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Pharmaceutical
Last Updated: 12/28/11 ROPES & GRAY ANALYSIS - Federal Sunshine Law: Proposed Rule and Implementation Delay
(December 19, 2011)
- The Federal Payment Sunshine Law: On January 1, 2012, Will You Know Where Your Payments Are Going?
(September 26, 2011)
- Health Care Reform: Key Legislative Changes Impacting the Pharmaceutical, Biotechnology, and Medical Device Industries
(March 30, 2010)
- Physician Payment “Sunshine Provisions” Signed into Law as Part of Health Care Reform Legislation
(March 30, 2010)
- Congress Authorizes Abbreviated Regulatory Pathway for FDA Approval of Biological Products
(March 30, 2010)
- Comprehensive Health Reform Expands Health Care Fraud and Abuse Law
(March 29, 2010)
IMPLEMENTING REGULATIONS AND GUIDANCE
- Medicare, Medicaid, Children’s Health Insurance Programs; Transparency Reports and Reporting Physician Ownership or Investment Interests
(December 19, 2011)
- Medicare - Proposed Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs for Contract Year 2013 and Other Proposed Changes; Considering Changes to the Conditions of Participation for Long Term Care Facilities
(October 11, 2011)
- Final Rule with Comment Period on Specific Fraud and Abuse Provisions of Affordable Care Act
(February 2, 2011)
- Proposed Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs
(November 10, 2010)
- CBO Analysis of Affordable Care Act Effects on Prescription Drug Prices
(November 4, 2010)
- State Medicaid Directors Letter: Revisions on Prescription Drug Rebates
(September 28, 2010)
- Advance Notice of Proposed Rulemaking and Request for Comments on 340B Drug Pricing Program ADR Process
(September 20, 2010)
- Advance Notice of Proposed Rulemaking and Request for Comments on 340B Drug Pricing Program Manufacturer Civil Monetary Penalties
(September 20, 2010)
- CMS Voluntary Self-Referral Disclosure Protocol
(September 20, 2010)
- CMS Memorandum: Additional Guidance on 2011 Coverage for Generic Drugs in the Coverage Gap
(May 21, 2010)
- State Medicaid Directors Letter: Prescription Drug Rebates
(April 22, 2010)
- State Medicaid Directors Letter on Medicaid Rebate Provisions in Health Reform
(April 22, 2010)
ANALYSIS PRIOR TO PASSAGE
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