Pharmaspective

CMS Will Hold a Conference Call on Wednesday, May 22 to Discuss the National Physician Payment Transparency Program

By Nancy A. Henshaw

The Centers for Medicare and Medicaid Services (CMS) is continuing its efforts to inform interested parties on its National Physician Payment Transparency Program (Program). The Program implements 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. 

 

On Wednesday, May 22, 2013, CMS will hold a conference call to discuss the Program. The target audience for this conference call are physicians and teaching hospitals. The conference call will provide an overview of the final regulations, a review of key dates for the Program, the role of physicians and teaching hospitals in the Program, and resources available to physicians and teaching hospitals.

 

As defined in the final regulations, a “teaching hospital” is “any institution that received a payment under 1886(d)(5)(B), 1886(h), or 1886(s) of the Act during the last calendar year for which such information is available.” CMS recently posted the list of teaching hospitals on its National Physician Payment Transparency Program: Open Payments website. This list identifies hospitals that are considered “teaching hospitals” under the Sunshine Act. Additionally, for the purposes of the Sunshine Act, the term “physician” includes the following practitioners who are legally authorized to practice by the State in which they practice:

 

• Doctors of Medicine
• Doctors of Osteopathy
• Dentists
• Podiatrists
• Optometrists
• Chiropractors

 

The conference call will be held on Wednesday, May 22nd from 2:30 to 4:00 p.m. Interested parties may register for the conference call by visiting CMS’ website:

 

http://goo.gl/0bg8T

 

CMS has indicated that the presentation for the conference call will be posted on its website at least one day prior to the call, and will be emailed to registrants on the day of the call.

CMS Posts Revised Templates For Data Collection and Submission of Reports Required By the Sunshine Act

By Rachael Garrison

The Centers for Medicare and Medicaid Services (CMS) is continuing its efforts to quickly implement 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.

On February 1, 2013, CMS announced the release of the final regulations implementing Sunshine Act. CMS also released proposed templates for data collection and submission of reports required by the Sunshine Act. Interested parties were permitted to submit comments on the proposed templates by April 9, 2013. CMS recently posted on its website the following revised templates for data collection and submission of reports required by the Sunshine Act:

• General Payments (Non-Research) Template;

• Physician Ownership Template; and

• Research Payment Template.

In addition to the revised templates, CMS also posted a “Revisions Crosswalk” document, which outlines the changes and additions that were made to the proposed templates and the reason for such changes and additions. Although the revised templates are currently undergoing final clearance, CMS has indicated that it intends to use the revised templates for 2013 data collection. 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 Publishes List of Teaching Hospitals Subject to Reporting Under the Sunshine Act

By James E. Squier

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.

 

As defined in the final regulations, a “teaching hospital” is “any institution that received a payment under 1886(d)(5)(B), 1886(h), or 1886(s) of the Act during the last calendar year for which such information is available.” In order to assist applicable manufacturers in identifying teaching hospitals, CMS stated that it will publish a list “at least 90 days before the beginning of the reporting year, or for the first reporting year, at least 90 days prior to the start of data collection.” As set forth in the final regulations, applicable manufacturers must begin data collection on August 1, 2013, and must file their first reports on March 31, 2014.

 

CMS recently posted the list of teaching hospitals on its National Physician Payment Transparency Program: Open Payments website. This list identifies hospitals that are considered “teaching hospitals” under the Sunshine Act. This list is to be used for payments and transfers of value made in 2013, to be reported to CMS by March 31, 2014. The teaching hospital list will assist applicable manufacturers in determining which payments must be reported and provides address information and a tax ID for each hospital. For future reporting years, a list of teaching hospitals will be posted on October 1st of each year.

 

In addition to the list of teaching hospitals, CMS has also updated its website to include a “Key OPEN PAYMENTS Activities” section. The section identifies ten key activities “that must happen on time so that 2013 OPEN PAYMENTS program cycle is successful” and information about the status of each. With respect to the report templates, CMS states that the 2013 reporting period data collection templates “are currently undergoing final public and federal clearance and therefore are subject to change. We anticipate that any changes that may arise will be minimal, and should not impact applicable manufacturer’s and applicable GPO’s ability to establish internal systems necessary to adhere to the OPEN PAYMENTS submission requirements.” Templates for future reporting periods will also be posted on October 1st of each year.

Musings From TEDMED 2013

By Scott S. Liebman

TEDMED is some creative combination of industry conference, Broadway production, nerd fest (me included), and health food store. The marble walls; the bright red carpet; the bronze bust of JFK at the Center for Performing Arts named in his honor: I felt like a tourist at the registration table. That feeling, however, subsided as soon as I entered The Hive—the designated social and exhibit area set up to buzz with the community’s brainpower and energy. After two and a half days, I rode the Acela home to New York City feeling not only that I experienced healthcare innovation in progress, but also that I had uncovered an urgent demand for greater problem solving in healthcare-aligned industries like my own.*

 

If it isn’t clear from the line-up of influential professionals, let me emphasize that TEDMED is all about the people. This concept hit home for me when I realized that, at a restrictive 15-20 minutes, the presentations by impressive, accomplished thinkers for their equally ambitious and effective audiences seemed to have been processed into intellectual junk food.   But the concentration of all these overall great people makes the conversations that take place in the hallway, inside The Hive, at dinner, and even on the walk back to the hotel truly remarkable. Brilliant. Inspiring. I am not the first to make this observation. TEDMED calls this unstructured but invaluable meld of delegates the “unexpected connections.” Admittedly, I laughed when I saw that tagline, but, in all frankness, my experience validates its premise.

 

Among the all-star scientists and caregivers, I still found a void in the conference. Actually, it was more of a missing link. Laws and regulations so often mold the healthcare system, especially with the ongoing implementation of the Patient Protection and Affordable Care Act (PPACA). Yet, the PPACA was barely discussed, if at all. TEDMED has done a stellar job providing a public platform for healthcare innovation. But from my experience in the compliance industry, I know that innovation can only work with the support of and within the confines of laws and regulations. Now, more than ever, PPACA is necessitating structural innovation. There was no discussion of Accountable Care Organizations or Healthcare Insurance Exchanges, which are just two areas in need of major innovation.  In fact, they are in their infancy and require the smartest and best minds of our generation—the TEDMED Community—to invest time and energy.  Both of these areas will have significant impact on the American healthcare system.  If we get these wrong, the consequences will be far and wide; but if we get them right, we will all benefit.  These areas require innovation that would affect everyone at the Kennedy Center for TEDMED and many that watched from home.

 

On the train back home, while I thought about all I had experienced in my half-week long trip to a healthcare-industry oasis, a fellow TEDMEDster asked if I would attend next year. The answer: yes. For one reason and one reason only: the people.

 

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* For substantive comments or great ideas presented at TEDMED 2013, follow my Twitter feed @ScottLiebmanPLS.

 

CMS Is Accepting Comments on the Proposed Templates for Data Collection and Submission of Reports Required By the Sunshine Act

By Monica Aurelien

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.

In addition to the final regulations, CMS also released the following proposed templates for data collection and submission of reports required by the Sunshine Act:

• Non-research Payment Template;
• Physician Ownership Template; and
• Research Payment Template.

 

CMS is currently accepting comments on the proposed templates. Interested parties may submit their comments electronically to:

http://www.regulations.gov/#!documentDetail;D=CMS-2013-0052-0001

Comments may also be submitted via regular mail to the following address:

CMS, Office of Strategic Operations and Regulatory Affairs
Division of Regulations Development
Attention: Document Identifier/OMB Control Number CMS – 10419
Room C4–26–05
7500 Security Boulevard
Baltimore, Maryland 21244–1850

Comments must be submitted by April 9, 2013, to assure consideration.

OPDP Restructures Again: Promotional Review By Therapeutic Area Instead of Audience

By Kim C. Capone

According to a recent FDA announcement, the Office of Prescription Drug Promotion (OPDP) is restructuring its review process. OPDP currently reviews and analyzes its workload and review processes through two divisions: the Division of Consumer Drug Promotion, and the Division of Professional Drug Promotion. According to the March 8 announcement, pending final approval, OPDP will rename and restructure its divisions to oversee different therapeutic classes of drugs.

 

The divisions will be renamed and organized as follows:

The Division of Advertising and Promotion Review I:

- Neurology, Psychiatry

- Hematology/Oncology (blood cancers)

- Oncology (solid tumors)

- Analgesics, Anesthetics, Antivirals

 

The Division of Advertising and Promotion Review II:

- Osteoporosis, Reproductive, Urology

- Dental, Dermatology, Metabolic & Endocrine

- Allergy, Gastroenterology, Pulmonary, Rheumatology

- Anti-Infective, Cardiovascular, Medical Imaging,

- Ophthalmology, Renal, Transplant

 

According to Janet Woodcock, Director of the Center for Drug Evaluation and Research (CDER), "As a way to distribute the work evenly, each division will oversee different therapeutic classes of drugs. These changes will allow OPDP to review direct-to-consumer (DTC) and health professional advertising more effectively."

Minnesota Legislature Proposes to Repeal the Annual Disclosure Requirement for Wholesale Drug Distributors and Manufacturers

By Jenna Gervasio

Minnesota law [Minn. Stat. § 151.47(f)] currently requires wholesale drug distributors and manufacturers to report annually to the Minnesota Board of Pharmacy (Board) all "payments, honoraria, reimbursement or other compensation" permitted under the gift prohibition statute and provided to practitioners during the previous calendar year.  On March 5, 2013, the Minnesota Senate introduced Senate Bill 1081 (SB 1081), which would repeal this section of the law.

 

The introduction of SB 1081 comes almost two months after the Board indicated in a letter that it will not require wholesale drug distributors and manufacturers to submit annual disclosure reports for the 2012 calendar year. The Board’s letter noted that the Sunshine Act provisions of the federal Patient Protection and Affordable Care Act (Sunshine Act) preempts state laws that require manufacturers to report the same information required by the federal law. Since the Board requires wholesale drug distributors and manufacturers to report most of the information required by the Sunshine Act, the Board indicated that it will not require these entities to report data for the 2012 calendar year. In this letter, the Board also noted that it intended to ask the Minnesota Legislature to repeal section 151.47(f) of the law.

 

SB 1081 would not repeal the gift ban [Minn. Stat. § 151.461], which prohibits wholesale drug distributors and manufacturers from offering or giving any gift to a practitioner in excess of $50 per calendar year.

 

On Friday, February 1, 2013, the Centers for Medicare & Medicaid Services (CMS) announced the much anticipated release of the final regulations implementing 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.

 

Understanding the Global Transparency Landscape: The Beginning of An Ongoing Journey

By Brian P. Sharkey

The quest for transparency in the relationships between life sciences companies and healthcare professionals has become a global movement, as companies are beset by a multitude of obligations designed to make public their interactions with their customers.  Effectively managing those obligations while concurrently ensuring compliance with the growing body of international transparency requirements and anti-corruption legislation is a significant challenge to the continued growth and success of life sciences companies.

 

For a number of years, pharmaceutical companies doing business in the United States have dealt with a host of states that impose limits and reporting obligations on interactions with healthcare professionals.  Device companies were brought into the fray more recently when several states expanded the applicability of their laws.  However, the past two years have seen the rise of transparency challenges throughout the world.  Two countries, France and Slovakia, have enacted laws similar to the US Sunshine Act.  In other countries, reform is taking place through industry codes enacted by the relevant industry association.  Pharmaceutical industry codes including reporting requirements have been enacted in a number of countries, including, significantly, the Netherlands, the United Kingdom, Japan, and Australia.  The transparency trend has not affected the medical device industry as much yet, as medical device industry associations have yet to impose reporting requirements in their codes.

 

It is widely anticipated that numerous countries will join this growing trend.  The key question for the life sciences industry is whether reporting requirements will be imposed through governmental action or voluntary industry self-regulation.  Although a self-regulatory solution would likely be more consistent and efficient than a plethora of disparate legislative obligations, in either case it is imperative for life sciences companies to monitor which approach is adopted in individual countries and regions.

 

Another transparency challenge facing the life sciences industry is the burgeoning body of anti-corruption laws.  Although these laws are distinct from the transparency codes and laws, in no small part because violations can lead to criminal penalties, anti-corruption laws relate to transparency requirements in two ways:  1) both are aimed at rooting out corruption and reducing the cost of doing business; and 2) the increase in transparency reporting can provide ammunition to prosecutors in seeking indictments.

 

The purpose of this post is not to explore these global challenges; rather, it is to introduce these issues to our loyal readers and outline how we will be addressing them going forward.  We envision periodic posts about these types of global compliance issues –for example, we may highlight the transparency requirements in Australia’s pharmaceutical industry code; or discuss the United Kingdom’s Bribery Act; or analyze Eucomed’s White Paper on transparency issues.  Unfortunately for companies in the life sciences industry, the possibilities for topics that we can cover is endless.  We intend to do our best to span the globe and keep you informed about the latest news and trends in this evolving area, and we welcome your feedback about how you may dealing with these challenges.

 

An Update From CMS on the Sunshine Act…Draft Templates!

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 final rule was published in the Federal Register today, and will become effective on April 9, 2013.

 

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.

 

In preparation for reporting, CMS has posted on their website the following proposed templates for data collection and submission of reports required by the Sunshine Act:

 

-  Non-Research Payment Template;

-  Physician Ownership Template; and

-  Research Payment Template

 

Additionally, CMS has set up a “National Physician Payment Transparency Program: OPENPAYMENTS” website. This website will provide ongoing information and updates on the Sunshine Act, including:

 

- General information

- Fact sheets

- Tools and instructions

- Resources

- Dates of webinars, calls and meetings

- Frequently asked questions

 

Stay tuned!

 

Don't forget to check out our other posts regarding the Sunshine Act Final Regulations:

The Who and the What of the Sunshine Act Regulations,Sunshine Act: Reporting Food, CME, and Research...Oh My! and Sunshine Act: Indirect Payments: Reportable or Excluded?

FDA May Change Regulations to Allow Generics to Change their Product Warnings

By Frank Fazio and Genevieve Spires

@frankfaziopls    @gmspires

A single footnote in a brief filed by the Department of Justice has garnered a lot of attention this week, and understandably so.  The footnotes states: “This office has been informed that FDA is considering a regulatory change that would allow generic manufacturers, like brand-name manufacturers, to change their labeling in appropriate circumstances. If such a regulatory change is adopted, it could eliminate preemption of failure-to-warn claims against generic-drug manufacturers.”

The background of this statement is complex, but briefly, the United States Supreme Court ruled last year that plaintiffs claiming injuries as a result of their use of generic drugs may not sue generic manufacturers for their failure to warn of an alleged drug-related danger.  In deciding this, the Court found that these claims are preempted – and therefore barred – by federal law, largely because generic manufacturers are not permitted to make changes to their product labels under the current regulatory scheme (even in cases where they think stronger warnings are needed).

Under current FDA regulations, generic manufacturers cannot unilaterally update their product labeling.  Only brand-name manufacturers have the ability to update warnings on product labeling and must get FDA approval to make those changes.  Generic manufacturers are required to adopt the warnings of their  brand-name counterpart.

Any change in regulations to allow generics to change their labels will undoubtedly reopen the litigation floodgates and result in a slew of failure to warn cases being brought against generic drug manufacturers.   Likewise, such a rule can result in inconsistencies in warning information on the same drug which can certainly result in increased liabilities for those companies who fall behind in regard to labeling updates adopted by competitors.  And while we do not know the source of the information referenced in the DOJ brief, we will definitely stay tuned to see if Congress takes steps to alter the generic drug label regulatory scheme.