RISE summarizes recent regulatory-related news.
White House preps for long fight as DOJ appeals court ruling on abortion drug
The Justice Department on Monday asked an appeals court to put on hold a federal judge’s ruling to suspend the Food and Drug Administration’s (FDA) approval of mifepristone, a common method of abortion in the country.
U.S. Department of Health and Human Services (HHS) Secretary Xavier Becerra said the department “will vigorously fight” last week’s decision by U.S. District Judge Matthew Kacsmaryk, who suspended approval of mifepristone, which has been widely available since 2000 when it received approval by the FDA. In his ruling for the Texas lawsuit brought by anti-abortion groups, Kacsmaryk argued that the FDA didn’t adequately review scientific evidence and safety risks when it approved the drug. However, he issued a stay on the order for seven days to give the FDA time to file an appeal.
Meanwhile, in a separate lawsuit over restrictions on mifepristone filed in Washington State, Judge Thomas Rice issued a conflicting ruling, blocking FDA from taking any action to remove the drug from the market.
As a result of the conflicting opinions, it’s likely the case will end up before the Supreme Court.
During a White House briefing on Monday, Press Secretary Karine Jean-Pierre said the administration stands by FDA’s approval of mifepristone and is prepared to have a long, legal fight. “That is our commitment to women out there. That is our commitment to Americans across the country,” she said. The court decision threatens access to this medication, which is not only used for abortion but also for helping women manage miscarriages. “If the decision stands, it will put women’s health at risk and under the FDA’s ability to ensure patients have access to safe and effective medications when they need them most."
On Friday, Becerra called the Texas district court’s decision a “regressive ruling by a single court in a single state that will have a disastrous impact on women and families across America if not overturned.” In addition to jeopardizing the health of women across the United State, Becerra said it undermines the nation’s entire system of drug approval. “It opens the door for courts to overturn FDA’s evidence-based decisions for purely political or ideological reasons.”
AHIP report: Medigap enrollees 3 times less likely to have problems paying medical bills than those on Original Medicare
A new AHIP report that examines trends in Medicare Supplement insurance finds that 54 percent of all original Medicare enrollees without any additional coverage chose a Medicare Supplement plan in 2020. And those enrollees were three times less likely to have problems paying medical bills than those with just original Medicare.
The report describes the various types of Medicare Supplement plans, demographics of who chooses to enroll in these plans, which are the fastest growing plans, and how enrollment breaks down state by state.
Here are the highlights:
- The percentage of original Medicare enrollees purchasing Medicare Supplement coverage grew from 35 percent to 41 percent between December 2017 and December 2021.
- Medicare enrollees with Medicare Supplement coverage were three times less likely to have problems paying medical bills compared to enrollees without Medicare Supplement policies. Only 3 percent of enrollees with Medicare Supplement coverage reported having difficulty paying medical bills in the last 12 months, compared to 8 percent of original Medicare enrollees without Medicare Supplement coverage.
- A majority of Medicare Supplement (57 percent) are women, while 42 percent are 75 years old or older.
- A significant percentage of Medicare Supplement enrollees are people with lower incomes. For example, 11 percent have annual household incomes below $20,000, and 24 percent have incomes below $30,000.
COVID PHE to end on May 11
Th U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) has announced that the Notifications of Enforcement Discretion during the COVID-19 public health emergency (PHE) will expire at 11:59 pm on May 11, 2023, due to the expiration of the COVID-19 PHE. President Biden on Monday signed a bipartisan congressional resolution to end the national emergency.
“OCR exercised HIPAA enforcement discretion throughout the COVID-19 public health emergency to support the health care sector and the public in responding to this pandemic,” said Melanie Fontes Rainer, OCR Director. “OCR is continuing to support the use of telehealth after the public health emergency by providing a transition period for health care providers to make any changes to their operations that are needed to provide telehealth in a private and secure manner in compliance with the HIPAA Rules.”
OCR is providing a 90-calendar day transition period for covered health care providers to come into compliance with the HIPAA Rules with respect to their provision of telehealth. The transition period will be in effect beginning on May 12 and will expire at 11:59 p.m. on August 9. OCR will continue to exercise its enforcement discretion and will not impose penalties on covered health care providers for noncompliance with the HIPAA Rules that occurs in connection with the good faith provision of telehealth during the 90-calendar day transition period.
CMS proposes policies to improve patient safety, promote health equity in inpatient, long-term hospitals
The Centers for Medicare & Medicaid Services (CMS) on Monday issued a proposed rule for inpatient and long-term care hospitals that aims to advance health equity and support underserved communities. The 2024 inpatient prospective payment system (IPPS) and long-term care hospital prospective payment system (LTCH PPS) rule updates Medicare payments and policies for hospitals and if finalized as proposed, would adopt hospital quality measures to foster safety, equity, and reduce preventable harm in the hospital setting. The proposed rule would also recognize homelessness as an indicator of increased resource utilization in the acute inpatient hospital setting, which may result in higher payment for certain hospital stays. This action aligns with the Administration’s goal of providing support to historically underserved and under-resourced communities.
“CMS is helping to build a resilient health care system that promotes good outcomes, patient safety, equity, and accessibility for everyone,” said CMS Administrator Chiquita Brooks-LaSure in the announcement. “This proposed rule reflects our person-centric approach to better measure health care quality and safety in hospitals to reduce preventable harm and our commitment to ensure that people with Medicare in rural and underserved areas have improved access to high-quality health care.”
Among the provisions in the proposal:
- Make health equity adjustments in the Hospital Value-Based Purchasing Program by providing incentives to hospitals to perform well on existing measures and to those who care for high proportions of underserved individuals, as defined by dual eligibility status. his builds on previous efforts to advance health equity through the finalized health equity adjustment in the Medicare Shared Savings Program and finalized policies in Medicare Advantage and Part D Star Ratings Program.
- Recognize the higher costs that hospitals incur when treating people experiencing homelessness, when hospitals report social determinants of health codes on claims.
- Designate rural emergency hospitals as graduate medical education training sites. If finalized, this provision would allow more medical residents to train in rural settings, which can help address workforce shortages in these communities.
- Measure the rate of patients and residents in long-term care hospitals who are up to date on their COVID-19 vaccinations and new, additional measures for screenings for cancer and social drivers of health.
- Measure the rate of patients and residents in long-term care hospitals who are up to date on their COVID-19 vaccinations and new, additional measures for screenings for cancer and social drivers of health.
Click here for a fact sheet on the proposed payment rule or here to download the proposed rule from the Federal Register. The proposed rule is scheduled to be published in the Federal Register on May 1.
HHS proposes new rule to advance interoperability
HHS’ Office of the National Coordinator for Health Information Technology (ONC) has released a Notice of Proposed Rulemaking for public comment on proposals to implement certain provisions of the 21st Century Cures Act (Cures Act) and make several enhancements to the ONC Health IT Certification Program to advance interoperability, improve transparency, and support the access, exchange, and use of electronic health information.
Proposals include:
- Implementing the Electronic Health Record Reporting Program as a new Condition of Certification for developers of certified health information technology (health IT) under the program
- Modifying and expanding exceptions in the information blocking regulations to support information sharing
- Revising several Certification Program certification criteria, including existing criteria for clinical decision support (CDS), patient demographics and observations, electronic case reporting, and application programming interfaces for patient and population services
- Adopting the United States Core Data for Interoperability (USCDI) Version 3 as a standard within the Certification Program and establishing an expiration date for USCDI Version 1 as an adopted standard within the Certification Program
- Updating standards and implementation specifications adopted under the Certification Program to advance interoperability, support enhanced health IT functionality, and reduce burden and costs
The proposed rule will be published in the Federal Register on April 18 and will be available for public comment for 60 days.