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

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.

…

“Brand Memo” from the U.S. Department of Justice: Reading Between the Lines

By Melissa (Lisa) Thompson on Posted in Department of Justice, Fraud and Abuse, Government Enforcement

On January 25, 2018, Associate Attorney General Rachel Brand issued a memo on behalf of the U.S. Department of Justice (DOJ) prohibiting certain DOJ uses of federal agency guidance documents in affirmative civil enforcement (ACE) cases (the “Brand Memo”). ACE cases include lawsuits brought by the DOJ on behalf of the United States to recover money lost to fraud or other misconduct, or to impose penalties for violations of Federal health, safety, civil rights or environmental laws, for example, False Claims Act enforcement by the DOJ.

The “Brand …

CMS Issues Temporary Enrollment Moratorium on Home Health Agencies and Non-Emergency Ambulances in Selected States

By Melissa (Lisa) Thompson on Posted in Ambulance, Fraud and Abuse, Home Health Agencies, Medicare and Medicaid

On January 29, 2017, the Centers for Medicare and Medicaid Services (CMS) announced a temporary moratorium on enrolling Part B non-emergency ambulance providers/suppliers and home health agencies, subunits and branch locations in Florida, Illinois, Michigan, Texas, Pennsylvania and New Jersey.  CMS is taking this measure “to prevent and combat fraud, waste and abuse.”  The moratorium also extends to the Medicaid and Children’s Health Insurance Programs (CHIP).  According to CMS, the action is taken pursuant to Sections 1866(j)(7), 1902(kk)(4), and 2107(e)(1)(D) of the Social Security Act and CMS regulations at 42 …

OIG Advisory Opinion Allows Medical Center to Share Cost Savings with Neurosurgeons for Curbing Spinal Fusion Surgery Costs

By Melissa (Lisa) Thompson on Posted in Hospitals and Health Systems, Medicare and Medicaid, Office of Inspector General, Physicians and Allied Health Professionals, Reimbursement

On January 5, 2018, the Health and Human Services Office of Inspector General (OIG) posted a favorable Advisory Opinion, permitting an arrangement involving payment by a Medical Center to a multi-specialty physician Group for cost-reduction measures achieved through the efforts of certain Neurosurgeons, relating to the selection and use of products during spinal fusion surgeries (Program).  Payment under the Program was calculated as a percentage of cost savings realized by the Medical Center over a three-year period.  Though not yet paid at the time of the OIG advisory opinion, …

CMS Announces First Advanced Alternative Payment Model Under MACRA: Bundled Payments for Care Improvement Advanced

By Melissa (Lisa) Thompson on Posted in Home Health Agencies, Hospitals and Health Systems, Medicare and Medicaid, Nursing Facilities, Physicians and Allied Health Professionals, Reimbursement

On January 9, 2018, the Centers for Medicare & Medicaid (CMS) Center for Medicare and Medicaid Innovation announced a new voluntary bundled payment model called Bundled Payments for Care Improvement Advanced (BPCI Advanced).  BPCI Advanced is the first Advanced Alternative Payment Model (Advanced APM) launched under the Quality Payment Program that was implemented as part of the Medicare Access and Chip Reauthorization Act (MACRA). …

OIG Advisory Opinion Allows Pilot Collaborative Program Proposed by Pharmaceutical Manufacturer for Medication Therapy Management Interventions

By Melissa (Lisa) Thompson on Posted in Health Information Technology, Hospitals and Health Systems, Managed Care, Medicare and Medicaid, Office of Inspector General, Pharmaceuticals and Biologics

On December 11, 2017, the Health and Human Services Office of Inspector General (OIG) posted a favorable Advisory Opinion, permitting a proposed pilot Program involving a collaboration between a pharmaceutical manufacturer (the Requestor), a trade association (Association), a Medicare Advantage Part D plan (MA Plan), a Hospital System, and a Vendor.  As proposed, the program would provide new technology to allow real-time access to patient discharge information for use by MA Plan pharmacists who conduct medication therapy management (MTM) services. …

CMS Releases 2018 OPPS/ASC Payment Systems Final Rule

By Melissa (Lisa) Thompson on Posted in Ambulatory Surgical Centers (ASC), Hospitals and Health Systems, Medicare and Medicaid, Reimbursement

The Centers for Medicare and Medicaid Services (CMS) issued the 2018 Medicare: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs Final Rule with comment period, scheduled to be published in the Federal Register on November 13, 2017. The Final Rule, effective January 1, 2018, includes the following changes to Medicare payment rates and policies, among others:

  • Increased Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment Rates. CMS is increasing the payment rates under the OPPS by 1.35 percent for CY 2018.
…

Ninth Circuit Denies Arbitration in a False Claims Act Case

By Melissa (Lisa) Thompson on Posted in Arbitration, Employment Law, False Claims Act, Fraud and Abuse

On September 11, 2017, the Ninth Circuit in US and State of Nevada ex rel. Welch v. My Left Foot Children’s Therapy, LLC, upheld the denial of the defendant’s motion to compel arbitration in a False Claims Act (FCA) relator case, holding that an employee-relator’s FCA claims did not fall within the scope of the arbitration agreement with her former employer.  The FCA claims were based on allegations that the employer had filed fraudulent Medicaid claims.

The Court first looked to the Federal Arbitration Act (FAA) in determining that …

FDA Issues Guidance on Hurricane Readiness for Medical Devices

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

By Melissa (Lisa) Thompson on Posted in Fraud and Abuse

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

By Melissa (Lisa) Thompson on Posted in Fraud and Abuse, Legislation, Medicare and Medicaid, Reimbursement, Stark Law, Telemedicine

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

By Nathaniel Arden and Melissa (Lisa) Thompson on Posted in Fraud and Abuse, Government Enforcement, Health Information Technology, Privacy and Security, Reimbursement

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

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

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

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

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

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

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

By Melissa (Lisa) Thompson on Posted in Home Health Agencies, Medicare and Medicaid

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

By Melissa (Lisa) Thompson on Posted in Fraud and Abuse, Government Enforcement, Home Health Agencies, Hospice, Hospitals and Health Systems, Medicare and Medicaid, Physicians and Allied Health Professionals

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

By Melissa (Lisa) Thompson on Posted in FDA, Medical Devices

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

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

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

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

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 …

LexBlog