The U.S. Department of Health and Human Services (HHS) Health Resources and Services Administration’s (HRSA) long-awaited administrative dispute resolution (ADR) final rule went into effect last week, on January 13, 2021. The...more
The proposed 2020 Outpatient Prospective Payment (OPPS) rule was published on August 9, 2019. Buried in the 819 pages of proposed changes and justifications, CMS took another swing at cutting Medicare Part B reimbursement...more
Long time readers of our blog may recall that five years ago, I predicted that 2014 might be a game-changing year for the 340B Drug Discount Program. 2014 saw attempts at regulatory changes, but a successful court challenge...more
3/5/2019
/ Covered Entities ,
Drug Pricing ,
HRSA ,
Medi-Cal ,
Medicare ,
Medicare Part B ,
OIG ,
Pharmaceutical Industry ,
Prescription Drugs ,
Reporting Requirements ,
Section 340B
On November 1, 2017, CMS announced that it is in fact cutting Medicare Part B reimbursement for 340B drugs to the tune of $1.6 billion. To be accurate, what CMS announced is its intent to finalize proposed rule changes to the...more
11/3/2017
/ Centers for Medicare & Medicaid Services (CMS) ,
Covered Entities ,
Drug Pricing ,
Final Rules ,
HCPCS ,
Medicare ,
Medicare Part B ,
Outpatient Prospective Payment System (OPPS) ,
Physician Medicare Reimbursements ,
Prescription Drugs ,
Section 340B
Earlier this month the House Energy and Commerce Committee’s subcommittee on Government Oversight and Investigations held its second hearing on the 340B Drug Discount Program. The hearing followed on the heels of a July 18th...more
11/2/2017
/ CEOs ,
Charitable PAPs ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
FQHC ,
GAO ,
GPOs ,
HRSA ,
Medicare ,
OIG ,
Pharmaceutical Industry ,
Physician Medicare Reimbursements ,
Prescription Drugs ,
Reporting Requirements ,
Section 340B
In March, I posted about the Uncertain Future of the 340B Drug Discount Program. When opining about What Could Happen Next I speculated about possible changes to government reimbursement for 340B drugs “so that government...more
7/17/2017
/ Budget Cuts ,
Centers for Medicare & Medicaid Services (CMS) ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Executive Orders ,
Medicare ,
Medicare Part B ,
MedPAC ,
OIG ,
Outpatient Prospective Payment System (OPPS) ,
Physician Medicare Reimbursements ,
Prescription Drugs ,
Section 340B
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
10/21/2015
/ Affordable Care Act ,
Comment Period ,
Congressional Committees ,
Congressional Investigations & Hearings ,
Covered Entities ,
Drug Pricing ,
HRSA ,
Interpretive Rule ,
Omnibus Guidance ,
Orphan Drugs ,
Pharmaceutical Industry ,
Pharmacies ,
PHRMA ,
Section 340B
We have now had more than 30 days to digest HRSA’s proposed 340B Drug Pricing Program Omnibus Guidance (“Proposed Guidance”), intended to clarify expectations and provide guidance on key issues in the 340B Program. There are...more
10/8/2015
/ Comment Period ,
Covered Entities ,
Drug Pricing ,
Health Care Providers ,
Healthcare ,
Hospitals ,
HRSA ,
Interpretive Rule ,
MCOs ,
Medicaid ,
Medicare ,
Omnibus Guidance ,
Patients ,
Pharmaceutical Industry ,
Pharmacies ,
Proposed Regulation ,
Section 340B ,
State Medicaid Programs
Recently, HRSA publicly announced the issuance of a final rule clarifying when 340B covered entities can purchase and distribute orphan drugs through the 340B Drug Pricing Program. Separately, HRSA quietly posted a report on...more