Section 340B

News & Analysis as of

Administration Releases Spring 2016 Regulatory Agenda with Timeline for Rulemaking

The Obama Administration has posted its updated 2016 regulatory agenda, which lists major pending or planned rulemaking and the expected timing for action. The latest agenda includes numerous rules in the pipeline impacting...more

Provider-Based Update: Congress Offers Encouraging Step to Reduce Scope of BBA Reimbursement Reductions

On Wednesday, members of the House Ways and Means Health Subcommittee introduced bipartisan legislation that would provide some welcome relief to hospitals who had already invested resources to develop new provider-based...more

CMS Update to Medicaid Managed Care Regulations Should Prompt Significant Change

The Centers for Medicare & Medicaid Services (“CMS”) has released the final version of its much anticipated revisions to the regulations governing Medicaid managed care (the “Final Rule”). First proposed in May 2015, the...more

Also In The News - Health Headlines - April 2016

CMS Extends Participation in Bundled Payments for Care Improvement by Two Years – CMS has offered awardees the opportunity to extend participation in Models 2, 3, and 4 of the Bundled Payments for Care Improvement program...more

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

HHS Reopens Comment Period for Proposed Rule on 340B Drug Program

The U.S. Department of Health and Human Services (HHS) is reopening the comment period for the proposed rule titled “340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation.” HHS released...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

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

MedPAC Releases Annual Recommendations to Congress on Medicare Policy

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...more

MedPAC Publishes Report to Congress on 2017 Policies, Recommends Payment Reforms and Cuts to Part B Payments to Hospitals for 340B...

On March 15, 2016, MedPAC submitted its 2016 annual report to Congress on Medicare payment policies for 2017. In the Report, MedPAC makes a number of recommendations to Congress pertaining to payment under Medicare...more

MedPAC Report Recommends Reduction in Medicare Part B Payments to 340B Hospitals

On March 15, 2016, the Medicare Payment Advisory Commission (MedPAC) released its latest report to Congress that included 340B Implications for Medicare Part B Drugs along with a quick fact sheet regarding the report. Key...more

340B Program Update

The new year has already gotten off to a busy start for health care providers that participate in the 340B Drug Pricing Program (“340B Program”) and government agencies that reimburse these providers. Following on the heels...more

Second Circuit Invalidates CMS Regulation and Holds That Hospitals Designated as Rural May Apply for an Urban Wage Index While...

On February 4, 2016, the United States Court of Appeals for the Second Circuit struck down HHS regulations that prohibited hospitals from seeking classification as “urban” for purposes of their standardized amount and wage...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

Medicaid Program: Covered Outpatient Drugs, Final Rule with Comment Period Summary

On January 21, 2016, the Centers for Medicare & Medicaid Services (CMS) released the final rule implementing the prescription drug rebate provisions enacted as part of the health care reform law, the Affordable Care Act...more

MedPAC Votes to Recommend Changes to 340B Drug Payment Under Medicare Part B

For most of the past year, the Medicare Payment Advisory Commission (MedPAC) has been examining Medicare Part B payments to hospitals that participate in the 340B drug purchasing discount program in an effort to better align...more

Final ACA Medicaid Drug Pricing Rule Published: Changes to 5i, Bundling, RCP and Other Provisions Leave a Lot for Manufacturers to...

On Thursday, January 21, the Centers for Medicare & Medicaid Services (CMS or “the Agency”) published its long-awaited final rule with comment period implementing the Medicaid pricing and reimbursement provisions of the...more

Potential Part B Drug Payment Cuts for 340B Hospitals

The influential Medicare Payment Advisory Commission (MedPAC) has voted to recommend to Congress in its March report that Medicare Part B drug payment rates for 340B drugs be reduced by 10 percent for hospitals participating...more

Blog: Key Health-Related Provisions Tucked into Year End Spending Bill

Last week, Congress passed and the President signed into law the Consolidated Appropriations Act of 2016 (“the Omnibus”). This legislation contains both $1.1 trillion in government spending for FY16 as well as $650 billion...more

Health Update - December 2015

Lessons from Hawaii's Trailblazing ACA 1332 Waiver Proposal - Editor's Note: On September 9, Hawaii became the first state to post a draft 1332 waiver proposal for public comment. While Hawaii's proposal focuses on the...more

MedPAC Assesses Payment Adequacy for Medicare Services and Status of Medicare Advantage Program

On December 10-11, 2015, the Medicare Payment Advisory Commission (MedPAC) held a public meeting to report on the status of a number of Medicare payment systems, and to develop draft recommendations for payment updates that...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

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