Life Science Compliance Update

June 23, 2017

Amgen Biosimilar Report Released


For the past three years, Amgen has faithfully released an annual “Trends in Biosimilars Report.” This year’s report highlights various viewpoints from experts in the United States reimbursement community, as well as information on current physician and patient perceptions.

While much of the report will not provide surprising or new information for our readers who are well-versed in biosimilars, it does call attention to several trends that we should have our eyes on.

Transparency Isn’t Going Anywhere

Seth Ginsberg, the president of the Global Healthy Living Foundation writes in his report, “If you want us (and our physicians) to be confident in our choice of biologic or biosimilar, we want…full transparency at the manufacturer level. We want to know who’s making the product, how it’s made, and what their track record is.” even launched its own survey asking whether American-made biosimilars would be more successful in the U.S. Out of 117 people, 70 percent believe manufacturing location will not make a biosimilar more successful. A second question asked if U.S. physicians and patients would care about where a biosimilar was made. Seventy-five percent of 118 respondents said, “No.”

Initiatives Against Non-Medical Switching Becoming Popular

Patients’ concerns about non-medical switching have been prominent over the past year or so. In his statement, Ginsberg also noted that “We aren’t willing to let financial and bureaucratic obstacles stand between us and the biologics we depend on. [Global Healthy Living Foundation] recently helped write a bill, adopted into law in New York State, which allows for an appeal process and accelerated approval pathway when an insurer requires a patient to obtain prior authorization or go through steps to get their meds. Prior to that legislation, patients and physicians had little recourse if insurance companies required a step-edit.” That law was signed by Governor Andrew Cuomo in December 2016.

Insurance plans often implement step therapy programs to put patients on more cost-effective treatments prior to paying for newer, more costly, medications. Therefore, patients who are prescribed a high-cost treatment may be required to try other treatments and demonstrate they are not effective before being able to receive the higher-cost treatment. These steps can be avoided if physicians obtain authorization from the insurer.

The New York state law is not the only law that has been implemented to improve the prior authorization process. Just a quick glance at the National Conference of State Legislatures webpage on prescription drug legislation will show that there are several other bills in various states on similar topics. For example, Arkansas, California, Georgia, Hawaii, Missouri, Ohio, Oklahoma, and West Virginia have legislation pending and/or approved that will impact step therapy and prior authorization protocols.

Legislation like this allows physicians to authorize the use of the reference product for biologic patients who are just starting out with a new insurance company. It’s likely that these laws will continue to be implemented in the coming months and years.

The Importance of the Supply Chain

When selecting treatments, there are several factors payors consider including the device, available dosages, and patient support programs. However, as we begin to enter the age of oncology biosimilars, supply-chain reliability is expected to become a large consideration. According to the Amgen report, shortages are particularly common in the oncology field. Such a shortage can lead to disruptions in therapy, or forcing doctors to determine which patients can be taken off therapy earlier than planned.

Just as patients will judge a brand based on its quality, this report suggests supply-chain reliability will be another competitive factor. The size of the U.S. market cannot be compared to the European markets. As such, a company’s success abroad will not necessarily translate to success in the U.S. without adequate supply-chain preparations.

Chicago’s Attempt to Regulate Drug Reps - A Real Public Health Initiative or Simple Revenue Generator?


Lately pharmaceutical marketing has been under increasing attack at both state and federal governmental levels. Now Chicago has joined D.C. in the attempt to regulate pharmaceutical representatives. Billed by Chicago Mayor Rahm Emanuel as a measure to curb opioid addiction, the actual purpose seems less clear. What is clear is that the ordinance will induce additional costs and complexities for pharmaceutical compliance officers charged with overseeing sales activities.

The origins of the Chicago ordinance date back to October 2016. The city faced with increasing crime and overdose rates tied to illegal drugs needed to do something. As a result, Mayor Rahm Emmanuel announced new initiatives to combat heroin addiction in Cook County based on recommendations developed by a Task Force. Part of those initiatives was increasing the regulation of pharmaceutical representatives working within Chicago.

It is interesting to note that nowhere in the recommendations of the Task Force was there a call for licensing pharmaceutical representatives. However, the Mayor in his press releases stated that the new licensing requirement is part of a larger series of efforts by the city to combat heroin and opioid addiction. The Illinois Attorney General echoed this sentiment. “I support the City’s efforts to license pharmaceutical sales representatives to curb the abusive overprescribing of opioid painkillers that feed our country’s heroin epidemic,” said Illinois Attorney General Lisa Madigan. “My office has investigated misconduct of pharmaceutical sales representatives and recently filed a lawsuit against the maker of a powerful opioid for directing its sales reps to promote prescriptions for inappropriate uses that can be addictive and deadly.”

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June 22, 2017

MACRA Letters Went Out, Finally


The Centers for Medicare and Medicaid Services (CMS) finally mailed out letters to medical practices, providing clinicians with their participation status in the Merit-based Incentive Payment System (MIPS). MIPS is one of two payment tracks within the Medicare Access and CHIP Reauthorization Act (MACRA). The letters were supposed to go out in December, but that deadline came and went without any letters mailed. Roughly 419,000 providers were notified that they are participating in MIPS and must meet the reporting requirements for 2017. CMS uses historical claims data and data from the performance period to make the determination whether or not a physician/other healthcare provider is eligible for MIPS participation.

Meanwhile, there were over 800,000 providers who received the news that they do not need to participate in the MIPS program this year. Physicians are exempt from MIPS participation if they have less than $30,000 in Medicare charges and less than 100 Medicare patients per year. Additionally, physicians who are new to Medicare this year are also exempt.

Depending on whether a particular medical practice reports as a group, even physicians who do meet those exemption requirements may be required to participate. If the medical practice reports as a group all of the providers within the group’s Tax Identification Number (TIN), all providers will be included, even if an individual provider falls below the minimum thresholds above. Additionally, if providers participate in more than one TIN, they will need to verify their reporting status with each practice.

The number of clinicians who will participate in MACRA overall, however, will be higher than the estimated 419,000 participating in MIPS. The others will participate via alternative payment models (APMs). CMS expects that more physician practices will participate under MIPS as opposed to APMs, as MIPS allows the greatest financial reward, but also requires the doctors to take on more risks.

The number of MIPS participants differed from estimates made in the MACRA final rule released last fall, based on an updated eligibility formula. Under MIPS, physicians will receive Medicare payments based on quality measures and their use of electronic health records.

The letter provides instructions on what steps MIPS participants need to take, as well as reinforces deadlines to help physicians avoid a four percent negative payment adjustment for not participating. The letter also comes with an attachment with additional participation information and a list of frequently asked questions.

Physicians still unsure if they must participate in MIPS can visit, click on the MIPS Participation Look-up Tool and use their National Provider Identifier (NPI) to check their status. The look-up tool can also be helpful to practice administrators or clinicians who did not personally view the letter mailed because it was received by administrative leaders or a corporate office.


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