Stay Informed About Upcoming Legislation for State and Federal Transparency Reporting

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  • Legislative Alert – CMS Annual Report Fiscal Year 2014 – Summary

    On April 26 2015, the Centers for Medicare and Medicaid Services (CMS) submitted its annual report to Congress on the Open Payments Program for fiscal year 2014 as required by 42 U.S.C. 1320a-7h(d)(1). The following MediSpend® Legislative Alert will summarize the salient points of the annual report along with legislative updates related to the Open …Read More
  • CMS Announces Final Disclosure Provisions of the Affordable Care Act

    On February 1, 2013, The Centers for Medicare & Medicaid Services (CMS) announced the final ruling of the Physician Payment Sunshine Act provisions, a measure designed to increase transparency within the health care market.  The ruling finalizes provisions requiring pharmaceutical and medical device manufacturers to report payments and transfers of value that they make to …Read More
  • Minnesota Board of Pharmacy Requests Repeal of State Regulations

    On January 8, 2013, Cody Wiberg, the Executive Director of the Minnesota Board of Pharmacy, wrote a letter requesting repeal of the requirement for pharmaceutical manufacturers to report on payments and transfers of value to physicians for the 2012 calendar year.  The Board of Pharmacy will ask the Minnesota Legislature to repeal state regulations since …Read More
  • Powerful Healthcare Advocates Push OMB to Issue Sunshine Act Regulations

    On January 14, 2013, the AARP, AFL-CIO, and 17 other healthcare advocacy groups wrote a letter urging the Office of Management and Budget (OMB) to issue the Physician Payments Sunshine Act regulations. The letter expressed the urgency to approve these regulations in that they are expected to protect patients and eliminate fraud in Medicare and …Read More
  • Massachusetts Subject To Quarterly Reporting: Public Health Council Approves Out-Of-Office Meal Amendments

    On November 21, 2012, the Massachusetts Public Health Council approved amendments to the Pharmaceutical and Medical Device Manufacturer Code of Conduct to allow manufacturers to provide out-of-office meals to health care providers for the purpose of educating and informing attendees about the benefits, risks and appropriate on-label uses of prescription drugs and medical devices. The …Read More
  • CMS Submitted Final Rule To Implement Physician Payment Sunshine Act

    On November 27, 2012, CMS submitted the final rule to implement the Physician Payment Sunshine Act to the Office of Management and Budget for clearance.  Stay tuned for a summary when released by OMB.  The proposed rule was originally issued by CMS on December 19, 2011. During a 60 day comment period, CMS received over …Read More
  • The Department of Public Health Holds Public Hearing in Boston to Discuss Proposed Regulations for Massachusetts

    On October 19, 2012, the Department of Public Health will hold a public hearing at 10 AM ET in the Public Health Council Room at 250 Washington Street in Boston Massachusetts to discuss the proposed regulations for the state of Massachusetts; emergency amendments to 105 CMR 970.000, Pharmaceutical and Medical Device Manufacturer Conduct. See the …Read More
  • Significant Changes Regulating Pharmaceutical and Medical Device Manufacturer Conduct and Reporting Included in 2012 Mass Budget

    On July 8, 2012, Massachusetts Governor Deval Patrick signed the fiscal 2012 budget, which included significant changes to Chapter 111N, regulating pharmaceutical and medical device manufacturer conduct and reporting.  Specifically, the 2012 budget expands the ability for pharmaceutical and medical device companies to provide modest meals and refreshments in conjunction with non-CME educational presentations. Prior …Read More
  • CMS Delays Industry Data Collection of Physician Payments

    On May 10, 2012, the Centers for Medicare and Medicaid Services (CMS) announced that federal requirements for drug and device manufacturers to collect information on gifts and payments to physicians would not begin until 2013 due to the proposed transparency rules needing further revision and clarification. Creating physician awareness and developing a proactive disclosure of …Read More
  • Senators Kohl and Grassley Push CMS to Implement the Sunshine Act by June 2012

    On April 4, 2012, Senators Herb Kohl and Charles Grassley wrote a letter to the acting administrator, The Honorable Marilyn Tavenner, from the Center for Medicare and Medicaid Services (CMS), requesting that the final ruling of the Physician Payments Sunshine Act (“Sunshine Act”) be released this June so that partial data collection for 2012 can …Read More
  • Analysis of Proposed Rules in Support of the PPACA

    On December 19, 2011, the Centers for Medicare & Medicaid Services (CMS) published the proposed rule implementing the transparency provisions set forth at section 6002 of the Patient Protection and Affordable Care Act (PPACA).Read More
  • CMS Released Proposed Regulations

    On December 14, 2011, the Centers for Medicare & Medicaid Services (CMS ) announced the release of the proposed rule to implement the Federal Sunshine Act codified at 42 U.S.C.A. § 1320a-7h.  The proposed rule will be published in the Federal Register on December 19, 2011. CMS will accept comments on the proposed rule until February 17, 2012, and …Read More
  • PPACA Reporting Procedures Still Missing

    With only 9 weeks until 2012, pharmaceutical and medical device manufacturers are still waiting for federal regulations to provide guidance for the implementation of the Federal Sunshine Act. Senators Grassley and Kohl have already sent a memorandum directly to CMS requesting an immediate explanation on missing the deadline, but no response was received. There is …Read More
  • Centers for Medicaid and Medicare Services (CMS) Fail to Explain Missed Deadline

    Senator Grassley continues to express his disappointment with CMS for missing their deadlines as they relate to the Physicians Payment Sunshine Act. On October 3, 2011, Senators Grassley and Kohl sent CMS a letter requesting an update as to the timetable for implementing the Sunshine Act as well as an explanation for CMS’ failure to …Read More
  • Senators Grassley and Kohl Express Severe Disappointment Over Missed Deadline

    As pharmaceutical and medical device manufacturers diligently prepare for transparency reporting pursuant to the Physician Payment Sunshine Act (incorporated into the Patient Protection and Affordable Care Act), the Centers for Medicaid and Medicare Services (CMS) quietly missed their deadline for producing implemented regulations as required by 42 U.S.C.A. § 1320a-7h(c)(1)(A).  On October 3rd, CMS was …Read More
  • Maine Repeals Aggregate Spend Laws

    As previously reported in the MediSpend blog (see here), on February 18, 2011, a bill was submitted (House Paper No. 530) to "Make Certain Prescription Drug Disclosure Laws Consistent with Federal Law." Specifically, House Paper No. 530 sought to repeal 22 MRSA §2698-A which established the requirement for pharmaceutical manufacturers to report marketing costs, including …Read More
  • State of the States: Update on Aggregate Spend and Transparency Reporting Legislation

    While pharmaceutical and medical device manufacturers await the implementing regulations under the transparency provisions of the Patient Protection and Affordable Care Act (42 U.S.C.A. § 1320a-7h), commonly referred to as “The Sunshine Act,” state legislatures have been active in updating their respective legislation as it relates to aggregate spend and transparency reporting.   In order …Read More
  • Just When You Thought you were Ready to Report to VT . . .

    On June 3, 2011, twenty-seven days before the close of the reporting period, the Vermont Attorney General’s office issued proposed changes to the reporting requirements for the reporting period July 1, 2010 to June 30, 2011. Revisions to the reporting requirements and the database will be addressed during the following conference call with the AG’s …Read More
  • Vermont Revisions to FY11 Disclosure Form and Database

    From: Wendy Morgan Date: Fri, 3 Jun 2011 16:12:14 -0400 Subject: FW: June 16, 2011 Conference Call on Draft Consolidated Guide for 2011; Revisions to FY11 Disclosure Form and Database We will have a conference call to get your feedback on these documents on:                                Thursday, June16, 2011                                1 p.m., Eastern Standard Time                                Toll Free:             1-888-757-2790                                …Read More
  • Vermont Amends Gift Ban and Aggregate Spend Reporting Requirements . . . Again.

    A new legislative biennium in Vermont means further changes to the Vermont Gift Ban (18 V.S.A. §4631a) as well as the aggregate spend reporting requirements (18 V.S.A.§4632). On May 6, 2011, the Vermont House and Senate approved Senate Bill 104 which is currently awaiting the signature of Governor Shumlin. See the MediSpend Legislative Watch for …Read More