Covington advises and represents pharmaceutical manufacturers, device manufacturers, and health care providers on issues involving reimbursement in the Medicare and Medicaid programs and issues of health information privacy. Our broad practice and deep-rooted understanding of the structure and operations of federal and state reimbursement programs enable us to develop workable solutions to complex problems and to assist our clients in developing strategies that provide a competitive advantage, minimize risk, and optimize opportunities. Whether we are providing advice, working with legislators, or negotiating with the Centers for Medicare & Medicaid Services (“CMS”), we have the knowledge, skills, and expertise to assist clients with the intricacies of Medicare and Medicaid reimbursement.
Our lawyers bring to the table a unique combination of:
- Government experience;
- Detailed knowledge of relevant laws and regulations; and
- Ability to work with regulators and legislators.
Resources
Medicaid Drug Rebate Program
Sunshine Act
Branded Prescription Drug Fee
Qualifying Therapeutic Discovery Projects
Medicare Part D Coverage Gap Discount Program
- CMS, Operational Guidance to Manufacturers, December 17, 2010
- CMS, Memo re Final Manufacturer Agreements, August 3, 2010
- CMS, Instructions re Agreements, August 3, 2010
- CMS, Final Model Manufacturer Agreement, August 2, 2010
- CMS, Final Third Party Administrator Agreement, August 2, 2010
- CMS, Coverage Gap Labeler Spreadsheet, August 3, 2010
- CMS, Memo re Draft Manufacturer's Data Use Agreement and Draft Third Party Administrator Agreement, July 9, 2010
- CMS, Draft Manufacturer's Data Use Agreement, July 9, 2010
- CMS, Draft Third Party Administrator Agreement, July 9, 2010
- CMS Conference Materials, Manufacturers and the Medicare Coverage Gap Program: 2011 and Beyond, June 1, 2010
- CMS, Additional Guidance on 2011 Coverage of Generic Drugs in the Coverage Gap, May 25, 2010
- CMS, Medicare Coverage Gap Discount Program Model Manufacturer Agreement, May 21, 2010
- CMS, Revised Part D Sponsor Guidance and Responses to Summary Public Comments on the Draft Guidance, May 21, 2010
- CMS, Draft Guidance to Part D Sponsors re: Medicare Coverage Gap Discount Program Beginning in 2011, Apr. 30, 2010
January 31, 2011 Ruling, Florida v. U.S. Department of Health and Human Services
Memorandum Opinion
December 13, 2010 Ruling, Virginia v. Sebelius
Memorandum Opinion
Covington E-Alerts
- CMS Issues Proposed Rule to Implement Drug Pricing and Rebate Provisions of the Affordable Care Act, February 10, 2012
- CMS Issues Proposed Rule Implementing Sunshine Act Reports Regarding Ownership or Investment Interests Held by Physicians, January 3, 2012
- CMS Issues Proposed Rule Implementing Sunshine Act: Review, Correction, and Publication of Data on Public Website, December 30, 2011
- CMS Issues Proposed Rule Implementing Sunshine Act, December 23, 2011
- IRS Issues Regulations on Calculation of Branded Prescription Drug Fee, September 1, 2011
- Accountable Care Organization Basics, April 15, 2011
- Health Care Reform: Federal Court Strikes Down Individual Coverage Mandate; Rest of Law Unaffected, December 1, 2010
- IRS Issues Guidance on Calculation of Branded Prescription Drug Fee, December 2010
- Update on the Medicare Coverage Gap Discount Program, June 3, 2010
- Guide to Applying for Therapeutic Discovery Project Grants and Tax Credits, June 2010
- CMS Issues Draft Guidance on Medicare Part D Discount Program, May 3, 2010
- Health Care Reform: 340B Drug Pricing Program, April 2010
- Health Care Reform: Annual Fee on Prescription Drug Manufacturers and Excise Tax on Medical Device Manufacturers, April 2010
- Health Care Reform: Biosimilars Licensing and Reimbursement, April 2010
- Health Care Reform: Therapeutic Discovery Project Tax Credits and Grants for Small Employers, April 2010
- Health Care Reform: Medicaid Prescription Drug Reimbursement, April 2010
- Health Care Reform: Medicare Part D Donut Hole and Protected Classes, April 2010
- Health Care Reform: Sunshine Provisions, April 2010
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