HRSA

News & Analysis as of

A&B Healthcare Week in Review

I. REGULATIONS, NOTICES, & GUIDANCE - On April 21, 2016, CMS issued a proposed rule entitled, “Medicare Program: FY 2017 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Requirements.” This...more

A&B Healthcare Week in Review

I. REGULATIONS, NOTICES, & GUIDANCE - On April 15, 2016, the Food and Drug Administration (FDA) issued a proposed rule entitled, “Applications for Approval and Combinations of Active Ingredients Under Consideration for...more

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...more

340B Proposed Pricing Rule Reopened for Comment: Penny Pricing, New Drug Pricing and Definition of “Knowing and Intentional” Back...

On Monday, April 18, the Health Resources and Services Administration (“HRSA”) published a Notice reopening comment on its June 17, 2015 Proposed Rule regarding 340B pricing and manufacturer civil monetary penalties....more

HRSA reveals new tool for rural GME

In the face of rural physician shortages, the Health Resources and Services Administration (HRSA) unveiled a new tool on April 11 to help assess whether a rural hospital is currently a teaching hospital. Knowing whether a...more

A&B Healthcare Week in Review

I. REGULATIONS, NOTICES, & GUIDANCE - On April 4, 2016, the Centers for Medicare & Medicaid Services (CMS) issued the Final Calendar Year (CY) 2017 Medicare Advantage Capitation Rates and Medicare Advantage (MA) and...more

340B Drug Discounts: Potential HRSA Policy Shift May Limit Eligibility for Preferred Pricing

The 340B drug pricing program requires drug makers to offer covered outpatient drugs to safety net hospitals and certain other designated healthcare providers at discounted prices. A potential shift in how the governing...more

A&B Healthcare Week in Review

I. REGULATIONS, NOTICES, & GUIDANCE - On March 29, 2016, Centers for Medicare & Medicaid Services (CMS) issued a final rule entitled, “Medicaid and Children’s Health Insurance Programs: Mental Health Parity and...more

A&B Healthcare Week in Review

I. REGULATIONS, NOTICES, & GUIDANCE - On March 15, 2016, the Centers for Disease Control and Prevention (CDC) issued voluntary guidelines entitled, “CDC Guidelines for Prescribing Opioids for Chronic Pain — United...more

CMS Notifies States of AMP Rule Requirements: 340B Providers Should Take Note

Last week, Mintz Levin and ML Strategies released a joint Alert analyzing key provisions of the Covered Outpatient Drug final rule (“Final AMP Rule”) and their impact on manufacturers, pharmacy benefit managers (“PBMs”), and...more

Alert: 340B Self-Audits: The Best Defense Is A Good Defense

Federally qualified health centers (FQHCs) participating in the 340B Drug Pricing Program (the “340B Program”) are subject to audits by Health Resources and Services Administration (HRSA) and the drug manufacturers who...more

The Pharmacy Industry – 2015 Year In Review

With 2015 coming to a close, we wanted to provide a recap of the major updates impacting the pharmacy industry and what pharmaceutical manufacturers, pharmacy benefit managers (“PBMs”), and pharmacies might expect in 2016. ...more

2016 Expected to Be Monumental Year for 340B Drug Discount Program

The 340B Program continues to be an area of focus from federal policymakers, and recent activity and publications indicate that 2016 could be a monumental year for the program. Below is a breakdown of the recent and upcoming...more

OIG Reports on, Proposes Alternatives to Medicare Part B Reimbursement for 340B Drugs

In November 2015, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) published a report (the Report) on the subject of Medicare Part B (Part B) payments made for covered outpatient drugs...more

Alert: What to Expect During an FTCA Site Visit

The Health Resources and Services Administration (“HRSA”) announced last year that it intends to increase the number of Federal Tort Claims Act (“FTCA”) site visits it will conduct each year. Most site visits occur between...more

A&B Healthcare Week in Review, November 2015

I. REGULATIONS, NOTICES, & GUIDANCE - On November 21, 2015, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule entitled “Patient Protection and Affordable Care Act; HHS Notice of Benefit and...more

New FAQs on Preventive Services, Wellness Program Rewards and Mental Health and Substance Use Treatment: McGuireWoods Healthcare...

This is the 54th in a series of WorkCite articles concerning the Patient Protection and Affordable Care Act and its companion statute, the Health Care and Education Reconciliation Act of 2010 (referred to collectively as the...more

Recent Government-Issued FAQs Cause Plan Sponsors to Clarify Preventive Care and Wellness in Health Plan Communications

On October 23, 2015, the U.S. Departments of Labor (DOL), Health and Human Services (HHS), and Treasury issued frequently asked questions (FAQs) on the implementation of preventive care and wellness provisions of the...more

Passage of the Bipartisan Budget Act: What You Should Not Do Now

Tips on preserving the provider-based status for existing clinics. The Bipartisan Budget Act of 2015 (H.R. 1314) was signed into law on Monday, November 2. Notwithstanding significant concerns raised by the hospital...more

Congress Take Step Toward Site-Neutral Medicare Payments in Bipartisan Budget Act of 2015

On October 28, 2015, the U.S. House of Representatives approved legislation that, if enacted, would, among other things, substantially alter how and how much Medicare pays for outpatient services furnished by hospitals. The...more

District Court in D.C. Vacates HHS’ Interpretive Rule Regarding Orphan Drug Exclusion from 340B Discount Pricing

In what amounts to a victory for the pharmaceutical industry, on October 14, 2015, the U.S. District Court for the District of Columbia vacated the interpretive rule issued by the U.S. Department of Health and Human Services...more

340B Orphan Drug Interpretive Rule Struck Down by D.C. District Court: HHS and HRSA Lose In Second Round of Litigation Over 340B...

In an Opinion issued October 14, 2015, D.C. District Court Judge Rudolph Contreras granted Pharmaceutical Research and Manufacturers of America’s (“PhRMA”) motion for summary judgment against the U.S. Department of Health and...more

Alert: Proposed 340B Drug Pricing Program Omnibus Guidance - Defines "Eligible Patient"

On August 28, 2015, the Health Resources and Services Administration (“HRSA”) published the proposed 340B Drug Pricing Program Omnibus Guidance (“Omnibus Guidance”) which is intended to clarify for covered entities, such as...more

Does Invalidation of 340B Orphan Drug Rule Doom HRSA’s Guidance?

Our recent post on HRSA’s Omnibus Proposed Guidance for the 340B Drug Discount Program (Proposed Guidance) noted that since the DC District Court had yet to rule on the validity of HRSA’s “interpretive” 340B orphan drug rule,...more

Federal Court Rejects HHS Interpretation of 340B Program’s Orphan Drug Rule

On October 14, 2015, the United States District Court for the District of Columbia (the Court) issued a decision in Pharmaceutical Research and Manufacturers of America v. United States Department of Health and Human...more

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