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Melissa (Lisa) Thompson

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Lisa Thompson advises companies, senior management, and boards of directors, with a focus on the health care, life sciences, technology, and food and beverage industries. She is a member of the firm’s Health Law Group, Government Investigations, Food and Beverage Industry Group, and Data Privacy + Cybersecurity Team. Lisa is co-chair of the Health Law Section of the Boston Bar Association. She also serves as an international and domestic arbitrator on the Commercial, Life Sciences, and Health Care panels of the American Arbitration Association. She is a member of the AAA Life Sciences Advisory Council and the advisory committee for the Boston International Arbitration Council (BIAC).

Lisa has represented domestic and international clients in the health care, life sciences, technology, and food and beverage industries. Lisa handles a range of matters, including corporate law and contracting, government investigations and audits, clinical research law, and matters involving Institutional Review Boards (IRBs). She has extensive experience representing clients on matters involving privacy and security including HIPAA, reimbursement, Medicare and Medicaid, state and federal surveys and termination actions, managed care disputes, pharmacy and compounding laws, fraud and abuse, Stark Law, anti-kickback, and federal program exclusions. Read her full rc.com bio here.

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On November 20, 2020, the Department of Health & Human Services (HHS) released heavily anticipated final rules revising the regulatory exceptions to the Physician Self-Referral Law (also known as the Stark Law), the Anti-Kickback Statute (AKS) safe harbors, and the Beneficiary Inducements Civil Monetary Penalties (CMP) regulations.  The changes to the regulations go into effect on January 19, 2021 (except for one change to the Physician Self-Referral Law that becomes effective January 1, 2022). In a separate rule also released November 20th, HHS removed safe harbor protection for rebates involving prescription pharmaceuticals and created a new safe harbor for certain point-of-sale reductions in price on prescription pharmaceuticals and pharmacy benefit manager service fees.

The full text of each rule is available below.

Continue Reading Physician Self-Referral Law (Stark), Anti-Kickback Statute, and Beneficiary Inducement CMPs – HHS Releases Final Rules

On November 2, 2020, the Centers for Medicare & Medicaid Services (CMS) finalized its 2021 End-Stage Renal Disease Prospective Payment System Rule. Among other things, the final rule expands Medicare payments for in-home dialysis equipment and supplies as part of an effort to encourage in-home care for populations vulnerable to COVID-19. We previously wrote about the proposed rule here.
Continue Reading CMS Finalizes 2021 End-Stage Renal Disease Prospective Payment System Rule Expanding Payments for In-Home Dialysis Equipment and Supplies

On October 14, 2020, the Centers for Medicare & Medicaid Services (CMS) expanded the list of telehealth services covered by Medicare during the COVID-19 Public Health Emergency. CMS also announced it would be providing additional support to state Medicaid and Children’s Health Insurance Program (CHIP) agencies in delivering telehealth services. CMS added the telehealth services using, for the first time, an expedited process that does not involve rulemaking which had been established by CMS in May 2020.
Continue Reading CMS Announces New Telehealth Services Covered by Medicare and Provides States with Medicaid and CHIP Telehealth Expansion Assistance

On July 6, 2020, the Centers for Medicare and Medicaid Services (CMS) proposed its calendar year 2021 End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) rule. ESRD PPS rules are promulgated on an annual basis, providing updates to payment policies and rates for renal dialysis services furnished to beneficiaries. The 2021 proposed rule also proposes to update the acute kidney injury (AKI) dialysis payment rate for renal dialysis services furnished by ESRD facilities to individuals with AKI, and proposes changes to the ESRD Quality Incentive Program. In addition to the annual technical updates, the 2021 rule proposes, at a high level:

  • Changes to the eligibility criteria and determination process for the transitional add-on payment adjustment for new and innovative equipment and supplies (TPNIES), and defining “new” to be within three years, beginning on the date of the FDA marketing authorization;
  • Expansion of the TPNIES to include new and innovative capital-related assets that are home dialysis machines, used in the home for a single patient;
  • Updates to the outlier policy and outlier services fixed-dollar loss amounts as well as the Medicare allowable payment amounts;
  • An addition to the ESRD PPS base rate to include calcimimetics in the ESRD PPS bundled payment;
  • A change to the low-volume payment adjustment eligibility criteria and attestation requirement to account for the COVID-19 public health emergency; and
  • An update to the ESRD PPS wage index to adopt the new Office of Management and Budget (OMB) delineations with a transition period.

Continue Reading CMS Proposes 2021 End-Stage Renal Disease Prospective Payment System Rule

On June 9, 2020 the Health and Human Services Office for Civil Rights (OCR) announced it had reached an Early Case Resolution (ECR) with the State of Connecticut and a separate ECR with Hartford Hospital. Both ECRs involve the rights of patients with disabilities to have reasonable access to support persons in hospital settings during COVID-19. OCR had received complaints that the COVID-19 hospital visitor policies of the State and the hospital violated the Americans with Disabilities Act (ADA) by failing to make exceptions for patients needing support persons for their care.
Continue Reading OCR Reaches Early Case Resolutions with the State of Connecticut and a Private Hospital Regarding Rights of Persons with Disabilities to Have Reasonable Access to Support Persons in Hospital Settings During COVID-19

On May 11, 2020, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule to update Medicare payment policies for hospitals under the Inpatient Prospective Payment System (IPPS) and the Long-Term Care Hospital (LTCH) Prospective Payment System (PPS) for FY 2021 (the “Rule”).  IPPS and LTCH PPS proposed rules are released on a fiscal year cycle to define payment and policies for inpatient hospitals, long-term care hospitals, inpatient rehabilitation facilities, inpatient psychiatric facilities, skilled nursing facilities, and hospices. CMS also released a fact sheet highlighting certain major provisions in the Rule.
Continue Reading CMS Proposes IPPS and LTCH PPS Payment and Policy Changes for FY 2021

On May 11, 2020 the Centers for Medicare and Medicaid Services (CMS) announced additional blanket waivers for hospitals and other facilities in response to the COVID-19 pandemic. According to CMS, the new waivers “provide the flexibilities needed to take care of patients during the COVID-19 public health emergency.” The blanket waivers have a retroactive effective date of March 1, 2020 and do not require a waiver request or notice to CMS to apply.
Continue Reading CMS Releases Additional Blanket Waivers in Response to COVID-19 Pandemic

On May 8, 2020, the Centers for Medicare & Medicaid Services (CMS) published an interim final rule with comment period (the “Interim Rule”) in the Federal Register, setting forth additional regulatory waivers and other changes to healthcare regulations and policies in response to the COVID-19 public health emergency (PHE). At a high level, the Interim Rule encompasses topics including expansion of telehealth, support for and expansion of COVID-19 testing, allowing certain licensed professionals to practice at the top of their licenses, Medicare payments for teaching hospitals, changes to the Medicare Shared Savings Program regarding financial methodologies, and application and risk assumption deadlines for accountable care organizations, among other changes. CMS has also updated provider-specific fact sheets on recent waivers and flexibilities, available here. Below are highlights from the Interim Rule.  Providers are encouraged to read all applicable sections of the Interim Rule in their entirety here. Comments may be submitted to CMS within 60 days of the date of publication in the Federal Register.
Continue Reading CMS Interim Rule Makes Sweeping Changes in Response to COVID-19 Public Health Emergency

On April 30, 2020, the Centers for Medicare & Medicaid Services (CMS) issued an interim final rule with comment period published in the Federal Register on May 8, 2020 (the April 30 Interim Rule) building on previous regulatory waivers and other revisions to regulations issued March 31, 2020 in an interim final rule (March 31 Interim Rule) in response to the COVID-19 public health emergency (PHE). Among other changes, the April 30 Interim Rule further broadens access to patient care provided via telehealth and other communication technology-based services and increases reimbursement for some of these services. Highlights of these changes and pertinent background are provided below.
Continue Reading CMS Broadens Telehealth Access Across the Board, Including Audio-Only Telephone Services

On April 21, 2020, the Centers for Medicare & Medicaid Services (CMS) announced that clinicians participating in the Quality Payment Program (QPP) can earn credit in the Merit-based Incentive payment system (MIPS) by attesting to a new COVID-19 Clinical Trials improvement activity based on participation in a clinical trial and reporting information. Clinicians who may earn this MIPS credit include physicians, physician assistants, nurse practitioners and others. MIPS is one of two options for clinicians to participate in Medicare’s QPP, and requires clinicians to report certain quality, cost and other data to Medicare. A clinician’s Medicare reimbursement may be reduced if the clinician does not meet certain quality and performance measures.
Continue Reading CMS Announces Merit-Based Incentive Payment for Clinicians Participating in COVID-19 Clinical Trial