Archives: Department of Health & Human Services Regulations

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Proposed Rules to Modernize Stark Law and Anti-Kickback Statute Released Today

Today, the Department of Health and Human Services (HHS) announced proposed changes to modernize the regulations that interpret the Physician Self-Referral Law (the Stark Law) and the Federal Anti-Kickback Statute. In a press release, HHS states these proposed rules are intended to “provide greater certainty for healthcare providers participating in value-based arrangements and providing coordinated … Continue Reading

SAMHSA Proposes Clarifications to Rules Governing the Confidentiality of Substance Use Disorder Patient Records

The Department of Health & Human Services (HHS) Substance Abuse and Mental Health Services Administration (SAMHSA) has proposed revisions to federal rules governing the confidentiality of patient records created by federally-assisted substance use disorder (SUD) treatment programs.  The proposed rule is intended to support coordinated care among providers that treat patients with SUDs, while maintaining … Continue Reading

HHS Announces Extended Comment Period for Healthcare Interoperability Proposed Rules, Releases New HIPAA FAQs

Today the U.S. Department of Health and Human Services (HHS) announced that it would extend until June 3, 2019 the comment periods for the Centers for Medicare & Medicaid Services (CMS) and Office of the National Coordinator for Health Information Technology (ONC) proposed interoperability and information blocking rules.  CMS also announced that as a result … Continue Reading

CMS Clarifies Regulatory Requirements for Line Extension Drug Medicaid Rebate Calculations

The Centers for Medicare & Medicaid Service (CMS) has issued regulations to address revised statutory requirements related to manufacturer calculation of Medicaid drug rebates.  Specifically, CMS recently published an interim final rule with comment period that revises the regulatory text at 42 CFR § 447.509(a)(4) to reflect Bipartisan Budget Act (BBA) of 2018 language revising … Continue Reading

HHS Finalizes Updates to State Medicaid Fraud Control Unit Rules

The Centers for Medicare & Medicaid Services (CMS) and the Office of Inspector General (OIG) have finalized changes to State Medicaid Fraud Control Unit (MFCU) regulations to reflect statutory changes and policies adopted since the MFCU rules were first issued in 1978.  Among other things, the regulations incorporate statutory policies that:  authorize a federal matching … Continue Reading

HHS Proposes Updates to CLIA Proficiency Testing Rules

The Centers for Medicare & Medicaid Services (CMS) and the Centers for Disease Control and Prevention (CDC) have proposed updates to the Clinical Laboratory Improvement Amendments of 1988 (CLIA) proficiency testing (PT) regulations to address the evolution in laboratory testing technology since the CLIA PT regulations were initially established in 1992.  The proposed rule would, … Continue Reading

HHS Proposes Changes to HIPAA Transaction Standard for Prescriptions for Schedule II Drugs in Retail Pharmacy Transactions

The Department of Health and Human Services (HHS) has issued a proposed rule that would modify the current HIPAA transaction standard for retail pharmacy transactions (the August 2007 revision of NCPDP telecommunications standard D.0) with respect to claims and similar transactions for Schedule II drugs.  HHS states that the change would enable covered entities to … Continue Reading

HHS Proposes Rescinding Standard Unique Health Plan Identifier and Other Entity Identifier

The Department of Health and Human Services (HHS) is proposing to rescind the standard unique health plan identifier (HPID) and the other entity identifier (OEID), along with related implementation specifications and requirements for their use. HHS adopted the HPID and OEID in a September 5, 2012 final rule, but HHS announced a delay in enforcement … Continue Reading

OCR Seeks Feedback on HIPAA Rule Reforms to Reduce Burdens, Promote Value-Based Care

The Office for Civil Rights (OCR) is requesting public input on reforms to Health Insurance Portability and Accountability Act (HIPAA) privacy and security rules to promote care coordination and the health system’s transformation to value-based health care while protecting the privacy and security of individuals’ protected health information (PHI).  Specifically, in a request for information … Continue Reading

It’s Official:  January 1, 2019 is Effective Date for HRSA 340B Ceiling Price/CMP Rule

The Health Resources and Services Administration (HRSA) has announced that it will implement its January 5, 2017 340B drug pricing program rule on January 1, 2019.  The oft-delayed final rule addresses:  (i) the calculation of the 340B “ceiling price” that may be charged to covered entities; (ii) the substantive standards applicable to civil monetary penalties … Continue Reading

HRSA Changes Course on 340B Ceiling Price/CMP Rule Implementation, Proposes Accelerating Effective Date to January 1, 2019

After multiple implementation delays, the Health Resources and Services Administration (HRSA) now seeks to move up the effective date of its January 5, 2017 rule on 340B drug pricing program ceiling price calculation and civil monetary penalties (CMPs).  By way of background, HRSA most recently delayed implementation of the 2017 rule because the Trump Administration was “developing … Continue Reading

Trump Administration Highlights Regulatory and Deregulatory Priorities for HHS

As part of the Trump Administration’s fall regulatory agenda, the Department of Health and Human Services (HHS) emphasizes its commitment to “reducing and streamlining its regulations and improving the transparency, flexibility, and accountability of its regulatory processes.”  One of the specific deregulatory initiatives noted is a future proposed rule to remove outdated Medicare and Medicaid … Continue Reading

Federal Health Fraud Penalties Are Rising Once Again

The Department of Health and Human Services (HHS) has just announced annual inflation-related increases to civil monetary penalties (CMPs) in its regulations, including those promulgated by the Office of Inspector General, the Centers for Medicare & Medicaid Services, and the Food and Drug Administration.  Specifically, pursuant to the Federal Civil Penalties Inflation Adjustment Act Improvements … Continue Reading

Trump Administration Finalizes Rule Expanding Availability of Short-Term, Limited Duration Health Insurance

The Departments of Treasury, Labor, and Health and Human Services have issued a final rule that expands the availability of short-term, limited duration insurance policies that are exempt from Affordable Care Act (ACA) qualified health plan standards (e.g., the requirement to provide essential health benefits, prohibition on preexisting condition exclusions, lifetime and annual dollar limits, … Continue Reading

HHS Delays 340B Ceiling Price/CMP Rule Implementation for Another Year — until July 1, 2019

The Health Resources and Services Administration (HRSA) is once again delaying the effective date of its January 5, 2017 rule on 340B drug pricing program ceiling price calculation and civil monetary penalties (CMPs). Specifically, under a final rule published June 5, 2018, HRSA is pushing back the 340B ceiling price/CMP rule’s effective date for an … Continue Reading

Trump Administration Releases Drug Pricing “Blueprint” and Request for Comments on Reducing Drug Costs

The Trump Administration has launched a high-profile initiative aimed at reducing prescription drug prices, including release of a blueprint containing a series of short- and long-term policy proposals and a request for public comments on additional reforms. First, on May 11, 2018 the Department of Health and Human Services released its “Blueprint to Lower Drug … Continue Reading

HHS Weighing Additional 1-Year Delay in 340B Ceiling Price/CMP Rule Implementation

The Department of Health and Human Services (HHS) is seeking comments on an additional delay in the effective date of the January 5, 2017 Health Resources and Services Administration (HRSA) final rule addressing calculation of the ceiling price and application of civil monetary penalties under the 340B drug pricing program. Specifically, HHS proposes to push … Continue Reading

SAMHSA Finalizes Changes to Rules for Disclosure of Substance Abuse Records to Support Health Care Operations

The Substance Abuse and Mental Health Services Administration (SAMHSA) has issued a final rule addressing the disclosure of substance use disorder patient records that is intended to facilitate health care activities while protecting patient privacy.  The final rule identifies the circumstances under which lawful holders of patient identifying-information may disclose such information to their contractors, … Continue Reading

Trump Administration Outlines Planned Regulatory — and Deregulatory — Actions for 2018

The Trump Administration has updated its “Unified Agenda of Regulatory and Deregulatory Actions,” which lists the scope and anticipated timing of pending and future regulations. In releasing the agenda, the Administration highlights its “ongoing progress toward the goals of more effective and less burdensome regulation,” including its plans to finalize three deregulatory actions for every … Continue Reading

Interim Final Rules Expand Contraceptive Coverage Exemption Based on Religious/Moral Beliefs

The Trump Administration has issued interim final rules to make it easier for employers and health insurance plans to qualify for an exemption from ACA rules mandating coverage of contraceptive services without cost sharing on the basis of religious or moral objections. The extent to which group health plans must cover contraceptive services in cases … Continue Reading

HRSA Delays Final 340B Penalty Rule until July 1, 2018; Additional Rulemaking in the Works

The Health Resources and Services Administration (HRSA) has adopted its proposal to delay the effective date of its final rule revising the calculation of the 340B “ceiling price” that may be charged to covered entities and related civil money penalties.  As previously reported, while implementation of the January 5, 2017 rule was already delayed until … Continue Reading

HRSA Proposes Delaying 340B Drug Pricing Program Reforms until July 1, 2018

The Trump Administration is proposing to once again push back the effective date of a January 2017 final rule making changes to the calculation of the 340B “ceiling price” that may be charged to covered entities and related civil money penalties. As previously reported, while implementation of this rule has already been delayed until October … Continue Reading

As ACA Repeal/Replace Debate Drags On, Trump Seeks Advice on How to Make Improvements to Health Care Markets

In a tacit acknowledgement of the hurdles ahead for enactment of Affordable Care Act (ACA) repeal/replace legislation, the Trump Administration is soliciting suggestion for changes that could be made within the current legal framework to improve health insurance markets and meet Administration reform goals. In particular, the Department of Health and Human Services (HHS) is … Continue Reading

HRSA Pushes Back 340B Rule Implementation Until October 1, 2017

Changes to the rules governing calculation of the ceiling price and application of civil monetary penalties under the 340B drug pricing program will not be implemented until October 1, 2017 under a rule published by the Health Resources and Services Administration (HRSA) on May 19, 2017.  The rule initially was scheduled to go into effect … Continue Reading
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