Life Science Compliance Update

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30 posts from April 2015

April 29, 2015

“Encouraging Continuing Medical Education For Physicians” Incorporated Into Newly Updated 21st Century Cures Discussion Draft

Notable updates to January's Draft include bipartisan concessions: New provisions to increase NIH funding; removal of provisions for increased exclusivity periods. 

Ladd email

Today, the House Energy and Commerce Committee released an updated discussion draft of 21st Century Cures legislation (view the legislative text, whittled from 400 pages to 199 pages since January); a section-by-section explainer; and a 1-page summary). “The yearlong 21st Century Cures listening session explored the complete cycle of cures – from the discovery of clues in basic science, to the development of new treatments, to the delivery of those cures, and back again to further discovery,” the House notes in the press release for the new bill.

Unlike January’s release of the draft, which Democrats did not formally endorse, today's document  is issued as a bipartisan bill by Chairman Fred Upton (R-MI), Oversight and Investigations Subcommittee Ranking Member Diana DeGette (D-CO), Full Committee Ranking Member Frank Pallone, Jr. (D-NJ), Health Subcommittee Chairman Joe Pitts (R-PA), and Health Subcommittee Ranking Member Gene Green (D-TX).

Concessions: NIH Funding In; Market Exclusivity Out

One of the most notable new aspects of the bill—clearly evidenced as the lead off provision—is that the 21st Century Cures bill would raise NIH funding to $31.8 billion in 2016 and to $34.85 billion in 2018. The bill would also create an NIH Innovation Fund of $2 billion per year to support “precision medicine” and “young emerging scientists.”

Another important change is the absence of provisions which extended the marketing exclusivity. The January version of the bill included a 15-year marketing exclusivity for “dormant therapies,” defined as medicine that “is being investigated or is intended to be investigated for an indication to address one or more unmet medical needs…”  The old bill also sought more exclusivity for “New Therapeutic Entities” and “Orphan Products.” View Title 1, Subtitles L, M, and N in the old bill’s language, not found in the new version. 

Encouraging Continuing Medical Education for Physicians

Most interesting to Policy and Medicine readers likely concerns the status of the continuing medical education provision in the new bill. The language is updated considerably from the first go-round. 

Subtitle C—Encouraging Continuing Medical Education for Physicians:Exempting from manufacturer transparency reporting certain transfers used for educational purposes.  

Updates to the Sunshine Act reporting requirements are included in red. 

Transparency Reports and Reporting of Physician Ownership or Investment Interests, Sec. 1128G. [42 U.S.C. 1320a-7h]

(B) Exclusions.—An applicable manufacturer shall not be required to submit information under subsection (a) with respect to the following:

  • (iii) Educational materials that directly benefit patients or are intended for patient use, including peer-reviewed journals, journal reprints, journal supplements, and medical textbooks;
  • (xiii) In the case of a covered recipient who is a physician, an indirect payment or transfer of value to the covered recipient 
    • (I) for speaking at, or preparing educational materials for, an educational event for physicians or other health care professionals that does not commercially promote a covered drug, device, biological, or medical supply; or
    • (II) that serves the sole purpose of providing the covered recipient with medical education, such as by providing the covered recipient with the tuition required to attend an educational event or with materials provided to physicians at an educational event.

This language is much clearer than previously set forth. CME Coalition Senior Advisor, Andy Rosenberg, was encouraged by the language in the new bill, and commended the bipartisan effort set forth in the 21st Century Cures initiative.  

Sharing Off-Label Data and Social Media

Also of note, the original draft's provision encouraging FDA to consider a new regulatory approach to social media has been dropped from the final bill. This could be in recognition of the fact that FDA has agreed to align their guidances concerning scientific exchange with the First Amendment. 

This new bill includes an important section entitled "Facilitating Dissemination of Health Care Economic Information," which offers some regulatory leniency concerning communications with payors and formulary committees. This is especially significant given the more prominent decision-making role payors play in the current health care environment. 

Other Highlights in the Bill 

The Energy and Commerce Committee ran down a short list of provision highlights in the bill, which, in addition to increasing the flow of funds to NIH, also:

  • Incorporate the patient perspective in the discovery, development, and delivery process.
  • Foster development of treatments for patients facing serious or life-threatening diseases.
  • Repurpose drugs for serious or life-threatening diseases and conditions.
  • Modernize clinical trials.
  • Break down barriers to increased collaboration and data sharing among patients, researchers, providers, and innovators.
  • Help the development of personalized and precision medicines so the right patient can receive the right treatment at the right time.
  • Provide for continued work in the telehealth space.
  • Advance a truly interoperable health care system.
  • Provide clarity for developers of software products used in health management and medical care.

We will continue to cover this important legislation as it makes its way through Congress. 

Open Payments Review & Dispute Resolution Ends May 20 for Physicians and Teaching Hospitals; No Extensions for Lost Disputed Records, Web Downtime

On April 6, the Centers for Medicare and Medicaid Services (CMS) opened the review and dispute period, during which healthcare providers can log-in to Open Payments and review the payments attributed to them. Originally, CMS announced on April 6, 2015 that physicians and teaching hospitals have 45 days from April 6, 2015 to voluntarily review data reported by drug and medical device makers about them, and, if necessary, dispute payments.  

April 6 2015

This week they clarified that the 45 day period ends on May 20, 2015.  Payments that are disputed but not resolved within 15 days after the review period (June 3) will be made public on June 30th. Providers can continue to register disputes until the end of the year, but resolutions will not be publicly displayed until the next reporting cycle.

May 20 2015

As we recently reported, the dispute resolution period got off to a rocky start for physicians looking to check on their data. Doctors reported that registration issues and website outages cost them a fair amount of time. The Open Payments system locks accounts if there is no activity for 60 days or more and deactivates accounts if there is no activity for 180 days or more, which also added to the challenge.

Lost Disputes

Most troubling, though, applicable manufacturers and covered recipients were notified by CMS that during an approximately 3 day window, records that had been disputed by physicians were lost in the system. This same email went to both manufacturers and covered recipients (physicians and teaching hospitals) the email is written in code for which the translation is "Our computer system lost the record of your disputes please enter again":

CMS Email

It is now up to the physicians to figure out whether their disputes are still there, then re-enter the disputes, before manufacturers can do anything about it. At CBI's aggregate spend conference in San Diego last week, Doug Brown of CMS spoke to the issue of lost disputes. He stated that CMS doesn't want manufacturers to correct the lost disputes, but instead to wait until covered recipients re-enter the dispute before they can correct them. CMS also noted that they are unsure how many disputes were lost in their system.

Polaris Management stated:

If you received notifications for disputes initiated by HCPs within the first few days of the 45-day dispute window, you may have a hard time locating them in the Open Payments system. This is due to a data refresh that occurred on April 8th, resulting in all disputed initiated between April 6th – 8th being lost. CMS has since reached out to HCPs letting them know if they initiated a dispute during this timeframe, they will have to do it all over again because it’s not longer in the system. However, this issue has not been proactively communicated to the Applicable Manufacturers that initially received the dispute notifications by email. So pay attention to the disputes that you’ve gathered and are researching, they may no longer be valid.

Despite the issues with the dispute resolution process (and the confusion surrounding the dispute date as evidenced by news reports running varying dispute deadlines - See bellow), CMS is holding to May 20th as the deadline for disputes. 

June30

This is the second reporting cycle for Open Payments, and it covers payments made in 2014. Last year, CMS published information about 4.45 million payments valued at $3.7 billion for the last five months of 2013. During the first year's review and dispute period, 26,000 physicians registered in the Open Payments system to review payments attributed to them. This is out of 366,000 physicians in the system--so only around 7 percent. It will be interesting to see whether the second year of the review phase attracts more interest from physicians, and if the final stretch of the process is hassle-free. 

For an interesting inside look at some of the problems affecting physicians engaged in the dispute process, see Steven Ladd's Twitter account, which he updates regularly. Ladd, the President of Primacea, is an expert at the review and dispute process, his company having monitored Open Payments data for a substantial number of physicians as their “Open Payments agent” over the past year. 

For example:

Ladd email

 

 

April 28, 2015

Connecticut Delays Sunshine Reporting For APRNs Until 2017

CT

Connecticut recently passed a law requiring manufacturers to report their transfers of value made to advance practice registered nurses (APRNs) practicing in Connecticut. This group includes nurse practitioners, clinical nurse specialists, nurse anesthetists, and nurse midwives. APRNs are excluded from the reporting obligations under the Federal Physician Payments Sunshine Act, but Connecticut passed this disclosure requirement as part of a new initiative allowing APRNs to practice and prescribe independently of physicians. This law was originally supposed to go into effect July 1, 2015.

On Friday, April 24, Connecticut enacted Public Act 15-4, which pushed the start date back to July 1, 2017. The new law also shifts the reporting requirements from a quarterly obligation to an annual obligation. 

(b) (1) Not later than July 1, [2015] 2017, and [quarterly] annually thereafter, an applicable manufacturer that provides a payment or other transfer of value to an advanced practice registered nurse, who is practicing not in collaboration with a physician in the state, in accordance with subsection (b) of section 20-87a, as amended by this act, shall submit to the Commissioner of Consumer Protection, in the form and manner prescribed by the commissioner, the information described in 42 USC 1320a-7h, as amended from time to time, for the preceding calendar year.

(2) In determining whether an applicable manufacturer is required to submit information concerning a payment or other transfer of value to an advanced practice registered nurse in accordance with the provisions of this subsection, the applicable manufacturer shall refer to the list of advanced practice registered nurses who are authorized to practice not in collaboration with a physician published by the Commissioner of Public Health on the Department of Public Health's Internet web site in accordance with subsection (b) of section 20-87a, as amended by this act.

Another complicated aspect of Connecticut reporting is that manufacturers must keep track of which APRNs have made the decision to work independently and have the ability to prescribe, and only track and report those payments. Public Act 15-4 also provides some insight into how manufacturers should best keep tabs on APRNs practicing in the state. 

Not later than December first, annually, the Commissioner of Public Health shall publish on the department's Internet web site a list of such advanced practice registered nurses who are authorized to practice not in collaboration with a physician.

 

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