RISE summarizes recent regulatory-related headlines.
CMS announces plans to expand audits in FAQ for 2024 MA final rule
The Centers for Medicare & Medicaid Services (CMS) this week released a memo with Frequently Asked Questions to clarify how it expects Medicare Advantage (MA) plans to comply with the 2024 Medicare Advantage Final rule. The 14-page memo includes guidance on the use of artificial intelligence to assess coverage decisions, how the final rule impacts the use of prior authorization, and how the utilization management requirements apply to MA supplemental benefits.
The memo also explains that CMS will enforce changes in coverage criteria and utilization management requirements through a combination of routine and focused audits in 2024. The agency said it expects to evaluate the utilization management-related performance of plans serving approximately 88 percent of people with MA. During both routine and focused program audits, CMS intends to use physician reviewers to review denied requests to assess whether organizations are meeting new clinical coverage requirements. CMS said it has increased its scheduled program audit activities to ensure MA beneficiaries get the care they need without excessive burden or delays and have access to their entitled benefits and services.
To address non-compliance with the new requirements, CMS said it can issue compliance actions, including notices of non-compliance, warning letters, and requiring corrective action plans. It can also conduct enforcement actions, such as civil money penalties and enrollment and/or marketing sanctions.
CMS proposes rule to bolster oversight of accrediting organizations
In response to concerns related to the performance of accrediting organizations (AOs), CMS on Thursday released a proposed rule to improve oversight of AOs and ensure providers meet health and safety standards. The proposed changes would:
- Hold AOs accountable to the same standards as State Survey Agencies that also conduct surveys on behalf of CMS
- Address conflicts of interest and places limitations on the fee-based consulting services AOs provide to the health care facilities they accredit
- Prevent AO conflicts of interest by prohibiting AO owners, surveyors, other employees, and their immediate family members that have an interest with a health care facility accredited by the AO from participating in surveys
- Address potential and actual conflicts of interest by requiring AOs to report specific information to CMS about how they will respond to conflicts of interest
- Require AOs with poor performance to submit a publicly reported correction plan to CMS
- Align AO survey activity requirements and staff training with those of State Survey Agencies
For more information, read the CMS fact sheet.
Montefiore Medical Centers to pay $4.75M to settle potential violations of HIPAA Security Rule
The U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR), this week announced it reached a settlement with Montefiore Medical Center, a non-profit hospital system based in New York City for several potential violations of the Health Insurance Portability and Accountability Act (HIPAA) Security Rule. The $4.75 million monetary settlement and corrective action resolves multiple potential failures by Montefiore Medical Center relating to data security failures by Montefiore that led to an employee stealing and selling patients’ protected health information over a six-month period.
“Unfortunately, we are living in a time where cyber-attacks from malicious insiders are not uncommon. Now more than ever, the risks to patient protected health information cannot be overlooked and must be addressed swiftly and diligently,” said OCR Director Melanie Fontes Rainer in the announcement. “This investigation and settlement with Montefiore are an example of how the health care sector can be severely targeted by cyber criminals and thieves—even within their own walls.”
FAH recommends CMS adopt measure requiring payers to report prior authorization denial rates
Federal of American Hospitals has recommended that CMS adopt a quality measure that increases transparency and accountability within the Medicare Advantage (MA) prior authorization process. The measure, developed by FAH, would provide transparency on how many MA plans’ denials of care or services are overturned on appeal, and provide additional insights to seniors and regulators on whether plans are abusing the prior authorization process to arbitrarily deny or delay care. FAH hopes that CMS will include the measure in the next round of rulemaking.
KFF: New $2K Medicare Part D cap could reduce out-of-pocket drug costs for more than a million people
A KFF analysis shows that a new out-of-pocket spending cap in Medicare Part D could translate into savings for well over one million beneficiaries when it takes effect next year, including more than 100,000 people each in California, Florida, and Texas, based on analyses of drug spending in 2021.
The $2,000 cap, part of the Inflation Reduction Act of 2022, will lead to thousands of dollars in savings for Medicare patients who take high-cost drugs for cancer, rheumatoid arthritis, and other serious conditions, KFF said in an announcement. This new limit follows the elimination this year of a longstanding requirement that Part D enrollees pay five percent of their drug costs out-of-pocket after their drug expenditures reach a certain threshold.
Based on KFF’s review of Part D drug claims data, if the cap been in place in 2021, 1.5 million Medicare beneficiaries would have benefited because their out-of-pocket costs for prescription drugs exceeded $2,000. Of the total 1.5 million, about 200,000 Medicare beneficiaries spent $5,000 or more for their prescriptions that year, while another 300,000 expended between $3,000 and $5,000. The rest spent between $2,000 and $3,000.