On February 1, 2023, the Federal Trade Commission (“FTC”) announced an enforcement action (“Enforcement Action”) against California-based telehealth and prescription drug discount provider GoodRx Holdings, Inc. (“GoodRx”) for allegedly violating section 5 of the FTC Act and the Health Breach Notification Rule (“HBNR”). The proposed order (“Proposed Order”), which was brought by the U.S. Department
Hospital at Home Programs Extended, But Final Push Is Needed
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 NeededCMS Issues Proposed Rule to Standardize Electronic Health Care Attachments Transactions and Electronic Signature under HIPAA
On December 21, 2022, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule that would adopt standards under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) for “health care attachments” transactions, which would: (1) support health care claims adjudication and prior authorization transactions; (2) adopt standards for electronic signatures to
HHS Issues Proposed HIPAA Rule to Adopt Updated Version of Retail Pharmacy Standards for Electronic Transactions
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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HHS Proposes Significant Amendments to Part 2 Regulations Governing the Confidentiality of Substance Use Disorder Records
Earlier this week, the United States Department of Health and Human Services (“HHS”) released a Notice of Proposed Rulemaking (“NPRM”) that proposes to make sweeping changes to regulations at 42 C.F.R. part 2 (“Part 2”) governing the confidentiality of substance use disorder (“SUD”) records. These modifications, which implement provisions of section 3221 of the Coronavirus
OCR Issues Anti-Discrimination Guidance for Pharmacies Related to Reproductive Health Care Services
On July 13, 2022, the U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) issued guidance to the nation’s retail pharmacies about their nondiscrimination obligations to ensure access to reproductive health care services, including medications used to terminate pregnancies. As we previously discussed, the Biden Administration and OCR have been taking action as some states seek to restrict or criminalize abortion services in response to the Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization.
Continue Reading OCR Issues Anti-Discrimination Guidance for Pharmacies Related to Reproductive Health Care ServicesBiden Acts to Protect Reproductive Health Care Services: Executive Order and Privacy Guidance
The Biden Administration is taking action to support access to reproductive health care in response to the Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization. This is occurring as some states seek to restrict or criminalize abortion services. So far, there has been action by the White House, through an Executive Order, and by the U.S. Department of Health and Human Services (HHS), through guidance on HIPAA and privacy.
Continue Reading Biden Acts to Protect Reproductive Health Care Services: Executive Order and Privacy GuidanceIncreased Cyber Risk for Health Care Organizations Due to the Russia-Ukraine Conflict
The Russia-Ukraine conflict is increasing the risk of ransomware attacks and other cyber threats for U.S. companies, and those in the health care industry may be targeted. In a recent analyst note from the Department of Health & Human Services (“HHS”), HHS describes the cyber capabilities of Russia, one of the world’s major cyberpowers, and analyzes two malware variants most likely to impact the U.S. health care and public health sector.
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FDA Publishes Principles for AI and ML in Medical Devices
On October 27, 2021, the U.S. Food and Drug Administration (FDA) in collaboration with Health Canada, and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), published Guiding Principles for the use of artificial intelligence and machine learning (AI/ML) in medical devices. The principles are designed to support good machine learning practices (GMLP) and to help promote safe, effective, and high-quality medical devices that use AI/ML. The FDA is accepting public comment on these principles on an ongoing basis.
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CMS Innovation Center Announces New Strategic Direction Under the Biden Administration
Today, CMS released its strategy for the CMS Innovation Center (the “Strategy”) in a White Paper, Innovation Center Strategy Refresh. This Strategy and the connection to broader CMS priorities was outlined by CMS Administrator Brooks-LaSure and CMS Innovation Center Director, Liz Fowler, in a webinar and is intended as a blueprint for the next 10 years. While the Innovation Center’s overarching goal continues to be expansion of successful models that reduce program costs and improve quality and outcomes for Medicare and Medicaid beneficiaries, CMS highlights five strategic objectives: Drive Accountable Care, Advance Health Equity, Support Innovation, Address Affordability, and Partner to Achieve System Transformation and created a new vision: “A health system that achieves equitable outcomes through high-quality, affordable, and person-centered care.”
Continue Reading CMS Innovation Center Announces New Strategic Direction Under the Biden Administration