Providers continue to face a massive Medicare appeals backlog before the Office of Medicare Hearing and Appeals (OMHA). Pending appeals number in the hundreds of thousands and the current average processing time for an appeal is over three years, with newly filed appeals likely to reach closer to five. While OMHA and Medicare reimbursement appeals face endemic issues, new developments and alternative programs may present strategic opportunities for providers and chip away at the backlog.

Regulatory changes from the U.S. Department of Health and Human Services (HHS) have come into play and are designed to provide clarity, reduce delays, and streamline the appeal process.  For example, HHS has recently revamped the OMHA case processing manual, “deputized” OMHA attorney adjudicators, and determined that some decisions from the Departmental Appeals Board (the appellate level above OMHA) will now be precedential.

Additionally, OMHA and the Centers for Medicare & Medicaid Services (CMS) have initiated new programs that provide alternatives to the traditional appeals procedure with the goal of reducing the backlog. These include 1) the OMHA Settlement Conference Facilitation alternative dispute resolution process; 2) the Statistical Sampling Initiative; 3) CMS’s Low Volume Appeals settlement options, and 4) CMS’s Formal Telephone Discussion Demonstration for Durable Medical Equipment providers. Further, recent Federal Circuit court cases, including American Hospital Association, et al v. Thomas Price, may significantly impact the Medicare appeals process.

During the AHLA Annual Meeting on Monday, June 25, McDermott lawyer and former OMHA attorney advisor, Nicholas Alarif, and Amanda Axeen, the Director of Program Evaluation & Policy at OMHA, will share their unique perspectives around the challenges faced by providers, as well as those faced by OMHA in administering the Medicare appeals process in the wake of such a huge surge of filings at the agency.  The presentation will give providers a general understanding of developments at OMHA related to the Medicare appeals process and potential alternative avenues for pending appeal resolution, which may be strategically advantageous for their particular types of appeals. The presentation will also provide guidance as to alternative avenues for appeal resolution providers may qualify for, as well as the benefits and key considerations of each program.

Medicare Hearings and Appeals: Litigation, New Initiatives, and Opportunities to Exit the Backlog
AHLA Annual Meeting, Chicago, IL | June 25, 2018 | 3:15 – 4:15 pm | Registration and program details.

McDermott’s Cocktail Reception during the AHLA Annual Meeting
The Art Institute of Chicago | June 26, 2018 | 6:00 – 8:00 pm

Following the AHLA Annual Meeting programming on Tuesday, we invite you to join us for our annual cocktail reception at The Art Institute of Chicago. We look forward to an evening of networking, cocktails and private gallery tours with our colleagues, friends and fellow AHLA members. RSVP today!

McDermott is gearing up for an exciting week of programming during the 2018 BIO International Convention. A number of McDermott partners will on the ground as panelists and moderators across a range of programs during BIO and we hope to see you there!

Thursday, May 31 | Al Sokol will moderate a panel discussion on “Getting and Leveraging Funding” at Mass Life Sciences Innovation Day.

Friday, June 1 | Dale Van Demark will co-moderate the panel “Digital Health – Hospital of the Future” during the IBA 6th Annual World Life Sciences Conference.

Saturday, June 2 | Emmanuelle Trombe will moderate the panel, “Biopharmaceutical Market: Collaboration vs. M&A,” and Al Sokol will be a speaker on the panel “Hot Topics in Venture Capital Investments,” during the IBA 6th Annual World Life Sciences Conference.

Sunday, June 3 | Emmanuel Trombe will moderate, and Veleka Peeples-Dyer will be on the panel, “What is Your Regulatory Strategy?” during the Boston-Paris Biotechnology Summit.

Monday, June 4 | Byron Kalogerou and Jennifer Bock will speak to business investors about the legal issues involved with establishing or expanding an operation in the United States during the SelectUSA FDI Seminar at BIO 2018.

Roger Kuan and Kristina Bieker-Brady will present “Operation Valuation: Maximizing the Value of your Asset Portfolio” during the Redefining Early Stage Investments (RESI) Conference.

Tuesday, June 5 | Sarah Hogan will moderate “Paths to Success in Life Sciences: A Conversation with Women Leaders,” a panel discussion with women executives from across the Life Sciences industry. The Women’s Executive Breakfast will be held at McDermott’s Boston office.

Wednesday, June 6 | Join us for “Connecting the Dots: A Cross-Border Mergers and Acquisitions Case Study, Linking Life Sciences Hubs in Europe, Asia and North America.” Our panel, led by Al Sokol, will connect the dots between the structuring and closing of a cross-border life sciences transaction, focusing on a hypothetical case study involving the auction of a US biotech company with platform technology. The panel will discuss the context, cross-border dynamics, practicalities, opportunities and challenges, underlying the growing volume of international life sciences transactions. Register here.

Immediately following, we hope you’ll join us for an evening of live music by Men In Black, fun in the sun, and networking with life sciences executives during the McDermott Beach Bash. RSVP here.

#BIO2018

Specialty pharmacy is not going away any time soon – by 2020, it’s expected that the pharmacy industry’s revenue will exceed $483 billion, with almost all growth as a result of specialty drugs (high-cost medications used to treat chronic conditions, such as cancer). It’s also estimated that the next generation of pharmaceutical “blockbusters” will be primarily specialty products. As the make-up of the pharmaceutical market shifts, we’re also seeing changes with the role of pharmacy benefit managers and other medical groups in the process. How are these shifts in specialty pharmacy impacting the health care system as a whole?

We asked Karen Gibbs, McDermott partner and former VP and Senior Counsel at CVS, to share her expertise on the subject and her thoughts on what’s to come.

Q.  Investments in niche sectors of pharmacy services, specialty pharmacy and pharmacy benefit management have gained huge traction recently. What’s driving the shift away from more traditional pharmacies?   

A.  Traditional pharmacies are retail establishments and have been suffering from the same earnings pressure that all retail establishments have endured. Pharmacy benefit managers (PBMs) typically own mail and specialty pharmacy operations, which generate revenue in a manner complementary to that derived from the pharmacy benefit management services. The margin on specialty pharmacy and PBM services is significantly more than retail pharmacy. Continue Reading Q&A: Shifting Trends in Specialty Pharmacy to Continue in 2018