Pharmaspective

Porzio Life Sciences' Inaugural State of Life Sciences Healthcare Compliance Survey

 

Porzio Life Sciences, LLC (PorzioLS), a wholly-owned subsidiary of the law firm of Porzio, Bromberg & Newman, P.C. (Porzio), is dedicated to helping pharmaceutical, medical device and biotechnology organizations master the evolving regulatory environment.

In order to create a better understanding of the life sciences healthcare compliance environment and gain insight into how companies handle compliance challenges, PorzioLS has created the inaugural State of Life Sciences Healthcare Compliance Survey.

This survey is a compilation of the responses gathered from compliance professionals across a variety of life sciences companies, throughout all industry sectors and company sizes. The hope is that this data will serve as a useful benchmarking tool for life science compliance programs throughout the upcoming year.

To read the full survey results, please click here.

Massachusetts Life Science Companies: Stuck Between a Rock and a Hard Place

Life Sciences is an industry important to the Massachusetts economy and one in which the Commonwealth takes great pride.  The Massachusetts government web site prominently notes that  "The Massachusetts life sciences super cluster includes the activities of the state's world-class universities, teaching hospitals and research institutions, biotechnology, medical devices and pharmaceutical companies as well as a professional service industry, which contributes to the growth and vitality of our economy."  Most of the "super cluster" of small, innovative companies are "virtual" manufacturers of pharmaceuticals, biologics, and devices.  They do not actually manufacture or ship their own products, but rather, use contract manufacturers and third-party logistics provider to ship their products nationwide.  But these companies now find themselves at a competitive disadvantage because they are based in Massachusetts.

Although these companies never actually handle products at their corporate headquarters, as the seller of the product, the corporate address appears on their invoices.  In roughly half of the states, that act of selling requires the seller to obtain a non-resident distribution license for the invoicing address.  Simple enough: fill out a few forms and get a license.  But there is a catch.  Generally, in order to get a non-resident license, the company must first demonstrate that they hold a license in their home state.  Sounds simple so far.  It would be, but for the fact that Massachusetts will not issue a license unless you actually manufacture or warehouse product.  Massachusetts will not issue a license if the facility is only a corporate headquarters.  Until recently, this has not been a problem.  Massachusetts has posted on its web site that such companies do not require a license and other states have accepted that and issued a license.  As problems with drug diversion continue, some states are refusing to issue licenses in the absence of a resident state license.  New York, a key consumer of pharmaceuticals and medical devices, is one of those states.  The New York statute requires an applicant for a non-resident permit to first have a resident permit.  There are no exceptions.  As the overwhelming majority of Massachusetts companies are "virtual," they cannot get a resident permit and New York will no longer issue a non-resident permit.  New York's position not only impacts new companies; New York is refusing to renew the permits of Massachusetts companies that have been licensed for years unless they can produce the resident state license.  As Massachusetts refuses to license them, their New York license will lapse.  Georgia and New Mexico have taken a similar position, raising the number of states in which Massachusetts virtual manufacturers cannot obtain a license to three.  That number is likely to increase.

This is a significant problem for both the life sciences companies and their customers in New York, New Mexico and Georgia.  From the company standpoint, they lose the ability to directly sell their product to any customer in those states.  They cannot sell directly to distributors, hospitals, doctors, pharmacies, or any of the other customers within that state's border.  But, competitors headquartered in other states can sell directly to customers, putting the Massachusetts-based companies at a competitive disadvantage.  It also puts the customers and patients in those states at a disadvantage.  All sales into those states will have to come in through wholesalers with whatever price mark-up the wholesaler adds on to its cost.  Small distributors in New York, New Mexico and Georgia will also suffer if they lose the ability to buy direct.  Given this disadvantage, it will be difficult for Massachusetts to attract new life sciences companies.  Why would a company set up headquarters in Massachusetts and lose the ability to make direct sales to New York, a key state, when they can set up in nearby Connecticut, Rhode Island, or New Hampshire, and quickly obtain a license?

This is not an issue that is getting much attention.  As New York licenses renew only every three years, there are numerous companies in Massachusetts that do not yet know that their ability to renew is in jeopardy.  If Massachusetts is interested in promoting itself as a good place for life science companies to set up shop, then it should also license its virtual pharmaceutical, biotech, and device companies.  It is not difficult.  A simple form requesting some basic information and the issuance of a certificate is all that is needed to put Massachusetts back on a level playing field and retain an industry that is key to its economy. 

Frank Fazio  ffazio@pbnlaw.com

Vermont AG's Office Offers Amnesty to Medical Device and Biologic Manufacturers That Failed to Report Activities as Required by the Prescribed Products Gift Ban and Disclosure Law

 

By Ingrid A. Pelzer

The Vermont Attorney General's Office (AG's Office) is offering to accept a payment to the State in the amount of $10,000 per reporting period to settle failures to report under the Prescribed Products Gift Ban and Disclosure Law (Law) for prior reporting years.  According to the Law, manufacturers of prescription drugs, biological products, and medical devices are required to disclose to the AG's Office the value, nature, purpose, and recipient of any allowable expenditure or permitted gift. Manufacturers are also required to submit samples disclosure reports that include the product, recipient, number of units, dosage, and other information for all samples provided to Vermont health care providers. Disclosure reports are due to the AG’s Office by April 1st of each year. According to the Law, each failure to disclose constitutes a separate violation, which may result in a civil penalty of no more than $10,000 per violation.

 

The AG's Office has indicated that this offer applies only to medical device and biologic manufacturers whose obligation to comply with the Law began on or after July 1, 2009, but who failed to report their activities for any of the following reporting periods:

 

• FY10 (July 1, 2009 – June 30, 2010)
• FY11 (July 1, 2010 – June 30, 2011)
•  2011 (July 1, 2011 – December 31, 2011)
• 2012 (January 1, 2012 – December 31, 2012)

 

This offer is also available to those manufacturers that anticipate failure to report for 2013 (January 1, 2013 – December 31, 2013).

 

Please note that this offer is for "amnesty from additional financial penalties the Attorney General is authorized to seek under the Law for failures to report, and from the back-payment of registration fees.  It does not apply to other violations of the [L]aw, such as gift ban violations." This offer will be open until May 1, 2014. Entities wishing to take advantage of this offer must email prescribedproducts@atg.state.vt.us on or before May 1st, and include the following information:

 

• The manufacturer's name;
• The reporting period(s) for which the manufacturer failed to report; and
•  The name, physical address, email address and phone number of the person the AG's Office  should communicate with about the unreported activity.

 

Additionally, the manufacturer would be required to execute an Assurance of Discontinuance to secure its future compliance with the Law. The AG's Office has indicated that it "does not anticipate seeking full disclosure for unreported activity." The AG's Office may, however, require disclosure of some aggregate information related to the activity at a later date.

 

This offer comes days after the AG's Office announced that it had settled with 3 manufacturers for violations of the Law. In this instance,  the manufacturers paid a total of $102,500 to the State in fees and civil penalties. Additionally, one manufacturer donated $35,000 to the Vermont Head Start Tooth Tutor Program, a program that helps provide children with access to adequate dental care. Also note that in September 2013, the AG’s Office settled with 25 manufacturers for violations of the Law. In this instance, the manufacturers paid a total of $25,250 to the State in fees; one manufacturer paid $36,000 in civil penalties to settle gift-ban violations. In both instances, each of the manufacturers self-reported and agreed to prospective compliance with the Law. With respect to both instances, the Vermont Attorney General William H. Sorrell noted that “similarly situated manufacturers that are less forthright or less cooperative will not receive such favorable treatment.”

 

 

Vermont Attorney General Settles With 25 Manufacturers for Violations of Vermont’s Prescribed Products Gift Ban and Disclosure Law

By Rakan F. Ghubej

 

The Vermont Office of the Attorney General (AG’s Office) recently filed and posted on its website Assurances of Discontinuance executed by 25 manufacturers settling violations of Vermont’s Prescribed Products Gift Ban and Disclosure Law (Law). According to the Law, manufacturers of prescription drugs, biological products, and medical devices are required to disclose to the AG's Office the value, nature, purpose, and recipient of any allowable expenditure or permitted gift. Manufacturers are also required to submit samples disclosure reports that include the product, recipient, number of units, dosage, and other information for all samples provided to Vermont health care providers.  Disclosure reports are due to the AG’s Office by April 1st of each year. According to the Law, each failure to disclose constitutes a separate violation, which may result in a civil penalty of no more than $10,000 per violation.

 

On September 23, 2013, the AG’s Office issued a press release stating that it has settled with 25 manufacturers for violations of the Law. The press release summarizes that 24 of the manufacturers failed to file disclosures entirely, and paid a total of $25,250 to the State in fees; one manufacturer paid $36,000 in civil penalties to settle gift-ban violations. The press release notes that these violations of the Law were all self-reported. According to the press release, Vermont Attorney General William H. Sorrell stated, “Similarly situated manufacturers that are less forthright and cooperative will not receive such favorable treatment.”

 

Please see the AG’s Office website to view copies of the Assurances of Discontinuance.

 

Sunshine Act Data Capture: CMS Has a Mobile App for That

By: Kerry Miele

On February 1, 2013, the Centers for Medicare and Medicaid Services (“CMS”) announced the release of the final regulations implementing the Transparency Reports and Reporting of Physician Ownership or Investment Interests section of the Patient Protection and Affordable Care Act, commonly referred to as the “Sunshine Act.” The Sunshine Act requires applicable manufacturers of covered drugs, devices, biological products, and medical supplies to report annually certain information regarding payments and other transfers of value to physicians and teaching hospitals. An additional provision requires applicable manufacturers and group purchasing organizations (“GPOs”) to report all ownership and investment interests held by physicians or members of their families. As set forth in the final regulations, applicable manufacturers and GPOs must begin data collection on August 1, 2013, and must file their first reports on March 31, 2014.

CMS  recently released two mobile applications (“apps”) to assist physicians and applicable manufacturers and GPOs with the implementation of the Open Payments program, and tracking of payments and transfers of value required by the Sunshine Act. 

The new apps, OPEN PAYMENTS Mobile for Physicians and OPEN PAYMENTS Mobile for Industry (for applicable manufacturers and applicable GPOs), were produced to ensure greater data accuracy and simplify required annual reporting. Among other things, physicians and applicable manufacturers and GPOs may utilize these apps for individual tracking of transfers of value in real-time  and to share  transfer of value information between physicians and applicable manufacturers and GPOs. Physicians are not required to report payments or transfers of value to CMS, but can use the physician targeted app to ensure accuracy of information regarding their financial relationships with industry.

CMS also posted Frequently Asked Questions regarding the functionality and usage of the apps:

http://www.cms.gov/Regulations-and-Guidance/Legislation/National-Physician-Payment-Transparency-Program/Downloads/Mobile-App-Public-FAQs.pdf. 

Additionally, for more information on the apps, please visit CMS’ Open Payments website at:

http://www.cms.gov/Regulations-and-Guidance/Legislation/National-Physician-Payment-Transparency-Program/index.html.   

Please note that CMS stated it “will not validate the accuracy of data stored in the app, nor will it be responsible for protecting data stored in the app.”  According to CMS, use of the OPEN PAYMENTS’ apps is optional and voluntary, and intended for information collection and storage purposes only. Both apps are now available for download for iOS (Apple™) and Android™ mobile phones.

Reporting Requirements for Wholesale Distributors and Manufacturers – the Onus is on You

By Frank Fazio and Heather M. Przyhocki

Pharmaceutical and device manufacturers are in a constant state of flux.  Companies are bought and sold and officers change.  Corporate offices move into bigger and better office space, or a contact individual or designated representative leaves the company.  What pharmaceutical and device companies must understand is that all of these changes must be reported to the state licensing agencies in which licenses are held at or about the time the change occurs.

 State distribution licenses are non-transferable.  They are both owner and address specific. Hence,  a change in ownership or location require new applications to be prepared and submitted.  Applications mandated by changes in ownership or location are the same as initial applications and completing them is a burdensome, time-consuming process.  The time limitations that apply to notifications related to such changes are extremely tight.  Although the timeframe to submit the change notification is short, the turnaround at the state level is not.  While a company can fully move over a weekend, it will take the states much longer to process the application and issue an updated license reflecting the new address.    

 The acquisition of a company clearly triggers change of ownership notification obligations. However, there are many other situations that may be considered a change of ownership for notification purposes.  A private company going public, a public company going private, or reorganizations of a parent and subsidiary to sister corporations are all events that may trigger change of ownership notification obligations.  Likewise, a change in corporate structure from a limited liability company to an incorporated entity may also trigger these obligations. 

 Most states require notification of changes in name, ownership, corporate officers, location, and/or designated representative within seven to thirty days.  While some states impose more stringent requirements.  For example, Georgia requires manufacturers and wholesalers to report any changes to the Board of Pharmacy prior to the change.  As per Georgia regulations, § 480-7-.03. Drug Wholesale Distribution Licensing Requirement:  “(c) Licenses become null and void upon the sale, transfer or change of mode of operation or location of the business  . . . (e) Changes in any information in this section shall be submitted to the Board prior to such change.”  In addition, most state licensing agencies require immediate notification of any disciplinary actions.  This can be problematic in the event of a merger or acquisition between publicly traded companies.

 Some states require more than written notification when a company undergoes a significant change.   For example, when a company changes its corporate officers, certain states require  a company to complete either a change in officers form and/or submit a background check/fingerprint cards for the new corporate officer(s).  Since background checks can take at least 4-6 months to process, it is crucial that companies stay proactive and are aware of these filing requirements.  To this end, notification timelines should be included in the planning process for such significant changes.  Further, corporate counsel should involve those in charge of state licensing when planning any significant corporate events.  If you have not been reporting these changes, then your company may not be compliant with state licensing requirements.

 

Sunshine Act: Reporting Food, CME, and Research…Oh My!

By Sarah Canberg

 

As the life sciences industry continues to prepare to begin collecting data on payments and transfers of value to physicians and teaching hospitals on August 1, 2013, applicable manufacturers look for clarity and guidance on the scope of information to be reported. The final Sunshine Act regulations and lengthy preamble include numerous revisions to the draft regulation.  Here, we focus on a few key special rules for reporting food and beverage in a group setting, payments or transfers of value to accredited continuing education providers, and payments for research.

 

Allocating Food and Beverage in Group Setting

The final regulations modified how applicable manufacturers are to capture and report food and beverages provided to covered recipients in a group setting.  Applicable manufacturers are to report the cost of the group meal by allocating the cost per person, not the cost per covered recipient, to each covered recipient “who partook in the meal,” which is a substantial change from the draft regulations.  For example, if an applicable manufacturer brings a platter of sandwiches to a doctor’s office that costs $150 and 5 physicians and 5 office staff members participate in the meal, the applicable manufacturer  must report the cost per person ($150/10 = $15) for each of the 5 participating physicians. This is a common sense approach to reporting meals in a group setting.

 

Exclusion of Speaker Payments for Qualifying CME Programs

In recognition of the unique and important role of industry support for accredited or certified continuing education, CMS excluded payments to speakers participating in qualifying continuing medical education (CME) programs from reporting requirements.  For speaker compensation to be excluded from Sunshine Act reporting requirements, all of the following conditions must be met:

 

(1)    the program meets the accreditation or certification requirements for continuing education of one of five specifically listed organizations (e.g., the Accreditation Council for Continuing Medical Education (ACCME));

(2)    the applicable manufacturer does not select the covered recipient speaker or even provide a distinct list of potential speakers to be considered by the CME provider; and

(3)    the applicable manufacturer does not pay the covered recipient directly.

 

If all of the above conditions are met, the payment to the covered recipient to serve as a speaker at the qualifying CME program will not be subject to reporting.  On the other hand, if the above conditions are not met, such payment must be reported under the either of the appropriate nature of payment categories:

 

• “Compensation for serving as faculty or as speaker for an accredited or certified continuing education program,” or

• “Compensation for serving as a faculty or as a speaker for a unaccredited non-certified continuing education program.” 

 

Special Rules for Reporting Research

Following the publication of the draft Sunshine Act regulations in December 2011, the lack of clarity surrounding the reporting of research payments caused confusion and concern throughout the life sciences industry.  With the release of the final regulations, CMS’ substantial modification of reporting requirements for research-related payments reflected thoughtful revisions aimed at capturing the actual payment stream for research. 

 

In the final regulations, CMS removed the requirement for the applicable manufacturer to indicate whether the payment was direct or indirect, which was a source of much of the confusion in the draft regulations and concern that many payments would be double reported.  Instead, the final regulations require that research payments be reported separately from other reportable payments and transfers of value.  Further, research payments are to be reported as a single payment including the name of the individual or entity that actually received the payment for the research services and indicating the principal investigator(s) of the applicable research payment.  For example, if an applicable manufacturer provides payment to a CRO, and the CRO provides the payment to the academic institution conducting the research that involves Dr. John Smith as the principal investigator, the applicable manufacturer will report the payment as a single payment to the academic institution and include Dr. John Smith as the Principal Investigator in that single reportable interaction.  The final regulations require specific information to reported regarding the research payment, such as the name of the research study and the names of the related covered product (and National Drug Code if a drug or a biological), but also provides the option for the applicable manufacturer to provide context for the research payment.

 

While the regulations set forth the data elements that must be collected and reported for each of the above interactions, we look forward to reviewing the report layout, especially as related to the section for research-related payments.

 

For additional information on the Sunshine Act and to view a copy of the final regulations as released by CMS on February 1, 2013, please see visit the Federal Register website. 

 

Don't forget to check out yesterday's post for The Who and the What of the Sunshine Act Regulations.

The Who and the What of the Sunshine Act Regulations

By Sarah Canberg

With the long awaited Sunshine Act final regulations in hand, members of the life sciences industry continue to sift through the 285 page regulatory tome to parse out the regulatory reporting requirements that resulted from Centers for Medicare & Medicaid Services’ (CMS) consideration of over 373 comments from medical professionals and organizations, industry members and organizations, consumers, and others. While we do not attempt to summarize the entirety of the final regulations here, we highlight a few key changes to definitions and modifications to reporting requirements.

 

The Who

The first step for many in the life sciences industry is an evaluation of whether their company has an obligation to comply with the Sunshine Act.  In making this determination, the company must determine if their operations fall within the definition of an “applicable manufacturer” of a “covered drug, device, biological, or medical supply” which is operating in the United States.  The final regulations provide clarification and details regarding these two key definitions.

 

“Applicable Manufacturer”

Here, we highlight a few noteworthy clarifications included in the preamble regarding the scope of who is included and excluded within the definition of “applicable manufacturer.”  The regulatory definition of applicable manufacturer includes distributors and wholesalers that take title to a covered drug, device, biological or medical supply.  As a result, these entities are subject to the reporting requirements.  While distributors that do not take title to covered products do not fall within the definition of applicable manufacturer and are not subject to reporting.  It is important to note that distributors that qualify as “applicable manufacturers” have an independent obligation to submit reports pursuant to the Sunshine Act. 

 

The final regulations confirm the “all in” concept that requires a company that falls within the definition of an applicable manufacturer to report all payments or transfers of value to covered recipients regardless of whether the payments are related to covered products.  Yet, the final regulations provide that if an applicable manufacturer has less than 10% of its total (gross) revenue from covered drugs, devices, biologicals or medical supplies during the previous fiscal year, then the applicable manufacturer may report payments or other transfers of value related only to its covered products.

 

Further, if an applicable manufacturer has separate operating divisions that do not produce covered products (the example provided is an animal health division), the final regulations state that such divisions will only be required to report payments or other transfers of value related to the company’s covered products.

 

“Covered Drug, Device, Biological or Medical Supply”

The definition of “covered drug, device, biological or medical supply” includes two parts: (1) a drug, device biological or medical supply for which payment is available under Medicare, Medicaid, or CHIP, either separately or a bundled payment), and, if a drug or biological, requires a prescription, or, if a device, requires premarket approval or premarket notification to the FDA.  To  qualify as a “covered drug, device, biological or medical supply,” the product must satisfy both parts of this definition.

 

The What

“Indirect Payments or Other Transfers of Value”

In response to comments seeking clarification on which indirect payments or transfers of value are subject to the exclusion and which must be reported, CMS confirms that some indirect payments will be subject to reporting.  Specifically, the statutory exclusion of indirect payments turns upon the whether or not the applicable manufacturer is aware of the covered recipient of such payment.  If the applicable manufacturer is aware of the identify of the covered recipient, then the payment or transfer of value must be reported. In the preamble to the final regulations, CMS notes that excluding from the reporting requirements all payments made through a third party would create a  significant loophole by allowing manufacturers to funnel payments through a third party and not report them; such a loophole would significantly undermine the intent of the reporting requirements.  (pg. 28)

 

CMS further clarifies that if a covered recipient requests that an applicable manufacturer make a payment to a third party, and the third party then provides the payment to the covered recipient, the applicable manufacturer has an obligation to report such indirect payment or transfer of value against the covered recipient. This example of a reportable indirect payment differs from the situation where an applicable manufacturer provides a payment to a third party, and the third party provides a payment to a covered recipient without the applicable manufacturer’s knowledge or direction, which would fall within the indirect payment exclusion. For example, if an applicable manufacturer makes a payment to a consulting firm and, unbeknownst to and without direction from the applicable manufacturer, the consulting firm employs and pays a physician to work on the project, the applicable manufacturer would have no obligation to report such indirect payment from a third party to a covered recipient.

 

Be sure to visit our blog later this week for further analysis and discussion highlighting key provisions in the final regulations.

 

For additional information on the Sunshine Act and to view a copy of the final regulations as released by CMS on February 1, 2013, please see visit the Federal Register website. 

Amnesty! Courtesy of the Vermont Attorney General's Office!

Pursuant to Vermont's Prescribed Products Gift Ban and Disclosure Law (Law), manufacturers of prescription drugs, biological products and medical devices are required to disclose annually to the Attorney General’s Office (AG's Office) the value, nature, purpose, and recipient of any allowable expenditure or permitted gift. On September 6, 2012, the AG’s Office sent a memorandum to manufacturers of medical devices and biologics offering limited amnesty to those “whose obligation to comply with the [Law] began on or after July 1, 2009 but who failed to report their activities in any of the following reporting periods: FY10 (7/1/09-6/30/10), FY11 (7/1/10-6/30/11), or 2011 (7/1/11-12/31/11).” Notably, this offer is limited to amnesty from the “financial penalties the [AG’s Office] is authorized to seek under the Law for failure to report, and does not apply to back-payment of registration fees or penalties for other violations of the law, such as gift ban violations.”

In order to take advantage of this offer of limited amnesty, manufacturers of  medical devices or biologics must email prescribedproducts@atg.state.vt.us on or before October 1, 2012, with the following information:

•    The manufacturer’s name;
•    The reporting period(s) for which the manufacturer failed to report; and
•    The name, physical address, email address and phone number of the person with whom the AG’s Office should communicate with about the unreported activity.

The AG’s Office has indicated that it “does not anticipate seeking full disclosure for unreported activity[.]” The AG’s Office does, however, “anticipate requiring disclosure – at a later date –  of some aggregate information related to the activity.” Also note that the AG’s Office may seek to execute an Assurance of Discontinues “to secure a manufacturer’s future compliance with the law notwithstanding that manufacturer’s acceptance of the offer of limited amnesty.”

Let the Sunshine In!

On Wednesday, September 12, 2012, Senator Herb Kohl, Chairman of the U.S. Senate Special Committee on Aging, will convene a roundtable discussion entitled “Let the Sunshine In: Implementing the Physician Payments Sunshine Act.”  The “Sunshine Act” provisions of the Patient Protection and Affordable Care Act requires drug, device, biological product, and medical supply manufacturers to report annually certain information regarding payments and other transfers of value to physicians and teaching hospitals. An additional provision requires manufacturers and group purchasing organizations (GPOs) to report all ownership or investment interests held by physicians or members of their family. Further, the Secretary of the Department of Health and Human Services is required to establish procedures for making reported information publicly available through an Internet website.

 According to a press release issued by the U.S. Senate Special Committee on Aging, the roundtable discussion will focus on “how these payments will be made available to the public, the complexities of reporting and collecting payments, and how to engage stakeholders in implementing the law.” The roundtable will be moderated by Dr. Mark McClellan, Director of the Engelberg Center for Health Care Reform at the Brookings Institution. Senator Charles Grassley, co-author of the Sunshine Act, is expected to participate in the discussion, as well as the Centers for Medicare and Medicaid Services (CMS) and a wide range of stakeholders. The following individuals are also expected to participate (subject to changes):

 

- Niall Brennan, Director in the Policy and Data Analysis Group, Centers for Medicare and Medicaid Services (CMS), Washington, D.C.

- Dr.  Jeremy A. Lazarus, President, American Medical Association, Chicago, Ill.

- Dr. Douglas Peddicord, Executive Director, Association of Clinical Research Organizations (ACRO), Washington, D.C.

- Dr. Daniel Carlat, Project Director, Pew Charitable Trusts, Washington, D.C.

- Dr. James H. Scully, Jr., Medical Director and CEO, American Psychiatric Association, Arlington, Va.

- Dr. Charles Rosen, Clinical Professor of Orthopedic Surgery, University of California, Irvine School of Medicine, Orange, Calif.

- Elizabeth O’Farrell, Senior Vice President of Policy and Finance, Eli Lilly and Co., Indianapolis, Ind.

- Diane Biagianti, Vice President, Chief Responsibility Officer, Edwards Lifesciences, Irvine, Calif.

 

In December 2011, CMS issued a notice of proposed rulemaking announcing the publication of draft regulations to implement the Sunshine Act. Although the Sunshine Act requires manufacturers and GPOs to begin collecting data starting January 1, 2012, CMS has indicated that it will not require data collection by applicable manufacturers and applicable GPOs before January 1, 2013. Both Senators Kohl and Grassley have publicly expressed their disappointment in delaying implementation of the Sunshine Act. Senator Grassley has noted that “consumers need to know more about the financial relationships between their doctors and drug companies sooner rather than later,” and expressed that it is “important that CMS get this right in every way, including the usefulness and accuracy of the information.” Senator Kohl also noted his disappointment with the delay, but looks forward to “working with CMS to finalize the rules so that data collection can begin in January 2013.”

 

The roundtable discussion will take place on Wednesday, September 12^th at 2:30 p.m. at the following location:

 

Dirksen Senate Office Building, Room 562

First Street and Constitution Avenue, NE

Washington, D.C. 20510