Life Science Compliance Update

November 11, 2014

“Continuing Medical Education” meets “Quality Improvement Education”


The Alliance for Continuing Education in the Health Professions is supporting an initiative to promote quality improvement programs through continuing education activities.

ACEhp members are invited to submit comments on the “Quality Improvement Education” Roadmap for the committees’ consideration until November 24, 2014. ACEhp will host a webinar this Friday, November 14, to discuss the Roadmap, provide feedback, and hear comments from colleagues.

We have featured an article written by Destry Sulkes, MD, MBA, Board President of the Alliance for Continuing Education in the Health Professions (ACEhp)


“Continuing Medical Education” meets “Quality Improvement Education”

Destry Sulkes, MD, MBA, Board President of the Alliance for Continuing Education in the Health Professions (ACEhp)

It’s no secret that a lack of coordination and continuity is a serious flaw in the nation’s health system. Even with electronic health records, an estimated 80 percent of serious medical errors involve some form of miscommunication.

As a healthcare education leader for over 15 years and current Board President of the ACEhp, it’s increasingly clear that continuing medical education (CME) must expand to all healthcare stakeholders, and focus more on the daily interactions among practitioners and their patients.

Until recently, CME and broader healthcare professional development has been very successful in helping us maintain competence, licensure requirements and to learn about new and developing areas of their field. Each profession and each medical specialty has outlined critically important updates in skills. But we’re realizing we have had our heads down too far. We’re missing the big picture.

“The Pennsylvania Project” is a perfect example of dramatic improvement in care made possible through an expanded focus on not just medical education, but a broader “inter-professional” education effort that focuses on National Quality Forum measures, in this case targeted to those at the center of the big picture – community pharmacists.

One in five prescriptions written are never filled, failing to improve patients’ health and reduce hospitalization. To address this problem, the project used the expertise and accessibility of pharmacists and care teams to keep patients on track in taking medications prescribed by their doctors.

The University of Pittsburgh School of Pharmacy trained care teams to screen patients to identify those at risk for missing or skipping medications for chronic conditions like diabetes, high-cholesterol, hypertension and heart disease.

This innovative “screening and brief intervention” approach, featured in the August 2014 Health Affairs, brought pharmacists and patients together to work through barriers like cost, side effects or silent symptoms that keep patients from taking medications as prescribed.

As part of “The Pennsylvania Project,” pharmacists access a cloud-based report card that keeps track of patient adherence by condition and compares rates to neighboring pharmacy patients. The monthly report cards spark conversations with patients who need more help with their medications. The patients are provided with more information about their medication and also have more interactions with their primary care physicians.

After a year, adherence rates significantly improved for all conditions tracked. An additional 1,500 patients in the project’s pharmacies started taking medications as prescribed to improve their health. This represents a 5% increase in adherence rates overall.

Non-adherence raises the risk for mortality from 12 to 25 percent for cholesterol-lowering statins and 50 to 80 percent for drugs that treat cardiac disease.  Medication non-adherence costs between $100 billion and $289 billion and 125,000 lives annually. A 1 percent improvement among Medicare patients is estimated to save the federal government $1.5 billion, according to the Congressional Budget Office.

We can no longer afford continuing medical education that operates independently of other healthcare professionals, patients, and quality improvement efforts. Bringing “quality improvement” and “continuing medical education” together is our “Eureka” moment in health care.

Pharmacists are an untapped source of patient engagement and quality improvement in health care. They train to get a doctorate in pharmacy and are uniquely positioned to see all the medications each patient is taking and all the practitioners who are prescribing them. It only makes sense for continuing education efforts to enlist pharmacists in quality improvement.

With the US healthcare environment in the midst of a refocus on results and outcome metrics versus quantity of services delivered, we have a great opportunity to bridge divides and forge a collective responsibility for better results. This new era of continuing education for health professionals creates new collaborations among healthcare stakeholders who haven’t traditionally worked together.

To jumpstart a more systemic focus on education’s role in quality improvement, ACEhp issued a Call for Comments on a Draft Quality Improvement Education (QIE) Roadmap. The QIE Roadmap will provide a vision for improving the quality of health care through continuous education of practicing health professionals. We see this as a prime opportunity for health education professionals and the practitioners they train to focus broad healthcare continuing education where it matters most – the daily interactions among and between health care providers and patients.

With so many new advances and discoveries being made in health care every day, continuing education for health professionals is one of the most challenging and critically important jobs. Now is a prime time to move from compliance-driven continuing medical education to performance-driven quality improvement education.  

September 26, 2014

American Hospital Association Supports Stark and Anti-Kickback Safe Harbors for “Gainsharing,” as Proposed by Medicare Anti-Fraud Act


In August, House Ways and Means Subcommittee on Health Chairman, Kevin Brady (R-TX), released the Protecting Integrity in Medicare Act of 2014 (PIMA), a discussion draft aimed at combating fraud, waste, and abuse in Medicare . The Act put forth more than 20 measures, which range from removing social security numbers from Medicare cards to implementing programs to prevent prescription drug abuse for “high-risk beneficiaries” under Medicare Part D. Rep. Brady noted that he looked forward to hearing from stakeholders about their comments and concerns regarding the Act.

The American Hospital Association (AHAs) obliged and recently offered step-by-step feedback to the Subcommittee. Perhaps most interesting was AHA’s discussion of the potential negative impact of fraud and abuse laws on “gainsharing,” or clinical integration. Under a typical gainsharing agreement, a hospital pays participating physicians a share of any reduction in the hospital’s costs attributable to the physicians’ cost-saving efforts in providing medical services. 

Current fraud and abuse laws, including the Stark law and Anti-Kickback statute call into question the legality of such gainsharing arrangements. Understanding the benefits of hospitals and doctors working towards efficient care, PIMA seeks to amend these existing fraud and abuse laws in “through exceptions, safe harbors, or other narrowly targeted provisions, to permit gainsharing arrangements that otherwise would be subject to the civil money penalties…or similar arrangements between physicians and hospitals, and that improve care while reducing waste and increasing efficiency.”

AHA noted that they appreciated the “Committee’s interest in moving forward in the area of clinical integration by studying how gainsharing could work and what laws would need to be changed to yield more effective and efficient care under Medicare.” 

“Hospitals are increasingly working more closely with physicians, including a growing trend of employing physicians,” AHA states. “A primary factor in this trend is barriers to clinical integration when physicians are not employed by the hospital.” Addressing the Stark Law and Anti-Kickback Statute in particular is "a good first step to comprehensively addressing these barriers to clinical integration in the following ways.”

Stark Law

The Stark law was enacted to ban doctors from self-referrals, that is, sending patients to facilities in which the doctor has a financial interest. Despite the law’s good policy, AHA states that the “tight web of regulations and other prohibitions that have grown up around the law can now ban arrangements designed to encourage hospitals and doctors to team up to improve patient care in a clinical integration program.”

For one, “the Stark law requires that compensation for health care providers be fixed in advance and paid only for hours worked,” AHA states. “As a result, payments that are tied to achievements in quality and efficiency (such as gainsharing contemplated in the draft bill) instead of hours worked do not meet the law’s strict standards.” Under the Stark Law, AHA notes, “a hospital or clinic that rewards a doctor, and the doctor who earns the reward for following protocols that guide the clinical integration program, can be found in violation.”

The best solution, AHA argues “is to return the Stark law to its original focus of regulating self-referral to physician-owned entities. This could be accomplished by removing compensation arrangements from the definition of ‘financial relationships’ that are subject to the Stark law.” AHA notes that these compensation agreement would still be regulated under the more appropriate anti-kickback and civil monetary penalty laws, which they address in turn.  

Anti-Kickback Law

The anti-kickback law states that anyone who knowingly and willfully receives or pays anything of value to influence the referral of federal health program business, including Medicare and Medicaid, can be held accountable for a felony. “Today, the law has been stretched to cover any financial relationship between hospitals and doctors,” AHA states. “If, as part of a clinical integration program, a hospital rewards a doctor for following evidence-based clinical protocols, the reward could be construed as violating the anti-kickback law.” Such a reward could technicaly “influence a doctor’s order for treatment or services.”

AHA notes that the law carries both civil and criminal penalties and can result in both the hospital and the doctor being barred from Medicare, Medicaid and other federal programs, effectively shutting down the hospital and ending the doctor’s career. “Congress, recognizing that the anti-kickback statute sometimes thwarts good medical practices, has periodically created ‘safe harbors’ to protect those practices,” states AHA. “However, there is no safe harbor for clinical integration programs that reward physicians for improving quality, such as gainsharing.”

“Congress should create a safe harbor for clinical integration programs,” AHA concludes. “The safe harbor should allow all types of hospitals to participate, establish core requirements to ensure the program’s protection from anti-kickback charges, and allow flexibility in meeting those requirements so the programs can achieve their health care goals.”

AHA also notes that the Civil Monetary Penalties law prohibits hospitals from rewarding physicians for reducing or withholding services to Medicare or Medicaid patients. These penalties have also stood in the way of hospitals and physicians effectively working together to lower costs and improve care in a gainsharing arrangement. 


We will continue to follow PIMA, as the legislation could signal changes in Medicare fraud and abuse laws. 

September 25, 2014

“Doctoring in the Age of ObamaCare” Sheds Light on the Mounting Administrative Tasks that Take Physicians Away From Patients

Steth and Comp

A recent editorial published in the Wall Street Journal entitled "Doctoring in the Age of ObamaCare" provides a glimpse at a day in the life of an endocrinologist working in solo private practice. Dr. Mark Sklar has experienced the changing healthcare landscape over the past two-decades, and argues that “[t]he practice of medicine in the current environment is unsustainable.”

Today, doctors must demonstrate “meaningful use” of electronic health records, call insurance companies to pre-authorize drugs for coverage, and adjust to quality reporting requirements. Furthermore, doctors may have to front questions about their collaborations with industry as the Open Payments database goes public at the end of the month. All of these ancillary tasks, while potentially intended to help patients, have actually taken almost all the time away from one-on-one patient care. 

“Although it is convenient to have patient records accessible on the Internet,” Dr. Sklar notes that “the data processing involved has been extremely time consuming—a sentiment echoed by most of my colleagues.”

Dr. Sklar was advised to enter data into the electronic record during his patients’ office visits, but he notes that typing in the data during the appointment was disruptive. “My eyes were focused on the keyboard and the lack of direct contact kept patients from opening up and discussing their medical and personal problems,” he states. “I soon returned to my old method of dictating notes and pasting a print-out of the dictation into the electronic record.”

The financial incentives (and now penalties) from Medicare, however, are based on doctors demonstrating "meaningful use" of the electronic record. Doctors must document that they covered a checklist of items during an office visit. Dr. Sklar notes that he spends “90 minutes each day entering mostly meaningless data. This is time better spent calling patients to answer questions or keeping updated with the medical literature.”

Unfortunately, all the work put into digitizing this information does not translate to interconnected patient records. “If electronic records ever allow physicians to obtain data from previous laboratory and imaging testing, it will improve costs and patient care,” Dr. Sklar states. “So far, however, the data in electronic records—like paper charts—can't be shared unless physicians work in the same health-care system.”

Dr. Sklar notes that he “quickly adopted the new Medicare requirements for electronically prescribing medications.” Often, however, he found that his patients did not want their prescription sent electronically. “They want a physical copy—either because they don't trust the Internet or because they don't need to fill the prescription immediately,” according to Dr. Sklar. “If I don't electronically prescribe for a certain number of Medicare patients, I am penalized with a decrease in reimbursement that can rise to a maximum of 5%. Patients should have a choice in how their prescriptions are delivered, and physicians shouldn't be penalized for how the patients choose.”

In addition to EHR requirements, Dr. Sklar discusses the time-consuming process of pre-authorization. "To prevent physicians from prescribing more costly medications and tests on patients, insurers are increasingly requiring physicians to obtain pre-authorizations," he states. "This involves calling a telephone number, often being rerouted several times and then waiting on hold for a representative. The process is demeaning and can take 30-45 minutes." Dr. Sklar believes that instead of requiring physicians to pre-authorize, the high cost of brand name drugs should be addressed. 

Furthermore, to avoid Medicare penalties, doctors also must participate in the Physician Quality Reporting System program. "Initially, this involved choosing three codes during the patient visit to reflect quality of care, such as blood pressure or blood-sugar control, and reporting them to Medicare," states Dr. Sklar. "In 2015, the requirement will increase to nine codes."

Dr. Sklar also takes issue with ICD-10, which, while postponed from the October 2014 deadline, is still on a lot of doctors' minds. The present ICD-9 system has about 15,000 medical diagnostic codes that doctors use for billing insurance. The newer system will contain about 70,000 codes. "The Physician Quality Reporting System and ICD-10 requirements are intended to benefit population research," Dr. Sklar notes, "but the effect is to turn physicians into adjuncts of the Census Bureau who spend time searching for codes—and to further decrease the amount of direct contact with patients."

Dr. Sklar concludes:

The multiple bureaucratic distractions in my day consume so much time that I have to give up what little personal time I have in the morning, evening and on weekends if I want to continue to provide excellent care during office hours.

If high-quality medical care is the goal, the bureaucracies need to be tamed. Our government and insurance companies understandably want to measure outcomes of health-care dollars spent. However, if the health-care system rewards data entry, that is what it will get—the quality of care seems an afterthought.

Open Payments

While not addressed in Dr. Sklar's piece, the pending Open Payments release threatens to further drive a wedge in between the patient and the doctor. The Open Payments system will publicly show a doctor's financial relationship with pharmaceutical and device manufacturers. Collaboration between industry and physicians is often an essential element of innovation. However, without proper context in the news or in the system itself, physicians may be responsible for justifying their industry work to any patient who may ask. 

Lance K. Stell, a medical ethics specialist and teacher at the Department of Internal Medicine at Carolinas Medical Center, recently spoke to this issue from a practical perspective given the immense strains on doctors' time.

He asks: “In our 10 minute interview, would you prefer that I spend more time discussing the details of my reimbursement, industry consulting and visiting with industry reps and
less time discussing your medical condition, test results & treatment options or the reverse?"  

Additional Studies

Last year, the Journal of General Internal Medicine published a study that found that internal medicine interns spent only a minority of their time directly caring for patients. The New York Times featured the study and noted that new doctors’ average face-to-face time with patients is around eight minutes. “Instead, current interns spend the majority of their time in activities only indirectly related to patient care, like reading patient charts, writing notes, entering orders, speaking with other team members and transporting patients,” the article stated.

“The dramatic decrease in time spent with patients compared with previous generations appears to be linked to new constraints young doctors now face, most notably duty hour limits and electronic medical record-keeping.”

Because most documentation must be done electronically, the study found that interns now spend almost half their days in front of a computer screen.


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