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, August 27, 2014

Another industry organization calls for a change to the Sunshine Act, manufacturers claim data entered into Open Payments is now lost, the Supreme Court is petitioned to review the definition of instrumentality as it pertains to the FCPA, and questions are raised about potential reporting loopholes in the Medicine’s Australia Code of Conduct.

Bananas, fish fingers and custard for all! Doctor Who, season eight, is here! Finally, 12 makes his debut, and we can only hope that he still thinks bow ties and fezzes are cool. And can we just take a moment to thank BBC America for scheduling Doctor Who to run here in the U.S. when it runs on BBC 1? Now we don’t have to spend months trying to avoid news about the show, like we do for Downton Abbey. So let’s jump in the TARDIS and take a journey back in time with this week’s News in Review.

Exterminate! Exterminate! That’s the sentiment of the Council of Medical Specialty Societies (CMSS) regarding CMS’ proposed change to the rule in the Sunshine Act about payments for CME. The Council said the current exemption for payments associated with accredited CME needs to remain in place for several reasons. First, a distinction should be maintained between accredited and certified CME and other educational programs in order to preserve the independence of CME programs. Second, faculty payments should not be subject to reporting because the faculty member’s relationship is with the CME provider, not the manufacturer. Finally, attendees of accredited CME should not be subject to the reporting of payments, because like faculty, attendees have no relationship with the manufacturers providing grants for a program.

Speaking of Sunshine, after Open Payments came back online, drug and device manufacturers reported that payment data once in the system is now gone. CMS says the missing data is due to matching issues. Some of the issues are the result of a data marrying problem that took the system down recently. In other cases, information such as license numbers and names do not exactly match the information in CMS’s database. Policy and Medicine was informed by manufacturers and physicians alike that information that was accurate in Open Payments is now missing. One manufacturer claims all of its clinical research data is now gone. According to the article, the problem could be with the NPPES (National Plan and Provider Enumeration System) database. Portions of New Jersey doctors’ state license numbers were cut off in the database. Also, an analysis last year by the OIG found that almost half of the NPPES records that were inspected contained at least one inaccurate piece of information.

What is instrumentality under the FCPA? We could ask the Inner Council on Gallifrey, but since that is fictional (what!?), the U.S. Supreme Court will have to do. The high court has been petitioned by two individuals convicted of bribery under the FCPA to review a federal appeals court’s definition of an “instrumentality.” The two were convicted of paying kickbacks to employees of a government-owned telecommunications company. The government argued the telecom company was an instrumentality of the government, and the appeals court agreed.

 

Some advocacy groups are already looking for a regeneration of Medicines Australia’s transparency requirements in the latest edition of that group’s Code of Conduct. The Code is pending authorization by the Australian Competition and Consumer Commission (ACCC). The organizations have petitioned the ACCC to not authorize Medicines Australia’s Code of Conduct based on potential loopholes that will allow physicians to opt out of having their payment information publicly disclosed.

 

Well, that bring us to the end of this week’s episode. Based on the plethora of recent news stories related to Open Payments, the demand for transparency when dealing with HCPs isn’t going away anytime soon. The Sunshine Act: The Federal Physician Spend Disclosure Law, from our PharmaCertify™ suite of customizable online compliance modules, offers the content your team needs to stay abreast of the ramifications and reporting requirements of the law. We even offer a complementary Sunshine Act mobile app to help ensure your reps have the information where they need it most – in the field and at their fingertips.

 

Have a great week everyone!

 

Have a great week everyone!