Archives: Department of Health & Human Services Regulations

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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  One of the specific deregulatory initiatives noted is a future proposed rule to remove outdated Medicare and Medicaid … Continue Reading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

340B Ceiling Price/CMP Rule Effective Date Pushed Back to May 22, 2017 — “At the Earliest”

The Health Resources and Services Administration (HRSA) is delaying the effective date of its January 5, 2017 final rule on the calculation of the ceiling price and application of civil monetary penalties (CMPs) under the 340B drug pricing program until May 22, 2017 – with a longer delay being contemplated.  The January 5, 2017 final rule … Continue Reading

HRSA Publishes Final Rule on 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties

The Health Resources and Services Administration (HRSA) has published a final rule to implement civil money penalty (CMP) provisions added to section 340B of the Public Health Service Act under the Affordable Care Act.  In particular, the final rule addresses:  (i) the calculation of the 340B “ceiling price” that may be charged to covered entities; … Continue Reading

SAMHSA Releases Final and Supplemental Proposed Rules on Substance Abuse Records Privacy Protections

A new Substance Abuse and Mental Health Services Administration (SAMHSA) final rule is intended to modernize federal regulations governing the confidentiality of substance abuse records. SAMHSA explains in the preamble that it the agency “wants to ensure that patients with substance use disorders have the ability to participate in, and benefit from health system delivery … Continue Reading

CDC Issues Final Quarantine Rule to Strengthen Control of Communicable Diseases

The Centers for Disease Control and Prevention (CDC) has issued a final rule to strengthen the federal government’s ability to prevent the introduction, transmission, and spread of communicable diseases into the United States and interstate. The regulation is intended to both aid public health responses to outbreaks of new or re-emerging communicable diseases and provide due … Continue Reading

Out with the Old Rules? Will Trump and Republicans Target Health Care Regulations for Reversal in the New Year under Congressional Review Act?

The Congressional Review Act (CRA) has been used to overturn only one final rule in 20 years, but that situation may be about to change.  According to a new Congressional Research Service (CRS) analysis, a “specific set of circumstances” will occur when President-elect Trump is sworn in, namely, turnover in White House party control when … Continue Reading

Obama Administration Releases Regulatory Agenda – But Changes Expected Under Trump Administration

The Obama Administration has updated its regulatory agenda, listing the anticipated timing of pending and future regulatory actions, including a number of Department of Health and Human Services regulations. Note, however, that with the transition to the new Trump Administration, federal regulatory priorities can be expected to change.  Indeed, a new Administration often triggers a … Continue Reading

ONC Revises Health IT Certification Program Requirements

The HHS Office of the National Coordinator for Health Information Technology (ONC) has adopted a final rule to enable the ONC to directly review certified health information technology (IT) to determine whether it conforms to the requirements of the ONC Health IT Certification Program (‘‘Program’’). Such ONC review would be independent of, and may be … Continue Reading

October 16 Deadlines Quickly Approaching for the ACA’s Nondiscrimination Requirements: Are You Ready?

By October 16, 2016, all health programs and activities receiving federal financial assistance from the Department of Health and Human Services (HHS), those administered by HHS, and Health Insurance Marketplaces (Covered Entities), must be in compliance with the final pieces of the final rule issued by the Office for Civil Rights (OCR) issued May 18, … Continue Reading

SAMHSA Final Rule on Medication Assisted Treatment for Opioid Use Disorders Reporting Requirements

On September 27, 2016, the Substance Abuse and Mental Health Services Administration (SAMHSA) published a final rule establishing annual reporting requirements for certain practitioners who prescribe buprenorphine-based medication-assisted treatment for opioid disorders under the Controlled Substances Act. As previously reported, SAMHSA published a rule on July 8, 2016 that expanded from 100 to 275 the … Continue Reading
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