Melissa (Lisa) Thompson

Melissa (Lisa) Thompson

Lisa Thompson advises companies, senior management, and their boards of directors, with a focus on the health care and life sciences industries. She has extensive experience in regulatory and corporate law, government investigations and audits, administrative and federal court appeals, commercial contracting, managed care disputes, clinical research law and IRBs, reimbursement, Medicare and Medicaid, state and federal surveys and termination actions, pharmacy and compounding laws, fraud and abuse, Stark Law, anti-kickback, federal program exclusions, and privacy and security (HIPAA / HITECH). Ms. Thompson’s life sciences experience includes FDA regulatory matters, product recalls and claims, FDA citizen petitions and appeals, labeling review, advertising and marketing compliance, drug and device reimbursement, clinical research agreements, and commercial contracting.

Her clients have included hospital systems, academic medical centers, pharmaceutical companies, medical device manufacturers, biotechnology companies, technology services providers, laboratories, pharmacies and retail pharmacy chains, physician practices, and others in the health care and life sciences industries. She is an arbitrator and mediator with the American Arbitration Association, serving on their Commercial Panel and National Healthcare Panel. She is also on the panel of arbitrators and mediators of the American Health Lawyers Association. Read her full rc.com bio here.

Subscribe to all posts by Melissa (Lisa) Thompson

FDA Issues Guidance on Hurricane Readiness for Medical Devices

The U.S. Food & Drug Administration (FDA) has issued important guidance on how to prepare for hurricanes when dependent on medical devices.  FDA stresses that during hurricanes and other emergency situations, medical devices may be exposed to fluctuating power, contaminants, or unusual levels of heat or humidity. The guidance links to pages providing information on the use of medical devices during and during emergency situations and afterwards, including:

OIG Issues Advisory Opinion to Pharmacy

On September 7, 2017, the HHS Office of Inspector General (OIG) issued an Advisory Opinion to the owner of a retail pharmacy chain (Pharmacy) that would allow Federal health care program beneficiaries to participate in a paid membership program (Program).  The Program would include discounts and rebates on certain prescriptions and, where offered, on selected clinic services.

The Program was being offered previously to customers who satisfied certain eligibility criteria and paid an annual fee to join, but Federal program beneficiaries had not been permitted to enroll. In seeking the …

House Bipartisan Act Would Amend Stark Law and Medicare Part B

On July 25, 2017, the U.S. House of Representatives passed by voice vote a bipartisan bill which is now in the Senate’s hands for consideration, the Medicare Part B Improvement Act of 2017. The bill would amend the Stark Law (Section 1877(h)(1) of the Social Security Act) and impact other provisions governing Medicare Part B.

The bill would amend the Stark Law:

  • to provide that the writing requirement for certain compensation arrangements may be satisfied by means determined by the HHS Secretary, including “a collection of documents, including contemporaneous

EHR Vendor Settles False Claims Act Suit for $155 Million

Electronic health record (EHR) vendor eClinicalWorks (eCW) recently entered into a settlement with the US Department of Justice (DOJ) and the Department of Health and Human Services’ Office of Inspector General (OIG) to resolve allegations under the federal False Claims Act (FCA) that eCW misrepresented its software and paid customers kickbacks to promote its products. The settlement imposes joint and several liability for payment on the EHR Vendor and three of its founders for $154.92 million, and liability for settlement payments individually by a developer ($50,000) and two project managers …

CMS Reverses Direction in Proposed Rule on Long Term Care Facility Arbitration Agreements

The Centers for Medicare & Medicaid Services (CMS) announced a Proposed Rule scheduled to be published in the Federal Register on June 8, 2017, revising its prior restrictions on binding arbitration provisions between long term care facilities and their residents set forth in a Final Rule published in October 2017.  Comments are due sixty days after publication of the Proposed Rule. In the Final Rule published last year, CMS had prohibited pre-dispute binding arbitration agreements and imposed requirements on facilities that asked residents to sign arbitration agreements.  The U.S. District …

U.S. Supreme Court – the FAA Preempts State Court Ruling in Nursing Home Arbitration Case

On May 15, 2017, in a closely-watched case involving arbitration clauses in nursing home contracts and powers of attorney, the U.S. Supreme Court held that the Federal Arbitration Act preempted a rule applied by the Kentucky Supreme Court when it refused to enforce two binding arbitration agreements between a nursing home and individuals holding general powers of attorney on behalf of two former residents of the nursing home.  Kindred Nursing Centers Ltd v. Clark, et al. 

As part of the nursing home’s resident intake process, the two individuals holding powers …

Federal Court Holds Online Medical Products Auction Contract Violates the AKS

The U.S. District Court for the District of Connecticut granted a motion for summary judgment in favor of Becton, Dickinson & Co. (BDC), a medical products provider, on the grounds that its contracts with MedPricer.com, Inc. (MedPricer), a company operating an online auction platform, violated the federal Anti-Kickback Statute (AKS), and were therefore unenforceable under Connecticut state law. MedPricer.com, Inc. v. Becton, Dickinson & Co., 2017 U.S. Dist. LEXIS 30854 (Memorandum opinion).

As described in the opinion, MedPricer enters into service agreements with hospitals and other health care providers to …

CMS Proposes Delay of Home Health Agency Conditions of Participation

The Centers for Medicare & Medicaid Services (CMS) is proposing to delay the effective date for the revised Conditions of Participation (CoPs) for Home Health Agencies (HHAs).  The original effective date was July 13, 2017.  The proposed delay would extend the effective date for an additional six months, until January 13, 2018.  In a previously published post, we discussed the HHA CoPs.…

CMS Revises Process for Reporting Stark Law Violations and Posts New SRDP Forms

On March 28, the Centers for Medicare & Medicaid Services (CMS) revised the procedures and posted new forms for its Voluntary Self-Referral Disclosure Protocol (SRDP).  The SRDP is a mechanism established pursuant to the Affordable Care Act for health care providers and suppliers to facilitate settlement of violations of the physician self-referral law (Stark Law).

Under the Stark Law, physicians (or their immediate family members) who have a financial relationship with an entity are prohibited from making referrals to that entity for certain designated health services (DHS) that are payable …

FDA’s Center for Devices and Radiological Health Issues Strategic Priorities

The Center for Devices and Radiological Health (CDRH) recently issued strategic priorities for 2016-17.  The primary strategic priorities include:

  1.  Establish a National Evaluation System for Medical Devices (NEST), to efficiently harness real-world “evidence of clinical experience.” Actions taken to date include, among others:
  • A multi-stakeholder Planning Board and the Medical Device Registry Task Force issued a series of reports that outline the organizational structure and infrastructure for the NEST Coordinating Center, in February 2015, April 2016, August 2015, and September 2016.
  • The FDA awarded $3

FDA Delays Intended Use Regulations

The U.S. Food and Drug Administration (FDA) announced that it was delaying until March 19, 2018, a Final Rule that has been viewed as having a chilling effect on scientific speech in attempting to broaden FDA’s authority to find an “intended use” for an approved or cleared medical product.  FDA extended the effective date to allow additional public comments after a petition filed on behalf of various industry groups challenged the Final Rule (dockets FDA-2011-P-0512, FDA-2013-P-1079, FDA-2015-N-2002, and FDA-2016-N-1149).

In the Final Rule, FDA had amended the intended use …

US and EU Agreement Allows Mutual Recognition of GMP Inspections

On March 2, 2017, U.S. Food and Drug Administration (FDA) announced that the United States had reached an agreement with the European Union (EU) that will allow FDA and EU regulators to use each other’s good manufacturing practice (GMP) inspections of pharmaceutical manufacturing facilities.  The agreement, entered into after several years of joint collaboration and evaluation, should help to avoid duplication of drug inspections and lower inspection costs. The FDA’s authority to enter into the agreement is derived from the Food and Drug Administration Safety and Innovation Act, which allows …

DOJ Announces $23 Million in Settlements Related to Implantation of ICD Cardiac Devices

On February 17, 2017, the U.S. Department of Justice (DOJ) announced settlements with 51 hospitals related to implantable cardioverter defibrillators (ICD), totaling over $23 million.  Combined with previously announced settlements, the DOJ has now reached agreements with more than 500 hospitals totaling more than $280 million relating to ICDs.   According to the DOJ, most of the 51 settling defendants were named in a False Claims Act qui tam lawsuit filed by a health care reimbursement consultant and a cardiac nurse.  U.S. ex rel. Ford et al. v. Abbott Northwestern

$5.5 Million HIPAA Settlement Emphasizes Importance of Audit Controls of Access by OHCA Affiliates

On February 16, 2017, the Office for Civil Rights (OCR) announced a $5.5 million settlement with South Broward Hospital District d/b/a Memorial Healthcare System (Healthcare System), to settle potential violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA).  The Healthcare System is a nonprofit corporation that operates several hospitals, an urgent care center, a nursing home, and ancillary health care facilities throughout south Florida.  The Healthcare System is also affiliated with physician offices through an Organized Health Care Arrangement (OHCA).…

21st Century Cures Act – Implications for Investigators and Research Sites

Below is a summary of some of the key provisions relevant to investigators and research sites included in the recently enacted, bipartisan 21st Century Cures Act, including human subjects protections and the privacy and security of health information used in clinical research.  Among other requirements, the Act:

*requires the Department of Health and Human Services (HHS) to harmonize the U.S. Food and Drug Administration (FDA) Human Subjects Regulations with the HHS Human Subject Regulations (the Common Rule), which should help streamline research that falls under both sets of regulations;…

LexBlog