Life Science Compliance Update

February 14, 2017

Connecticut APRN Reporting Policy Starting to Come to Fruition...Kind Of

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We have previously written about Connecticut policy that was aimed at reporting payments from pharmaceutical and device manufacturers to nurse practitioners. Back when the law was originally passed, Connecticut planned to require pharmaceutical and device manufacturers to report payments and transfers of value to advance practice registered nurses (APRNs), starting July 2015. APRNs include: nurse practitioners, clinical nurse specialists, nurse anesthetists, and nurse midwives. The first reporting date is from July 1, 2015 to June 30, 2017, and requires annual reports on July 1, 2017 (rather than quarterly filings as was in the original legislation).

Under the Connecticut General Statutes, a licensed APRN who has maintained their license for at least three years, and engaged in the performance of advanced practice level nursing activities in collaboration with a physician for at least three years (and at least two thousand hours), may – with or without physician collaboration –

Perform the acts of diagnosis and treatment of alterations in health status and prescribe, dispense and administer medical therapeutics and corrective measures and dispense drugs in the form of professional samples in all settings. Any advanced practice registered nurse electing to practice not in collaboration with a physician shall maintain documentation of having engaged in the performance of advanced practice level nursing activities in collaboration with a physician for a period of not less than three years and not less than two thousand hours.

Companies are required to register and pay a fee.

Any eligible APRNs are required to submit written notice to the Department of Public Health of his or her intention or practice without physician collaboration prior to beginning such a practice. The Department of Public Health is responsible for annually publishing a list of such APRNs who are authorized to practice not in collaboration with a physician, which can be found here.

There are only roughly 450 providers listed who are authorized to practice not in collaboration with a physician. However, the list of providers does not include an address – just the provider name and license number. Such an effort at transparency could lead to unnecessary confusion and uncertainty, on the part of both patients and those trying to keep up with reported payments.  

With no address or much of any identifying information, it could be difficult to be certain that the APRN whose information they are looking at online is the APRN they are seeing. While there are many unique names on the list of APRNs who can practice without physician collaboration, even the most unique names can be shared by multiple people, not to mention many common names.

Further, we have seen the difficulties with the federal Open Payments, and how many payments get attributed to the incorrect physicians, with more information available to them than just a name and license number. Typically, there are hospital affiliations, addresses, etc. that help to identify and confirm physician identities. Even still, there are many payments that are misattributed year after year.

The dates of reporting is also news to applicable manufacturers (GPO's, Distributors, Drug and Device Manufacturers), It is not known why they went back to the July 1, 2015 recording date after the state legislature had delayed reporting.

This move by Connecticut was an expansion of the requirements from under the current Open Payments System; under federal law, APRNs are excluded from the reporting obligations.     

In the interim, keep your eye on Connecticut and other states who are also looking to expand the federal Sunshine Act, as well as moves made by Congress to expand the federal Sunshine Act even further (to be expounded upon in a future article).

July 01, 2016

Open Payments 2015 Data Released

Background

The Centers for Medicare & Medicaid Services (CMS) published the 2015 Open Payments data, along with newly submitted and updated payment records for the 2013 and 2014 reporting periods yesterday, June 30, 2016.

As a broad overview, for Open Payments program year 2015, health care industry manufacturers reported $7.52 billion in payments and ownership and investment interests to physicians and teaching hospitals. This amount encompasses 11.9 million records attributable to 618,931 physicians and 1,116 teaching hospitals.

The Open Payments 2015 program year is the second full year of data available and allows the public the opportunity to explore trends in the health care industry manufacturers' payments to physicians and teaching hospitals for items and services such as food and beverage, travel, education, honoraria, and research.

In the 2015 program year, there was a notable shift toward charitable contributions and fewer payments to physicians in the form of honoraria and gifts. In terms of dollar value, companies increased charitable contributions on behalf of physicians by over 120%. Payments for food and beverage, travel and lodging, and consulting fees were either flat or slightly declined. Payments for honoraria declined by about fifty percent and by more than thirty percent for gifts.

Open Payments Changes 2014-2015

Graph from CMS blog post 6-30-2016

Annual Comparisons

To compare year to year progress of Open Payments Records and Reporting, see the below table, which highlights the number of records and covered entities for 2013, 2014, and 2015. For 2015 the number of companies reporting payments actually dropped by 7.8%, the number of physicians remained the same, the number of teaching hospitals dropped slightly probably due to consolidation in that industry. Total number of payments grew by less than .3% so no real differences.

 

The total payments made to physicians actually fell in two of the major categories, when comparing 2014 data to 2015 data, as outlined in the chart below.

When examining the same data for teaching hospitals, interestingly, the payments for research dropped a significant amount while general payments rose slightly. The drop in research could be caused by more payments selected for delay of reporting.

When combing through the data, it is easy to see companies that seem to have constant interactions with physicians. The below chart lays out the top ten global pharmaceutical companies, and looked at total spending for research and general databases. It is interesting to note that although there was little change year over year in the total amount spent, there were significant differences in spending on a company by company level.

Reactions

A spokesman for Novartis, the manufacturer with the largest amount of reported payments $539 million with $513 million or 95% of their funding is in research in 2015, stated,  these payments show our "ongoing strong commitment to R&D leading to one of the most robust pipelines in the industry." In addition "we consult doctors to get their insights and advice on diseases and products to help ensure we're developing medicines that meet the needs of patients. We facilitate programs where physicians who are experts in their fields meet with their peers to help educate them about the appropriate use of FDA-approved medicines; this helps physicians to make informed prescribing decisions with their patients." Novartis should be applauded for the 45% increase in research spending as opposed to being maligned by the media for having the largest total spend.  

Changes in spending for GlaxoSmithKline and Novartis are likely a result of an asset swap the companies did in 2015.

Roche/Genentech is also highly ranked on the list but the vast majority of their $325,804,125 in general payments, ($306,412,967) goes towards a royalty settlement to City of Hope National Medical Center in California.

This recent release still concerns the American Medical Association (AMA), which noted that "continued data errors and registration challenges during the previous two years have thwarted many physicians from participating in the review and validation process" and that the "integrity goals of the Open Payments database will not be met as long as physician review is obstructed by a registration procedure that is confusing, time consuming and overly burdensome."

Shantanu Agrawal,MD the director of the CMS office of program integrity, wrote in a blog post, "the Open Payments Program does not identify whether financial relationships are beneficial or may indicate conflicts of interest."

Overall the media has shown very little interest in this years publication of the Open Payments Data.  It will be interesting to see if this trend continues in future years.

The August issue of our sister publication, Life Science Compliance Update, will have a full analysis of the Open Payments data. Please register here for a sample issue to learn more.

May 12, 2016

Senate Finance Committee Majority Staff Releases Updated POD Report

Orin hatch

The Senate Finance Committee Majority Staff recently issued a report entitled, “Physician Owned Distributorships: An Update on Key Issues and Areas of Congressional Concern.” This report serves as an update to the Committee’s 2011 Physician Owned Distributorship (POD) report, which focused on concerns Senator Orrin Hatch had about the “spike in the utilization of medical procedures by physicians invested in these entities.”

The 2011 Report

The 2011 report came about based on information provided by a surgeon who was offered the opportunity to become an investor/owner in a POD and who felt that the arrangement appeared questionable. The Senate investigation concluded that “in the absence of stronger enforcement guidance, these entities would continue to grow at a rapid pace,” and resulted in two bipartisan letters being sent by Hatch and other senators, one to the Centers for Medicare and Medicaid Services (CMS) and the other to the United States Department of Health and Human Services (HHS) Inspector General, both calling for an investigation.

The HHS OIG stated that the guidance it had already issued was more than sufficient and that additional guidance was not necessary. CMS indicated in its response that it would address these issues in its final regulatory language. The final regulations issued in February 2013 did include PODs among the entities that are required to report to CMS any ownership interest and investment interests that are held by physicians.

2011 to Present

Since the time of the 2011 report, the Senate Finance Committee and its staff have continued to keep an eye on the growth and development of PODs. In forming this updated report, Committee staff reached out to “healthcare entities, including physicians (both those who participate in a POD and those who do not), insurers, medical device manufacturers, state and federal government agencies, medical ethics boards, hospitals, and patients.” In addition to those stakeholders, Committee staff spoke with representatives of several PODs and POD advocacy groups.

On November 17, 2015, the Finance Committee held a hearing on PODs, for which Chairman Hatch and Ranking Member Wyden issued the following joint statement:

While the vast majority of doctors operate with the highest ethical standards, those with a vested stake in medical device distributorships raise a number of concerning questions about the physician’s motivation in prescribing a procedure, as well as the overall cost to the health care system. When physicians have a financial incentive to recommend and perform a surgery, a potential conflict of interest and occur and jeopardize the health of patients. With this hearing, the Committee will have the opportunity to hear views on all sides of the debate, and we look forward to a constructive conversation on how to ensure major health decisions are made in the best interest of the patient and not the physician’s pocketbook.

That hearing did hear from several different viewpoints, including: Dr. Scott Lederhaus, President of the Association for Medical Ethics; Dr. John Steinmann, of the American Association of Surgical Distributors; Suzie Draper, the Vice President of Business Ethics and Compliance at Intermountain Healthcare; and Kevin Reynolds, the son of a patient who was treated by a POD physician.

Throughout the hearing and in the days that followed, it became clear that PODs are a concern for several members of the Committee, including the Chairman. Therefore, it is likely that, even following the release of this report, the Committee will conduct additional oversight efforts.

The 2016 Report

The 2016 report essentially went through the history of PODs from 2011 through today. The report discussed the Special Fraud Alert (SFA) issued by the HHS OIG, which was issued to “inform the medical community of the dangers posed by PODs,” and many health systems have implemented new policies to avoid those dangers.

The report also discussed an analysis of whether or not POD surgeons perform surgery at a higher frequency than non-POD surgeons. The Committee found that POD surgeons saw 24% more patients than non-POD surgeons, that POD surgeons performed fusion surgery on nearly twice as many patients as non-POD surgeons, and that POD surgeons performed surgery 44% more often than non-POD surgeons. Those findings concerned the Committee, and prompted several recommendations, covered in more detail below.

The Sunshine Act

The report also carved out a section on the Sunshine Act and its impact on POD arrangements. The Committee believes that “there are serious gaps in Sunshine reporting of POD arrangements,” and that those “shortcomings prevent patients and hospitals from having access to information about the financial interests of physicians.” It will be interesting to see if the Committee tries to force further transparency of PODs through the Sunshine Act, via additional inquiries and requests for CMS to release additional rules. 

Committee Recommendations

The Committee is concerned that there is a lack of transparency relating to PODs and issued three recommendations along those lines:

(1) for an update to federal law, requiring physicians to disclose any ownership they or their family members have in non-publicly traded device companies to the hospitals where they practice, and also disclosure to patients;

(2) to require hospitals and ambulatory surgical centers to not only examine Open Payments data, but also document that they have taken that data into account when making device purchasing decisions; and

(3) that CMS and HHS OIG should examine whether current compliance guidance about PODs is sufficient, or if it needs to be supplemented.

The Committee also issued a recommendation to the GAO to examine the costs and benefits of CMS requiring hospitals that choose to purchase from PODs to perform enhanced quality assurance and utilization review activities in connection with surgeries using POD-supplied products, out of a concern that hospitals that purchase from PODs perform medically unnecessary or overly complex surgeries.

The Committee is recommending law enforcement continue (and expand) their efforts to charge and prosecute doctors, PODs, and hospitals, that are violating the law.

The Committee is also making recommendations relating to PODs and their shifting payment structures. The Committee makes three recommendations revolving around that general idea:

(1) that CMS undertake increased enforcement actions to ensure compliance with Sunshine Act reporting requirements;

(2) that HHS OIG study the impact of the Special Fraud Alert (SFA) and recent litigation on PODs and update its 2013 report and SFA as needed; and

(3) that CMS provide additional Sunshine Act guidance or rulemaking to make clear that the exception from reporting requirements for employment applies only to manufacturers, and only to bona fide employment.

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