Category: Health Reform

HHS Releases Long-Awaited Proposed Rules Related to AKS, Stark, CMP Laws for Value-Based and Coordinated Care Arrangements

The U.S. Department of Health and Human Services (HHS) announced today the release of two long-awaited proposed rules to “modernize and clarify” federal laws relevant to value-based and patient coordinated care programs. As previously discussed, these proposed rules are part of HHS’ Regulatory Sprint to Coordinated Care and arise from […]

OIG Report on Reasonable Assumptions in Manufacturer Reporting

Last week the Department of Health and Human Services Office of Inspector General (OIG) published a report titled “Reasonable Assumptions in Manufacturer Reporting of AMP and Best Prices” (Report) that reviewed the use of assumptions made by a sample of drug manufacturers participating in the Medicaid Drug Rebate Program (MDRP) […]

***Additional Update*** HHS Releases Plan to Require Drug Makers to list prices on TV ads

***Further update – Federal Court Vacates Rule*** Yesterday, U.S. District Court for the D.C. Circuit Judge Amit Mehta invalidated the final rule.  In ruling on the merits, Judge Mehta said the Department of Health and Human Services went beyond its rulemaking authority.   Specifically the ruling states, “[n]either the Act’s text, structure, […]

OIG Seeks Comments to Anti-Kickback Statute and Beneficiary Inducements CMP Related to ‘Patient Centered Care’

The Health and Human Services (HHS) Office of Inspector General (OIG) published today a request for information (RFI) seeking ways in which it might modify or add new safe harbors to the federal Anti-Kickback Statute (AKS) and exceptions to the definition of “remuneration” in the beneficiary inducement provision of the Civil […]

CMS Requests Information Regarding The Stark Law’s Potential Barriers to Coordinated Care

On June 25, 2018, the Centers for Medicare and Medicaid Services (“CMS”) published a Request for Information (“RFI”) in the Federal Register regarding section 1877 of the Social Security Act, also known as the “physician self-referral law” or the “Stark Law”. The Stark Law is a strict liability statute that: […]

**UPDATED*** Administration Releases Long-Awaited Drug Pricing Reform Plan

***5/14/2018 Update***   This morning, HHS Secretary Azar gave a speech offering additional details on the Blueprint.  Included in his remarks are plans to publicly identify companies suspected of “using public health rules to pad their profits”; send letters to all Medicare Part D plan sponsors indicating gag clauses in pharmacy contracts are unacceptable […]

President set to outline drug pricing plan: how far will it go?

Tomorrow at 2 p.m., EST,  the President is scheduled to deliver a long-awaited drug pricing strategy speech to put “America’s patients first.”  While details of the speech have been closely held, it is anticipated that it will  discuss a “comprehensive strategy” for combating the rising cost of prescription drugs and build on two previous actions which […]