Life Science Compliance Update

December 05, 2014

National Quality Forum Begins Annual Review of Quality Measures, Comments Open December 23 on the 202 Proposed Measures


On Monday, the Measure Applications Partnership (MAP) began its annual review of performance measures that the Centers for Medicare and Medicaid Services (CMS) is considering for use in 20 federal health programs. The 202 measures considered by the group have been made public (view the  PDF), and will be available for review and comment beginning December 23, 2014.

Established by the National Quality Forum (NQF) in 2011, MAP is a forum of approximately 150 healthcare leaders and experts, representing nearly 90 private-sector organizations. MAP comprises consumers, purchasers, labor, health plans, clinicians and providers, communities and states, suppliers, and liaisons from seven federal agencies.

“MAP brings the public and private sectors to consensus on how quality can be measured effectively and efficiently in federal health programs,” said NQF President and CEO Dr. Christine Cassel. “A key goal for MAP is to streamline the measures used by the federal government so that patients receive the quality care they deserve and providers can focus on how best to improve the care they deliver.”

What do some of these 202 new measures look like?

The measures included for review cut across a wide variety of treatments. Measures included on the list cover preventative care and a number of conditions, including diabetes, asthma, surgery, and cancer.

One measure, x4208, looks at opioid addiction. It seeks to quantify the percentage of patients with a diagnosis of current opioid addition who were counseled regarding psychosocial and pharmacologic treatment options for opioid addition within the 12 month reporting period.

Another, measure x3798, quantifies how often patients with diagnosis of a muscular dystrophy had a scoliosis evaluation ordered. Measure E0056 measures how many patients with diabetes received a foot exam during the measurement year. Another measure seeks to curb "unnecessary colonoscopies" in patients over age 86, when the risks apparently are reduced (X3769).

Some measures are extremely detailed. For example, x3773, entitled "Optimal Asthma Care," covers a wide range of required testing, tracking, and patient education protocols.

The list of applicable Federal programs (available on pg. 6-7 of the PDF) includes:

  • Ambulatory Surgical Center Quality Reporting Program;
  • End‐Stage Renal Disease (ESRD) Quality Incentive Program;
  • Home Health Quality Reporting Program;
  • Hospice Quality Reporting Program;
  • Hospital‐Acquired Condition Reduction Program;
  • Hospital Inpatient Quality Reporting Program;
  • Hospital Outpatient Quality Reporting Program;
  • Hospital Readmission Reduction Program;
  • Hospital Value‐Based Purchasing Program;
  • Inpatient Psychiatric Facility Quality Reporting Program;
  • Inpatient Rehabilitation Facility Quality Reporting Program;
  • Long‐Term Care Hospital Quality Reporting Program;
  • Medicare and Medicaid Electronic Health Record (EHR) Incentive Program for Eligible Professionals;
  • Medicare and Medicaid EHR Incentive Programs for Eligible Hospitals or Critical Access Hospitals;
  • Medicare Shared Savings;
  • Medicare Physician Quality Reporting System;
  • Physician Compare;
  • Physician Feedback/Quality and Resource Utilization Reports;
  • Physician Value‐Based Payment Modifier Program;
  • Prospective Payment System‐Exempt Cancer Hospital Quality Reporting Program; and
  • Skilled Nursing Facility Value‐Based Purchasing Program.

Starting on p. 330, the pdf breaks down the CMS program that corresponds to each measure title.  

Download CMS List of Quality Measures


CMS notes that they are issuing this list of measures to comply with Section 1890A(a)(2) of the Social Security Act, which requires the Department of Health and Human Services to make publicly available a list of certain categories of quality and efficiency measures that it is considering for adoption through rulemaking for the Medicare program. “Because this List contains measures that were suggested to us by the public, this List contains more measures than will ultimately be adopted by CMS for optional or mandatory reporting programs under Medicare,” states the report. “When organizations, such as physician specialty societies, request that CMS consider measures, CMS makes every effort to include those measures and make them available to the public so that [MAP], the multi‐stakeholder groups convened as required under 1890A of the Act, can provide their input on all potential measures.” 

The measures considered by the group are made public at the beginning of the forum and will be available for review and comment beginning December 23, 2014.

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. 


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