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Ryan Cuthbertson is an Associate in the Health Law Practice and focuses primarily on transactional and regulatory matters, including mergers and acquisitions, joint ventures, regulatory compliance review, and licensing activities.  Ryan has also provided due diligence support, and insurance, licensing, and other regulatory guidance to pharmacies, pharmacy benefit managers, laboratories, durable medical equipment suppliers, hospital systems, dialysis and long-term care providers, medical practices, and payors.

Before joining the firm, Ryan spent nearly 10 years as an acquisitions officer in the US Air Force, where he was responsible for managing cost, schedule, and performance of various defense development programs.

A bipartisan congressional effort is underway to convince CMS to reverse its biosimilar reimbursement policy implemented under the Obama administration. We discussed the current reimbursement policy in a March 2016 blog post when CMS initially released the guidance.  CMS implemented the controversial guidance as a final rule in October 2016.

The current policy requires all biosimilars that are related to a reference product to be given a shared Healthcare Common Procedure Coding System (HCPCS) code. For Medicare Part B, reimbursement is then calculated based on the average sales price (ASP) of all of the biosimilars with that HCPCS code plus 6% of their reference product’s ASP. Continue Reading CMS Urged To Reverse Obama-Era Biosimilar Reimbursement Policy

ML Strategies has published the first installment of a new weekly preview, designed to give you quick overview of health happenings in the coming week. The preview highlights upcoming activity in the House and Senate and other hot topics on the Hill.

Spoiler alert: the confirmation processes for Dr. Scott Gottlieb (FDA) and Judge Neil Gorsuch (Supreme Court) will get a lot of attention this week.

See HERE for this week’s preview and be sure to stay tuned in the coming weeks.

Earlier this month, Mintz Levin’s Health Care Enforcement Defense Group published its most recent Health Care Qui Tam Update that looks at 18 health care-related qui tam cases unsealed in October and November of 2016.

The Update presents two unique cases in-depth and covers some of the trends revealed in these recently unsealed cases:

  • The cases identified were filed in federal district courts in 12 states, including California (5), New York (3), Alabama (1), Arkansas (1), Florida (1), Hawaii (1), Kansas (1), New Jersey (1), New Mexico (1), North Carolina (1), Oklahoma (1), and Pennsylvania (1).
  • The federal government declined to intervene in nine of the 18 cases. Five more cases were voluntarily dismissed before any action was taken by the government. The federal government intervened, in whole or in part, in three cases. In the two remaining cases, the government’s intervention status could not be discerned from the unsealed filings.
  • Nature of the Claims
    • Nine of the recently unsealed cases included both state and federal claims.
    • Four involved allegations of unlawful kickbacks. Of these, two also alleged violations of the Stark Law (42 U.S.C. § 1395nn).
    • Claims for relief under state or federal anti-whistleblower retaliation provisions appeared in nine of the 18 recently unsealed cases.
    • The cases remained under seal for an average of just over two years (774 days). The median number of days cases remained under seal was 573.5. United States ex rel. DiBenedetto v. Vahedi, which was heard in the U.S. District Court for the Central District of California, was under seal for the shortest amount of time, at 104 days. United States ex rel. Harmsen v. Moore County Dental Care Center, which was filed in the U.S. District Court for the Middle District of North Carolina, was under seal the longest, at 2,075 days (over five and a half years)
  • In nearly three-quarters of the unsealed cases (13 of 18), relators were current or former employees of the defendant.

See HERE for the full Update and to find our key takeaways from the cases discussed.

 

Join us next Wednesday, February 15 from 1pm – 2pm Eastern for the final installment of our three-part webinar series on the 21st Century Cures Act (the “Cures Act”).  Part III of the series will focus on the Cures Act’s impact on the FDA and will have some great takeaways for anyone who interacts with the FDA or has an interest in the Cures Act.

In this presentation, our colleagues Bethany Hills and Joanne Hawana will discuss the following FDA-related provisions of the Cures Act and take a deep dive into the practical implications and implementation processes for each of:

  • Regenerative Medicine
  • Medical software/digital health
  • FDA restructuring/structural improvements
  • Health care economic info and off-label communications
  • Data source changes – patient experience, RWE and summary data

Click HERE to register!

Today, my colleagues Laurence Freedman, Samantha Kingsbury, and Karen Lovitch released the latest in our ongoing series reviewing health care enforcement activities in 2016 and their impacts looking forward to 2017. The client alert highlights major case law developments that influenced health care enforcement in 2016 and that will likely have major effects on the health care industry in the year ahead.

The client alert addresses the following issues raised by these important cases and what each might mean in 2017:

  • Implied false certification theory and materiality requirement (Escobar)
  • Anti-Kickback Statute discount exception and safe harbor (Organon; CCS Medical)
  • Proof of falsity in False Claims Act medical necessity cases (AseraCare)
  • Statistical sampling to prove liability in False Claims Act cases (Agape; Life Care Centers of America)

Please refer to our Health Care Enforcement Review and 2017 Outlook blog post series for additional insights on key government policies, regulations, and enforcement actions from 2016 and their expected impact on health care enforcement in the year ahead. We also encourage you to sign up for our annual webinar, Health Care Enforcement Review & 2017 Outlook, which will take place on Wednesday, January 25 at 1:00 p.m. ET.  Registration and additional information are available here.

As we’ve previously reported, the Massachusetts Department of Public Health (DPH) has recently proposed a number of amended regulations in connection with the regulatory review and overhaul mandated by Governor Baker’s Executive Order 562. Senior DPH staff presented these proposed regulations at a Public Health Council Meeting on September 14 (the “PHC Meeting”).  Today we are looking at proposed regulations related to Dialysis Units.  For our prior analysis of the proposed regulations on hospital licensing, please see here. Continue Reading Massachusetts Dialysis Unit Licensing Proposed Regulations – Key Take-Aways

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”).

Despite determining that the Proposed Arrangement does not qualify for protection under the GPO safe harbor, the OIG considered whether allowing the GPO to be wholly owned by the same entity that also owns almost 1% of the member pool increases the risk of fraud and abuse to Federal health care programs.

The GPO Structure

The GPO has over 84,000 members nationwide, many of which are hospitals, nursing facilities, clinics, physician practices, laboratories, home care, and equipment organizations. It operates by negotiating products and pricing with vendors on behalf of its members and receives administrative fees from the vendors based on a percentage of the value of sales to the members.  The GPO provides annual written disclosures to the members regarding purchases made on behalf of each member and maintains records regarding discounts and vendor administrative fee distributions to members.

The Proposed Arrangement

To increase efficiencies, the GPO underwent a series of mergers and stock sales (not at issue here), after which the Health System owned 95% of the GPO, with an unrelated entity owning the remaining 5%. About 800 of the 84,000 members (just under 1%) are owned by the Health System.  Under the Proposed Arrangement, the Health System would purchase the remaining 5% of the GPO to become the sole owner. Continue Reading OIG Issues Favorable GPO Advisory Opinion

21st Century Oncology Holdings, a company that operates a chain of 181 cancer treatment centers in the US and Latin America, announced on Friday March 4 that it was latest victim of a cyber-attack affecting 2.2 million individuals. When did the attack occur? Months ago.

The breach occurred as early as October 3rd of last year when a hacker accessed a database containing current and former patient names, Social Security numbers, physician names, diagnosis and treatment information and insurance information. The FBI informed the company of the possibility of a breach in November of 2015, prompting the company’s investigation. After a five-month delay, requested by the FBI, the company announced the breach (see HERE) and is offering patients one year of identity theft protection services. Continue Reading Oh No, Not Again…Chalk Up Yet Another Health Data Breach

As the year winds down, we look back with a mixture of nostalgia and queasiness on the major Health Insurance Portability and Accountability Act (HIPAA) events that defined 2015.    Incredibly large data breaches became disturbingly routine, calling into question the ability of insurers and providers to protect their increasingly large troves of sensitive health information.  We also saw the release of an Office of Inspector General (OIG) report that was highly critical of the Federal government’s ability to effectively enforce HIPAA, followed almost immediately by signs of more aggressive enforcement from the Office for Civil Rights (OCR), perhaps in response.  We waited for commencement of the second round of HITECH-mandated audits, but it never came.  As regulated entities prepare for a new year of regulatory challenges, we review the highlights — and lowlights — of HIPAA 2015, and prepare for what’s to come in 2016. Continue Reading HIPAA and Health Care Data Privacy – 2015 Year in Review

The HHS Office for Civil Rights (OCR) has released a new platform to provide mobile health developers (and any other interested stakeholders) a sounding board to ask questions, voice concerns, and “spitball” ideas about HIPAA and its interplay in the Health IT space. Users can submit questions and comments on the site, on which other viewers can comment and vote (similar to “liking” a timeline post on Facebook). All comments remain anonymous and OCR has stated specifically that they will not be used as the basis of enforcement actions. Although OCR will not normally respond to these comments, it has said that feedback provided through the platform will be used to inform the development of future guidance. Continue Reading OCR Launches Platform for Developer HIPAA Questions