Archives: Department of Health & Human Services Regulations

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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

NIH Finalizes New Drug and Device Clinical Trial Reporting Requirements

The National Institutes of Health (NIH) has finalized the requirements for submitting clinical trial information for applicable clinical trials of drug products (including biological products) and device products on ClinicalTrials.gov. The rule is intended to clarify as well as establish additional procedures and requirements for submitting: (i) registration, (ii) summary results, and (iii) adverse event … Continue Reading

HHS Inflation Adjustment Rule Hikes CMPs Across Department Programs

The Department of Health and Human Services (HHS) is increasing maximum civil monetary penalty (CMP) amounts applicable to HHS agencies and programs, in compliance with the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (which was part of the Bipartisan Budget Act of 2015).  The magnitude of the individual CMP increases varies depending … Continue Reading

CMS Proposes New Rule in an Effort to Address Significant Medicare Appeals Backlog

The Centers for Medicare & Medicaid Services (CMS) recently issued a proposed rule to address the significant backlog resulting from “an unprecedented and sustained increase” in its Medicare appeals. According to CMS, the Office of Medicare Hearings and Appeals (OMHA) had more than 750,000 pending appeals as of April 30, 2016, while it has only an adjudication capacity … Continue Reading

Obama Administration, Congress Take Steps to Fight Opioid Epidemic

HHS has announced a series of actions to address the nation’s opioid epidemic, as Congress has cleared the Comprehensive Addiction and Recovery Act for the President’s signature. As part of the HHS activities, the Substance Abuse and Mental Health Services Administration (SAMHSA) has published a final rule to expand from 100 to 275 the number … Continue Reading

HHS Proposes Rules to Streamline the Medicare Appeals Process to Address Backlog

The Department of Health and Human Services (HHS) has issued a proposed rule intended to address the significant backlog resulting from “an unprecedented and sustained increase” in Medicare appeals.  According to HHS, its Office of Medicare Hearings and Appeals (OMHA) had more than 750,000 pending appeals as of April 30, 2016, while it has only an … Continue Reading

HHS Finalizes ACA Nondiscrimination Protections for HHS Programs

The Department of Health and Human Services (HHS) has published a final rule implementing Section 1557 of the Affordable Care Act (ACA), which prohibits discrimination on the basis of race, color, national origin, sex, age, or disability in any health program or activity that receives financial assistance from or is administered by HHS or any … Continue Reading

HRSA Reopens Comment Period on 340B CMP Proposed Rule

On April 19, 2016, the Health Resources and Services Administration (HRSA) is publishing a notice reopening for 30 days the comment period on its June 17, 2015 proposed rule entitled “340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation.”  While comments may be submitted on any aspect of the proposed rule, feedback … Continue Reading

ONC Seeks Input on MACRA EHR Interoperability Requirements

The Office of the National Coordinator for Health Information Technology (ONC) is seeking comments on how to achieve widespread exchange of health information through interoperable certified electronic health record (EHR) technology nationwide by the end of 2018, as is called for by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA).  MACRA also mandates … Continue Reading

HHS Proposes Doubling the Buprenorphine Patient Cap to Expand Access to Opioid Dependence Treatment

HHS has proposed increasing from 100 to 200 the patient limit for qualified practitioners who prescribe buprenorphine-based medication-assisted treatment under the Controlled Substances Act to expand access to treatment for opioid use disorders.  Buprenorphine is an opioid medication used to treat opioid addiction that can be dispensed for take-home use, by prescription. The proposed rule … Continue Reading

ONC Proposes Changes to Health IT Certification Program

The HHS Office of the National Coordinator for Health Information Technology (ONC) has proposed changes to the ONC Health IT Certification Program that are intended to “further enhance the safety, reliability, transparency, and accountability of certified health IT for users.”  Notably, the proposed rule would: Establish a process for ONC to directly review certified health … Continue Reading

SAMHSA Proposes Revisions to Substance Abuse Records Privacy Protections to Support Delivery Reform

The Substance Abuse and Mental Health Services Administration (SAMHSA) published a proposed rule on February 9, 2016 that is intended to modernize regulations governing the confidentiality of substance abuse records to ensure that patients with substance use disorders have the ability to participate in new integrated health care models that emphasize coordinated care while addressing … Continue Reading

HHS Finalizes HIPAA Amendments to Allow Reporting of Certain Mental Health Information to the National Instant Criminal Background Check System

On January 6, 2016, HHS published a final rule to modify the HIPAA Privacy Rule to expressly permit certain HIPAA covered entities to disclose to the National Instant Criminal Background Check System (NICS) the identities of individuals who are subject to a federal “mental health prohibitor” that disqualifies them from shipping, transporting, possessing, or receiving … Continue Reading

ONC Corrects EHR Certification Criteria Final Rule

The HHS Office of the National Coordinator for Health Information Technology (ONC) has published a notice correcting errors and clarifying provisions of its October 16, 2015 rule that finalized the 2015 edition health information technology certification criteria and a new 2015 Edition Base Electronic Health Record (EHR) definition.… Continue Reading

HHS, Treasury Issue Guidance on ACA State Innovation Waivers

The Departments of Health and Human Services (HHS) and Treasury have issued joint guidance on Affordable Care Act (ACA) “Section 1332” waivers, through which states can apply to implement alternative mechanisms to provide access to health care for their residents if certain conditions are met.  Under the ACA, Section 1332 waivers can only be approved … Continue Reading

HHS Posts Fall 2015 Regulatory Agenda Listing Rules in Pipeline

The Obama Administration has released its latest regulatory agenda, which lists major pending or planned regulatory actions and the anticipated timing of rulemaking activity. The agenda includes numerous pending HHS proposed and final rules affecting a wide range of policy areas, including Medicare payment rules, fraud and abuse authorities, the 340B drug pricing program, and … Continue Reading
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