PCORI announces $6.5 million in grants to implement ‘shared decision making’

The Patient-Centered Outcomes Research Institute (PCORI) will release of $6.5 million in grant funding to organizations willing to implement shared decision making strategies for patients and care providers. According to the institute, the funding is designed to address concerns by doctors and other care providers that implementing the programs will cost too much time or “interfere with their routine clinical workflow.”

Shared decision making, research around which PCORI has provided nearly $200 million in funding, is an umbrella term for strategies that help patients better understand their treatment options in a given healthcare situation, particularly when the right choice is not clear or could be impacted by a patient’s preferences.

“PCORI recognizes that for many clinical situations, patients and clinicians need to work together to consider all available treatment options, informed by the patients’ preferences,” PCORI Executive Director Joe Selby said in a statement. “For a variety of reasons, shared decision making isn’t as widely used in practice as it should be.”

Examples of the research conducted includes a $1.6 million research project out of the Mayo Clinic, highlighted by PCORI in January of this year, looking at the implementation of “Chest Pain Choice.” The materials were developed in light of concerns that patients at a low-risk for heart attacks who reported chest pain in an emergency room were suffering unnecessary anxiety, as well as possibly increasing healthcare costs, after being transferred to the hospital for further testing. Another $1.4 million project from the University of Texas MD Anderson Cancer Center looked at the development of a video to help heavy smokers between the ages of 55 and 77 understand the risks and benefits of the CT lung cancer screenings, which were recently authorized by Medicare.

Grants are currently available only to those institutions that have served as past recipients of PCORI grants for shared decision making project, which they have completed, or new applicants working closely with one of those institutions to implement one of the research-based strategies. Clinicians have until October 2 of this year to submit their letters of intent for consideration, with an implementation start date of October 2018, at the earliest.

PCORI said it had funded $164 million in research on shared decision making projects as of September 2016. The initial funding comes with a commitment to authorize another $6.5 million to $8 million per cycle, with up to two cycles per year, for continued implementation.

Kusserow on Compliance: Investigating CIAs with physician practices

Last year, there were 19 corporate integrity agreements (CIAs) with physician practices. These CIAs, which generally were executed with smaller entities, represented about one fourth the total number entered into in that year. Accordingly, these CIAs were modified to address both the size and type of health care entity. Unlike many other settlements where there were mandates for board and executive oversight, including certifications, agreements with physician practices were different in that they did not include these major oversight and reporting requirements. However, there are many other features of the agreements that warrant attention.

Tom Herrmann, JD, who previously served in the Office of Counsel to the Inspector General, has specialized over the past several years in providing Independent Review Organization (IRO) services. He notes, “there are many significant differences with physician practice CIAs, but that is not surprising. The OIG has long recognized that physician practices are different from other types of providers, and the OIG’s compliance guidance for physician practices reflects these differences. One example calls for prominently posting a notice for patients on how to report fraud and abuse violations to the [Office of Inspector General (OIG)] Fraud Hotline. Often these CIAs with a physician practice are for three years duration, rather than five years. In addition, quarterly IRO review of claims coding, billing, and submission is mandated.”

Dr. Cornelia Dorfschmid, a nationally recognized top expert on claims reviews and utilization of the OIG’s RAT-STATS Statistical Sampling requirements common to CIAs, notes that “physician practice CIAs require quarterly claims samples in the first year, rather than annually for most other types, and must ensure their IRO is expert in the OIG RAT-STATS in the claim samples for accuracy review. The IRO must use reviewers who possess a nationally recognized coding certification. Although only 30 claims are required for the quarterly review, it creates an intensive effort with one review ‘dove tailing’ into the next. Furthermore, there is the 5 percent error rate threshold. If it is lower than that, no additional sampling or extrapolation is required, however, if greater, the IRO is required to estimate the actual overpayment for that period using extrapolating that error rate finding. The practice will have to repay the point estimate of the extrapolated overpayment. With only 30 claims, any errors in the sample endanger violating that threshold. It is also worth noting that if the OIG believes that an IRO quarterly claims review is inaccurate or substandard, it can conduct its own validation review. This would not be a good thing and the practice would have to pay the cost of any such reviews.”

Selecting an IRO is a critical and challenging step in meeting compliance obligations under the CIA especially when the time allotted is only 60 days, rather than the 90 days for most other CIAs. It is critical to ensure that a company meets all the IRO requirements set forth in the CIA, including that the IRO provides identities and credentials of those who will: (1) design the review methodology utilized for claims review; and (2) perform the reviews. The IRO is required to provide to a certification that it adheres to the Government Accountability Office (GAO) professional independence and objectivity standards to the OIG. The IRO must also certify it has reviewed the CIA in its entirety, understands the requirements, and can meet all of the specified standards.

Richard P. Kusserow served as DHHS Inspector General for 11 years. He currently is CEO of Strategic Management Services, LLC (SM), a firm that has assisted more than 3,000 organizations and entities with compliance related matters. The SM sister company, CRC, provides a wide range of compliance tools including sanction-screening.

Connect with Richard Kusserow on Google+ or LinkedIn.

Subscribe to the Kusserow on Compliance Newsletter

Copyright © 2016 Strategic Management Services, LLC. Published with permission.


Doctors know they’re putting patients at risk, but work sick anyway

Employees come to work for different reasons while they are sick. Some are not offered paid sick leave, others do not wish to “waste a sick day on a sick day,” and some feel that even though sick leave is available, they are expected to show up anyway. In February 2016, an article in The Journal of the American Medical Association (JAMA) discussed the implications of an earlier study revealing that though the vast majority of respondents felt that they put their patients at risk while working when they were sick, the concern of letting down colleagues and patients caused them to work through it.

Toughing it out

The concept of working while sick is not a groundbreaking one. Last year, NSF International, a public health organization, conducted a survey that revealed at least 26 percent of Americans go to work while they are ill. Although most judged their fellow co-workers for coming in sick, they admit that these people are hard workers. A quarter of those that work while sick reported doing so because their boss expected it of them. The Centers for Disease Control and Prevention released findings from an Environmental Health Services (EHS) study that showed 12 percent of restaurant food workers surveyed reported working even when experiencing vomiting or diarrhea. They were more likely to work when sick if the restaurant served more than 300 meals a day, did not have a policy requiring manager notification of illness, did not have a replacement on-call, and had less experienced managers.

The state of Massachusetts passed the Earned Sick Time law, which took effect July 1, 2015, requiring companies with at least 11 employees to offer paid sick leave. Nearly a year prior, Dr. Mark Schuster, Chief of General Pediatrics as Boston Children’s Hospital and a professor at Harvard Medical School, issued his thoughts on the necessity of family leave policies in a New England Journal of Medicine (NEJM) editorial. He noted that even though sick children are encouraged to stay home from school and see a doctor if necessary, parents are often unable or experience difficulty taking their children to a doctor.

Yet what if that doctor is coming to work sick? A 2015 JAMA Pediatrics study revealed that 83.1 percent of the 536 physicians and advanced practiced clinicians surveyed worked sick at least once in the past year, with 9.3 percent working sick at least five times. They would work with diarrhea, fever, and significant respiratory symptoms. Over 90 percent did not want to let colleagues or patients down and had staffing concerns. Over half mentioned in free-text responses that they felt there was no clearly defined ‘too sick to work’ standard. In response, Dr. Schuster noted that even when a clinician has good intentions while toughing it out, that decision can make others feel that they need to do the same. He felt that a cultural shift was required, as well as providing a better sick relief system with better workload coverage.

Not there yet

The February JAMA article revived the discussion about health care providers placing their patients at risk. Physicians were more likely to report concerns about continuity of care for their patients, at odds with the knowledge that working while sick can actually harm patients. One physician said it is actually much less stressful to work while sick than to make arrangements to cover care while out. Another noted that peak performance was expected at all times, and that providers were expected to deny smaller, basic needs, such as meals and bathroom breaks, in order to be as productive as possible, so taking time off for being sick was not feasible due to a lack of accommodation. The co-authors of this follow-up discussion article called on health care systems to come up with better solutions for coverage and backup in the event of illnesses.