BIOPHARMACEUTICAL AND MEDICAL DEVICE MANUFACTURERS
Ross provides strategic counseling for both emerging and mature life sciences companies with regard to coverage, coding, and reimbursement under the Medicare, Medicaid, and 340B programs. Representative experience includes:
- Successfully represented multiple biopharmaceutical, medical device and diagnostic manufacturers in obtaining Medicare New Technology Add-On Payment (NTAP) designation for their novel therapies. Achieved multiple “firsts,” including the first NTAP for an orally administered therapy, the first NTAP for a diagnostic and the first Qualified Infectious Disease Product to receive NTAP conditional approval prior to FDA approval
- Represented manufacturers with respect to their obligations under the 340B Drug Pricing Program, including in Alternative Dispute Resolution proceedings with providers
- Drafted Technical Assistance (TA) for state and Federal legislative committees on behalf of multiple manufacturer clients, regularly incorporating amended legislative text to help achieve client goals
- Implemented multiple manufacturer and non-profit led Patient Assistance Programs (PAPs), including requests for OIG Advisory Opinions, development of PAP Policies and Procedures and policy/regulatory oversight
- Achieved multiple unique ICD-10 procedure and diagnosis codes on behalf of biopharmaceutical and medical device clients
- Developed novel legal arguments and assembled compelling scientific evidence that successfully reversed an adverse Medicare policy decision affecting the coding and payment for a biotechnology product
- Persuaded the Center for Medicaid and CHIP Services (CMCS) to issue a rare guidance document instructing state Medicaid agencies on their coverage obligation for a new, novel therapy
- Collaborated with a biopharmaceutical manufacturer in its engagement with the US Pharmacopeia (USP) to develop a new category/class under the Medicare Model Guidelines
- Advised a home hemodialysis manufacturer in its discussions with CMS and Medicare Administrative Contracts (MACs) after receiving the first-ever approval for a Transitional Add-on Payment Adjustment for New and Innovative Equipment and Supplies (TPNIES)
- Worked with the Center for Medicare and Medicaid Innovation (CMMI) on an innovative payment and service delivery model to improve quality of care for federal health care beneficiaries
- Assisted manufacturers in negotiating multiple value-based agreements with payers, including State Medicaid agencies
PAYERS AND PHARMACY BENEFIT MANAGERS (PBMs)
Ross advises health plans and PBMs on all aspects of compliance and strategy with respect to the Medicare Prescription Drug (Part D) and Medicare Advantage (Part C) programs, as well as Federal and state rules and regulations regarding Medicaid fee-for-service and Medicare managed care. Representative experience includes:
- Led policy and regulatory responses on behalf of multiple PBM clients in the face of multiple regulatory threats, including the constantly changing rules regarding rebates, benefit design, formulary requirements, pharmacy access standards, the exceptions and appeals process and questions of state law preemption. Developed novel legal arguments to challenge these policy proposals
- Represented payers and PBMs in negotiations with the Centers for Medicare and Medicaid Services (CMS), the Office of Management and Budget (OMB), and on Capitol Hill
- Provided advice to health plans in implementing new Transparency in Coverage requirements under the No Surprises Act
- Successfully challenged the application of state anti-competitive “anti-PBM” laws on ERISA and Part D pre-emption grounds
- Developed a consensus-led framework for a trade organization on pharmacy quality measures in the Medicare Advantage and Part D programs
- Helped a Medicare Advantage plan secure designation by a state Medicaid agency and CMS as a dual-eligible special needs plan (Dual SNP)
- Received CMS approval for a novel novation request involving a complex transaction consisting of multiple large Medicare Advantage organizations
- Led efforts to received CMS approval for a new Primarily Health-Related Supplemental Benefit for a Medicare Advantage organization
HEALTHCARE PROVIDERS AND HOSPITALS
Providers looking to successfully navigate the complex web of state and Federal regulatory requirements look to Ross for a variety of legal needs. Representative experience includes:
- Advised hospitals and hospital-based entities on CMS site-neutrality policies, including compliance with the Medicare program’s “provider-based” billing requirements
- Represented multiple Federally Qualified Health Centers (FQHCs) before HHS and the Health Resources and Services Administration on issues related to coverage and reimbursement
- Convinced CMS and a state Medicaid agency that a residential treatment facility was not an institution for mental disease (IMD), thereby allowing Medicaid payment for inpatient hospital services provided at the facility to continue uninterrupted
- Assisted hospitals in remaining compliant with EMTALA program rules represent hospitals in EMTALA investigations by the Department of Health and Human Services Office of Inspector General
- Provided compliance assistance to providers with respect to Federal and state anti-kickback laws, as well as the Physician Self-Referral Law (Stark law)
OTHER REPRESENTATIVE EXPERIENCE
- Represented multiple digital health companies, including leaders in the prescription digital therapeutics (PDT) space, in various strategic partnerships and financing transactions, and with respect to coverage, coding and reimbursement issues
- Advised multiple health insurance agents and brokers, including web-brokers, with respect to the sale of Medicare Advantage and Part D plans pursuant to the Medicare Marketing Guidelines, as well as the sale of qualified health plans on the Exchanges created by the Patient Protection and Affordable Care Act
