Tag Archives: pharmaceutical industry

Physician Payment Sunshine Act Deadline is Here-Are You Ready?

GFI Blog LabelBy George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law and Lance O. Leider, J.D., The Health Law Firm

As of August 1, 2013, the Physician Payment Sunshine Act (Sunshine Act) goes into effect. The Sunshine Act, contained in Section 6002 of the Patient Protection and Affordable Care Act (PPACA), is designed to highlight the financial relationship between doctors and the manufacturers of medical devices and pharmaceuticals. The act requires that light be shined on the payments being made to physicians by pharmaceutical and medical device manufacturers, bringing these out into the “sunshine.”

Some of the items tracked include gifts worth more than $10, five-star dinners, trips, money paid to physicians for speaking engagements, etc. The medical device and pharmaceutical manufacturers will be responsible for reporting the figures to the Centers for Medicare and Medicaid (CMS). However, it’s important that physicians keep their own records to verify the accuracy of the reports.

To read a summary of the Sunshine Act, click here.

What Has to be Reported and What Does Not Have to Be Reported.

All manufacturers of pharmaceuticals and medical devices will have to disclose how much money they pay physicians and hospitals in cash and gifts, as well as how much stock doctors and their families own in the particular manufacturer’s company.

As required by law, this information will be published by CMS starting in September 2014. There are several reporting exceptions, such as gifts less than $10, drug samples for patients and educational materials given to patients, according to a Huffington Post article.

To read the entire Huffington Post article, click here.

Physicians Need to Track Their Records.

The burden of collecting and reporting data will be the responsibility of the manufacturers of medical devices and pharmaceuticals, but physicians are encouraged to keep their own records. They will have 45 days to review disclosures and seek corrections if they dispute what is being reported. According to Modern Healthcare, CMS will not mediate disagreements but will note if a figure is being disputed.

Physicians can register with CMS starting January 1, 2014, to receive a consolidated report on activities each June for the prior reporting years.

To read the Modern Healthcare article, click here.

Helpful Resources for Physicians.

The Sunshine Act affects all physicians with a current medical license. The American Medical Association (AMA) has a “Physician Sunshine Act Tool Kit” available on its website to help physicians navigate the Sunshine Act changes. The AMA is also working on tools to aid physicians in talking with their patients about the transactions included in the new Sunshine Act database. Click here to access the AMA’s Physician Sunshine Act Tool Kit.

CMS is holding a national provider conference call on August 8, 2013. Doctors of medicine, osteopathy, chiropractic medicine, dentistry, dental surgery, optometry and podiatry are encouraged to participate and ask questions. CMS also recently introduced a free mobile app called “Open Payments Mobile for Physicians.” The app will help physicians and businesses track financial relationships.

Contact Health Law Attorneys Experienced in Representing Health Care Professionals.

The Health Law Firm routinely represents pharmacists, pharmacies, physicians, nurses and other health providers in investigations, regulatory matters, licensing issues, litigation, inspections and audits involving the Drug Enforcement Administration (DEA), Federal Bureau of Investigation (FBI), Department of Health (DOH) and other law enforcement agencies. Its attorneys include those who are board certified by The Florida Bar in Health Law as well as licensed health professionals who are also attorneys.

To contact The Health Law Firm, please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

Comments?

What are your concerns about the Sunshine Act? Are you ready for the law to go into effect? How have you prepared for the Sunshine Act? Please leave any thoughtful comments below.

Sources:

Robeznieks, Andis. “Reform Update: Aug. 1 Brings Deadline to Report Physician Payments.” Modern Healthcare. (July 29, 2013). From: http://www.modernhealthcare.com/article/20130729/NEWS/307299967/reform-update-aug-1-brings-deadline-to-report-physician-payments

Aronfeld, Spenser. “Here Comes the Sunshine Act – And It’s All Right.” Huffington Post. (July 16, 2013). From: http://www.huffingtonpost.com/spencer-aronfeld/here-comes-the-sunshine-act_b_3595394.html?view=print&comm_ref=false

Lasher Todd, Heather. “AMA Reminds Physicians: Sunshine Act Reporting Starts This Week.” American Medical Assocations. (July 30, 2013). From: http://www.ama-assn.org/ama/pub/news/news/2013/2013-07-30-sunshine-act-reporting-this-week.page

About the Authors: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

Lance O. Leider is an attorney with The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com  The Health Law Firm, 1101 Douglas Avenue, Altamonte Springs, Florida 32714, Phone:  (407) 331-6620.

“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.
Copyright © 1996-2012 The Health Law Firm. All rights reserved.
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Supreme Court Rules that Government Regulators Can Sue Over Pay-for-Delay Agreements Between Brand and Generic Drug Manufacturers

George F. Indest III, Board Certified by The Florida Bar in Health Law

George F. Indest III, Board Certified by The Florida Bar in Health Law

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

The U.S. Supreme Court ruled on June 17, 2013, that pay-for-delay agreements between brand name and generic drug manufacturers are subject to anti-trust scrutiny. These pay-for-delay agreements, or reverse payments, are usually a form of settlement between the two manufacturers in patent litigation. The Supreme Court decided that each instance must be considered on a case-by-case basis. This verdict rewrites the rules governing the release of generic drugs. It is likely to increase the number of generic drugs in the marketplace and reduce the price of generic drugs.

To read a previous blog on pay-for-delay agreements, click here.

What is a Pay-for-Delay Agreement?

Pay-for-delay agreements came as the result of the Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch-Waxman Act. The Hatch-Waxman Act gives generic drug manufacturers an incentive to challenge brand name drug patents because the first generic drug manufacturer to received U.S. Food and Drug Administration (FDA) approval to launch a generic copy of a brand name drug can receive a 180-day marketing exclusivity period for the product. The FDA cannot approve any other generic applications for the same drug until the first-to-file generic manufacturer has sold its product for 180 days or has given up its exclusivity period. Click here to read the Hatch-Waxman Act.

Brand name manufacturers often challenge generic drug manufacturers who try to sell their product prior to patent expiration. This results in litigation to determine whether the generic manufacturer is violating the brand name manufacturer’s patents.

Instead of going to court over this, brand name manufacturers often choose to pay a settlement to the generic drug manufacturers for agreeing to delay the launch of its competing product.

Why the Supreme Court Overruled Court of Appeals Decision.

The 5-3 vote overruled the 11th Circuit Court of Appeals decision that said pharmaceutical companies can’t be sued unless the patent litigation is a sham or a generic drug maker agrees to delay introduction of a generic drug into the market even after the patent has expired.

A Med Page Today article lists the Supreme Court’s five reasons why the appellate court made a mistake in giving blanket immunity to pay-for-delay agreements from the decision written by Justice Stephen Breyer:

–  “A reverse payment, where large and unjustified, can bring with it the risk of significant anticompetitive effects.”

–  “One who makes such a payment may be unable to explain and to justify it.”

–  “Such a firm or individual may well possess market power derived from the patent.”

–  “A court, by examining the size of the payment, may well be able to assess its likely anticompetitive effects along with its potential justifications without litigating the validity of the patent.”

–  “Parties may well find ways to settle patent disputes without the use of reverse payments.”

Click here to read the entire Med Page Today article.

Pay-for-Delay Agreements Allegedly Cost Patients Millions of Dollars a Year.

According to Bloomberg, the high court’s decision may discourage brand name and generic pharmaceutical companies from reaching settlements. It’s been found that pay-for-delay agreements can delay a generic drug almost 17 months before it can be put on the market. In the meantime, patients must pay higher prices for the brand name version. This also impacts Medicare and Medicaid programs. The Federal Trade Commission (FTC) claims pay-for-delay agreements cost consumers $3.5 billion a year in the form of higher drug prices.

To read the Bloomberg article, click here.

The Case of the FTC v. Solvay Pharmaceuticals.

The Supreme Court case center around AndroGel, a treatment for low testosterone in men, made by Solvay Pharmaceuticals, Inc. The FTC sued Solvay and three generic drug companies. According to Bloomberg, the FTC said that a payment made by Solvay, the holder of a patent on AndroGel, to the generic drug manufacturers represented an unlawful restraint of trade because it was intended to keep cheaper, generic versions of AndroGel off the market until 2020.

FTC Enthusiastic About the Decision.

In a statement, the FTC Chairwoman said the Supreme Court’s decision is a “significant victory for American consumers, American taxpayers and free market.” She also stated, “The court made it clear that pay-for-delay agreements are subject to antitrust scrutiny.”

Click here to read the full statement from the FTC.

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

The Health Law Firm represents pharmacists and pharmacies in investigations, regulatory matters, licensing issues, litigation, inspections and audits. The firm’s attorneys include those who are board certified by The Florida Bar in Health Law as well as licensed health professionals who are also attorneys.

To contact The Health Law Firm please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

Comments?

What do you think of the Supreme Court’s ruling? Do you agree or disagree? What effect do you think it will have on the pharmaceutical industry? Please leave any thoughtful comments below.

Sources:

Stohn, Greg. “Drugmakers Opened to ‘Pay for Delay’ Suits by High Court.” Bloomberg. (June 17, 2013). From: http://www.bloomberg.com/news/2013-06-17/drugmakers-opened-to-pay-for-delay-suits-by-high-court.html

Frieden, Joyce. “Supreme Court Split on Pharma ‘Pay for Delay’ Deals.” Med Page Today. (June 17, 2013). From: http://bit.ly/18SfhKb

Kaplan, Peter. “Statement of FTC Chairwoman Edith Ramirez of the U.S. Supreme Court’s Decision in FTC v. Actavis, Inc.” (June 17,2 013). From: http://www.ftc.gov/opa/2013/06/actavis.shtm

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.
Copyright © 1996-2012 The Health Law Firm. All rights reserved.