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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

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

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. …
Continue Reading Increased Cyber Risk for Health Care Organizations Due to the Russia-Ukraine Conflict

On January 18, 2022, the U.S. Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) and the entity chosen as a contracting partner, The Sequoia Project, Inc., published the long-awaited Trusted Exchange Framework and Common Agreement (TEFCA) for health information exchange. In simple terms, TEFCA is a framework that health information networks (HINs) may enter into to share health data with other HINs, individuals, and entities. The stated goal of TEFCA is to develop uniform policies and technical requirements to scale health information exchange nationwide and ensure that HINs, health care providers, health plans, individuals, and other stakeholders can access real-time, interoperable health information.
Continue Reading ONC Releases a Framework for Nationwide Health Information Exchange

On August 20, 2020 the Department of Health and Human Services (HHS) published a notice of proposed rulemaking (85 Fed. Reg. 51397) on good practices for the release and maintenance of agency guidance documents. Comments must be posted by 11:59 pm on September 16, 2020.

As instructed in the October 9, 2019 Executive Order 13891 (EO), titled ‘‘Promoting the Rule of Law Through Improved Agency Guidance Documents (84 FR 55235 (Oct. 15, 2019)), HHS proposes to issue regulations to ensure (i) there is proper notice of any new guidance, and (ii) that the guidance does not impose obligations on regulated parties that are not already reflected in duly enacted statutes or regulations.

This proposed rule appears to follow the Office of Management and Budget, “Final Bulletin for Agency Good Guidance Practices,” issued on January 25, 2007 (72 Fed. Reg. 3432) with respect to the significant guidance document that may, for example “adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities” or “materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof” and generally requires a 30 day notice and comment period.

Background…

Continue Reading HHS Proposes a New Rule to Govern Release and Maintenance of Agency’s Guidance Documents

As of October 3, 2019, the Office of Management and Budget completed its review of the proposed rules for “modernizing and clarifying” the Physician Self-Referral Regulations and revising the safe harbors under the Anti-Kickback Statute and rules regarding the Beneficiary Inducement Civil Monetary Penalties Law.

These regulations were the subject of two Requests for Information…

A patient has an emergency and goes to a hospital she knows is in her plan’s network. She receives treatment. She leaves the hospital. Weeks later, she receives a medical bill for tens of thousands of dollars. Unbeknownst to her, some or all of her treating doctors were out-of-network.

This all-too-common story has contributed to a significant medical debt crisis in this country, and has captured the attention of policymakers on all sides of the political spectrum—leading to the rare circumstance of executive and legislative alignment and the potential for bipartisan legislative action.

Proponents of price transparency hope that it will improve competition and allow patients to better understand their financial responsibility ahead of receiving services. The idea is that disclosing prices to individuals will incentivize them to “shop around” for health care services, which may drive down costs. On the other hand, opponents of price transparency argue that releasing such information could compromise bargaining leverage between third party payers and providers, and have the effect of driving up prices since information exchanges in concentrated markets can lead to tacit coordination that’s difficult to detect and punish under the antitrust laws.…

Continue Reading Trump Administration and Congress Are Moving Quickly on Health Care Price Transparency and Lowering Costs

In order to move health care organizations towards consistency in mitigating important cybersecurity threats to the health care sector, the Department of Health & Human Services (HHS) published multiple guidance documents on best practices for health care organizations to reduce cybersecurity risks (“HHS Cyber Guidance”). The HHS Cyber Guidance is the result of HHS’ public-private partnership with more than 150 cybersecurity and health care experts. While compliance is voluntary, this guidance serves as direction to health care entities on important practices that should be considered and implemented to reduce risk.

Why HHS has published this guidance…

Continue Reading HHS Releases Voluntary Cybersecurity Practices Guidance

The U.S. Department of Health and Human Services (“HHS”) announced a proposed rule to modernize the federal substance abuse confidentiality rules set forth in 42 C.F.R. Part 2.  The proposed updates seek to address longstanding complaints from providers and Health Information Exchanges (“HIE”) that the highly stringent confidentiality rules often stymie patient care by limiting …