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.

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OCR Comments on Recent Ciox Case Vacating Certain Omnibus Rule Regulations and Guidance Relating to Fees for Providing Patient Records

By Melissa (Lisa) Thompson on Posted in Health Information Exchanges and Electronic Medical Records (EMRs), Health Information Technology, Healthcare Technology, HIPAA

The U.S. Department of Health and Human Services’s (HHS) Office for Civil Rights (OCR) issued an Important Notice Regarding Individuals’ Right of Access to Health Records through its email list serve on January 29, 2020.  In the Notice, OCR addressed the recent memorandum Opinion issued in Ciox Health v. Azar, et al, No. 18-cv-00040 (D.D.C. January 23, 2020).

In that case, Ciox Health, LLC, a specialized medical records provider, had challenged certain provisions of the 2013 Omnibus Rule, including provisions pertaining to what can be charged for delivering records …

Bipartisan Bill for Federal Regulation of CBD in Foods and Dietary Supplements

By Melissa (Lisa) Thompson on Posted in Dietary Supplements, Food and Beverage

A bipartisan bill was introduced in the U.S. House of Representatives on January 13, 2020, that (1) would allow hemp-derived cannabidiol (CBD) to be regulated as a dietary supplement, if all other applicable requirements for a dietary supplement are met, and (2) would not prohibit CBD from being included in foods that are introduced into interstate commerce. The bill was filed by the Chairman of the House Agricultural Committee, Representative Collin Peterson (D-MN), and co-sponsored by Representatives Thomas Massie (R-KY), James Comer (R-KY) and Chellie Pingree (D-ME).…

DOJ Announces $26.67 Million Settlement with Laboratory to Resolve FCA Allegations

By Melissa (Lisa) Thompson on Posted in Department of Justice, False Claims Act, Fraud and Abuse, Government Enforcement, Hospitals and Health Systems, Medicare and Medicaid, Office of Inspector General, Stark Law

On November 26, 2019, the Department of Justice (DOJ) announced a $26.67 million settlement with a laboratory testing corporation, Boston Heart Diagnostics Corporation (Boston Heart). The settlement resolves allegations of False Claims Act (FCA) violations related to alleged payments for patient referrals in violation of the Anti-Kickback Statute (AKS) and the Physician Self-Referral Law (PSR Law) – commonly known as the Stark Law – and other improper billing.…

Government Releases Proposed Rules on Physician Self-Referral Law (Stark Law), Anti-Kickback Statute and CMP Law; Significant Regulatory Changes Intended to Encourage Care Coordination and Value-Based Care

By Conor Duffy and Melissa (Lisa) Thompson on Posted in Academic Medical Centers, Accountable Care Organizations, Commercial Health Insurance, False Claims Act, Fraud and Abuse, Government Enforcement, Health Information Exchanges and Electronic Medical Records (EMRs), Health Information Technology, Hospitals and Health Systems, Legislation, Medicare and Medicaid, Office of Inspector General, Physicians and Allied Health Professionals, Reimbursement, Stark Law

On October 9, 2019, the Department of Health and Human Services (HHS) released its long-awaited proposals (the Proposed Rules) to update regulatory exceptions and safe harbors, for the federal Physician Self-Referral Law (also known as the Stark Law), the Anti-Kickback Statute (AKS), and the beneficiary inducement Civil Monetary Penalties Law (CMP). The Centers for Medicare & Medicaid Services (CMS) issued a proposed rule to update exceptions to the Physician Self-Referral Law (the PSR Rule), and the HHS Office of Inspector General (OIG) issued a proposed rule to update the …

CMS Announces Pilot Program for Clinicians to View Claims Data of Medicare Beneficiaries

By Melissa (Lisa) Thompson on Posted in Health Information Exchanges and Electronic Medical Records (EMRs), Health Information Technology, Healthcare Technology, Managed Care, Medicare and Medicaid, Privacy and Security

On July 30, 2019, the Centers for Medicare & Medicaid Services (CMS) announced “Data at the Point of Care” (DPC), a pilot program that will provide clinicians with access to claims data. The pilot program follows on the heels of the recently proposed Interoperability and Patient Access Proposed Rule, which would require regulated health plans to make patient data available through an application programming interface (API). These actions are also part of the MyHealthEData initiative spearheaded by the White House Office of American Innovation.…

CMS Issues Final Rule Restricting Arbitration Agreements with Long Term Care Facilities

By Melissa (Lisa) Thompson on Posted in Arbitration, Long Term Care and Nursing Homes, Medicare and Medicaid

On July 18, 2019, the Centers for Medicare & Medicaid Services (CMS) published a Final Rule establishing requirements for arbitration agreements between long-term care (LTC) facilities and their residents. The Final Rule represents a revamping by CMS of a prior rule that had been published in October 2016 that prohibited pre-dispute binding arbitration agreements. CMS undertook to revise the 2016 rule after the U.S. District Court for the Northern District of Mississippi enjoined enforcement of the prohibition on pre-dispute binding arbitration agreements.…

Federal Judge Vacates Final Rule on Drug Pricing Transparency in Consumer Advertising

By Melissa (Lisa) Thompson on Posted in Medicare and Medicaid, Pharmaceuticals and Biologics, Pharmacy Law

In a Memorandum Opinion, Judge Amit P. Mehta, of the U.S. District Court for the District of Columbia, vacated a U.S. Department of Health and Human Services (HHS) Final Rule, just days before its July 9 effective date. The Final Rule would have required the list prices of prescription drugs to be included in direct-to-consumer advertisements.…

U.S. Supreme Court Clarifies Scope of False Claims Act Statutes of Limitations

By Melissa (Lisa) Thompson and Conor Duffy on Posted in Department of Justice, False Claims Act, Fraud and Abuse, Government Enforcement, Hospitals and Health Systems, Medicare and Medicaid, Physicians and Allied Health Professionals, Reimbursement

In a unanimous decision issued on May 13, 2019, the U.S. Supreme Court sought to resolve lingering confusion over the statute of limitations under the False Claims Act (FCA) for qui tam suits in which the federal government declines to intervene. In Cochise Consultancy, Inc. v. United States Ex Rel. Hunt, the Court held that a relator’s claim may be brought within 3 years after the government was made aware of underlying material claims, even where the government did not intervene in the case, because 10 years had not …

CMS Amends Regulations to Lower Drug Prices and Reduce Out-Of-Pocket Expenses in Medicare Advantage and Part D Prescription Drug Benefit Program

By Melissa (Lisa) Thompson on Posted in Health Information Technology, Healthcare Technology, Medicare and Medicaid, Pharmaceuticals and Biologics, Pharmacy Law

The Centers for Medicare and Medicaid Services (CMS) announced a final rule, to be published on May 23, 2019, amending the Medicare Advantage program (Part C) and Prescription Drug Benefit program (Part D) regulations. According to CMS, the purpose of the rule is to lower drug prices and reduce out-of-pocket expenses in the Medicare Advantage and Part D drug programs.

The major provisions are:

  1. Protected classes. The final rule contains an exception to the requirement that Part D sponsors include all Part D drugs in these protected classes
…

CMS Final Rule on Drug Pricing Transparency in Consumer Television Ads

By Melissa (Lisa) Thompson on Posted in Medicare and Medicaid, Pharmaceuticals and Biologics, Pharmacy Law

On May 10, 2019, the Centers for Medicare and Medicaid Services published a Final Rule on drug pricing transparency in consumer advertisements. The new rule requires direct-to-consumer (DTC) television advertisements to include the list price of prescription drugs and biological products distributed in the US that are reimbursable by Medicare or Medicaid, whether directly or indirectly.…

CBD Update: FDA Issues Statement, Calls Public Hearing, and Announces Warning Letters on Products Containing Cannabis and its Components

By Melissa (Lisa) Thompson and Rickie Sonpal on Posted in CBD - Cannabis, FDA, Medical Devices, Pharmaceuticals and Biologics, Pharmacies, Pharmacy Law

On April 2, 2019, the Federal Food and Drug Administration (FDA) issued a statement and announced a public hearing on consumer products derived from cannabis and its components, including cannabidiol (CBD). Recognizing the need to provide clarity on the authority of FDA to regulate these products, and what pathways are available for marketing them, the agency outlined its next steps:

  • A public hearing will be held on May 31, and written comments are being sought from the public.
  • FDA is forming a high-level internal agency working group to explore potential
…

CMS Proposes Revised Prescription Drug Regulations to Lower Drug Prices and Reduce Out of Pocket Expenses

By Melissa (Lisa) Thompson on Posted in Life Sciences, Medicare and Medicaid, Pharmaceuticals and Biologics, Pharmacy Law

The Centers for Medicare and Medicaid Services (CMS) announced a Proposed Rule to amend Medicare Advantage (MA) regulations and Prescription Drug Benefit program (Part D) regulations.  The Proposed Rule was published on November 30, 2018. The Proposed Rule is intended to help lower drug prices for health and drug plans and reduce out-of-pocket costs for MA and Part D enrollees. Major provisions include: Providing Plans with increased flexibility in managing drug formularies. Current policy requires Part D formularies to include all drugs in the following categories: (1) antidepressants; (2) antipsychotics; …

OIG Issues Favorable Advisory Opinion for Trust Donations to Public-Private Research Institute Affiliated with a Health System Having Ongoing Business Relationships with Trustee-Owned Long-Term Care Facilities

By Melissa (Lisa) Thompson on Posted in Academic Medical Centers, Advisory Opinions, Clinical Research, Fraud and Abuse, Government Enforcement, Hospitals and Health Systems, Office of Inspector General

On November 6, 2018, the Office of Inspector General (OIG) of the Department of Health and Human Services published a favorable Advisory Opinion regarding a proposed arrangement comprised of substantial donations that were earmarked for biomedical research purposes, made by a charitable trust (“Trust”) to a public-private medical research institute (“Research Institute”). The Research Institute had been formed by a health care system (“Health Care System”) and a public university (“University”). In addition, one of the Trustees planned to make a separate, individual donation to the Research Institute, through the …

OIG Advisory Opinion Allows PHO Network Hospitals to Give 100% Discount on Medigap-Covered Inpatient Deductibles, with Savings Shared as a Premium Credit to Patients

By Melissa (Lisa) Thompson on Posted in Advisory Opinions, Fraud and Abuse, Managed Care, Medicare Advantage, Medicare and Medicaid

The Office of Inspector General (OIG), Health and Human Services, issued an Advisory Opinion allowing an arrangement between a licensed offeror of Medicare Supplemental Health Insurance policies (Medigap Offeror) and a preferred hospital organization (PHO) having network hospitals across the U.S. (the “Arrangement”).  Under the Arrangement, the PHO’s network hospitals would provide discounts of up to 100% on Medicare Part A inpatient deductibles incurred by patients who are Medigap policyholders (the “Arrangement”). Normally, these deductibles would have been covered by the Medigap Offeror. Each time a network hospital provides a …

FDA Approves Marijuana-Derived, CBD-Containing Drug Epidiolex to Treat Certain Epilepsy-Associated Seizures

By Melissa (Lisa) Thompson on Posted in FDA, Life Sciences, Pharmaceuticals and Biologics, Pharmacy Law, Physicians and Allied Health Professionals

On June 25, 2018, the U.S. Food and Drug Administration approved Epidiolex, an orally administered drug derived from the marijuana plant, Cannabis sativa. The drug is approved for use for patients two years and older, for the treatment of seizures associated with Lennox-Gastaut syndrome and Dravet syndrome, both of which are rare and severe forms of epilepsy. It is the first drug that FDA has approved for Dravet patients.…

HHS Delays 340B Program Final Rule on Drug Ceiling Price and Manufacturer Civil Monetary Penalties (Again)

By Melissa (Lisa) Thompson on Posted in 340B Drug Pricing Program, Hospitals and Health Systems, Pharmacy Law

On June 1, 2018, the Health Resources and Services Administration (HRSA) announced it was once again delaying the final rule that had set forth the calculation for the 340B Program ceiling price and drug manufacturer civil monetary penalties (Final Rule).  Enforcement on the Final Rule is delayed to July 1, 2019. …

OIG Posts Telemedicine Advisory Opinion

By Melissa (Lisa) Thompson on Posted in Advisory Opinions, Fraud and Abuse, Office of Inspector General, Telemedicine

The Office of Inspector General (OIG), Health and Human Services issued an Advisory Opinion allowing an arrangement proposed by a federally qualified health center look-alike (FQHC look-alike) to provide free technology items and services to a clinic run by a county Department of Health (County Clinic), that would facilitate telemedicine encounters (the Arrangement).  Although the OIG found that the Arrangement could potentially implicate the anti-kickback statute (AKS), the OIG concluded that it would not impose administrative sanctions.…

Medicare Appeals Settlement Program Expanded

By Melissa (Lisa) Thompson on Posted in Medicare and Medicaid, Reimbursement

The Office of Medicare Hearings and Appeals (OMHA) has announced the expansion of their Settlement Conference Facilitation (SCF) program.  SCF is a dispute resolution process for Medicare appeals that provides for payments as percentage of the Medicare approved amount.  The percentage is negotiated during a telephone settlement conference utilizing a mediation facilitator.  Utilizing dispute resolution processes such as SCF will be very important in helping to reduce a very significant backlog of Medicare appeals, which the government estimates would take OMHA at least eleven years to process.…

CMS Updates Medicare Advantage and Part D (Prescription Drug Benefit)

By Melissa (Lisa) Thompson on Posted in Health Information Technology, Long Term Care and Nursing Homes, Managed Care, Medicare and Medicaid, Nursing Facilities, Pharmaceuticals and Biologics, Pharmacies, Reimbursement

On April 2, 2018, the Centers for Medicare & Medicaid Services (CMS) issued a Final Rule, updating Medicare Advantage (MA) and the prescription drug benefit program (Part D).  The Final Rule includes, among other provisions:

  • Preclusion List Requirements for Prescribers in Part D and Individuals and Entities in Medicare Advantage, Cost Plans, and PACE: The Final Rule eliminates the MA and Part D prescriber and provider enrollment requirement.  Instead, CMS is compiling a “Preclusion List” of prescribers, individuals, and entities that: (1) are currently revoked from Medicare, under
…

CMS Extends Hospital and CAH Attestation Deadline

By Melissa (Lisa) Thompson on Posted in Hospitals and Health Systems, Medicare and Medicaid

The Centers for Medicare & Medicaid Services (CMS) has extended the eligible hospital and critical access hospital (CAH) attestation deadline from February 28, 2018 to March 16, 2018. The extension provides additional time to submit attestation data and electronic clinical quality measure (eCQM) data. Eligible hospitals and critical access hospitals attesting to the CMS Electronic Health Records (EHR) Incentive Program are required to submit data through the QualityNet Secure Portal (QNet). “Subsection (d) hospitals” that are paid under the Inpatient Prospective Payment System (IPPS), CAHs, and Medicare Advantage hospitals are …

FDA Amends Regulations for Acceptance of Data from Foreign and Domestic Investigation for Medical Devices

By Melissa (Lisa) Thompson on Posted in Clinical Research, FDA, Life Sciences, Medical Devices

On February 21, 2018, the Food and Drug Administration (FDA) published a Final Rule, amending its regulations on acceptance of data from investigations for medical devices that are performed outside of the United States as well as modifying certain regulations applicable to data from US-sited investigations. The Final Rule does not go into effect until February 21, 2019 – a full year after promulgation.  The FDA also issued guidance in the form of Frequently Asked Questions (FAQ) addressing the new regulations.  In the FAQ document, the FDA explained its …

FDA Issues New Compounding Guidance

By Melissa (Lisa) Thompson on Posted in FDA, Pharmaceuticals and Biologics, Pharmacy Law

In January 2018, the U.S. Food & Drug Administration (FDA) published two guidance documents on Compounded Drug Products That Are Essentially Copies Of Approved Drug Products under Section 503A and Section 503B of the Federal Food, Drug, and Cosmetic Act (the Act). As emphasized in a recent U.S. Department of Justice policy memorandum, FDA noted that its guidance documents do not establish legally enforceable responsibilities and, instead should be viewed only as agency recommendations, unless specific regulatory or statutory requirements are cited.

…

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