Life Science Compliance Update

May 20, 2016

Senator Durbin Asks Medical Associations to Endorse Mandatory Opioid CME – AMA Shows Interest

Following last month's letter to the Pharmaceutical Research and Manufacturers of America (PhRMA), asking the group to "take financial responsibility for the drug industry's role in curtailing the opioid overdose epidemic," United States Senator Dick Durbin sent a letter to four physician associations asking them to endorse mandatory CME programs.

The letter, which was sent to the American Medical Association (AMA), the American Academy of Family Physicians (AAFP), the American College of Emergency Physicians (ACEP), and the American Dental Association (ADA), noted several steps the Senator feels as though the associations can take to address the opioid epidemic. While the letters all had the same goal and the same roadmap to get there, each one was individually focused on the addressed association, using their mission statements to reach out and personalize his prayer for support.

Sen. Durbin believes that "the increased frequency with which prescription opioids have been prescribed in recent years has played a major factor in our nation's escalating heroin epidemic, including an alarming increase in opioid-related emergency room visits, opioid-related treatment admissions for abuse, and opioid-related overdose deaths." He cited statistics, including the statistics that the United States accounts for almost 100% of the world total consumption of hydrocodone and 81% of the world total consumption of oxycodone.

He believes that the best way to reduce the number of Americans who suffer from opioid addictions is to ensure that patients never become addicted in the first place.

Senator Durbin believes that the associations each can address the opioid and heroin crisis by "supporting evidence-based interventions." In part, he recommended that the AMA could prioritize helping physicians be more judicious in their prescribing patterns, while working to protect access for those who need opioids to manage their pain.

Several of the steps Senator Durbin mentioned in his letters to the associationswere: endorsing mandatory continuing medical education programs for opioid prescribers; supporting initiatives that require physicians to check prescription drug monitoring programs before prescribing painkillers to patients; and supporting increased transparency in physician prescribing practices and proper intervention for those who may be outliers.

Senator Durbin, in his letter, does acknowledge that there are "many patients suffering from acute and chronic pain" and that "doctors face a challenge in evaluating its existence or severity," since pain is always subjective.

Durbin HealthExec Interview

After publishing his letters, Senator Durbin participated in an interview with HealthExec, where he was asked whether or not he had heard from doctors that what he's asking of the associations would actually help. He responded, saying that he has heard from doctors in both directions. He believes that doctors who say it isn't their fault, that they try to keep their patients happy and satisfied, aren't providing a good answer, or doing their job. He believes that they "have to make certain they're doing what's medically necessary, number one, and do no harm to the patient."

In the interview, Senator Durbin did not appreciate the idea of training new professionals to not prescribe opioids en masse, though. He feels as though there should be some responsibility taken by current physicians, and some actions to rectify the current situation.

AMA Response

Following receipt of the letter from Senator Durbin, AMA President Steven Stack, MD, penned an open letter to medical professionals to "play a lead role" in reversing the rise in opioid addiction, but did not endorse the standards that were advocated in Sen. Durbin's letter.

Instead of endorsing mandatory continuing education programs, however, Stack endorsed ideas such as: avoiding prescribing opioids for new patients who have chronic pain unrelated to cancer; to register and use Prescription Drug Monitoring Programs (PDMPs); and work on reducing opioid exposure to patients who are already on chronic opioid therapy when the risks exceed the benefits.

Interestingly, on May 17, 2016, Inside Health Policy reported that the AMA is starting to warm up to the idea of mandatory opioid prescriber education tied to DEA registration. This is a huge change from before, when the AMA tended to focus on an alternative approach because they felt as though mandatory CME was too "one size fits all."

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.

January 15, 2016

AMA House of Delegate Recommendations on Maintenance of Certification and Licensure

During November's American Medical Association (AMA) House of Delegates (HOD) meeting in November, many resolutions and recommendations were adopted, some of which we have previously touched upon.

In addition to the aforementioned HOD actions relating to price control measures on pharmaceutical products and banning direct to consumer advertising, the AMA House of Delegates also adopted some changes recommended by the Council on Medical Education Report. Council on Medical Education Report 2 reviewed and consolidated existing AMA policy on Maintenance of Certification (MOC), Osteopathic Continuous Certification (OCC) and Maintenance of Licensure (MOL) to ensure that the policies are current and coherent.

AMA Principles on Maintenance of Certification (MOC)

The AMA voted to amend Policy H-275.924, Maintenance of Certification. Some of the changes made were for clarification purposes, such as the change that now requires any changes to the MOC process for a given medical specialty board to occur no more frequently than the "intervals used by that specialty board" for MOC. Previously that requirement had used "intervals used by each board" for MOC, possibly creating some confusion as to whether the longest interval by any specialty board controlled, or the interval used by the specialty board in question.

A new statement was added into the policy, #10. The new statement reads,

"In relation to MOC Part II, our AMA continues to support and promote the AMA Physician's Recognition Award (PRA) Credit system as one of the three major credit systems that comprise the foundation for continuing medical education in the U.S., including the Performance Improvement CME (PICME) format; and continues to develop relationships and agreements that may lead standards accepted by all U.S. licensing boards, specialty boards, hospital credentialing bodies and all other entities requiring evidence of physician CME."

MOC's importance was also clarified, with the AMA now saying that MOC is

"but one component to promote patient safety and quality. Health care is a team effort, and changes to MOC should not create an unrealistic expectation that lapses in patient safety are primarily failures of individual physicians."

Another change made was the addition of the following statement, "Our AMA will include early career physicians when nominating individuals to the Boards of Directors for ABMS member boards."

Additionally, the AMA has also advocated policy so that physicians with lifetime board certification are no longer required to seek recertification and no qualifiers or restrictions should be placed on diplomats with lifetime board certification recognized by the ABMS related to their participation in MOC.

Members of the AMA House of Delegates are encourage to increase awareness of these, and other proposed changes to physician self-regulation, through their specialty organizations and other professional member groups.

AMA Principles on Maintenance of Licensure (MOL)

The AMA House of Delegates recommended a new chunk of requirements be added to these principles.

One new requirement reflects the aforementioned change in MOC above. The new requirement asks that the AMA:

"Continue to support and promote the AMA Physician's Recognition Award (PRA) Credit system as one of the three major CME credit systems that comprise the foundation for continuing medical education in the U.S., including the Performance Improvement CME (PICME) format, and continue to develop relationships and agreements that may lead to standards accepted by all U.S. licensing boards, specialty boards, hospital credentialing bodies, and other entities requiring evidence of physician CME as part of the process for MOL."

Additionally, the AMA is to advocate that if state medical boards move forward with a more intense or rigorous MOL program, each state medical board shall be required to accept evidence of successful ongoing participation in the ABMS MOC and AOA-Bureau of Osteopathic Specialists (AOA-BOS) Osteopathic Continuous Certification (OCC) to have fulfilled all three components of the MOL, if performed.

The AMA will also advocate for acceptance by state medical boards of programs created by specialty societies as evidence that the physician is participating in continuous lifelong learning. The AMA will also encourage state medical boards to allow physicians to choose which programs they participate in to fulfill their MOL criteria.

Lastly, the AMA agreed to oppose any MOL initiative that creates barriers to practice, is administratively unfeasible, is inflexible with regard to how physicians practice (clinically or not), does not protect physician privacy, or is used to promote policy initiatives about physician competence.

An Update on Maintenance of Licensure

The AMA is also set to amend Policy D-275.957. The AMA has agreed to continue to monitor the evolution of Maintenance of Licensure (MOL), continue its active engagement in discussions regarding MOL implementation, and report back to the House of Delegates on the issue. The AMA will also continue to review published literature and emerging data as part of the Council on Medical Education's efforts to review MOL issues and work with the Federation of State Medical Boards (FSMB) to study whether principles of MOL are important factors in a physician's decision to retire or if they have a direct impact on the U.S. physician workforce.

The AMA will also encourage the FSMB to continue working with individual state medical boards to accept physician participation in the American Board of Medical Specialties MOC and the AOA-BOS OCC as meeting the requirements for MOL and also to develop alternatives for physicians who are not certified or recertified, and advocate that MOC or OCC not be the only pathway to MOL for physicians.

The AMA will also continue to encourage rigorous evaluation of the impact on physicians of any future proposed changes to MOL processes, including cost, staffing, and time.

Maintaining Medical Specialty Board Certification Standard

Policy H-275.926 will be amended to signify AMA's opposition of discrimination against physicians based solely on lack of ABMS or equivalent AOA-BOS board certification. The AMA also opposed discrimination that may occur against physicians involved in the board certification process, including those who are in a clinical practice period for the specified minimum period of time that must be completed prior to taking the board certifying examination.

The AMA is also encouraging member boards of the ABMS to adopt measures aimed at mitigating the financial burden on residents related to specialty board fees and fee procedures, including ideas like shorter preregistration periods, lower fees, and easier payment terms.

Rescinded Policies

The AMA will rescind a list of policies, including: H-275.923, Maintenance of Certification/Maintenance of Licensure; H-275.944, Board Certification and Discrimination; H-405.974, Specialty Recertification Examinations; and D-275.971, American Board of Medical Specialties – Standardization of Maintenance of Certification Requirements. Most of these rescinded policies contained ideas mentioned above that were added to other policies and standards.

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