Health Industry Washington Watch : Washington DC Healthcare Industry Law Firm : Reed Smith : Health Industry Washington Watch : Regulations, Medicare/Medicaid, Governmental Organizations

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 efforts to obtain CMS clarification on various outstanding questions related to the reporting requirements. In addition, CMS has announced a May 22 National Provider Call on the Sunshine Act reporting requirements, directed to physicians and teaching hospitals and covering the Final Rule, key dates, the role of covered recipients, and resources available to covered recipients.

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This post was written by Elizabeth B. Carder-Thompson, Katie C. Pawlitz and Nancy E. Bonifant.

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 certain manufacturers of drugs, devices, biologicals, and medical supplies covered by Medicare, Medicaid and CHIP 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.  In addition, they require manufacturers and certain group purchasing organizations (GPOs) to report to HHS information on physician ownership and investment interests. 

While the Final Rule provides needed clarity on some troubling aspects of the proposal, it leaves a number of questions unanswered.  Please click here to read our detailed analysis of the Sunshine provisions, including an overview and summary of the Final Rule as well as discussion of the important issues that stakeholders should be considering as they prepare for Sunshine implementation.

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This post was written by Elizabeth Carder-Thompson, Katie C. Pawlitz, and Nancy E. Bonifant.

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 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.

The official version of the final rule, titled “Transparency Reports and Reporting of Physician Ownership of Investment Interests” (the “Final Rule”), will be published in the Federal Register on February 8, 2013. A proposed rule was previously published in the Federal Register on December 19, 2011, for which CMS received over 300 comments from a wide range of stakeholders.

The Final Rule provides important guidance to manufacturers and GPOs regarding the Physician Payments Sunshine Act, resolves several questions remaining after publication of the Proposed Rule, and raises some new ones. Notably, CMS has announced that manufacturers and GPOs will not be required to collect required information until August 1, 2013. Manufacturers and GPOs will be required to report the data for August through December of 2013 to CMS by March 31, 2014 and CMS will release the data publicly by September 30, 2014. 

We are in the process of conducting a full review of the lengthy Final Rule and will release shortly a Client Alert providing a detailed analysis of the Rule. In the meantime, please contact Elizabeth Carder-Thompson (202-414-9213), Katie C. Pawlitz (202-414-9233), Nancy E. Bonifant (202-414-9353) or any other member of the Reed Smith Health Care Group with whom you work, if you would like additional information or if you have any questions. 

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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 the HHS 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. CMS published the proposed version of the rule to implement these provisions on December 19, 2011, and subsequently announced that it will not require pharmaceutical, device, and other applicable manufacturers and GPOs to begin collecting reportable data before 2013. We will be providing an analysis of the final rule when it is available. In the meantime, for our previous reports on the Sunshine Act provisions, click here.

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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 Life Sciences Legal Update blog.
 

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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 disclosure of payments and transfers of value to HCPs. The emergency amendments, which follow state legislative amendments, now allow manufacturers to provide modest meals and refreshments to HCPs at non-CME educational presentations and modify applicable reporting requirements. The amendments also address the interaction of state requirements and federal law, including the ACA’s Physician Payment Sunshine Act provisions. For additional details, see our full post.

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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 payments or other transfers of value to physicians and teaching hospitals. Additionally, applicable manufacturers and applicable group purchasing organizations must report certain information regarding the ownership or investment interests in them that are held by physicians or their immediate family members.  For our previous reports on the Sunshine Act provisions, click here.

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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 1, 2012. In order to take advantage of the offer, manufacturers must email prescribedproducts@atg.state.vt.us with the following information: (1) manufacturer name; (2) reporting periods not reported; and (3) name, address, email, and phone number of the representative with whom Vermont should communicate.

The reporting obligation under the Vermont Law became effective July 1, 2009 and, to date, manufacturers have been required to report to Vermont with respect to three reporting periods. The amnesty offer is limited to financial penalties authorized under the Law and does not apply to back-payment of registration fees or penalties for violations of other aspects of the Law, such as gift ban violations. The Office of the Attorney General has indicated that it does not anticipate seeking full disclosure for unreported activity, but that it does anticipate requiring at a later date, disclosure of aggregate information regarding the activity.

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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 are intended to loosen certain restrictions on providing meals and other expenses to HCPs, and relieve manufacturers of the duty to report to Massachusetts information that has been disclosed to federal agencies, such as data reported to CMS under the Sunshine Act. Massachusetts also will permit pharmaceutical manufacturers to offer drug coupons to Massachusetts residents if certain conditions are met. Additional information is available on Reed Smith’s Life Sciences Legal Update.

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This post was written by Elizabeth Carder-Thompson, Katie C. Pawlitz, Nancy E. Bonifant and Debra A. McCurdy.

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.

Once implemented, the Physician Payments Sunshine Act (Section 6002 of the Affordable Care Act) will require manufacturers and GPOs to report information regarding payments to physicians and physician ownership and investment interests.

In a blog entry on its website, CMS noted that it received over 300 comments from stakeholders in response the proposed rule published in December 2011, and that it is committed to addressing the input received in such comments.  In order to provide organizations sufficient time to prepare for data submission and to address input received, CMS stated that data collection will not be required before January 1, 2013. CMS also noted that it intends to release the final rule later this year.

To read our previous post regarding the Physician Payment Sunshine Act, click here. 

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This post was written by Elizabeth B. Carder-Thompson, Katie C. Pawlitz, Nancy E. Bonifant and Debra A. McCurdy.

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.

The Proposed Rule comes more than two months after CMS’s statutory deadline of October 1, 2011. CMS proposes an expansive reading of its statutory authority, arguably extending reporting requirements to manufacturers and payments not contemplated by Congress. Moreover, while offering some much-needed clarification regarding certain tracking and reporting obligations under the Act, it leaves many questions unanswered. Indeed, CMS solicits comments on almost every aspect of the Proposed Rule – 60 topic areas in all. Accordingly, significant ambiguity still remains in terms of compliance with certain aspects of the Act. Comments to the Proposed Rule are due no later than 5 p.m. ET February 17, 2012.

This Client Alert outlines the guidance and proposals included in the Proposed Rule. As further discussed in this Alert, CMS has delayed implementation of tracking requirements under the Physician Payment Sunshine Act, but applicable manufacturers and GPOs still are advised to continue to prepare for implementation of the Act, potentially occurring during this calendar year 2012. Applicable manufacturers and applicable GPOs may do so by taking steps to ensure that tracking and reporting systems conform to the requirements of the Act and the Proposed Rule, to the extent clarity is currently available, and by closely monitoring future CMS guidance in this area.

To read the full Alert, click here.

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This post was written by Elizabeth B. Carder-Thompson, Katie C. Pawlitz and Debra A. McCurdy.

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.

The official version of the proposed rule, titled “Transparency Reports and Reporting of Physician Ownership of Investment Interests” (the “Proposed Rule”), will be published in the Federal Register on December 19, 2011. Comments on the Proposed Rule are due no later than 5:00 PM EST on February 17, 2011.

Although released later than the statutory deadline for the regulations (October 1, 2011), upon initial review, the Proposed Rule appears to provide important guidance to manufacturers regarding several aspects of the Physician Payments Sunshine Act. Notably, CMS has announced that manufacturers and GPOs will not be required to collect required information until after the final rule is published (rather than the statutory January 1, 2012 deadline). CMS anticipates publishing the final rule “as soon as possible” in 2012.

We are in the process of conducting a full review of the Proposed Rule and will release shortly a Client Alert providing a detailed analysis of the proposal. In the meantime, please contact Elizabeth Carder-Thompson (202-414-9213 or ecarder@reedsmith.com), Katie C. Pawlitz (202-414-9233 or kpawlitz@reedsmith.com), or any other member of the Reed Smith Health Care Group with whom you work, if you would like additional information or if you have any questions.
 

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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 transparency in the relationships between drug and device companies and physicians by (among other things) requiring covered drug, device, biological or medical supply manufacturers that provide a payment or other transfer of value to a “covered recipient” – a physician or a teaching hospital – to submit detailed reports to the HHS Secretary. In addition, the provision requires certain manufacturers and group purchasing organizations (GPOs) to report to the Secretary certain information regarding ownership or investment interests held by a physician in the manufacturer or GPO. The text of the rule is not available at this stage, but the rule could reach the Federal Register in the near future. As noted in a separate posting, the Senate Aging Committee has scheduled a December 15 hearing on this issue.

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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 preparing to meet the new requirements, but in the absence of clear guidance from the federal government, they are preparing payment data in non-uniform ways that is making it difficult for consumers to use. The senators cited the need for federal guidance “to ensure the same information is disclosed in the same way, and is meaningful.” To that end, they requested that HHS promptly designate an agency to oversee the creation and operation of the database and to report to them on the Department’s implementation timeline.

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