Life Science Compliance Update

February 09, 2016

Biosimilars Clinical Studies and Analytical Similarity Summit – Update on Biosimilars

This year, Pharma IQ, a division of the International Quality and Productivity Center, will be hosting the Biosimilars Clinical Studies and Analytical Similarity Summit, March 21 through the 23, in Boston, Massachusetts. Attendees to the Summit will receive key insights from industry thought leaders into some of the biggest challenges in the analytical and clinical phases of biosimilar drug development.

This Summit boasts a full agenda spanning all three days, starting with Pre-Conference events on March 21 at 9:00 am. The Pre-Conference workshop day consists of three workshops with a wide range of topics: Compare, Contrast and Comply with US and EU Regulations that Govern Biosimilar Product Development; Establishing Structural Comparability with Effective Preclinical Characterization Methods; and Effective Clinical Study Design for Detecting Differences Between Biosimilar and Innovator Products Among Sensitive Populations.

Day One of the Summit gets off to a roaring start at 9:00 am with a keynote address given by Professor Andrea Laslop, the Head of Scientific Office at the Austrian Agency for Health & Food Safety, on the future of biosimilar approval in Europe. They keynote is followed by three discussions: one on the unique bioanalytical testing and clinical testing strategies for proving safety and efficacy; one on the legal and regulatory implications of "similarity" and "interchangeability"; and a third one on biosimilars regulations in the US market and where we are headed from here, presented by our very own Thomas Sullivan. The afternoon closes out with discussions on how to leverage the FDA's "Totality of Evidence" methodology for using foreign reference products, and how to reduce or eliminate nonclinical toxicity studies from biosimilar development programs.

Day Two of the Summit again begins with a keynote address, this time a regulatory update on Health Canada's new guidance for subsequent entry biologics, presented by Agnes V. Klein, M.D., the Director CERB, Biologics and Genetic Therapies Directorate, at Health Canada. Dr. Klein and Professor Laslop come together mid-day on Day Two to host a regulatory question and answer session, focused on similarities and differences in the market authorization of biosimilars, including regulatory, policy, and guidance background. Day Two ends with a presentation by Michael Retsky, a research associate with the Department of Environmental Health at the Harvard T.H.Chan School of Public Health, on the difficulty of using biosimilars in oncology and what can be done about it.

If you are interested in attending the Biosimilars Clinical Studies and Analytical Similarity Summit, you can register here. Those who register by February 19, 2016, could receive up to $400 off registration costs.

February 08, 2016

Electronic Health Records and the Meaningful Use Program: Is the End Near?

Let Doctors Be Doctors

Physicians are fed up with ERH, and are organizing with campaigns and creative music videos such as Let Doctors Be Doctors. They have even created an infographic outlining the problems with electronic health records .  The government finally seems to be listening.

While speaking both to members of industry and Congress, Andy Slavitt, Acting Administrator at the Centers for Medicare & Medicaid Services, hinted toward changes coming for the electronic health record Meaningful Use program. Citing the new MACRA law’s upcoming regulations, Slavitt noted the program will be different for physicians, prompting some to believe it will change from an “all or nothing” approach to one that may be more flexible and incentivizes using electronic records rather than offering penalties. CMS will have an important MACRA regulation in March, some speculate on March 25, which will outline changes to the Meaningful Use program, as it becomes a part of the new MACRA Merit-based Incentive Payment System.

The problem with EHRs

All of this is good news, especially to the American Medical Association. According to the AMA and other medical groups, one of their members’ biggest headaches is the rise of electronic health record systems, which they say are drowning physicians in red tape. Physicians say too much of their time is being taken up by clerical tasks. This is patently obvious if one views the website “Let Doctors Be Doctors,” where the voice of physicians uniformly speak against government mandates on electronic health records. This site was created as a forum to “amplify the voices of health care professionals and patients.”

“We need to talk about the elephant in the exam room. Electronic health records (EHRs) are failing to improve the connection between patients and providers—and distracting providers from their real work. With more than two-thirds of doctors saying they wouldn't recommend their EHR and the American Medical Association calling for a ‘major overhaul of EMR systems,’ it's time to demand change,” it further states. This and other campaigns have helped to inspire a significant amount of media attention and creative representations of the struggle faced by physicians, such as this viral YouTube hit “EHR State of Mind”.

The AMA’s campaign, “Break the Red Tape” calls for the government to postpone finalizing the Meaningful Use Stage 3 regulations on electronic health records in order to align the policy with other programs under the new Merit-based Incentive Payment System.

This comes as a new report indicates burnout among U.S. doctors is getting worse, showing physicians are worse off today than just three years earlier. Mayo Clinic researchers, working with the American Medical Association, compared data from 2014 to measures they collected in 2011 and found higher measures on the classic signs of professional burnout. More than half of physicians felt emotionally exhausted and ineffective. More than half also said that work was less meaningful.

Electronic health records play a role in this decline. “Instead of spending my days listening to patients and solving their problems, I feel that I spend most of my time struggling to make unique stories and needs fit into an arcane system of clicks and drop-down menus,” Dr. Laura Knudson, an Indiana family physician, recently told the Chicago Tribune. 

Congress and CMS Act to Expedite Exemptions

There has been some good news, however. Prior to adjourning for the holidays, Congress adopted legislation, S. 2425, the “Patient Access and Medicare Protection Act,” which included a provision granting CMS the authority to expedite applications for exemptions from Meaningful Use Stage 2 requirements for the 2015 calendar year. As described by the AMA in an email to stakeholders, in order to avoid a penalty under the meaningful use program, eligible professionals must attest that they met the requirements for meaningful use Stage 2 for a period of 90 consecutive days during calendar year 2015. However, CMS did not publish the Modifications Rule for Stage 2 of meaningful use until October 16. As a result, eligible professionals were not informed of the revised program requirements until fewer than the 90 required days remained in the calendar year.

A provision of the legislation adopted by Congress would grant CMS the authority to process requests for hardship exemptions to physicians through a more streamlined process, alleviating burdensome administrative issues for both providers and the agency. Members of Congress involved in the passing of the legislation include Rep. Tom Price, MD (R-GA), Sens. Orrin Hatch (R-UT) and Ron Wyden (D-OR), and numerous members of the House and Senate leadership from both parties.

However, this does not go as far as some have requested. In a November 20 letter from the GOP “Doctors Caucus” to Speaker of the House Paul Ryan, the 18-member caucus requested Speaker Ryan’s help in pressing for a delay of Stage 3 along with a blanket hardship waiver exception for Stage 2.

Implementation of more-stringent criteria is likely to create “a chilling effect on further EMR adoption as physicians conclude that the cost of implementation is simply not worth the bureaucratic hassle,” according to the letter. “Members of our caucus, as well as numerous congressional health care leaders, have engaged CMS on these issues to warn them of the potential negative consequences of placing these new requirements on providers in order to meet an arbitrary deadline. CMS has ignored Congress. Congressional action is the only solution left for preserving patient access, choice and quality.”

Additionally, CMS guidance on the legislation indicates the agency intends to focus on streamlining the application process. According to the application process for hardship exemptions from meaningful use penalties in 2015, CMS is allowing providers to check box “2.2.d” of the application for an exemption because the agency published its Stage 2 modification rule so late in the year. The penalties, which hit in 2017, total 3 percent of Medicare payments for providers who fail to attest to meaningful use or to get an exemption. Doctors and other eligible professionals have until March 15 to submit their applications for exemptions; hospitals have until April 1.

Meaningful Use Comments

In October, CMS and the Office of the National Coordinator for Health IT released the final rule for Stage 3 of the meaningful use program, modifications for 2015 through 2017 and the 2015 Edition Health IT Certification Criteria. The proposals for the meaningful use modifications for 2015 through 2017 and Stage 3 were combined into a single final rule, which was published on the Federal Register. Under the final rule, Stage 3 is optional in 2017, and providers who elect to begin Stage 3 that year will be able to attest for a 90-day reporting period. It will be mandatory in 2018 and contains eight reporting objectives for eligible professionals and hospitals, more than 60% of which require interoperability, compared with 33% under Stage 2.

In its comments, the American Medical Association recommended CMS allow for additional flexibilities, including multiple methods to meet the meaningful use program goals, elimination of the pass-fail structure of the program, and removing threshold requirements for performance measures. Other comments of note include the Healthcare Information and Management Systems Society (HIMSS), which expressed support for the rule. HIMSS asked that any changes made by CMS be published by February 29, 2016, so participants have enough time to prepare for the transitional year in 2017.

Health IT Security Concerns in 2016

As legislation moves in Congress and regulatory comments are shaping future health IT policies, stakeholders are outlining some concerns with the security of health records and other health IT programs. According to a report from PricewaterhouseCoopers’ Health Research Institute, the adoption and use of new health care technologies will help drive several new industry trends in 2016. During the year, many consumers will have their first video consults, be prescribed their first health apps, and use smartphones and diagnostic tools for the first time. Cybersecurity will be a major concern for these apps; however, they will help move the health care system away from the fee-for-service model as wireless technology improves. Remote technology will allow physicians to better manage health needs, and new databases will afford health systems the opportunity to analyze large and diverse datasets.

A report from Experian also raises security concerns, noting that data breaches will remain a top concern for the health care industry in 2016. According to the report, 90% of health care organizations have experienced a data breach within the last two years. Attacks will likely be focused on large insurers and health systems; however, “smaller incidents caused by employee negligence will also continue to compromise millions of records each year.”

Other reports echoing health IT security concerns go one step further. DirectTrust, a three-year old, non-profit, competitively neutral, self-regulatory entity created by and for participants in the Direct community, including Health Internet Service Providers (HISPs), Certificate Authorities (CAs), and Registration Authorities (RAs), suggests that Meaningful Use faces an “uncertain future” in 2016 and 2017. They speculate that it could be delayed or entirely phased out. It cites physician groups concerned that Stage 3 does not align well with new health care requirements in the MACRA (Medicare Access and CHIP Reauthorization Act of 2015) law. Providers may be willing to face penalties instead of spending more money on health IT that they may not see adding value to their organization, the report also notes.

These reports come as Congress recently passed the Cybersecurity Act of 2015 as part of the 2016 omnibus spending package. The legislation requires the Department of Health and Human Services to provide the Senate HELP Committee and the House Energy and Commerce Committee with a report within one year. That report is to provide a clear statement concerning who is responsible for leading and coordinating efforts at HHS regarding cybersecurity threats in the healthcare industry and provide a plan from each relevant operating division and subdivision. The legislation also creates a healthcare industry cybersecurity task force.

Life Science Compliance Update, February 2016: Technology and Compliance

The February 2016 issue of Life Science Compliance Update, available here (subscription required), explores the impact technology has on the world of compliance departments and their operations.

Issue Summary

This issue brings many outside voices to the fray, writing on a wide variety of topics, such as the new European Generic Medicines Association Code, a white paper issued by Seton Hall Law's Center for Health and Pharmaceutical Law & Policy on the role federal and state agencies and their relationships with relators affect enforcement of off-label promotion rules, and AdvaMed's new compliance app for mobile devices.

Table of Contents

In the Global Issues portion of the subscription, Editor Seth Whitelaw, Ph.D., and Staffer Mohamed Gorrafa, J.D., write up the new EGA Code and some of its novel tenets.

In the Enforcement section, Charles Sullivan, a professor of law at the Seton Hall University School of Law discusses the white paper mentioned above, which analyzes the role of federal and state agencies, and their relationship with relators in both direct and indirect enforcement of off-label promotion.

Some of the team at Huron Life Sciences collaborated on an article that gives five "thoughtful controls" to consider with your specialty pharmacy relationships.

Since this is a compliance publication, the "meat" of the issue focuses on compliance. Katherine Norris, the Director of the Berkeley Research Group goes through the history of CIAs, and some significant milestones that have been made along the way. Seth Whitelaw educates us on AdvaMed's new app that was developed with the intention of facilitating understanding and use of the AdvaMed Code. James Bone, the Executive Director of TheGRCBlueBook.com, writes about the way smart systems are being used in the life science industry to reduce risk and solve complex problems. Lastly, Kaitlin Fallon, J.D., summarizes for readers a roundtable discussion that recently took place at the Sixteenth Annual Pharmaceutical Compliance Congress and Best Practices Forum on joint ventures and co-promotes and best practices from a compliance perspective.

This month's transparency focus is presented by Timothy M. Moore, Esq., an attorney with Shook, Hardy & Bacon, LLP, and hypothesizes some possible reasons as to why even though the Sunshine Act allows for Civil Monetary Penalties (CMP), CMS has yet to bring a single CMP action.

Subscription

If you are interested in subscribing to the Life Science Compliance Update, annual individual subscriptions are available for $1,200.00, with multiple subscriber-based discounts available. For a limited time, new subscribers can get 15% off of their subscription with the code "CHARTER15."

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