Overview
For innovators, providers, and investors, setting the right strategy for securing coding, coverage, and reimbursement for new drugs, medical devices, and services is a complex task that involves a deep knowledge of multiple government agencies, health plans, providers, and other related stakeholders.
Our coding, coverage, and payment experience spans these distinct elements, as well as the application of the detailed laws, regulations, rules, and policies that govern how those decisions are made. Clients turn to us to develop integrated strategies to help them effectively and efficiently navigate issues involving the introduction of new technologies.
Epstein Becker Green’s team represents clients in connection with Medicare, Medicaid, and commercial plan coverage and reimbursement matters. This includes negotiating Medicare national and local coverage determinations and challenging adverse determinations in administrative hearings and litigation. In addition, we have applied for codes across the spectrum of code sets, including CPT and HCPCS codes.
Clients also rely on us to prepare strategic assessments tailored to the specific coverage, coding, and reimbursement environment that affects a new innovation and to assist in anticipating any challenges that may arise.
Meeting Client Challenges
In some cases, a new drug, medical device, or service fits comfortably within the existing coverage, coding, and reimbursement framework. However, when a drug, medical device, or service faces coverage, coding, or reimbursement hurdles, Epstein Becker Green has earned a reputation for effectively handling those challenges. We help our clients identify potential obstacles and evaluate the options for success. If the strategy requires a change in existing policies or rules, we are advocates for our client before health plans, government agencies, and other regulatory bodies to seek the necessary approvals or authorizations.
A Broader Perspective
Our team represents providers, payors, medical device manufacturers, and investors across virtually every type of entity in health care and life sciences. This broader perspective affords our lawyers a more comprehensive view of the industry landscape and our clients’ place within it. Our ability to understand the concerns and motivations of those on the other side of the table, regardless of the issue or its complexity, works to a client’s advantage.
Additionally, our lawyers approach each challenge as a mix of legal and business issues based on our deep understanding of the field. We work closely with a client’s general counsel and collaborate with the client’s entire business development team and scientific and technical staff who contribute to innovations. We can also draw upon the wide range of skills among Epstein Becker Green attorneys and our consultants in the EBG Advisors network.
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Experience
- Advised genomics companies in obtaining coverage and reimbursement for precision medicine diagnostics.
- Obtained, on behalf of wound care manufacturers and medical device manufacturers, Medicare National Coverage Determinations.
- Advised a medical device manufacturer in obtaining Medicare New Technology Add-on Payments.
- Represented medical device manufacturers and biologics companies in Centers for Medicare & Medicaid Services (CMS) rulemaking.
- Advised multiple companies on clinical trial design to include data demanded by health plans.
- Served as counsel of record for an oncology diagnostics company in multiple hearings and litigation challenging adverse medical necessity determinations.
- Successfully litigated a challenge to Medicare coverage determinations for a combination drug.
- Guided medical device and durable medical equipment clients in obtaining unique HCPCS billing codes for innovative products.
- Represented a cancer diagnostics company and behavioral health companies in all phases of their U.S. market entry.
- Served as counsel to multiple providers challenging Medicare and Medicaid facility cost report audits.
- Advised a drug manufacturer on issues relating to reimbursement for ophthalmic drugs under Medicare Part B.
- Provided strategic and legal advice to a global biotechnology company on a range of Medicare Part D issues, including exceptions and appeals processes, beneficiary protection provisions, formulary design, and annual CMS Call Letter guidance.
Contacts
- Member of the Firm
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Media
Events
Past Events
Insights
Insights
- Media CoverageBradley Merrill Thompson Quoted in “Convergence: Experts Offer Advice on Leveraging AI in Regulatory”3 minute read
- Media Coverage
Richard Hughes Quoted in “DOJ Will Ask SCOTUS to Take Up Braidwood”
3 minute read - PublicationsInteragency Strike Force on Unfair and Illegal Pricing Holds First Public Meeting1 minute read
- BlogsCMS Rules Propose Changes Regarding the Medicare Prescription Drug Inflation Rebate Program, Refundable Drugs, Skin ...13 minute read
- PublicationsCMS Issues Mandatory “TEAM Model” for Acute Care Hospitals to Improve Episode-Based Alternative Payments and Advance ...17 minute read
- PublicationsFTC Releases Controversial Interim Staff Report on PBMs’ Purported Impact on Drug Prices3 minute read
- Media CoverageJames Boiani Quoted in “CMS Takes Baby Steps in New 'Breakthrough' Device Policy”2 minute read
- BlogsFDA Guidance on DSCSA Small Dispenser Exemption and Exemptions and Waivers for Other Trading Partners13 minute read
- Media CoverageRichard Hughes Quoted in “Insurance Wouldn’t Pay for His Vasectomy. Such Birth Control Coverage May Become More ...2 minute read
- PublicationsNew Anti-Obesity Medications Should Be Considered Preventive Health Care2 minute read
- Media CoverageRichard Hughes Quoted in “Feds' 5th Circ. Win on Preventive Care May Imperil ACA”3 minute read
- Media CoverageRichard Hughes Quoted in “Obamacare Mandate Battle Shifts After Appeals Court Speaks”3 minute read
- Media CoverageRichard Hughes Quoted in “Court Upholds ACA’s Free Preventive Services Mandate”3 minute read
- Media CoverageRichard Hughes Quoted in “‘A Mixed Bag’: Fifth Circuit Rules on ACA Preventive Services Legal Case”3 minute read
- Media CoverageRichard Hughes Quoted in “News Briefs: Court Upholds ACA Preventive Services Coverage Mandate, for Now”2 minute read
- Media CoverageRichard Hughes Quoted in “Appeals Court Finds 'Obamacare' Pillar Unconstitutional in Suit Over HIV-Prevention Drug” ...3 minute read
- Media CoverageRichard Hughes Quoted in “Fifth Circuit Maintains ACA Preventive Mandate; but Remands Vaccine, Birth Control” ...1 minute read
- PublicationsThe IRA: Reducing Inflation or Threatening Patient Access?2 minute read
- Media CoverageHelaine Fingold Quoted in “Finalized Broker Pay Cap Appears to Exclude FMOs, but Impact Remains Unclear”2 minute read
- Media CoverageTheodora McCormick Quoted in “‘Vague’ NY Law Looms for the Vitamin Shoppe, Other Supplement Retailers”3 minute read
- Media CoverageTeddy McCormick Quoted in “NPA to Seek Injunction Against NY Law Related to Weight Loss Supplements”4 minute read
- PublicationsFTC Continues Investigation into PBM Practices2 minute read
- Publications
Will Religious Freedom Claims Trump Public Health? Braidwood and HIV Prevention
2 minute read - Media CoverageRichard Hughes Quoted in “ObamaCare Faces Key Hearing After Texas Ruling”2 minute read
- Media CoverageRichard Hughes Quoted in “4 Argument Sessions Benefits Attys Should Watch in March”4 minute read
- Media CoverageRichard Hughes Quoted in “Affordable Care Act Preventive Services Under Threat: Previewing Braidwood Oral Arguments” ...4 minute read
- BlogsVideo: Braidwood v. Becerra – Challenging the Affordable Care Act’s Preventive Services Coverage Provision – ...2 minute read
- Media CoverageRichard Hughes Quoted in “Doc Pay Patch Could Emerge in Scaled-Back Health Package; Budget Talks Continue”2 minute read
- Media CoverageJames Boiani Quoted in “Clinical Lab Consolidation Continues in 2023 While Key Policy Questions Go Unresolved” ...2 minute read
- Media CoverageJames Boiani Quoted in “FDA Braces for High Court, Final Rule Moves in Election Year”3 minute read
- Media CoverageConnie Wilkinson Quoted in “Stelara Biosimilar Tests Market Impact of Drug Price Program”3 minute read
- Media CoverageRachel Snyder Good Quoted in “'Devil's in the Details' of Biden's AI Health Plans, Experts Say”3 minute read
- PublicationsCMS Seeks Stakeholder Feedback About Medicare Transaction Facilitator Services for the Medicare Drug Price Negotiation ...4 minute read
- Media CoverageRichard Hughes Quoted in “Webinar Highlights Recommendations to Improve Disparities in CRC Screening”3 minute read
- Media CoverageRichard Hughes Quoted in “RSV Vaccines Aren’t Covered by Medicare for These Vulnerable Groups”2 minute read
- Media CoverageRichard Hughes Quoted in “Opinion: It Shouldn’t Be So Hard for Older Adults to Receive the RSV Vaccine”2 minute read
- Publications
Checking In on How SuperValu Has Altered FCA Litigation
4 minute read - Media CoverageHelaine I. Fingold Quoted in “The Medicare Advantage Marketing Problem and Where It’s Headed”3 minute read
- Media CoverageRichard Hughes Quoted in “Federal Watchdog: One Quarter of HIV-Positive Medicaid Enrollees Missed Care”3 minute read
- Media CoverageRichard Hughes Quoted in “New RSV Vaccines Aren’t Covered by Some Health Insurance Plans”3 minute read
- Media CoverageRobert Wanerman Quoted in “Hospitals Push Back on Safety-Net Payment Cuts”3 minute read
- PublicationsCMS Releases Its List of 43 Part B Rebatable Drugs for Q3: Inflation Reduction Act Updates7 minute read
- PublicationsManufacturers Must Request Small Biotech Exception by July 3: Inflation Reduction Act Updates4 minute read
- PublicationsBy Leaving "Therapeutic Alternatives" Undefined, CMS Tilts the Playing Field of Drug Price Negotiations3 minute read
- PublicationsCMS Seeks Comment on Initial Guidance for the Part D Manufacturer Discount Program: Inflation Reduction Act Updates ...2 minute read
- PublicationsFalse Claims Act: Businesses Should Consider How to Document Their Interpretations3 minute read
- Media CoverageWill Walters Quoted in “Senators Pull Few Punches at PBM Execs During Insulin-Cost Hearing”2 minute read
- Firm Announcements
Epstein Becker Green’s Amy Dow Honored in Crain’s 2022 Notable Women in Law
2 minute read - Firm AnnouncementsLynn Shapiro Snyder Serves on the Nashville Health Care Council’s Board of Directors2 minute read
- Media CoverageLynn Shapiro Snyder Continues Service on Nashville Health Care Council’s Board of Directors2 minute read