Healthcare policy

Can you trust clinical practice guidelines? Thank you, Gary Schwitzer of  HealthNewsReview.org for an excellent blog post on the BMJ (British Medical Journal) article about conflicts of interest on clinical practice panels. The BMJ article details some of the types of conflicts common on the clinical practice panels that issue treatment guidelines.

As a Minneapolis healthcare PR firm dedicated to promoting the transformation of healthcare to a patient-focused, outcomes-based model, we believe it is vitally important that engaged patients receive evidence-based, unbiased information.

Article offers suggestions on how to protect patient interest

British Medical Journal

For example, in the controversial area of PSA testing, the article notes that The American Urological Association’s best practice update in 2009 and its 2013 practice guidelines reflected potential conflicts of interest in the context of association sponsorship, committee chair conflicts and multiple panel member conflicts. The article contrasts this with the conflict-free status of the U S Preventive Services Task Force in 2012.

Who do you believe?

While the U.S. Preventive Services Task Force found harm from routine PSA testing and no evidence of net benefit, the American Urological Association 2009 guidelines promoted routine PSA testing. In 2013, the Association revised its guidelines to reflect a more conservative approach to PSA testing.

As noted elsewhere, studies have found troubling patterns of conflicts of interest in practice guideline panels, and or lack of full disclosure of those conflicts. Part of the answer is the new Physician Sunshine Act, which we’ve written about previously, that requires the reporting of financial payments to physicians by pharmaceutical and medical device companies.

Avoiding Red Flags

The BMJ authors recommend that professional journals avoid the following red flags:

  • Sponsor(s) is a professional society that receives substantial industry funding;

  • Sponsor is a proprietary company, or is undeclared or hidden

  • Committee chair(s) have any financial conflict*

  • Multiple panel members have any financial conflict*

  • Any suggestion of committee stacking that would pre-ordain a recommendation regarding a controversial topic

  • No or limited involvement of an expert in methodology in the evaluation of evidence

  • No external review

  • No inclusion of non-physician experts/patient representative/community stakeholders

  • *Includes a panelist with either or both a financial relationship with a proprietary healthcare company and/or whose clinical practice/specialty depends on tests or interventions covered by the guideline.

Please take note, healthcare PR professionals, healthcare marketing professionals and journalists. And for full disclosure, this Minneapolis healthcare PR firm works for the parent company of an online source of unbiased medical reference and clinical recommendations. The client had nothing to do with the writing of this blog post, and I take full responsibility for its contents.

What can healthcare PR and marketing professionals learn from the controversy regarding Penn State’s $1,200 surcharge on employees who do not meet a new requirement of the school’s wellness program to provide certain personal information and undergo a free biometric exam?

Penn State made an official announcement of the changes in early July, after consultations with faculty and other stakeholders. The Chronicle of Higher Education reported on the story in mid- and late July, “Weigh in or Pay,” followed by NPR on August 2nd. By mid-August the story had made The Wall Street Journal.

Opponents challenged the new policy, beginning with a post by a Penn State professor on the blog maintained by the Pennsylvania division of the American Association of University Professors, followed by coverage on the faculty senate blog and a drive on petition site Change.org, where opponents of the new requirements have gathered more than 2,000 signatures to date. Analysis has occurred on independent blogs, including the Harvard Business Review blog – see “The Dangers of Wellness Programs: Don’t Be the Next Penn State.

A few observations:

I don’t claim to be an expert on wellness plans, which are encouraged as part of the Affordable Care Act (Obamacare), but here are a few observations from a healthcare PR and marketing perspective:

1. Rewards are easier to market than penalties. If a plan reduces a member’s cost for taking a positive action, that’s likely to cause a lot less problem from a PR and marketing perspective than a penalty for not taking the same action.

2. Highlighting  plan member self-interest is generally superior to highlighting the needs of the employer. It’s possible that too much of the Penn State wellness program focus was on how much money it would save Penn State. Positively engaging plan members is probably easier when the health and lifestyle benefits of an action for them are the main thing emphasized. As we’ve stated elsewhere:

Suppliers to the healthcare market must communicate how their products and services will help…meet the new challenges and opportunities in healthcare. Providers must reach out to patients in new ways, emphasizing better outcomes and patient engagement.

3. Be prepared for controversy with vision, persistence…and evidence. Well-run wellness plans have demonstrated strong ROI, promoting healthier lifestyles and outcomes with genuine cost savings. Yet, critics of the Penn State plan, including the authors of the Harvard Business Review blog post (see above) attacked the merits and payoffs of the new requirements. Promoters of these plans must be ready to cite clear evidence that plan requirements result in better outcomes. And with social media, including petition sites, Facebook, blogs, etc., opponents have more tools at their disposal. It would be wise for plan promoters to have a comprehensive crisis management plan in place, including provisions for social media.

 

Physician diagnostic overconfidence may be harming patients, according to a new study published in JAMA. The study was actually about overconfidence regarding internists’ diagnoses. Even in difficult-to-diagnose cases, where the internists were correct in their diagnosis only 5.8 percent of the time, their confidence in their diagnosis was high. In easier cases, they were right only 55 percent of the time. For the study, that made the physician diagnoses wrong half the time.

As Cheryl Clark reports in a story for Health Leaders Media, one of the authors of the study makes the point that hospitals could do a better job of providing feedback to physicians whose initial diagnosis is wrong. Hardeep Singh, MD, principal author of the study, told Clark that the opportunity for learning is sometimes lost when feedback does not occur.

Singh suggests there is a serious problem regarding diagnostic accuracy:

The whole medical enterprise is based on the fact that one goes to a doctor in the belief that doctors usually know what they’re doing, otherwise you won’t go. If a doctor said, ‘you know, I’m kind of wrong half the time,’ no one is going to come to them.

Patient Engagement Needed

As we’ve previously written, patients and their families need to be engaged and consult reliable online resources and/or seek second opinions.

Since our post on 8/1/13, the Physician Payment Sunshine Act has received little attention, despite the recent start of record-keeping requirements for drug, medical device and certain other healthcare companies that make payments to physicians, and upcoming public reporting of such payments. However, The Wall Street Journal ran a story yesterday, “Doctors Face New Scrutiny Over Gifts.” The Journal reported that some physicians are already reconsidering what gifts, free dinners and other reportable compensation they receive from covered companies:

“John Mandrola, a cardiologist in Louisville, Ky., said he has been paid a total of $1,500 to $2,000 this year by medical-device makers for speaking engagements. Knowing that such transactions will become public has caused him to be more cautious about what fees to accept, he said. He avoids industry reps visiting his office, believing he can get information on new drugs elsewhere. I’ll continue to weigh the benefits and the negatives, and I think the Sunshine Act and the public reporting of all this stuff makes us think about that,” said Dr. Mandrola. “And I think that’s a good thing.”

CMS Advising Physicians to Keep Records

The story reported that the Centers for Medicare and Medicaid Management are advising physicians to keep records of all payments and transfers of value from industry.

Reporting to the Public Begins in September, 2014

Healthcare PR professionals can expect to see increased media coverage of this issue, especially when the data begins to be available on a government website beginning in September 2014. That’s a year away, but the reporting has already begun.

 

If you’re a healthcare PR or marketing professional, please note: Over-diagnosis and overtreatment resulting from cancer screenings has led an expert panel to suggest that the word “cancer” should not be applied to conditions that are not lethal. The U.S. National Cancer Institute commissioned a panel to study the problem created by too many growths found through screening that are clinically insignificant and indolent in nature. Writing in The Journal of the American Medical Association, the panel reported:

“Screening always results in identifying more indolent disease. Although no physician has the intention to overtreat or overdiagnose cancer, screening and patient awareness have increased the chance of identifying a spectrum of cancers, some of which are not life threatening. Policies that prevent or reduce the chance of overdiagnosis and avoid overtreatment are needed, while maintaining those gains by which early detection is a major contributor to decreasing mortality and locally advanced disease.”

The authors note that while mortality from certain cancers – e.g., breast and prostate – declined between 1975 and 2010, the incidence has increased significantly because the screenings found large numbers of insignificant cancers. In contrast, they note, screening for colon and cervical cancer decreased incidence as well as late-stage disease through detection and removal of precursor lesions.

The panel’s advice? Reclassify  non-lethal lesions as “IDLE” – indolent lesions of epithelial origin. What’s the implication for healthcare PR and marketing professionals? Use caution when promoting screening programs or technologies. Be aware that overtreatment and over diagnosis is a significant problem, and communications about screening or screening technology should reflect this. For example, testing for PSA (prostate specific antigen) should include “informed consent” between patient and doctor, in which the pros and cons of PSA testing are discussed. Healthcare PR professionals should consider including some cautionary statement in their promotions for screening programs and screening technologies. Cancer screening has saved many lives, but patients should be aware of the risks.

With the rise of patient engagement, candor and full disclosure are the new standard.

Data collection begins today for the Physician Payment Sunshine Act (Sunshine Act). Part of Obamacare, the Sunshine Act requires that manufacturers of pharmaceuticals, medical supplies and biologicals report payments they make to physicians and teaching hospitals. This is designed to bring transparency to these financial transactions, most of which are for legitimate purposes.

Some of these payments have raised concerns that prescribing physicians may not be impartial in what they choose to prescribe for their patients. With the Sunshine Act, these payments will now be in the light of day and it is hoped that this will encourage appropriate payment practices and improve confidence in the impartiality of prescribing physicians.

What Are the Implications for Healthcare PR?

What are the implications for healthcare PR? Healthcare PR professionals who work for companies covered by the act or who have such companies as clients should make preparations to handle inquiries that might arise from the media, including bloggers. An audit should be done of payments reported under the act, and potentially controversial payments identified. A plan should be thought through and put in place to handle any media inquiries. This plan would identify spokespersons, have basic answers drafted, and include specific steps for handling inquiries. If needed, spokespersons should receive media training. Key messaging should be prepared that connects back to the company’s core values and product development strategy.

For more information on the Sunshine Act, go to CMS.gov. The program is administered by The Centers for Medicare and Medicaid in the Department of Health and Human Services.