Hyman Phelps and McNamara
Search Firm Publications
  CMS Abandons Pilot Program to Test Alternative Drug Payment Models Under Medicare Part B,  October 11, 2017
  HHS Will Delay 340B Final Rule Implementation to July 2018,  October 2, 2017
  OIG Issues an Advisory Opinion on Providing Replacement Product,  August 28, 2017
  HHS Proposes Longer Delays to Implementation of the 340B Final Rule,  August 21, 2017
  Implementation of 340B Final Rule Postponed Until October 1, 2017,  May 19, 2017
  340B Rule Sinks Deeper Into Regulatory Freeze,  March 21, 2017
  HRSA Issues Final Rule Regarding the 340B Penny Pricing Policy and Manufacturer CMP,  January 11, 2017
  21st Century Cures Act: Three Notable Health Care Provisions and a Reminder to Sign Up for HP&M’s Two Complimentary Webinars,  January 5, 2017
  OIG Finalizes Antikickback Law Safe Harbors and CMP Rules that Would Offer Additional Protections for Pharmaceutical and Device Manufacturers,  December 14, 2016
  HHS OIG’s Latest Work Plan: What to Look Out for in FY2017,  November 22, 2016
  DOJ Weighs in on Discount Safe Harbor,  October 13, 2016
  Another Blow to the Discount Safe Harbor in Massachusetts District Court,  September 29, 2016
  Massachusetts District Court Guts Discount Safe Harbor,  September 14, 2016
  Texas Finalizes Repeal of Medicaid Price Reporting Requirement,  May 12, 2016
  HHS OIG Revises Factors Used to Evaluate Whether to Exclude Based on Health Care Fraud Activities,  May 3, 2016
  CMS Proposes Far-Reaching Pilot to Test Alternative Drug Payment Models Under Medicare Part B,  March 10, 2016
  Medicaid Rebate Final Rule Published in Federal Register; HP&M Issues Summary, Schedules Webinar,  February 2, 2016
  FDA and Product Jurisdiction: Time for Reforms  February 1, 2016
  CMS Releases Final Medicaid Rebate Rule,  January 22, 2016
  Commercialisation of Healthcare Global Guide  January 19, 2016
  Final Medicaid Rebate Regulation Clears OMB, Bound for Publication,  December 14, 2015
  Texas Proposes Repeal of Price Reporting Requirement,  November 10, 2015
  Thomas Reuters Commercialisation of Healthcare  October 1, 2015
  HRSA Issues Long-Awaited 340B Mega-Guidance; HP&M Issues Summary,  September 4, 2015
  Summary of HRSA 340B Proposed Guidance  September 3, 2015
  Recent OIG Advisory Opinions Involving Benefits Provided to Patients Are of Special Interest to Drug and Device Manufacturers,  August 12, 2015
  Long Awaited Medicaid Rebate Rule Under Review by OMB,  August 5, 2015
  HRSA Proposes to Collect Manufacturer Pricing Data Under 340B Program,  April 23, 2015
  Two Developments in Transparency Reporting,  April 2, 2015
  HRSA’s 340B Orphan Drug Exclusion Rule is Briefed for its Third Judicial Review,  March 15, 2015
  CMS Sets New Date for Final Medicaid Rebate Regulation Re-Write,  December 11, 2014
  HRSAs 340B Mega-Rule Becomes Casualty of PhRMA Lawsuit Against Orphan Drug Rule,  November 18, 2014
  CMS Eliminates CME Exclusion Under Sunshine Rule,  November 4, 2014
  OIG Proposes Antikickback Law Safe Harbors and CMP Rules that Would Offer Additional Protections for Pharmaceutical and Device Manufacturers,  October 13, 2014
  Mostly Cloudy with a Little Bit of SunshineAccuracy of CMSs Release of Sunshine Data Questioned,  October 2, 2014
  OIG Issues Favorable Advisory Opinion on Drug Manufacturer's Direct-to-Patient Discounted Drug Sales Program,  July 29, 2014
  New Developments in the Ongoing PhRMA v. HHS/HRSA Saga Over the Interpretation of the Exclusion of Orphan Drugs Under the 340B Program,  July 22, 2014
  Drug and Device Manufacturers Should Take Note of OIG Special Fraud Alert on Laboratory Payments,  June 25, 2014
  OIG Promises Scrutiny of Narrowly Focused Patient Assistance Programs Run By Independent Charities-Some Practices Previously Endorsed Now Suspected,  May 23, 2014
  Phase 2 Sunshine Reporting Information Released By CMS,  May 23, 2014
  Senator Lamar Alexander Asks HHS to Clarify Its Policy on Allowing Patients Direct Access to Health Information,  February 21, 2014
  OIG To Focus on a Number of Prescription Drug Issues in FY 2014,  February 12, 2014
  Sunshine Reporting Registration to Open February 18,  February 9, 2014
  HHS Wants to Empower Patients by Providing Direct Access to Test Results - Except When It Doesn't,  February 4, 2014
  Thomson Reuters Book: Commercialisation of Health Care  November 4, 2013
  HHS Announces Its Interpretation that Exchange Plans Are Not "Federal Health Care Programs" For Purposes of Fraud and Abuse Statute,  October 31, 2013
  As Partial Government Shutdown Kicks In, FDA's Foods Program Is Hardest Hit,  October 1, 2013
  HHS Issues Refill Reminders Guidance Ahead of Compliance Deadline for its HITECH Final Rule,  September 25, 2013
  HHS to Delay Enforcement and Provide Guidance on HIPAA/HITECH Act Final Rule on the Heels of Adheris Lawsuit ,  September 12, 2013
  Stormy Weather Ahead: Adheris Challenges HHS's Final Rule on HIPAA/HITECH Act, May Provide Further Insight into Supreme Court's Decision in Sorrell,  September 10, 2013
  Egg on its Face: Agency Could Not Impose Sanctions When its Interpretation of its Regulation Was Granted No Deference,  May 27, 2013
  Summary of CMS Final Rule on Transparency Reporting  February 12, 2013
  CMS Belatedly Issues Sunshine Rule; HP&M Promptly Issues Summary,  February 6, 2013
  HHS Finalizes HIPAA/HITECH Rule: Dramatic Revisions to Marketing Practices and Research Authorizations,  January 22, 2013
  Massachusetts Issues Final Rule on Drug and Device Manufacturer Marketing Conduct ,  November 27, 2012
  Massachusetts Relaxes Laws on the Offering of Prescription Drug Coupons and Meals to Health Care Practitioners,  July 15, 2012
  CMS Delays Sunshine Act Data Collection Until January 2013,  May 4, 2012
  CMS proposed ACA rule - 2-4-2012  April 2012
  CMS Publishes Proposed Rewrite of Medicaid Drug Rebate Program Regulation; HP&M Issues Summary,  February 5, 2012
  CMS Physician Sunshine Proposal Finally Sees Light of Day; HP&M Issues Summary Memorandum,  December 22, 2011
  CMS Proposed Rule on Reporting of Payments or Transfers of Value and Physician Ownership or Investment Interests  December 22, 2011
  Maine Repeals Laws Requiring Disclosures of Marketing Costs, Drug Prices, and Clinical Trials,  July 13, 2011
  OIG Issues Advisory Opinion on Manufacturer-Subsidized Patient Reminder Program,  June 12, 2011
  To Implement Health Reform Orphan Drug Exclusion, HRSA Issues First-Ever Proposed Regulation on 340B Drug Discount Program,  May 20, 2011
  Notorious Affiliate Exclusion Provision of PPACA Repealed,  December 21, 2010
  IRS Issues Notice to Implement Annual Fee on Brand Drugs,  December 10, 2010
  CMS Finalizes Withdrawal of AMP Regulations; Leaves Many Questions Unanswered,  November 10, 2010
  Improving Access to Clinical Trials Act Becomes Law,  October 19, 2010
  TRICARE Reissues Retail Pharmacy Refund Rule Largely Unchanged,  October 17, 2010
  OIG Enforcement Initiative Regarding AMP and ASP Reporting,  September 29, 2010
  HRSA Initiates Rulemaking to Implement Health Reform Changes to the 340B Drug Pricing Program,  September 22, 2010
  A High Wire Balancing Act: FDA and CMS to Consider Parallel Review of Medical Products,  September 21, 2010
  CMS Proposes to Withdraw Medicaid Rebate AMP and Federal Upper Limit Regulations,  September 7, 2010
  District Court to HHS: Failure to Consider FDA Approval in Coverage Decision is Arbitrary and Capricious,  August 10, 2010
  CMS Publishes Final Part D Coverage Gap Discount Agreements With Admonition to Act Quickly,  August 10, 2010
  HHS Issues Proposed HIPAA/HITECH Rule,  July 9, 2010
  Vermont Amends Gift Prohibition Law: Requires Reporting of Samples, Permits Coffee at Pharma Booths (Starbucks Breathes a Sigh of Relief),  June 8, 2010
  Health Care Reform Becomes Law - HP&M Issues Summary of Drug and Device Provisions ,  March 24, 2010
  President's Working Proposal for Health Care Summit Contains Familiar Drug and Device Provisions,  February 22, 2010
  TRICARE Involves Public in its Reconsideration of Retail Pharmacy Refund Program,  February 10, 2010
  Prominent Medical Researcher Charged with Health Care Fraud for Falsifying Research,  January 19, 2010
  Kaiser Permanente Submits Citizen Petition on REMS,  January 8, 2010
  Application of Health Care Fraud and Abuse Laws to Pharmaceutical Marketing  January 2009
  Personalized Medicine - Panacea or Pipedream?  September 2008
  PhRMA Releases Revised "Code on Interactions with Healthcare Professionals" More Restrictive than July 2002 Version; HPM Issues Summary Memorandum  July 10, 2008
  CMS Final Rule on the Drug Rebate Program  August 9, 2007
  CMS Issues Draft of Revised Clinical Trial Policy, Renamed Clinical Research Policy  April 11, 2007
  CMS Proposes Expanded Use of Part D Data - Will it Stay Confidential?  March/April 2007
  Medicare Coverage with Evidence Development and Potential Impact on Your Clinical Trial Policy  January 30, 2007
  Falling Short - Final Guidance on Coverage With Evidence Development  November/December 2006
  Application Of Health Care Fraud And Abuse Laws To Pharmaceutical Marketing  September 2006
  Getting CMS Reimbursement for Medical Technology Products  September 7, 2006
  CMS Proposed Changes to ASP Calculation Methodology  August 2006
  Coordination Between FDA And CMS: Strategic Considerations For Medicare Coverage And Payment, And The Growing Impact Of CMS In The Marketplace  August 22-25, 2006
  Medtronic Reaches Settlement over Allegations of Illegal Physician Payments to Promote Spinal Products  July 18, 2006
  CMS Coverage with Evidence Development Policy Highlights Differences Between FDA and CMS Clinical Evidence Requirements  July 12, 2006
  Medicare to Reconsider Clinical Trial Policy  July 10, 2006
  Health and Speech Rights at Risk from Attacks on Medical Education  April 12, 2006
  Medicare CED: Considerations and Implications  March/April 2006
  The Deficit Reduction Act of 2005: Amendments To The Medicaid Rebate Program and Drug Payment  February 2006
  Vermont AWP Disclosure and Drug Marketer Gift Reporting Laws  June 2004
  HIPAA and Drug Company Interactions with Physicians - Beyond Clinical Research  May/June 2003