Crowell Health Solutions

Throughout the COVID-19 pandemic, the Centers for Medicare and Medicaid Services (CMS) issued a number of waivers and flexibilities to help healthcare providers manage the influx of patients during the Public Health Emergency (PHE). The implementation of the Acute Hospital Care at Home (AHCaH) individual waiver in 2020 allowed qualifying hospitals to provide hospital at home (H@H) programs. These programs provide similar services as those administered during inpatient visits, such as physician visits and monitoring, drug prescription, nursing services, diagnostics, etc. Since its employment, 144 systems including 260 hospitals across 37 states have utilized the AHCaH waiver, rapidly increasing the number of H@H programs in the United States. While the initiative was originally set to expire with the end of the PHE, the AHCaH waiver program was extended until December 31, 2024, with the passing of the Consolidated Appropriations Act, 2023 (CAA 2023). The extension of this program sends a strong message about the importance of permanently integrating home-based care delivery models into our healthcare system. Despite the lengthy extension, the nature of this waiver program remains temporary and the concerns about the expiration effects on relevant stakeholders continue to be pertinent.

Continue Reading Hospital at Home Programs Extended, But Final Push Is Needed

On December 29, President Joe Biden signed into law the Consolidated Appropriations Act, 2023 (P.L. 117-164) (the “Act”)—an approximately $1.7 trillion spending package, which consists of all 12 fiscal year (FY) 2023 appropriations bills and funds the federal government through September 30, 2023, provides additional assistance to Ukraine, and makes numerous health care policy changes.  

Continue Reading President Biden Signs End-of-Year Legislation Including Telehealth, Medicare & Medicaid, Mental Health, Pandemic Preparedness, and Other Health Care Provisions

On November 9, the Department of Health and Human Services (HHS) issued a proposed rule to adopt updated versions of the retail pharmacy standards for electronic transactions adopted under the Administrative Simplification subtitle of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and to broaden the applicability of the HIPAA subrogation transaction.

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In late November, HHS proposed long-awaited changes to regulations at 42 C.F.R. Part 2 (“Part 2”) governing the confidentiality of substance use disorder (“SUD”) records as required under the Coronavirus Aid, Relief, and Economic Security (“CARES”) Act. Generally, HHS is attempting to align Part 2 requirements with the HIPAA (“Health Insurance Portability and Accountability Act”) Privacy Rule. The most significant changes are those to the rules governing consent for entities subject to Part 2’s restrictions to use, disclose, and redisclose Part 2 records with respect to treatment, payment, and health care operations (“TPO”) activities.

Continue Reading HHS Proposed Changes Would Align Part 2 Regulations on Substance Use Disorder Records with HIPAA

The results of the 2022 U.S. midterm elections—during which voters were focused on the economy, public safety, and health care and abortion issues—will have longstanding consequences for the development of health care policy over the next two years. With the U.S. House of Representatives and U.S. Senate controlled by different parties, it will be difficult

The Office for Civil Rights (OCR) at the Department of Health and Human Services (HHS) recently issued a bulletin to highlight the obligations of Health Insurance Portability and Accountability Act of 1996 (HIPAA) on regulated entities under the HIPAA Privacy, Security, and Breach Notification Rules when using online tracking technologies. The bulletin defines

President Biden signs Executive Order directing HHS to “consider additional actions to further drive down prescription drug costs”

On October 14, 2022, President Biden signed an Executive Order (EO) directing the Secretary of the Department of Health and Human Services (HHS) to consider new healthcare payment and delivery models the Center for Medicare & Medicaid Innovation (CMMI), part of the Centers for Medicare & Medicaid Services (CMS) and created by the Affordable Care Act, can test to lower drug costs and promote access to innovative drug therapies for Medicare and Medicaid beneficiaries. The EO specifies the HHS Secretary should include models that may lead to lower cost-sharing for commonly used drugs and support value-based payment initiatives that promote high-quality care. The Secretary must submit its report, describing any models selected, within 90 days of the EO’s issuance.  

Continue Reading White House looks to CMMI to test new ways to lower drug prices

On October 21st, the U.S. Food and Drug Administration (FDA) released a draft guidance that, if finalized, will update the agency’s 2018 guidance on its Breakthrough Devices Program (the “Program”). In the draft guidance, the FDA announced that when reviewing the eligibility of medical devices for the Program, the agency will also consider whether a

Crowell & Moring and Crowell Health Solutions hosted a HealthTech roundtable with discussions focused on value-based care, health equity, data privacy, artificial intelligence, and other trends in health care technology in the Washington, D.C. office on October 27. The sessions featured numerous experts from health technology companies, advocacy organizations, and trade associations, all of whom

Now that the Tri-agencies have drawn back the curtains to reveal some of the inner workings of their developing Mental Health Parity and Addiction Equity Act (MHPAEA) comparative analysis enforcement efforts, the question is: What’s next?
Continue Reading Mental Health Parity: What’s Next for Plans and Issuers?