Sunshine Act

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CMS is inviting comments on the Physician Payment Sunshine Act “Open Payments Program” dispute resolution and corrections process. As previously reported, the Physician Payment Sunshine Act requires pharmaceutical and medical device manufacturers and group purchasing organizations (GPOs) to register with and submit to CMS data on their financial relationships with physicians and teaching…

While attention has been focused on Medicare physician payment data released by CMS yesterday, upcoming Sunshine Act data will shine a new spotlight on financial relationships between physicians and pharmaceutical and medical device companies – with potential False Claims Act (FCA) implications.

Specifically, last week marked the deadline for pharmaceutical and medical device manufacturers and group purchasing organizations (GPOs) to register with and submit aggregate 2013 payment and investment interest data to the Centers for Medicare & Medicaid Services (CMS) on certain financial relationships between themselves and physicians and teaching hospitals, as required by the Physician Payment Sunshine Act. In May, manufacturers and GPOs will be required to submit to CMS detailed 2013 payment data. With some exceptions, CMS will be making these data public by September 1, 2014. While the publicly-available data are intended to provide more transparency for patients, to allow them to have a better understanding of the financial relationships between physicians and pharmaceutical and medical device companies, patients will certainly not be the only group interested in this public information. It is likely that the Department of Health and Human Services Office of the Inspector General, Department of Justice, and relators’ attorneys will utilize these data to initiate investigations and support complaints under the federal FCA.
Continue Reading Will Physician Payment Sunshine Act Data Usher in a New Era of False Claims Act Litigation?

This post was written by Katie C. Pawlitz.

On February 7, 2014, CMS announced a two-phase registration and data submission process for the 2013 Open Payments Program, the reporting mechanism for the Physician Payment Sunshine Act. Under Phase I, which begins February 18, 2014 and runs through March 31, 2014, applicable manufacturers and applicable …

Under the “Sunshine Act” provisions of the Affordable Care Act, certain manufacturers of drugs, devices, biologicals, and medical supplies covered by Medicare, Medicaid and CHIP must report annually to the Department of Health and Human Services (HHS) certain payments or transfers of value they have made to physicians and teaching hospitals. CMS has announced…

A recent OIG report links the growing presence of physician-owned distributorships, or PODs, to increased spinal surgery volumes and potentially increased Medicare costs. The OIG notes a “substantial presence” of PODs in the spinal device market, with PODs supplying spinal devices for 19% of the spinal fusion surgeries billed to Medicare in FY 2011. According…

CMS has released a list of teaching hospital “covered recipients” to which payments and other transfers of value must be reported by applicable drug and device manufacturers under the ACA Physician Payment Sunshine Act Final Rule, as discussed in a posting on our Life Sciences Legal Update blog. The posting also discusses industry…

The Centers for Medicare & Medicaid Services (CMS) has published the long-awaited Final Rule to implement the “Sunshine” provisions of the Affordable Care Act of 2010 (ACA).  The Sunshine provisions – intended to provide increased transparency regarding the scope and nature of financial and other relationships among manufacturers, physicians, and teaching hospitals – require that…

The Centers for Medicare & Medicaid Services (CMS) released late today its final rule implementing the physician payment transparency provisions of the Patient Protection and Affordable Care Act (Section 6002), commonly referred to as the “Physician Payments Sunshine Act.” Among other things, the Act requires drug, device, biological or medical supply manufacturers to report…

On November 27, 2012, CMS sent to the White House Office of Management and Budget for final clearance its long-awaited final rule implementing the ACA’s “Physician Payment Sunshine Act” provisions. Under the ACA, applicable manufacturers of drugs, devices, biologicals, or medical supplies covered under Medicare, Medicaid, or CHIP will be required to report annually to…

On November 21, 2012, the Massachusetts Public Health Council finalized amendments to the State’s Marketing Code of Conduct, which restricts certain payments by pharmaceutical and medical device manufacturers to Massachusetts health care practitioners and imposes other disclosure requirements regarding such payments. The rules, which are effective December 7, 2012, are summarized on the Reed Smith’s …

On the Reed Smith Life Sciences Legal Update blog, there is a recent post regarding the Massachusetts Public Health Council’s approval of emergency amendments to the State’s Marketing Code of Conduct regulations. The underlying regulations restrict certain gifts and payments by pharmaceutical and medical device manufacturers to Massachusetts health care practitioners (HCPs) and require…

On September 12, 2012 the Senate Aging Committee will hold a roundtable forum entitled “Let the Sunshine in: Implementing the Physician Payments Sunshine Act.”   The ACA’s Physician Payment Sunshine Act requires applicable manufacturers of drugs, devices, biologicals, or medical supplies covered under Medicare, Medicaid, or CHIP to report annually to the HHS Secretary certain…

This post was written by Katie C. Pawlitz.

Today the Office of the Vermont Attorney General announced that the Vermont Attorney General is offering limited amnesty to medical device and biologic manufacturers who have failed to report pursuant to Vermont’s Prescribed Products Gift Ban and Disclosure Law. The offer will remain open until October…

As drug and device manufacturers continue to await final federal rules implementing the Affordable Care Act’s Physician Payment Sunshine Act (“Sunshine Act”) provisions, Massachusetts has relaxed its similar state law banning the provision by manufacturers of gifts to health care practitioners (HCPs) and requiring disclosure of payments and transfers of value to HCPs. The revisions…

The Centers for Medicare & Medicaid Services (CMS), tasked with implementing the Physician Payments Sunshine Act, announced yesterday that it will not require pharmaceutical, device, and other applicable manufacturers and group purchasing organizations (GPOs) to begin collecting reportable data before 2013.
Continue Reading CMS Announces Data Collection for the Physician Payments Sunshine Act Will Not Be Required Before 2013

On December 19, 2011, the Centers for Medicare & Medicaid Services (“CMS”) published a proposed rule (the “Proposed Rule”) related to section 6002 of the Affordable Care Act, commonly referred to as the “Physician Payment Sunshine Act” (so referenced herein, or as the “Act”). The Physician Payment Sunshine Act requires applicable manufacturers of drugs, devices, biologicals, or medical supplies covered under Medicare, Medicaid, or CHIP to report annually to the Secretary of the Department of Health and Human Services (“Secretary”) certain payments or other transfers of value to physicians and teaching hospitals. Additionally, applicable manufacturers and applicable group purchasing organizations (“GPOs”) must report certain information regarding the ownership or investment interests in them that are held by physicians or their immediate family members.
Continue Reading Overview and Analysis of the Proposed Federal Sunshine Regulations

The Centers for Medicare & Medicaid Services (“CMS”) released today a proposed rule implementing the physician payment transparency provisions of the Patient Protection and Affordable Care Act (Section 6002), commonly referred to as the “Physician Payments Sunshine Act.” Among other things, the Act requires drug, device, biological or medical supply manufacturers to report payments or other transfers of value to physicians and other covered recipients. In addition, the Act requires manufacturers and group purchasing organizations (GPOs) to report certain information regarding ownership or investment interests held by a physician in the manufacturer or GPO.
Continue Reading CMS Releases Long-Awaited Physician Payments Sunshine Act Proposed Rule

The Centers for Medicare & Medicaid Services (CMS) has sent to the White House Office of Management and Budget (OMB) its long-awaited proposed rule to implement the Transparency Reports and Reporting of Physician Ownership of Investment Interests (also called the Physician Payment Sunshine Act) provisions of the ACA. These provisions are intended to encourage greater…

Senators Chuck Grassley and Herb Kohl have asked HHS Secretary Sebelius to take a number of steps to prepare for implementation of the ACA’s Physician Payments Sunshine Act provisions, under which drug and medical device manufacturers must disclose to HHS certain payments to physicians. The Senators note that some drug and medical device makers are…