Health Care

The pharmaceutical industry is facing the prospect of a rapidly evolving landscape, one that challenges its regulatory understanding and business model.

A few months ago, we noted that states were jumping into the drug pricing fray largely driven by a lack of federal action and a rising tide of public discontent.

Under the new payment methodology, EGWPs will no longer be paid based on their bid and applicable benchmark, rather they will be paid an amount established by comparing non-EGWP bids to the applicable benchmark (all adjusted for location, Star Ratings, and risk scores). This change was proposed for 2017, but CMS delayed the full implementation until 2018.

It is no secret that the Health Insurance Portability and Accountability Act (HIPAA) is a trap for the unwary. A recent study by the non-profit ProPublica has uncovered that the online review site Yelp (as well as other rating sites) are making it easier for covered entities to be ensnared.

One of the challenges of policy making is that bills must go before the Congressional Budget Office (CBO). CBO has one of the toughest jobs in Washington. Their job is to dispassionately look at policy and evaluate the cost of the bill to the federal treasury. Sometimes that means splashing cold water on the high-minded aspirations of policy makers. 

The Third Circuit granted on Tuesday the Federal Trade Commission’s (“FTC”) request for an injunction pending appeal of the proposed merger between Penn State Hershey Medical Center and Pinnacle Health System. 

Covered Entities need to continue to check their inboxes for emails from the HHS Office for Civil Rights (“OCR”) requesting verification of contact information in connection with Phase 2 of the HIPAA Audit Program. OCR previously indicated that Covered Entities would begin to receive verification emails in May.

The pharmacy industry is under increasing scrutiny from all angles. Whether at the legislative or agency level, Washington as well as many states seem intent on addressing perceived issues surrounding drug pricing, reimbursement and program integrity.

On May 10, 2016, FDA released its first draft guidance for medical device manufacturers who are using additive manufacturing (AM), commonly referred to as 3D printing.

The OIG recently issued a favorable advisory opinion permitting a health system (the “Health System”) to become the sole owner of a Group Purchasing Organization (“GPO”), some of whose members were also owned by the Health System (the “Proposed Arrangement”).

The Federal Trade Commission (“FTC”) and the state of Pennsylvania have two weeks to persuade the Court of Appeals for the Third Circuit that the pending merger of Penn State Hershey Medical Center (“Hershey”) and Pinnacle Health System (“Pinnacle”) is anti-competitive. 

Continuing our blog series on CMS’s massive proposed rule for the implementation of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), we dedicate this post to examining the Advance Payment Model (APM) provisions of the proposed rule.

Here in Washington, it seems everyone has an idea on a drug “fix”:  amendments to the provisions governing Medicare reimbursement, new rebate requirements, changes to price reporting measures, revisions to the 340B Drug Discount Program, etc. Proposals are interesting, but will Congress actually do anything?  If anything is actually going to pass, it has to get through the Senate.

The already enormous per-claim penalties under the federal False Claims Act (“FCA”) may nearly double by August 1, 2016, ratcheting up the stakes of FCA cases for health care providers, pharmaceutical and medical device manufacturers, and life sciences companies subject to the FCA.

Following our first panel discussing Drug Pricing Challenges and Opportunities, the second panel, which Theresa is moderating involves a subject near and dear to the heart of many of our clients: The New Wave of Value-Based Pricing and Contracting.

The Medicare Access and CHIP Reauthorization Act (MACRA) proposes a new approach, with new branding labels, to paying clinicians for the value and the quality of care that they provide by replacing a patchwork of existing quality-related programs, including the Electronic Health Records (EHRs) Incentive Programs, also known as “Meaningful Use.” 

We are thrilled that our inaugural Pharmacy Industry Summit is now less than a week away.  The Summit is next Tuesday May 10th, 2016, here in our DC offices.  Since we started planning for the Summit many months ago, this hottest of topics that we chose to cover, drug pricing, has become even hotter.

Last month, the FDA released three draft guidance documents that are expected to have significant implications for traditional pharmacy-based compounding and the distribution of those drug products.

On April 27, 2016, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that would put in place key parts of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA).

As noted in a post published yesterday, CMS issued the final rule regarding Medicaid managed care earlier this week. With this rule, CMS is taking a much more active role in overseeing states’ Medicaid managed care contracts.