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Stuart
M.
Langbein
Partner, Washington, D.C.
stuart.langbein@hoganlovells.com
Stuart Langbein's practice focuses on the regulatory aspects of the health care industry, with an emphasis on counseling clients on coverage, coding, and reimbursement issues, particularly related to new medical technologies and health care fraud and abuse. Stuart's clients include pharmaceutical companies, medical device companies, health care product and provider associations, and academic medical centers. He assists clients on coverage, coding, and reimbursement at every stage of the product cycle. Stuart develops reimbursement strategies for products that have yet to receive approval for marketing by the U.S. Food and Drug Administration (FDA), as well as products that have received such approval. He also works with clients to implement such coverage, coding, and reimbursement strategies, often through interactions with the Centers for Medicare and Medicaid Services (CMS). Stuart frequently speaks on reimbursement issues concerning providers and medical technology manufacturers.
Prior to joining Hogan & Hartson in 1997, Stuart served in the Office of the General Counsel for the U.S. Department of Health and Human Services, representing CMS, then the Health Care Financing Administration (HCFA). During his nearly six year tenure with the agency, Stuart drafted briefs and presented oral arguments on the agency's behalf before federal district and appellate courts. In addition, Stuart counseled CMS extensively on Medicare reimbursement issues.
REPRESENTATIVE EXPERIENCE
- Assisted a medical device company that manufactures an artificial heart reverse Medicare's national noncoverage decision for such devices and obtain more advantageous Medicare reimbursement by obtaining an inpatient new technology add-on and a Medicare Severity Diagnosis Related Group reclassification for the device.
- Assisting a medical device company in obtaining device-specific additional payments under Medicare’s hospital inpatient and outpatient payment system for its medical device – the first time one device obtained added payments under both systems.
- Representation of a medical device company seeking to obtain Medicare coverage and adequate payment for a new medical technology related to mammography.
- Successfully challenging through an administrative law judge hearing a denial of Medicare reimbursement for a course of treatment for diabetic patients.
- Representation of a number of hospital associations in a challenge to a Medicare outpatient hospital rule that resulted in a favorable administrative resolution.
Hogan Lovells Publications
24 February 2012
"CMS releases proposed rule on reporting and returning overpayments from the Medicare program." Health Alert, Hogan Lovells
07 February 2012
"Internal Revenue Service issues proposed rule implementing the Medical Device Tax." Health Alert, Hogan Lovells
26 January 2012
"PCORI releases its draft National Priorities for Research and Research Agenda for comparative effectiveness research." Health Alert, Hogan Lovells
23 January 2012
"PCORI’s Methodology Committee Issues a Request for Information Regarding Translation Table Framework for Comparative Effectiveness Research." Health Alert, Hogan Lovells
27 October 2011
"Insights and implications of CMS ACO final rule." Health Alert, Hogan Lovells
18 August 2011
"IRS issues temporary and proposed regulations for branded prescription drug fee." Pharmaceutical and Biotechnology Alert, Hogan Lovells
13 June 2011
"The impact of the Department of Health and Human Services' Preliminary Plan for Retrospective Review of Existing Rules on the Medicare and Medicaid programs." Health Alert, Hogan Lovells
08 April 2011
"Implications of federal agencies' proposed guidance on accountable care organizations." Health Alert, Hogan Lovells
13 December 2010
"Agencies seek comments regarding medical device excise tax." Health Alert, Hogan Lovells
21 September 2010
"CMS and FDA Announce New Parallel Review Process for Medical Products." Health Alert, Hogan Lovells
20 September 2010
"CMS Makes a Significant Change to HCPCS Applications for 2012." Health Alert, Hogan Lovells
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