RISE summarizes recent regulatory-related news.

HHS guidance: Providers must offer abortions in emergency situations

In the wake of President Biden’s executive order on reproductive health, the U.S. Department of Health and Human Services (HHS) announced new guidance to ensure all patients—including pregnant women and others experiencing pregnancy loss—have access to the full rights and protections for emergency medical care.

HHS, through the Centers for Medicare & Medicaid Services (CMS), issued clarifying guidance on the Emergency Medical Treatment and Active Labor Act (EMTALA) and reaffirmed that it protects providers when offering legally mandated, life- or health-saving abortion services emergencies. In addition to the guidance, HHS Secretary Xavier Becerra, in a letter to providers, made clear that this federal law preempts state law restricting access to abortion in emergency situations.

“Under the law, no matter where you live, women have the right to emergency care—including abortion care,” Becerra said in the announcement. “Today, in no uncertain terms, we are reinforcing that we expect providers to continue offering these services, and that federal law preempts state abortion bans when needed for emergency care. Protecting both patients and providers is a top priority, particularly in this moment. Health care must be between a patient and their doctor, not a politician. We will continue to leverage all available resources at HHS to make sure women can access the lifesaving care they need.”

The EMTALA statute requires that Medicare hospitals provide all patients an appropriate medical screening, examination, stabilizing treatment, and transfer, if necessary, irrespective of any state laws or mandates that apply to specific procedures. Stabilizing treatment could include medical and/or surgical interventions, including abortion. If a state law prohibits abortion and does not include an exception for the health or life of the pregnant person—or draws the exception more narrowly than EMTALA’s emergency medical condition definition—that state law is preempted.

Justice Department establishes Reproductive Rights Task Force

The Justice Department announced Tuesday the establishment of a task force to protect reproductive freedom under federal law.

Associate Attorney General Vanita Gupta will chair the task force, which will include representatives from the department’s Civil Division, Civil Rights Division, U.S. Attorney community, Office of the Solicitor General, Office for Access to Justice, Office of Legal Counsel, Office of Legal Policy, Office of Legislative Affairs, Office of the Associate Attorney General, Office of the Deputy Attorney General, and Office of the Attorney General.

The task force formalizes the department’s work over the last several months to identify ways to protect access to reproductive health care in anticipation that the Supreme Court may overturn Roe v. Wade and Planned Parenthood v. Casey.

As Attorney General Garland has said, the Supreme Court’s Dobbs decision is a devastating blow to reproductive freedom in the United States,” Gupta said in the announcement. “The Court abandoned 50 years of precedent and took away the constitutional right to abortion, preventing women all over the country from being able to make critical decisions about our bodies, our health, and our futures. The Justice Department is committed to protecting access to reproductive services.”

The task force will monitor and evaluate all state and local legislation and enforcement actions that threaten to:

  • Infringe on federal legal protections relating to the provision or pursuit of reproductive care
  • Impair women’s ability to seek reproductive care in states where it is legal
  • Impair individuals’ ability to inform and counsel each other about the reproductive care that is available in other states
  • Ban Mifepristone based on disagreement with the Food and Drug Administration’s expert judgment about its safety and efficacy
  • Impose criminal or civil liability on federal employees who provide reproductive health services in a manner authorized by federal law

In the event of such actions, the task force will coordinate appropriate federal government responses, including proactive and defensive legal action where appropriate.

BMA endorses bipartisan bill to simplify prior authorization for seniors

Better Medicare Alliance (BMA), a research and advocacy organization that supports Medicare Advantage (MA), has endorsed  S. 3018, Improving Seniors’ Timely Access to Care Act, a bipartisan bill that would modernize the way MA uses prior authorization as a clinical tool to facilitate high-value and coordinated care for beneficiaries.

The bill was sponsored by Senators Roger Marshall (R-Kan.) and Kyrsten Sinema (D-Ariz.) and cosponsored by one-third of U.S. Senate. The BMA’s endorsement of the Senate bill follows its endorsement of companion legislation in the U.S. House of Representatives earlier this year.

“Protecting the critical role of prior authorization in ensuring seniors receive safe, evidence-based care and working to improve this process for all involved are not mutually exclusive. This commonsense, bipartisan bill will take meaningful strides toward both goals,” Mary Beth Donahue, president and CEO of BMA said in the announcement. “With survey data showing that nine in 10 health plans are already taking action to streamline the prior authorization process for patients and providers, the Improving Seniors’ Timely Access to Care Act will support and build on those efforts while further strengthening the value of Medicare Advantage for the more than 28 million Americans who rely on its coverage and care.”

KFF: Marketplace insurers denied nearly 1 in 5 in-network claims in 2020

Insurers on the Healthcare.gov marketplace denied nearly 1 out of every 5 claims (18) submitted for in-network services in 2020, according to a new Kaiser Family Foundation (KFF) analysis. However, it’s unclear why the denial rates are so high and the ultimate consequences for consumers are difficult to access from the publicly available data.

The Affordable Care Act requires insurers to report data about claims denials and appeals to encourage transparency about how insurance coverage works for enrollees. The analysis examines data released by the Centers for Medicare & Medicaid Services (CMS) on more than 230 million claims submitted to 144 insurers selling marketplace coverage in 2020, the most recent year available.

The KFF analysis finds a huge variation across insurers, which have average denial rates as low as 1 percent and as high as 80 percent. Denial rates also vary by state, though insurers within the same state often show wide variations as well. In Florida, for example, the average denial rate was 15 percent, but the three insurers with the largest market share of enrollees reported denial rates of 10.5 percent (Florida BCBS), 11.1 percent (Health Options), and 27.9 percent (Celtic Insurance).

The CMS data include information about why in-network claims are denied, though the vast majority (72 percent) fall into a broad category of “all other reasons,” including administrative or paperwork errors and other issues.

Few claims cite a specific reason such as lack of prior authorization or referral (10 percent), an excluded service (16 percent) or lack of medical necessity (2 percent). Among the claims denied for reasons of medical necessity, about 1 in 5 involved behavioral health services.

Consumers appealed few of the denied in-network claims in 2020, with fewer than 61,000 appeals in 2020, reflecting just over one-tenth of 1 percent of those denials. Following those appeals, insurers usually upheld their initial denials (63 percent), and consumers rarely took the next step to file an external appeal, according to the KFF analysis.

OIG: Reduced outlier threshold on transfer claims didn’t significant increase Medicare payments

The Office of Inspector General (OIG) recently released the results of its audit to assess the financial impact that Medicare's transfer policy and reduced outlier threshold have on Medicare total payments for transfer claims compared with what hospitals would have been paid if the beneficiary had been discharged instead of transferred.

The Medicare program pays hospitals for inpatient hospital services based on a Medicare severity diagnosis-related group (DRG) rate per discharge. To protect hospitals from excessive losses due to unusually high-cost case and avoid giving hospitals an incentive to transfer patients to another health care facility early in the stay, the Medicare program supplements the DRG rate payment by making outlier payments.

During fiscal years 2011 through 2017, Medicare paid approximately $776 million in outlier payments for transfer claims. To conduct the audit, the OIG reviewed roughly 5,300 transfer claims with outlier payments totaling $66 million from 30 hospitals. Using Medicare claim data and information obtained from the Centers for Medicare & Medicaid Services (CMS) for the seven-year period, auditors calculated DRG rate amounts and outlier payment amounts without applying the transfer policy for these 5,300 transfer claims and compared the results with the actual payments that Medicare made for these transfer claims.

OIG analysts found the reduced outlier threshold for transfer claims did not have a significant impact on the total Medicare payments to the 30 hospitals audited. Of the 5,300 transfer claims, the total Medicare payments for 3,668 transfer claims were less than what Medicare would have paid the hospitals if they had discharged the beneficiaries. Under the transfer policy, Medicare decreased DRG rate payments by $10.8 million but, because of the reduced outlier threshold, Medicare increased outlier payments by $13.7 million, resulting in a net increase of $2.9 million in total Medicare payments compared to what hospitals would have been paid if they had discharged the beneficiaries.

Study finds MA members less likely to receive expensive diabetes treatment

Medicare Advantage plans may offer greater access to preventive care than traditional fee-for-service Medicare, but its members are less likely to receive newer diabetic therapies with proven outcome benefits in high-risk individuals, according to a new study published in Diabetes Care. Researchers conducted a retrospective cohort study of Medicare beneficiaries ages 65 years and older enrolled in the Diabetes Collaborative Registry from 2014 to 2019 with type 2 diabetes treated with one or more antihyperglycemic therapies. In the pool of 346,000 Medicare beneficiaries, 66 percent were enrolled in fee-for-service and 34 percent were in MA plans. They compared quality measures, cardiometabolic risk factor control, and antihyperglycemic prescription patterns between Medicare plan groups, adjusted for sociodemographic and clinical factors.

Researchers found MA members were more likely to receive preventive care, such as smoking cessation counseling and screening or retinopathy, foot care, and kidney disease, but less likely to receive newer treatments for diabetes to control blood sugar.