Life Science Compliance Update

September 29, 2016

Prescriber Education Campaign on Opioids Launched


We have been hearing for years about the opioid crisis our country is facing, a crisis that was partially brought about by abuse of prescription pain relievers. From Congressional investigations, to Executive branch actions, to a letter from the Surgeon General, many of our country’s leaders are concerned about the epidemic and are constantly trying to craft solutions.

The Partnership for Drug-Free Kids, an organization committed to helping families struggling with their son or daughter’s substance abuse, created the “Search and Rescue” campaign, a prescriber education campaign developed with support from the Food and Drug Administration (FDA) that gives healthcare providers the resources they need to prescribe opioids responsibly and prevent the misuse and abuse of medicine in their practices. The campaign was piloted in Maryland and Rhode Island in 2014, and expanded to six states in 2015. On September 15, 2016, the Partnership for Drug-Free Kids announced the national launch of the campaign.

The goal of the “Search and Rescue” campaign is to equip prescribers with skills to be proactive in identifying and helping patients at risk for prescription drug abuse. The campaign will attempt to connect prescribers to training, information, and resources that can help educate them, and the FDA encourages them to share the educational content with their peers.

FDA and Partnership Comments on “Search and Rescue”

Dr. Janet Woodcock, the Director of the FDA’s Center for Drug Evaluation and Research (CDER), is, along with the FDA, “proud to support this campaign to educate and inform providers about the risks of addiction and the misuse and abuse of opioids in their efforts to treat their patients’ pain responsibly and prevent the misuse and abuse of these drugs.” She further noted, “educating the healthcare community on appropriate prescribing of prescription opioid medications is a cornerstone of the FDA’s Opioid Action Plan, and continues to be a top priority for the agency, as well as for the Department of Health and Human Services (HHS) and across the federal government.”

According to Marcia Lee Taylor, President and CEO of the Partnership, “Today’s opioid epidemic has reached alarming and tragic proportions, with 78 opioid overdose deaths occurring daily in the United States. Addressing this dire national problem requires a multi-pronged approach, involving parents, educators, community leaders, treatment professionals and healthcare providers. The Partnership is proud to apply its communications expertise to the challenge of reaching and helping educate prescribers, who can and must be a huge part of the solution.”

The Website

The Search and Rescue website offers many resources for providers, including information on each state’s PDMP, brief educational videos, a database with accredited CME/CE REMS-compliant activities, an opioid risk assessment, links to a SAMHSA treatment locator to help patients find a local opioid treatment program, and a quick fact sheet for prescribers. 

Other Ways Search and Rescue is Helping

The “Search and Rescue” campaign makes innovative use of social media, optimized search, and earned media to reach family physicians, physician assistants and nurse practitioners, focusing on sending them to the website to learn more.

The Partnership is working with other national organizations, including the American Medical Association Task Force to Reduce Prescription Opioid Abuse, the American Academy of Pediatrics, the American Dental Association (ADA), and others, to promote “Search and Rescue” to their members.

June 07, 2016

Jazz Pharmaceuticals Discloses DOJ Subpoena on Patient Assistance Program

Jazz Pharmaceuticals recently revealed, in a filing with the Securities and Exchange Commission, that it received a documents subpoena from the United States Attorney's Office for the District of Massachusetts. The subpoena requested documents related to Jazz' support of 501(c)(3) organizations that provide financial assistance to Medicare patients.

Jazz also received requests about documentation about the provision of financial assistance to Medicare patients who receive the prescription Xyrem, a narcolepsy drug and Jazz' top-selling product.

The patient assistance programs at issue in Jazz' case involved a free product voucher program for Xyrem and copayment coupon programs for Xyrem and other products. Jazz also makes grants to independent charitable foundations that help financially needy patients with their premium, copayment, and coinsurance obligations.

Jazz Isn't the Only Company to Face Subpoenas

In 2015, Valeant Pharmaceuticals International, Inc., received similar subpoenas from the U.S. Attorney's offices in Massachusetts and Southern District of New York, seeking information on its patient assistance programs, drug distribution, and pricing decisions.

Other industry companies that have received recent subpoenas include: Merck & Co., Johnson & Johnson, and Endo International. Those government subpoenas sought information on a different topic, however: their contracts with pharmacy benefit managers related to specific drugs. These subpoenas came from the U.S. Attorney's Office for the Southern District of New York.

Health and Human Services Office of the Inspector General Guidance

For companies who value providing patient assistance, the Health and Human Services (HHS) Office of the Inspector General (OIG) recently modified an existing advisory opinion, originally published in 2006, on manufacturer grants to independent charitable foundations that provide financial assistance to patients in need. The OIG has also issued recent opinions on how the government views such programs.

What Does This Mean?

This recent subpoena for Jazz is the latest sign of the government's increasing interest in drug pricing, including scrutiny of drug companies' financial assistance programs. Patient assistance programs, which help Medicare patients pay for their drugs, have been criticized by some for steering patients to use the more expensive, brand-name products, instead of less costly generics or other alternatives. We encourage companies to review HHS OIG guidance on the topic before drafting their own plan to provide patient assistance.

In the disclosure document, Jazz noted its intention to cooperate with the subpoena.

What's Next?

It is possible that the issue of patient assistance programs will be the next "big thing" that the media focuses on when it comes to pharmaceutical companies. Foreshadowing that idea is Bloomberg Businessweek. A few weeks back, the magazine had a cover story, "Big Pharma is Here to Help."

The story opened with the story of Martin Shkreli and Daraprim, as many anti-pharma critics are wont to do. The story then went on to discuss Patient Services, Inc. (PSI), a charity that helps people meet insurance copayments on costly prescriptions. Turing and PSI supposedly got together to make Daraprim more affordable, right after Shkreli decided to raise the price of Daraprim by more than 5000%.

The article continues, expounding upon PSI, other patient assistance programs, and Turing (and Valeant, too), and the way they work together to raise drug prices while "getting rich" off of patients and Medicare beneficiaries.

The article did eventually, however, recognize that patient assistance programs are not all bad. The authors spoke with Daniel Klein, chief executive officer of PAN Foundation, who stated that his organization has nothing to do with the pricing of drugs, and that industry does not coordinate with patient assistance programs to take advantage of the consumer. "We are unaware of any data demonstrating that the help provided by charitable patient assistance organizations such as PAN has any impact on drug prices." According to the authors of the article, the "heads of several other copay charities also stressed their independence from donors."

It will be interesting to see if other news outlets begin to run with this idea, or if Bloomberg will be the only one. In any event, it serves as a wakeup call to review your current policies and ensure you are in full compliance with federal and state regulations.


December 17, 2015

HHS OIG Modifies Advisory Opinion on Patient Assistance Programs

The Department of Health and Human Services (HHS) Office of Inspector General (OIG) recently released a modification of OIG Advisory Opinion 07-11, concerning a non-profit, tax-exempt charitable organization's practice of providing financially needy cancer patients with grants to defray their out-of-pocket treatment costs. This modification is in response to guidance issued on May 21, 2014, in the Supplemental Special Advisory Bulletin regarding Independent Charity Patient Assistance Programs (PAPs).

The Supplemental Bulletin was sent along with targeted letters to all independent charities that had received favorable advisory opinions from HHS OIG to request certain clarifications and modifications to those favorable opinions.

On September 28, 2007, the OIG issued OIG Advisory Opinion 07-11 to the "Charity" – Charity and organization names are redacted as they are identifying information and can contain potentially privileged, confidential, or proprietary information – regarding Charity's operation of a PAP to help financially needy cancer patients pay for certain drugs used to treat certain types of cancer and certain conditions incident to cancer therapy. That AO approved certain features of the PAP that have since been determined to be problematic. The OIG asked Charity to modify certain areas of concern in order to retain its favorable AO, which Charity did and made appropriate certifications adhering to those modifications.

The modification of the original Advisory Opinion goes through each of the certifications Charity has made and explains in detail the changes that will be made to keep a favorable advisory opinion of its PAP.

One such change is that Charity "will not define its disease funds by reference to specific symptoms, severity of symptoms, method of administration of drugs, stages of a particular disease, type of drug treatment, or any other way of narrowing the definition of widely recognized disease states." Instead, Charity will "develop and maintain disease funds that would be limited to patients with certain metastatic cancers." Through those disease funds, Charity plans to cover all FDA-approved drugs for each particular type of cancer. Charity is not permitted to restrict coverage to FDA-approved products that are "expressly approved for the metastatic stage of the cancer."

Another change requires Charity to "not maintain any disease fund that provides copayment assistance for only one drug, or only the drugs made or marketed by one manufacturer or affiliates." However, if Charity establishes a fund for a disease that only has one FDA-approved drug, Charity "will provide support for other medical needs of patients with the disease, in addition to copayment support for the FDA-approved treatment of the disease." This means that Charity may be forced to provide copayment support for all prescription medicines used by a particular patient that are related to managing the disease or cancer.

Further, Charity is not permitted to limit its copayment assistance to only high-cost or specialty drugs. This means that generic or bioequivalent drugs must be given the same opportunities for assistance as expensive or specialty drugs, provided that they are approved by the FDA for treatment of the disease covered by the fund.

The screening process for eligibility determinations was also commented on in the modified advisory opinion: Charity must determine eligibility "according to a reasonable, verifiable, and uniform measure of financial need that is applied in a consistent manner." This screening process is applied uniformly across all funds and involves actions such as: verifying an applicant's financial resources through a third party service, collecting documentation of financial need from the applicant, or some combination of the two.

It is important to note that Charity's established disease funds provide assistance only to qualifying Federal health care program beneficiaries.

These changes in the Advisory Opinion show that when changes are made in the law, even through something as simple as guidance from HHS OIG, companies must pay attention and work to alter their existing programs so they are in full legal compliance. This modified Advisory Opinion can serve as a year-end reminder to ensure company policy is up-to-date and in full compliance with all laws and legal guidances.


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