News  

Delay in the Physician Payments Sunshine Act implementation

sunshine act, regulation compliance solution, compliance reporting solution, aggregate spend, aggregate spend compliance, FCPA, anti-kickback,due diligence,
For Immediate Release May 4, 2012
Delay in the Physician Payments Sunshine Act implementation

M E M O R A N D U M
To:    Reporters and Editors

Re:    Delay in the Physician Payments Sunshine Act implementation

Date:    Friday, May 4, 2012

Sen. Chuck Grassley and Sen. Herb Kohl, authors of the Physician Payments Sunshine Act, today made the following comments on news that the Centers for Medicare and Medicaid Services (CMS) needs more time to implement the act and will not begin data collection until 2013.  CMS’ statement is available here.

Grassley said, “It’s disappointing that CMS won’t even collect data at all this year.  The process has dragged on long past the statutory deadline for implementation.  Consumers need to know more about the financial relationships between their doctors and drug companies sooner rather than later.   It’s important that CMS get this right in every way, including the usefulness and accuracy of the information.  Given all of the extra time, CMS will have no further excuses for not accomplishing these goals.”

Kohl said, “While I am disappointed by this delay and the timeline, I do look forward to working with CMS to finalize the rules so that data collection can begin in January 2013.”

The senators developed the Physician Payments Sunshine Act, which was signed into law in 2010, after revelations of significant under-reporting of the amount of payments received by certain doctors from drug and device companies.  The new law requires public disclosure of the financial relationships between physicians and the pharmaceutical, medical device and biologics industries. The law required the Department of Health and Human Services (HHS) to establish reporting procedures for applicable manufacturers to submit information, as well as procedures for making that information available to the public, by October 1, 2011. CMS issued the guidance in December after more than a year of pushing for a timely release from Grassley and Kohl.

Grassley and Kohl have written to the acting CMS administrator with questions about implementation, including when CMS will begin data collection.

The text of the Grassley-Kohl April 4 letter to the acting CMS administrator is available here.
The acting CMS administrator’s May 3 response is available here.


© 2008, Senator Grassley

Updates to 2012 Guide to Vermont’s Prescribed Product Gift Ban and Disclosure Law

sunshine act, regulation compliance solution, compliance reporting solution, aggregate spend, aggregate spend compliance, FCPA, anti-kickback,due diligence,The Vermont Office of the Attorney General recently released a memo which provides updates to the 2012 Guide to Vermont’s Prescribed Product Gift Ban and Disclosure Law.  These updates will be included in the amended 2012 Guide by June. The most significant change is in regard to the distribution  of OTC products. On the November 2011 conference call, industry asked for a broad interpretation of the “OTC drug and medical device (gift ban) exception” so that it extends to non-prescription products such as lotions and eye drops. On the call, the Office of the Attorney General  stated that such distributions were allowable under the exception. The Office has since sought clarification and feedback from Vermont Legislators, and has now changed position.

Starting January 1, 2013, the Office will treat the distribution of lotions, eye drops, etc. as unlawful.  The OTC exception will only apply to over-the-counter drugs, nonprescription medical devices, and nonprescription durable medical equipment.

R-Squared Presenting at Concur Fusion 2012 – Sunshine Act

sunshine act, regulation compliance solution, compliance reporting solution, aggregate spend, aggregate spend compliance, FCPA, anti-kickback,due diligence,

How the Sunshine Act impacts you

Mike Bell, Esq., President and CEO of R-Squared has been asked by Concur to facilitate and present on key issues facing Concur’s Life Science clients.

Concur has gathered some of the leading experts in the Life Sciences legislation and collected relevant data to tell you what you need to know about how the deployment of section 6002 Patient Protection and Affordable Care Act (commonly known as the Sunshine Act) impacts you. Come ask the experts from Concur, R-Squared and Healthcare Data Solutions and get some of your most pressing questions answered.

Read More»

BREAKING NEWS: CMS Delays Sunshine Data Capture

newsFeature

No Data Capture Required in 2012

Surprise, surprise:  CMS missed its regulatory deadline to promulgate final Sunshine regulations and has announced more delays.  Despite Senators Grassley and Kohl urging CMS to issue a final rule governing the law by June (see letter), so that data collection can begin this year, CMS just announced via a May 3, 2012 blog post that it will issue final Sunshine Act regulations “later this year” and will not require data collection by applicable manufacturers and applicable group purchasing organizations before January 1, 2013.

Read More»

Senators Grassley and Kohl Letter Urging CMS to Implement Sunshine Regulations

newsFeature

Read the latest document SunshineActUpdate4.4.2012. With deadlines already missed and the demands of releasing the regulations combined with implementing a web site to make this data available to the public, tell us what you think about CMS’s ability to execute.

Concur T&E Cloud and Support of Sunshine Act Compliance

sunshine act, regulation compliance solution, compliance reporting solution, aggregate spend, aggregate spend compliance, FCPA, anti-kickback,due diligence,

Concur T&E Cloud Delivers Enhanced Capabilities in Support of Sunshine Act Compliance

Concur Connect Platform enables clients to enjoy instant access to comprehensive health care provider data, ensuring accurate and transparent reporting

REDMOND, Wash., March 21, 2012 /PRNewswire/ — Concur (Nasdaq: CNQRNews), a leading provider of integrated travel and expense management services, today announced that clients will now have access to enhanced capabilities to support compliance with the Patient Protection and Affordable Care Act, commonly known as the Sunshine Act. By connecting to the T&E Cloud via Concur Connect, leading solution provider R-Squared is now making accurate and standardized health care provider data available to Concur clients to streamline compliance and ensure accurate reporting.

Read More»

R-Squared and Concur Partner to Create Integrated Aggregate Spend Solutions

sunshine act, regulation compliance solution, compliance reporting solution, aggregate spend, aggregate spend compliance, FCPA, anti-kickback,due diligence,

The integration between R-Squared’s SpendTracker aggregate spend reporting solution and Concur’s expense reporting tools will provide Life Sciences companies with an easy and cost effective means to aggregate and report on physician spend. Creating an aggregate spend solutions.

Princeton, NJ (February 7, 2012) – R-Squared Services & Solutions, an industry leader in evidence-based compliance solutions, is pleased to announce its partnership with Concur®, the leading provider of integrated travel and expense management solutions.  This strategic alliance merges R-Squared’s SpendTracker® module with Concur’s expense reporting solution via the Concur Connect Platform, resulting in the optimal solution to streamline and facilitate compliance with the federal Physician Payment Sunshine Act requirements, and the growing body of transparency disclosure laws, which are known as “aggregate spend” reporting laws.

Read More»

R-Squared publishes a new CQR guide to the revised Vermont Law

On  January 2, 2012, R-Squared published its latest Vermont Compliance Quick Reference guide.  For a free copy, click here.

This version incorporates the Vermont Office of the Attorney General’s 2012 guidance document.

Member Access Only: R-Squared Summary of Proposed Sunshine Regs

The Physician Payment Sunshine Act/Transparency Reports proposed regulations were released today and will be published in the Federal Register on December 19, 2011.  This proposed rule provides much needed clarity, but from our cursory review, several questions remain.  Comments are due to CMS by February 19, 2012.

Perhaps most significant, CMS will not require applicable manufacturers and GPOs to begin collecting the required spend information on January 1, 2012, as set forth in the law.  Rather, manufacturers and GPOs will not be required to begin collecting relevant data until after the publication of the final rule, which likely will be sometime in April.  CMS may delay further the collection date until 90 days after publication of the final rule or until 2013.

Read More»

CMS Sunshine Regulations are on the way

UPDATE – CMS Sunshine Regulations are on the way. CMS sent proposed physician payment transparency rules to The Office of Budget and Management on 11/17/11. Typically, this signals that the regulations are imminent.

 

R-Squared will keep you posted with more information as it arrives.