Life Science Compliance Update

November 22, 2017

Urine Testing: The Next Shoe to Drop?

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Opioids have been a topic of discussion for months now, and every week it seems as though a new company or individual is in hot water over opioid prescribing practices, or over alleged opioid prescribing practices.

One facet of the opioid epidemic that has not been touched upon is the requirement many pain management physicians and others have that when a patient is under their care and receiving opioids and/or habit-forming prescriptions, the patient must affirm that they are not seeing other physicians for prescriptions and/or that all prescriptions are being filled at the same pharmacy. To that end, the patient typically must be willing to submit to random drug testing.

Recently, Bloomberg News published an article attempting to highlight the physicians who are "getting rich" off of this aspect of opioids. The article begins by focusing on one such group, Comprehensive Pain Specialists in Tennessee. The article notes that the doctor-owned network of 54 clinics is the largest pain-treatment practice in the Southeast. Medicare paid the company at least $11 million for urine and related tests in 2014, when five of its professionals stood among the nation’s top billers. One nurse practitioner at the company’s clinic in Cleveland, Tennessee, single-handedly generated $1.1 million in Medicare billings for urine tests that year, according to Medicare records.

Kaiser Health News, with assistance from researchers at the Mayo Clinic, analyzed available billing data from Medicare and private insurance billing nationwide and found that spending on urine screens and related genetic tests quadrupled from 2011 to 2014, to an estimated $8.5 billion a year—more than the entire budget of the Environmental Protection Agency. The federal government paid providers more to conduct urine drug tests in 2014 than it spent on the four most recommended cancer screenings combined.   

While one may think that being tested to ensure compliance with a prescribed medication regiment may be a good idea to help stymie the opioid epidemic, the analysts took issue with the concept. The concern seemed to center on the lack of national standards regarding who gets tested, for which drugs and how often. Medicare has spent tens of millions of dollars on tests to detect drugs that presented minimal abuse danger for most patients, according to arguments made by government lawyers in court cases that challenge the standing orders to test patients for drugs.

Unfortunately, the way the article is written, it seems that Bloomberg has more interest in promoting an agenda against industry than in promoting what may be a good idea. The article notes, "As alarm spread about opioid deaths and overdoses in the past decade, doctors who prescribed the pills were looking for ways to prevent abuse and avert liability. Entrepreneurs saw a lucrative business model: persuade doctors that testing would keep them out of trouble with licensing boards or law enforcement and protect their patients from harm. Some companies offered doctors technical help opening up their own labs."

Former CPS Chief Executive Officer John Davis, in an interview, described the urine-testing lab as part of a “strategic expansion initiative” in which the company invested $6 million to $10 million in computerized equipment and swiftly acquired new clinics. Kroll, one of the owners of CPS, said the idea was to “take the company to the next level.”

Davis, who led the initiative before leaving the company in June, would not discuss the private company’s finances other than to say CPS is profitable and that lab profits, “to a great degree,” drove the expansion. “Urine screening isn’t the reason why we decided to grow our company. We wanted to help people in need,” Davis said.

Dr. Peter Kroll, the CEO of CPS, also stated that the drive and impetus behind his passion for his career comes from watching his brother suffer and wanting to be in a position to help those similar to his brother – to try to make their life less painless and easier to live.

As we have seen before, any time a profit can be made, there will always be critics who say the action is only being taken because of the money behind it. While the money certainly helps to keep businesses (and charities) moving, it is hard to say the money is the reason for the action. We will keep an eye on urine testing to see if this possible solution to the opioid epidemic will be excoriated by the public, or if it will be accepted.

November 21, 2017

ICER Expanding Probe

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A nonprofit group, the Institute for Clinical and Economic Review (ICER), recently received a three-year $13.9 million grant from the Laura and John Arnold Foundation to expand its ongoing investigative scope on drug pricing to include all new medicines and price increases on existing treatments.

Up until now, ICER hasn’t had the resources to review all new medicines. The additional funding “puts us on a new trajectory,” according to Steven D. Pearson, president of ICER. “Now we’re going to be able to cover the landscape.”

ICER was essentially founded with a $5.3 million grant from the Arnold Foundation in 2015 and since then has published a series of reviews of new prescription drugs that treat conditions ranging from high cholesterol to congestive heart failure. While companies have typically agreed to participate in the reviews, ICER has found in most cases that the drugs have been priced above what it has deemed a fair value range.

Going forward, Pearson said, ICER will try to begin its reviews about 7½ months before the date the Food and Drug Administration (FDA) is anticipated to rule on a drug candidate. The reviews would be made public around the time a company sets the price of a newly approved medicine and health insurers decide whether to cover it.

While drug companies aren’t bound by the reviews, insurers and consumer groups are increasingly citing ICER’s “value frameworks” in negotiating how much they will pay.

According to Pearson, ICER staff also will begin examining the rationale drug companies use in determining whether to raise the price of drugs already on the market. Drug makers will be invited to take part in the review process.

ICER has previously issued reports outlining what it believes to be an appropriate cost for new medicines to treat high cholesterol, lung cancer, hepatitis C and other conditions, typically suggesting a value to patients that is a fraction of prices set by drug makers.

Rather than working from list prices as it did initially, ICER now attempts to “come up with a more precise estimate incorporating average net prices, taking rebates into account, to determine what it considers fair value-based pricing,” Pearson said.

Pharmacy benefit managers, insurers and government agencies have all used ICER reports in negotiating pricing and preferred formulary placements with manufacturers, ICER President Steven Pearson said in an interview, mentioning Express Scripts, CVS Health, the U.S. Department of Veterans Affairs and others.

Pearson said he had been informed by Express Scripts that it used ICER’s report in aggressively negotiating discounts on prices for new curative hepatitis C drugs with Gilead Sciences. “Veterans Affairs have used our reports to inform their thinking and price negotiations,” Pearson added.

The new funding comes at a time of increased scrutiny among politicians and insurers over the high cost of new prescription medicines in the United States, especially in comparison with other countries, and steep price hikes of some older generic medicines faced with little competition.

November 20, 2017

Could MIPS Data Be Used Against Physicians?

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One of the major changes thanks to MACRA and its associated Quality Payment Program (QPP) is the creation of MIPS, of the Merit-based Incentive Payment System. Much has been made about this new way physicians will be evaluated under Medicare. However, we have not seen the take of MIPS scores being used in other domains, such as medical malpractice lawsuits, until we came across this consulting firm’s hypothetical. Could MIPS data be used against physicians?

Hypothetical Malpractice Case

As described on MyMipsScores’ blog:

“[H]ere is another collateral effect of the MIPS score. This one is for our friends in the legal community and and I was made aware of it by our friend, Chuck Pope. Let’s say you are defending a provider who is being sued for malpractice. What if your provider client has a low MIPS score, say 23, and this is allowed to be entered into the proceedings. All the other side would have to do is point to the defendant’s MIPS score and the definition of the score as described by CMS:

The Composite Performance Score is based on four performance categories

  •      Quality 
  •        Resource use
  •        Clinical practice improvement activities
  •        Meaningful use of certified electronic health records (EHR) technology

Not looking so good for your client. On the other side, if a medical expert witness is on the stand and happens to have a high MIPS score it would point to credibility. See where I am going here? It is not just about avoiding penalties, it is about embracing the entire MIPS domain.”

Analysis

 

With this being the first reporting year of the QPP for MIPS, there are no documented cases of what was described having actually occurred in a courtroom. Could it happen? Possibly. Will it happen? Only time will tell. But it is an important reminder for physicians participating in Medicare that their MIPS data will be made public and can be searched by anyone with access to the Internet. We have some doubts as to whether this will be a tactic used in medical malpractice cases, but physicians worried about their MIPS score should start reporting this year to avoid even the potential of a problem down the line.

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