMS said it is currently resolving these cases within approximately 52 days of receipt.

Finally, since June, CMS has suspended 850 agents and brokers’ Marketplace agreements for reasonable suspicion of fraudulent or abusive conduct related to unauthorized enrollments or unauthorized plan switches. These agents and brokers are barred from participating in Marketplace enrollment, including receiving related commissions.