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Renee works with healthcare providers and others on Medicare and Medicaid reimbursement, Anti-Kickback and Stark compliance, healthcare fraud and abuse issues, and other matters.

The regulation of pharmacies at the state level might not be what Justice Louis Brandeis had in mind as an example of a “laboratory of democracy,” but for pharmacists and consumers, state-level policy-making can have important real-world effects and encourage efforts on the federal stage. Over the past twelve months a number of regulatory trends have played out that define the current operating environment for pharmacies, many of which are anticipated to continue in 2019.
Continue Reading Recent Developments in State Pharmacy Law & Regulation: Looking Back at 2018 and What to Expect in 2019

On Wednesday, the Department of Health and Human Services (“HHS”) reversed course in its delay of implementing fines against drug manufacturers that intentionally overcharge 340B providers. In a notice of proposed rulemaking, HHS intends to advance the effective date of its final rule on the 340B drug price ceiling and civil monetary penalties to January 1, 2019, rather than July 1, 2019, as previously proposed.
Continue Reading HHS proposes moving up the enforcement of 340B penalties to January 1, 2019

On September 10, 2018, the federal Food & Drug Administration (”FDA”) released its revised draft standard Memorandum of Understanding (“MOU”) between states and the FDA addressing the interstate distribution of compounded drug products.  See 83 Fed. Reg. 175, 45631 et seq. (Sept. 10, 2018). The draft is the latest in the FDA’s decades-long effort to clarify state and federal roles in investigating and responding to complaints related to compounded drug products shipped between states.
Continue Reading FDA publishes revised draft MOU addressing state and federal oversight of 503A compounding pharmacies

The 60-day repayment rule was implemented by the Centers for Medicare and Medicaid Services (CMS) effective March 14, 2016 to clarify Medicare providers’ obligations to investigate, report, and refund identified overpayments under the Affordable Care Act. The rule specifically details what it means to “identify” an overpayment and explains how to report and return identified overpayments to CMS.1 The rule also states that an overpayment must be reported and returned if it is identified within six years of the date it was received. This time period is generally referred to as the “lookback” period.
Continue Reading Lookback Periods for Medicaid Overpayments

Tax_155335696According to a newly released survey by the Massachusetts Medical Device Industry Council (“MassMEDIC”), medical device company executives say the federal medical device excise tax (“MDET”) has hampered industry development, leading to job reductions, reduced research and development spending, and an increased tax compliance burden.
Continue Reading Medical device executives report medical device tax has stifled industry growth

Medicine and new technologyThe Centers for Medicare & Medicaid Services (“CMS”) issued its Final Rule on Nov. 16 for the Comprehensive Care for Joint Replacement (“CJR”) model, which mandates that CMS pay providers a bundled payment per episode of care for a Medicare beneficiary undergoing a hip or knee replacement, also referred to as lower extremity joint replacement or LEJR. This marks the first mandated episode-based bundled payment by CMS; all other episode-based bundled payments programs (e.g., Bundled Payment for Care Improvement, or BPCI, initiatives) are voluntary with regard to provider participation. The CJR model will require hospitals in 67 markets to participate in the program initially. A list of the participant hospitals in the selected markets is available here.
Continue Reading CMS implements first-ever mandatory episode-based bundled payment program for lower extremity joint replacements