Recent House of Representatives committee hearings have focused on a variety of health care policy issues, including the following:

  • Energy and Commerce Committee hearings on: the growth and oversight of the 340B drug discount program; drug and device company communications, including clinical/economic data; state efforts to address the opioid crisis; and extension of safety net

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

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

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;

As has been the tradition for incoming administrations, the Trump Administration has ordered a regulatory freeze and review of final rules published by the Obama Administration that had not yet gone into effect.  In a January 20, 2017 memo to the heads of executive departments and agencies, Assistant to the President and Chief of Staff

The OIG recently examined how states that pay for drugs through Medicaid managed care organizations (MCOs) identify and exclude 340B drug claims when collecting Medicaid rebates, since states are prohibited from collecting “duplicate discounts” (i.e., when manufacturers pay Medicaid rebates on drugs sold at the discounted 340B price).  The OIG also reviewed potential vulnerabilities that

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

The Medicare Payment Advisory Commission (MedPAC) has released its annual recommendations to Congress on Medicare policies, including Medicare fee-for-service (FFS) payment updates and a status report on the Medicare Advantage and Medicare Part D programs.  The following are highlights of the recommendations for 2017 (some of which were recommended previously):
Continue Reading MedPAC Releases Annual Recommendations to Congress on Medicare Policy

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,

A new OIG report reviews Medicare Part B spending on drugs purchased by eligible health care providers through the 340B drug discount program.  The OIG describes the report as “an independent analysis to inform the ongoing discussion” among policymakers about the nature of 340B discounts and whether statutory changes should be made to enable Medicare and/or Medicaid to share in savings associated with 340B-purchased drugs. According to the OIG, Medicare Part B spent $3.5 billion for 340B-purchased drugs in 2013.  Medicare Part B payments for these drugs, based on 106% of average sales prices (ASP), totaled 58% more than the statutorily based 340B ceiling prices that year, enabling covered entities to retain approximately $1.3 billion.  The OIG described three “shared-savings arrangement” options that would have resulted in Medicare Part B savings between $162 million to $1.1 billion in 2013 “while still providing covered entities with incentives to purchase those drugs through the 340B Program”:
Continue Reading OIG Examines Medicare Part B Payments for 340B Purchased Drugs

On August 28, 2015, the Health Services Resources Administration (HRSA) published long-awaited 340B Drug Pricing Program Omnibus Guidance.  Although many aspects of the notice reiterate previous HRSA guidance, several elements will generate significant debate among program stakeholders regarding the scope of the 340B program, particularly because of its potential to narrow the scope of

The Government Accountability Office (GAO) has issued a report examining financial and other characteristics of hospitals that participate in the 340B Drug Pricing Program, focusing on disproportionate share hospitals (DSH) that account for the majority of 340B Program discount drug purchases.  Based on a review of Health Resources and Services Administration (HRSA) data for 2008

On June 17, 2015, the Health Resources and Services Administration (HRSA) issued a proposed rule to implement civil money penalty (CMP) provisions added to section 340B of the Public Health Service Act as part of the Affordable Care Act (ACA). The proposed rule addresses three primary issues: (i) the calculation of the 340B “ceiling price&rdquo

Today the Health Resources and Services Administration (HRSA) officially requested White House Office of Management and Budget (OMB) review of new “omnibus guidelines” on the 340B drug discount program. While the guidelines are not yet available to the public, the document will presumably fulfill HRSA’s pledge last year to address “key policy issues raised by

The Health Resources and Services Administration (HRSA) is seeking White House review of its proposed rule to implement new Affordable Care Act 340B drug discount program enforcement authorities and pricing policies. More than four years after soliciting comments on the planned rulemaking, the HRSA proposal will address its authority to impose civil monetary penalties (CMPs)

Congressional committees have held several hearings this week on health policy issues. On March 24, the Energy and Commerce Health Subcommittee held a hearing on the 340B drug pricing program. Also on March 24, the House Ways and Means Subcommittee on Oversight examined CMS’s use of the Fraud Prevention System (FPS) to identify and stop

The House Energy and Commerce Subcommittee on Health will hold a hearing on Thursday, March 5, 2015 on “Examining the 340B Drug Pricing Program,” focusing on the functionality of the program and the extent to which it meets its goal of improving access to prescription drugs for needy patients at facilities serving these populations. Scheduled

The Health Resources and Services Administration (HRSA) has officially withdrawn from Office of Management and Budget review a long-awaited proposed rule to establish comprehensive requirements for entities and manufacturers participating in the 340B Drug Pricing Program. HRSA notes in a web posting that it intends to issue proposed guidance for notice and comment in