Life Science Compliance Update

August 24, 2015

Purdue Pharma Settles With New York AG Over Oxycontin Promotion; Agrees To Long List of Requirements To Ensure “Responsible and Transparent Marketing”



New York’s Attorney General recently announced an agreement with Purdue Pharma, the manufacturer of OxyContin, that holds the company to a long list of requirements aimed at stemming the recent increase in opioid addiction and opioid-related deaths. The settlement resolves an investigation launched in December 2013 where the government found Purdue may have “failed to take the necessary steps” to ensure their sales reps properly flagged prescribers who may abuse or divert the medication. Further, the settlement resolves the government’s investigation into Purdue’s unbranded pain advocacy website. While “the site creates the impression that it is neutral and unbiased,” notes the government, it failed to disclose that a number of the healthcare providers providing testimonials had financial relationships with Purdue.  

In addition to a fine of $75,000, the settlement requires Purdue to modify its business practices in a number of significant ways. First, it adds to Purdue’s pre-existing “Abuse and Diversion Detection” (ADD) program. Under the ADD program, if a Purdue sales rep learns of or observes any of a variety of activities that suggest an HCP (or his or her patients) may be involved in the abuse and diversion of opioids, the rep must report it to Purdue. The company may then add those HCPs to a “No Call List.” (See page 4 of the settlement for the list of potentially suspicious behavior, which includes “An HCP who has a disproportionate number of patients who pay cash for office visits and dispensed medication “ and “An allegation that individuals from a particular HCP’s practice have overdosed.”)

Despite Purdue’s ADD program, the Attorney General’s investigation found that sales reps continued to detail certain suspicious HCPs, and some reps continued to call doctors on the “No-Call List.” Under the terms of the agreement, Purdue must continue to implement the ADD program in New York for so long as it markets OxyContin in the state. It also adds measures that Purdue must adopt to ensure it does not promote its opioid products to providers who may prescribe inappropriately or illegally. Such measures include adding new “red flags” that will trigger an internal investigation by Purdue. Further, sales reps “must now file reports about providers who may not be abiding by I-STOP, New York’s signature law requiring New York health care providers to consult a database of a patient’s prescription history before prescribing a controlled substance, including narcotic painkillers,” states the AG press release. The agreement further ensures that reps do not contact providers on the “no call” list by imposing such safeguards as: (a) requiring representatives to check the “no-call” list before contacting a provider, (b) subjecting representatives to potential disciplinary action for contacting such providers, and (c) not counting prescriptions of Purdue opioid products by such providers towards sales representatives’ bonuses.

Second, a condition of the settlement requires Purdue to disclose any financial arrangements with health care providers that appear on websites endorsing pain treatments like OxyContin. The Attorney General investigated Purdue’s website ( that, prior to the settlement, contained a number of HCP testimonials advocating for patients with chronic pain. While the website indicated it was the product of Purdue Pharma, it did not reveal that some of the HCP “advocates” were paid speakers or consultant. Thus, the settlement requires that the company reveal the existence of payments it has made to any such person on the website, going back three years. Interestingly, Purdue is required to use the information based on CMS Open Payments reports as the financial disclosures for any HCPs. 

Third, the government’s investigation pointed to “deficiencies in certain HCPs’ knowledge of appropriate opioid prescribing practices.” Thus, the settlement requires that the first time a Purdue sales rep visits a New York HCP each year, the rep must ask whether the HCP completed a training program for the appropriate prescribing of opioids. If not, the rep must provide the HCP information about training that is compliant with the Food and Drug Administration’s “REMS for Extended Release/Long Acting Opioids.” The information on ER-LA REMS CME courses are available here.

Finally, the government highlighted the need for patients undergoing opioid therapy to receive information about the risks of addiction and addiction treatment resources. 


The government has been focused on stemming opioid abuse, and diligent in its enforcement of healthcare providers who facilitate this abuse. The Office of Inspector General has targeted several HCPs with questionable opioid prescribing habits, and also recently released a report entitled “Questionable Billing and Geographic Hotspots Point to Potential Fraud and Abuse in Medicare Part D,” which focuses on commonly abused opioids.

This settlement shows that the government is not stopping their inquiry at prescribers. Here, New York is holding Purdue responsible for curtailing the misuse of the company’s products through a long list of required measures. With the government's increased focus on the opioid abuse epidemic, it seemed like only a matter of time before improper prescribing habits were traced back up the chain to the manufacturer. Indeed, New York’s Attorney General, Eric Schneiderman, announced that his office is “Committed to Preventing Opioid Abuse [and] Holding Drug Companies Accountable.” It will be interesting to see whether other states follow suit.

Another interesting aspect of the case is the government's recognition of required opioid-related continuing medical education as a beneficial tool to ensure safe prescribing. 

 View the NY Attorney General Press Release here.

August 12, 2015

The Unintended Consequences of Public Reporting

     ProPublica Surgeon Scorecard Ad

A major concern surrounding ProPublica’s recently released “Surgeon Scorecard” is that rating physicians in a public database solely on complication rates may discourage surgeons from operating on high-risk patients. The fear, it turns out, is a legitimate one. A study published this month in the Journal of the American College of Cardiology examined the effect that public reporting of procedural outcomes has on heart attack patients. The authors looked at two states, Massachusetts and New York, which mandate the public reporting of hospital outcomes of percutaneous coronary intervention (PCI) for myocardial infarction (MI). PCI, commonly known as an angioplasty, is a widely used procedure to open blood vessels that lead to the heart during or soon after a heart attack.

The investigators used the Nationwide Inpatient Sample to examine whether patients who were hospitalized for MI were more or less likely to go through PCI in states with public reporting compared to regional comparator states. Second, they looked at the impact of public reporting on patients with MI overall. The study found that in Massachusetts and New York, patients presented with MI were much less likely to undergo PCI than in non-reporting states. Further, this was disproportionately concentrated in patients with the highest risk: older patients and those with ST-segment MI (a severe heart attack) or cardiac arrest or cardiogenic shock. Cardiogenic shock, for example, is a severe condition where the heart suddenly cannot pump enough blood to meet the body’s needs—if treated immediately, about half of patients survive. 

More importantly, the study noted that patient health suffered in public reporting states. The study found that  patients with MI in reporting states had higher risk-adjusted in-hospital mortality rates than those in non reporting states. The study found that this was observed primarily in patients who did not receive PCI in the public reporting states. 

The results, while observational, strongly suggest that interventional cardiologists are shying away from difficult cases where a patient has a high risk of complication, including death, despite treatment. Under the PCI public reporting metric, providers aren't dinged if they choose to operate only on the patients with the greatest likelihood of survival. 

C. Michael Gibson, an interventional cardiologist, Harvard Professor, and founder of WikiDocs, posed this question that clearly frames the issue at hand: 

Heart Attack tweet

Clearly, if a patient wants a better chance at survival, PCI treatment is the way to go. However, the public reporting methodology and other transparency initiatives focus exclusively on complications. ProPublica's recently released Surgeon Scorecard, for example, defines complications as "readmissions related to the surgery" and deaths during the initial surgical stay. However, it does not show the negative effects of NOT doing a surgery.

Much of the pushback on ProPublica's search tool is that it positions itself as a comprehensive grading system and that patients will make actual healthcare decisions based on whether their surgeon falls in a green, yellow, or red category (i.e. "Making the Cut: Why Choosing the Right Surgeon Matters Even More Than You Know.")

This is an example of how a surgeon is ranked--this one performed over one hundred prostate removals. 

Surgeon's rate

ProPublica's Surgeon Scorecard has experienced pushback from the surgery community. An article on Kevin MD, which is worth a read, takes aim at how ProPublica defines “complication rate.” Here is a sample from the article:

So the 84-year-old patient three weeks out from hip replacement who is admitted through the ER with “increasing confusion” due to insomnia and overuse of narcotic pain meds is a red mark against the orthopedic surgeon.  Urinary tract infection two weeks after spinal surgery in a patient with known BPH.  The anxious 27-year-old lady readmitted at midnight two days after a LC because of refractory nausea.  The 49-year-old male who develops chest pains ten days after lumbar fusion surgery.  All these are reportable offenses that don’t necessarily have anything to do with the quality of said procedure performed.


Public reporting and efforts at increasing the transparency of surgical procedures have a laudable goal in mind of guiding patients to the best care. While it is easier to point out the flaws in a reporting system than come up with a perfect methodology, the public reporting of PCI study shows that true patient harm can result if the reporting metrics continue unchanged.  Further, a fundamental criticism of the Surgeon Scorecard is how it is being framed by ProPublica. Their ad campaign seemed like more "click-bait scare tactic" rather than a true patient tool. The scorecard could actually cause people who need surgery to avoid it altogether, and it points to surgeons as the enemy (watch this "teaser" video). 

The authors of the public reporting outcomes study conclude that moving forward, “public reporting of outcomes should balance the benefits of transparency and accountability against the potential influence of physician risk aversion.” Dr. Robert Yeh, one of the authors, notes that perhaps one improvement would be to exclude certain high-risk individuals, such as cardiac arrest patients, from public reporting (see his interview here). While it is very difficult, and potentially impossible, to find a metric that accounts for all the internal and external variables that take place when a patient goes in for a surgical procedure, the study hopefully guides reporting policies away from particularly problematic unintended consequences. 


June 26, 2015

Massachusetts Governor Orders Review of All State Regulations; Opportunity For Healthcare Industry Comment

Mass government

Earlier this year, the Governor of Massachusetts, Charles Baker, signed an executive order initiating a “comprehensive review’ for all regulations enforced by the Executive Department. Only those regulations which are mandated by law or essential to the health, safety, environment, or welfare of the Commonwealth’s residents will be retained or modified, the order states. The measure is aimed at reducing “burdensome regulations to increase efficiency and competitiveness.”

To meet the standard set forth in the order, agencies must show:

  1. There is a clearly identified need for governmental intervention that is best addressed by the Agency and not another Agency or governmental body;
  2. The costs of the regulation do not exceed the benefits that would result from the regulation;
  3. The regulation does not exceed federal requirements or duplicate local requirements;
  4. Less restrictive and intrusive alternatives have been considered and found less desirable based on a sound evaluation of the alternatives;
  5. The regulation does not unduly and adversely affect Massachusetts citizens and customers of the Commonwealth, or the competitive environment in Massachusetts;
  6. The Agency has established a process and a schedule for measuring the effectiveness of the regulation; and
  7. The regulation is time-limited or provides for regular review.

Perhaps most notably is the prong that the regulation not “exceed federal requirements."  This is an important announcement for life sciences companies—Massachusetts has long been one of the more complicated and challenging states to do business in based on several regulatory requirements that require time and resources above and beyond an already complex legal landscape. For example, Massachusetts instituted a physician payment disclosure law before the Federal Physician Payments Sunshine Act requirements set in during 2013.  While the Federal law preempts much of the Massachusetts measure, the state’s law includes more expansive definitions as to who constitutes a “covered recipient,” requiring additional resources and fees to comply.  

Furthermore, the state’s Pharmaceutical and Medical Device Manufacturer Code of Conduct is largely parallel to the PhRMA and AdvaMed codes that the respective industries follow.

“[C]onfusing, unnecessary, inconsistent and redundant government regulations inconvenience individuals, encumber cities and towns, stress resources of non-profit organizations, including our health care and educational institutions, inhibit business growth and the creation of jobs, and place Massachusetts for profit enterprises at a competitive disadvantage relative to their out-of-state and foreign competitors,” states the Order. In its assessment of the announcement the National Review noted:

For the citizens and businesses of Massachusetts, where state agencies have a long history of expansive regulatory programs, aggressive rule development, expansive regulatory programs, and sweeping administrative authority, this is an extraordinary measure, and it will undoubtedly reshape state government programs for many years to come.

This will be an important measure to follow and stakeholders should take advantage of the opportunity to participate in this regulatory review process. 


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