The 2015 Compliance Year in Review (and Look Forward to the Rest of 2016)

The start of 2016 may be filled with hope for good compliance-related news to come, but before we travel too far forward with our prognostications, let’s take a look back at some of the stories that really struck a chord in 2015. Charge up your flux capacitor everyone, as we travel back a few weeks and months, with this edition of the Compliance News in Review: the Yearly Edition.

In 2015, a full year’s worth of data was submitted to the Open Payments program. Considering the rejection of massive amounts of 2014 data, as well as the registration issues and delays that plagued the first Open Payments data submission period, system users certainly had cause to be concerned about the 2015 period. Happily, CMS made improvements, and the process, while not problem free, was smoother in 2015. The agency improved its validated physician list for manufacturers and its data matching processes, which resulted in fewer records being rejected. The improvements in the registration process seemed to help manufacturers, but did little to improve the physician experience.

CMS announced additional improvements that will hopefully improve users’ experience in 2016, including the removal of limitations around entering special characters in text fields, and improving users’ downloading capabilities.

The life sciences industry certainly pushed the free speech issue with the FDA in 2015. Two companies filed suits against the agency, arguing that they had the right to truthfully promote drugs for off-label uses. In the Amarin suit, the court granted an injunction, and the company is free to promote the drug for use in a wider patient population than the drug was originally approved.

On the heels of that case, Pacira filed suit over the FDA’s insistence that the company was promoting a pain killer for post-surgery pain, an unapproved use.  After the company received a warning letter, stating that drug was only approved for use following a specific type of surgery, Pacira argued that the FDA was illegally trying to narrow the approved use. The company also argued that even if it was promoting the drug for an off-label purpose, it had the right to do so, as long as it was sharing truthful information. The FDA quietly removed the warning letter from its website and eventually settled the case.

After years of chatter, but very little visible action, the Serious Fraud Office entered into its first deferred prosecution agreement with a corporate entity, over violations of the U.K. Bribery Act. Standard Bank was accused of failing to prevent bribery by an allied person. The DPA remains in effect for three years and requires the bank to pay $32.6 million; submit to a review of its anti-bribery policies by an independent reviewer and make any changes recommended by the reviewer; and cooperate with authorities in any other matters that arise from the indictment.

The year was devoid of multi-billion dollar settlements in the industry, but 2015 did see the largest settlement by the OIG under its civil monetary penalty authority. The OIG settled with Sandoz for $12.64 million over allegations the company submitted inaccurate ASP data to the Medicare program. The agency alleged that the company submitted inaccurate data between 2010 and 2012, which “undermined the integrity of the Medicare Part B drug pricing system.”

Any worthwhile year-end retrospective needs to include a look forward. So here are the issues that we think will be hot topics in 2016:

  1. Drug pricing transparency. In 2015, several states proposed laws that would require companies to disclose costs for drugs that run in the thousands of dollars per-dose or course of treatment. This push isn’t likely to go away, considering recent dramatic drug price hikes by companies like Valeant and Turing, which resulted in inquiries by lawmakers in the latter part of the year.
  2. Transparency in Europe. Staying on the transparency theme, we expect physician spend reporting in Europe to be a prominent news story toward the middle of the year. The first round of reporting under the EFPIA Transparency Code is due then, and the first round is sure to be thoroughly dissected and analyzed.
  3. Individual accountability. In September of 2015, the Department of Justice released a memo from Deputy Attorney General Sally Quillian Yates saying the agency plans to focus on holding individuals accountable in cases of corporate crime. Not exactly earth shattering news, but the DOJ has put it in writing, so they must really, really mean it. Whether the agency brings a case against an individual in 2016 or not, the policy is sure to be widely discussed by federal prosecutors and other agency representatives at conferences throughout the year.

Have a great 2016 everyone! We’ll see you at CBI’s Pharmaceutical Compliance Congress January 26 and 27.

Week in Review, May 6, 2015

Connecticut delays the implementation date for its the APRN reporting law, CMS releases 2013 Medicare Part D data, the Medicines Australia Code of Conduct is approved, and lawmakers release draft legislation that includes an exclusion for reporting CME payments under Sunshine.

Avengers Assemble! The highly anticipated Avengers: Age of Ultron, opened last weekend and apparently a lot of us assembled for the opening. The film managed to land the second largest opening weekend box office numbers in history. Considering the title holder is the first Avengers movie, coming in second isn’t that much of a loss for the franchise. You won’t find any spoilers here…after all, not all of the Compliance News in Review staff have seen it yet.

The next Avengers movie is slated for 2018, but in the meantime we can look forward to 2017 and the new Guardians of the Galaxy movie…and of course, collecting spend data for APRNs in Connecticut.  The State has once again delayed the implementation date for the law, which requires drug and device manufacturers to report transfers of value to APRNs.

$103 billion: Tony Stark’s net worth or Medicare drug spending? If you answered Medicare drug spending, you are correct. CMS released data revealing the prescriptions that were covered by Medicare Part D in 2013 and the names of the doctors who wrote the scripts. The costliest drug was Nexium at $2.5 billion, and the most prescribed drug was Lisinopril (cost $300M). PhRMA said the data does not reflect the substantial rebates pharmaceutical companies pay to Medicare. The American Medical Association said the data could be misleading because the dose and strength of the medication is not included in the information. Doctors often change the dosage or strength when patients don’t respond as expected.

After extensive negotiations, the Australian Competition and Consumer Commission (ACCC) has approved Medicines Australia’s Code of Conduct. Much to the chagrin of industry critics, the ACCC went along with a change that will impose a $120 spending limit on meals and beverages provided to physicians. The “opt out” loophole has also been removed. The Code goes into effect in mid-May.

Lawmakers introduced a draft legislation “sequel” that includes an exclusion for most payments associated with CME from the Sunshine Act reporting requirements. The move to exclude the requirements was applauded by the head of the CME Coalition. The legislation is part of the larger 21st Century Cures effort, and is a paired down version of a draft that was originally introduced in January. Drug makers would also be able to share health economic information about products with physicians.

With that, we have reached the end of this week’s compliance tale. Speaking of the Medicines Australia Code of Conduct, the new PharmaCertify™ module, Global Transparency: Reporting HCP and HCO Transfers of Value includes up-to-date covering the policy, as well as the EFPIA Disclosure Code and Loi Bertrand in France. Contact Sean Murphy at smurphy@nxlevelsolutions.com for more information.

Have a great week everyone!

Week in Review, September 30, 2014

PhRMA and the DOJ argue the details of the Integrilin case, sentences and a fine are handed down in the GSK Chinese bribery case, more elected officials weigh in on the removal of the CME exclusion from the Sunshine final rule, and the OIG raises concerns over drug coupons and the potential for kickbacks.

The cosmos (and Starbucks – welcome back Pumpkin Spice latte) say fall is officially upon us! Cooler weather is on the way, and so is pumpkin picking and that extra hour of sleep. Time to gather around the fire pit and scarf down a few S’mores! But before we lose ourselves in a soliloquy about the magical mysteries of a great corn maze, we’ll navigate the twists and turns of this week’s News Week in Review.

There’s a certain chill in the air between PhRMA and the DOJ. A few weeks back, we highlighted the story about PhRMA filing a “friend of the court” brief in a whistleblower case involving the off-label promotion of the heart drug, Integrilin. The brief presented the claim that the whistleblower’s arguments raised free speech issues and the organization asked the court to reject the whistleblower’s claims . In a response, the DOJ said PhRMA’s brief did not establish a First Amendment violation. In fact, according to the agency, no precedent existed to support PhRMA’s argument that the False Claims Act could not have been implicated. PhRMA shot back, saying for a person’s speech to knowingly cause a false claim to be submitted there has to be a “direct causal nexus between the speech and the claim” and sharing peer reviewed journals with truthful information about an off-label use does not meet this requirement according.

The summer has ended, and so has the GSK Chinese bribery scandal, with a court levying a $500 million dollar fine against the company. The country manager for GSK and four other executives were found guilty and faced prison terms of up to four years. The Chinese court suspended the sentences, and declared that the country manager, a British national, could be deported. According to the court, all of the country manager and executives pled guilty and had no plans to appeal the verdict. The fine imposed on GSK is the highest fine the Chinese government has ever imposed in a bribery case.

On the Sunshine front, U.S. Representatives Michael Burgess and Frank Pallone sent a letter to CMS expressing concern over the removal of the CME exclusion from the final rule. The two representatives say the current rule provides a clear exemption for payments and transfers of value related to CME, while the proposed changes are ambiguous. Burgess and Pallone ask CMS to carefully consider the comments they have received from stakeholders about the proposed change. Representative Burgess also teamed up with Representative Allyson Schwartz to introduce legislation to exempt textbooks, indirect CME payments and journal articles from the Sunshine Act’s reporting requirements.

Industry trade groups are bobbing for an explanation, again, as to why nearly one-third of data submitted to Open Payment was removed from the system. PhRMA, AdvaMed, and BIO sent a letter to CMS reiterating concerns that the agency still had not provided an explanation as to what happened to the data. The groups are hopeful that the issue can be resolved quickly, so the public can be confident in the accuracy of the data.

According to a report from the OIG, the use of drug coupons could lead to kickback violations. The OIG investigated the use of coupons to purchase drugs covered by Medicare. Nearly 7% of senior citizens reported using coupons to purchase drugs covered by Medicare Part D. Coupons cannot be used to purchase items covered by Medicare Part D and inducing consumers to do so can be considered a kickback. The agency found inconsistencies in how drug companies implemented safeguards on their coupons. Printed coupons tended to have language advising consumers the coupons could not be used for Part D purchases, but only 80% of web coupons included the same language. In addition, nearly one-third of manufacturers surveyed did not include eligibility information for the pharmacists. The OIG recommends CMS work with drug makers to improve the process of identifying patient enrollment in Medicare Part D, and to improve the reliability of pharmacy claims.

FDA’s social media guidance left PhRMA feeling a little chilly. In comments submitted to the FDA, the organization expressed concern that the guidance discourages manufacturers from sharing meaningful information with patients on social media networks. According to the comments, the guidance, as written, places undue responsibility on the manufacturers for what users say about the products.

With that, we close out the post autumnal equinox edition of the Compliance Week in Review. Have a great week everyone and enjoy the colors of fall!