A Ray of Sunshine?

It’s already 15 months overdue and it will be another year still before the information is public, but last week  the government  set out  the final rule for the Physician Payment Sunshine Act (Sunshine Act) in a 287 page document!

The Sunshine Act (passed in 2010 as part of the Affordable Care Act) requires manufacturers of drugs, devices, biologicals, and medical supplies to report all payments and other transfers of value to physicians and teaching hospitals. The rule was supposed to be published in October 2011, but has suffered continuous delays amongst intense lobbying both by groups keen to get the data in the public hands, such as the AARP, and those most affected by it, such as the American Medical Association (AMA).

The final rule announced February 1^st, officially puts the Industry on notice. They have until March 2014 to get their payments reporting act together. The U.S. Centers for Medicare and Medicaid Services (CMS), will then input the data, including payment information from August through December of this year, into a publicly available database which, they say, will be online by September 2014.

And its not only payments to doctors of medicine that have to be reported. Under the definitions of the Act, “physicians” include doctors of osteopathy, dentists, podiatrists, optometrists and chiropractors.

The rule also requires reporting on both the form and nature of payment or transfer of value made by a manufacturer to a physician.

Forms of payment included under the final rule :

• Cash or a cash equivalent
• In-kind items or services
• Stock, a stock option, or any other ownership interest, dividend, profit or other return on investment
• Any other form of payment or transfer of value

While, nature of payments include:

• Consulting fees
• Compensation for services other than Consulting
• Honoraria
• Gifts
• Entertainment
• Food
• Travel
• Education
• Research
• Charitable contributions
• Royalty or license
• Current or prospective ownership or investment interest
• Direct compensation for serving as faculty or as a Speaker for a medical education program
• Grants
• Any other payment

Advocates of the Sunshine Act have long argued that the public needs to know when doctors are getting paid and by who. “You should know when your doctor has a financial relationship with the companies that manufacture or supply the medicines or medical devices you may need,” said Peter Budetti, M.D. CMS deputy administrator for Program Integrity. “Disclosure of these relationships allows patients to have more informed discussions with their doctors.”

This increased transparency is also intended to help reduce the potential for conflicts of interest that physicians or teaching hospitals could face as a result of their relationships with manufacturers.

Relationships between doctors and drugmakers have been brought up in a number of cases when FDA advisory panels have ruled for or against drugs in which doctors had some interest. For example, last year an advisory panel voted 15-11 to support the approval of Bayer‘s Yaz birth control pills, but allegations later surfaced that four committee members had ties to the manufacturer.

Once the bill is introduced, doctors will get 45 days after information is submitted to vet it for accuracy.

The American Medical Association (AMA) is not happy.  The doctors’ group wants physicians to have more than 45 days to challenge information in the government’s database and add commentary to explain the payments. It also wants some corporate contributions to physicians excluded from disclosure, including sponsorships for educational activities and “indirect” payments, such as unsolicited contributions a company might make to a nonprofit group affiliated with doctors or to physicians’ employers or practices.

AMA president Jeremy Lazarus wants to ensure “the registries will provide a meaningful and accurate picture of physician-industry interactions. It is critical that the final rule provide physicians with a clear way to correct any inaccurate information and not place any substantial administrative burden on physician practices.”

And the AMA is not alone. Unsurprisingly, the Pharmaceutical Research and Manufacturers of America (PhRMA), the primary lobbying group for drugmakers, said that while it supports more disclosure, the new regulations should take into account the importance of context in the publication of physician payment information.

“Ethical interactions between biopharmaceutical companies and health-care professionals are essential to maintaining patient trust,” said Matthew Bennett, a spokesman for PhRMA. The principle behind the so-called sunshine provision “is complementary to this belief and it has great potential for helping patients understand the ways in which such collaboration benefits their health and medical innovation,”

What’s your take on this new rule? Is the government helping to let the sun shine in or is this a dark, dark day for doctors and pharma?  Let us know your thoughts.

Is Your Doctor Burned Out?

Is life / work stressing you out?  Thinking about going to see your doctor for help?  Before making that appointment you may want to think again.

According to a national survey of physicians, released this week nearly 1 in 2 US doctors are themselves suffering from burnout.  That’s more than any other US workers.

Overtaxed doctors are not only at risk for personal problems, like relationship issues and alcohol misuse, but their job-related fatigue can also erode professionalism, compromise quality of care, increase medical errors and encourage early retirement – a potentially critical problem as an aging population demands more medical care.

Survey participants completed a 22-item Burnout Inventory questionnaire, which measured emotional exhaustion, depersonalization (treating patients as objects rather than human beings) and low sense of personal accomplishment. Of the 27,276 physicians asked to participate, 26.7% responded. They had to report only one symptom to be included among those reporting burnout.

Differences in burnout rate varied by specialty: While most people assume that the surgical or cancer specialties would be at highest risk, the researchers from the Mayo Clinic found that emergency medicine, internal medicine, neurology and family medicine reported the highest rates.

“Nearly 60% of physicians in those specialties had high levels of burnout,” says says lead author Tait Shanafelt MD. “This is concerning since many elements critical to the success of health care reform are built upon increasing the role of the primary care providers.”

On the other hand, doctors practicing pathology, dermatology, general pediatrics and preventive medicine had the lowest rates of burnout.

In other words, it’s the physicians on the front line of care who are most likely to burn out.

And that’s not all. When asked about emotional exhaustion, 37.9% of physicians reported signs, compared with 27.8% reported by other workers surveyed.

“The rates are higher than expected,”. Commented Shanafelt “We expected maybe 1 out of 3.

Being asked to see more patients and not having enough time to spend with them creates an atmosphere of being on a hamster wheel, says physician Jeff Cain, president-elect of the American Academy of Family Physicians.

While the current prevalence of burnout is alarming many predict it could get worse as health care reform takes hold and the medical profession has to take on the additional workload associated with the millions of patients who will be newly insured under the health care law.

While the Affordable Care Act will put more pressure on the front lines, this new study could be an important wake-up call. The country needs to hear to build multidisciplinary health care teams to meet the need and help unburden our poor put-upon physicians, so they in turn can help us.

Nurses are the Key to Reducing Revolving-Door Readmissions

Shockingly, one in five elderly patients discharged from a hospital is readmitted within a month. Seeking to address the substantial human and financial burden of revolving door hospital readmissions, the Affordable Care Act has proposed a number of initiatives to improve care and health outcomes and reduce costs for the growing population of chronically ill people in the U.S.

While transitional care is a central theme in these provisions, there is little information available to guide those responsible for implementing these important opportunities. To bridge the gap, researchers at the University of Pennsylvania School of Nursing reviewed existing programs in order to determine what works, for whom and for how long.

They discovered “a robust body of evidence” that transitional care can improve health outcomes and reduce hospital readmissions. Their paper published in a recent edition of Health Affairs, highlights a range of solutions to reduce avoidable hospitalizations and health care costs.

The team conducted a systematic review of the research literature and summarized twenty one randomized clinical trials of transitional care interventions targeting chronically ill adults. From these, they identified nine interventions that demonstrated positive effects on measures related to hospital readmissions. “All nine interventions that showed any positive impact on readmissions relied on nurses as the clinical leader or manager of care,” wrote lead author Mary Naylor, Ph.D., R.N.

The strategies they identified have been shown to result in short term benefits and effectively reduce all-cause hospital readmissions through six or 12 months. “If we capitalize on what we know, the real beneficiaries will those living with complex chronic conditions and their family caregivers,” explained Naylor.

This makes sense to us and is certainly a lot easier than trying to understand the Affordable Care Act.

Ever Heard of a “Fun” Explanation of Health Care Reform?

While explanations of the implications of president Obama’s 2010 Affordable Care Act (ACA) are painfully boring for most Americans, a surprisingly comprehensive and entertaining video, aims to change all that.  The non-partisan, non-profit research organization, Kaiser Family Foundation, produced this delightful video narrated by NPR’s senior news analyst, Cokie Roberts.

We know that many industry and healthcare-insider readers can likely recite pages of the Act, but maybe this video will help convince your family and friends to become involved in the discussion.

We can always go back to boring them again tomorrow!