Governor Vetoes Donda West Cosmetic Surgery

Governor Arnold Schwarzengger has unexpectedly vetoed Assembly Bill 2968, the Donda West Law, which had easily passed the California Legislature roughly six weeks ago. The governor cited the state budget crisis and the limited ability to attend to other matters as the reasons for the veto, which was one of 131 bills vetoed on the same day (along with 64 signatures).

In light of the veto, California physicians (and dentists) are not required by law to obtain physical examinations of patients and clearance prior to performing cosmetic procedures. Nonetheless, such exams are asserted by the Medical Board of California to be standard of care (whether performed by the operating physician, nurse practitioner, or physician assistant, or, alternatively, by a primary care doctor).

Recommended Action: Irrespective of the veto, physicians (and dentists) should ensure that the documentation of a physical exam, including a complete medical history, is part of every patient chart prior to performing any cosmetic procedure. Although the passage of the law would have increased the potential penalty, in the absence of a new law, the Medical Board of California will nonetheless continue to initiate disciplinary actions routinely for violation of this standard.

Harry Nelson is a partner in Fenton & Nelson, LLP. Harry conducts audits and training programs for plastic surgeons and cosmetic healthcare providers to ensure effective risk management and compliance in medical practice. For additional information, please contact him at harry@fentonnelson.com

©Harry Nelson 2008

California Enacts Certification for Massage Therapists

Governor Schwarzenegger has signed into law the first California statewide certification system for massage therapists. S.B. 731 establishes a voluntary certification for the roughly 40,000 people who currently practice massage therapy in California as “massage practitioners” and “massage therapists.”The certification will be managed by a new Massage Therapist organization (MTO). Over the next six years, this organization is charged by the new law with creating a board, developing policies, processing applications, and, ultimately, issuing certifications.

Recommended Action: The establishment of statewide certification–and the attendant professionalization of massage therapy in California–is a positive development for healthcare providers whose current services incorporate massage therapy or who are considering expansion into massage therapy in the future. The current licensing of massage therapy–at the city and county level–is confusing and forces providers who employ massage therapists (for physical therapy or other purposes) to focus excessive attention on compliance requirements that vary from locale to locale. It is hoped that the MTO will work towards establishing uniform regulatory requirements across the state.

Harry Nelson is a partner in Fenton & Nelson, LLP. Fenton & Nelson advises healthcare providers on risk management and compliance issues, including scope of practice and training requirements. For additional information, please contact him at harry@fentonnelson.com

©Harry Nelson 2008

Helping Patients Challenge Insurance Denials

Watching patients struggle with health insurers’ refusal to cover treatments can often be excruciating for providers. Anna Matthews describes strategies that increasingly better educated patients are using to appeal payors’ denials in the Wall Street Journal. (“Pushing Back When Insurers Deny Coverage for Treatment,” 9/25/08).

First, Matthews, recommends, patients need to discover “what led to the insurer’s decision, and keep a careful paper trail.” Patients need to review the particular insurer’s procedure for appeals, and then to demand documentation of why coverage was denied. Second, patients need to establish proof that the treatment sought qualifies for coverage under their health plan. Third, patients may need to appeal to the state if the insurer rejects their appeal. Matthews also highlights helpful online resources, such as the Kaiser Family Foundation website and the Patient Advocate Foundation. In addition, she recommend the state advocacy resources compiled by Families USA. Sometimes employers will provide assistance; otherwise, patients can seek help from Health Proponent, Patient Care, or or a similar organization.

Recommended Action: Advising patients on how to challenge insurers can be time consuming for providers, who have enough struggles of their own in dealing with insurers. One upside of the trend towards consumer-directed care is patients who have the knowledge and resources to pick their own battles with payors. Providers can should have suggestions for patients to educate themselves and be able to challenge insurers directly.

Harry Nelson is a partner in Fenton & Nelson, LLP, a law firm that counsels healthcare providers on business and compliance issues. For additional information, please contact Fenton & Nelson at harry@fentonnelson.com

©Harry Nelson 2008

Physician Consolation and Apologies: How Much Should Providers Say?

Among the things that physicians and other healthcare providers generally don’t learn in medical school is how to speak with patients and their families after bad outcomes, particularly when a medical error or possible error is involved. Confusion about what kind of statements are legally protected, coupled with feelings of fear, guilt, shame, or the overwhelming emotional state of upset patients (or grieving family members) only add to the pressure. At the same time, the growing belief is that more forthright and empathetic communication from physicians reduces the incidence of malpractice lawsuits and licensing complaints dramatically. (E.g. William Sage, Rogan Kersh, MEDICAL MALPRACTICE AND THE U.S. HEALTH CARE SYSTEM, p. 151 (Cambridge University Press, 2006).) So what can and should physicians say?

1. What does the law protect?

California, like many states, has an “apology law” that provides that statement, writings, or benevolent gestures “expressing sympathy or benevolence relating to the pain [and] suffering” are inadmissible to prove liability. California protects statements of sympathy, no matter who makes them, as long as they are made to a patient or family member. However, the law does not protect statements that fault or substantiate plaintiffs’ allegations, which can be used against physicians.

• In other words, physicians can – and should freely make – compassionate statements, i.e. “I’m so sorry that you are in so much pain” without fear that the statements can be used against them.

• On the other hand, physicians cannot make acceptance-of-responsibility-statements without legal consequences, such as “I’m so sorry that I hurt you.”

2. So how much should the physician say?

What to express depends upon whether the circumstances call for expression of empathy or an acknowledgment of fault. It is beyond the scope of this article when fault should be acknowledged. (Consult your malpractice carrier, employer, or a lawyer.) Expressions of empathy are very different from apologies. If fault is being admitted, then Randy Pausch’s definition of a “good” apology works: a “good” apology expresses that (1) what I did was wrong; (2) I’m sorry I hurt you; and (3) how do I make it better? (Randy Pausch and Jeffrey Zaslow, THE LAST LECTURE, p. 162 (Hyperion 2008).) This model, however, only works for a case of unmistakable error. In the more common ambiguous circumstance where fault is not being conceded, physician are often not “apologizing” but instead are express empathy in a manner that must be more circumscribed and nuanced.

• Regardless of fault or the lack thereof, we recommend that physicians always convey three protected elements of what Dr. Michael Woods, author of Healing Words: The Power of Apology in Medicine (Doctors in Touch 2007), calls the 5 “R’s”:

• Regret: (“I am so sorry you are going through this”);

• Recognition: (“This has been so hard on you”); and

• Remaining engaged: (“I am here for you.”)

• On the other hand, Woods’ other two “R’s” – (taking) responsibility and (helping) remedy – should be reserved for cases where there is clear, conceded physician error. Based on the law above, physicians should expect that expressions of responsibility (i.e. Pausch’s expressions that “what I did was wrong” or that “I hurt you” or expressions of remedy (“how I will help you through this” or why “it will never happen again”) will be legally admissible.

3. How should the physician say it?

• Prepared: If consolation is a new skill, physicians should write out the points they want to convey to be prepared and ensure the right message is conveyed with the right tone. Nervousness can lead to saying too much (i.e. expressing fault) or to inappropriate defensiveness or, worse, lightheartedness. The consolation or apology should not be read, just thought out carefully in advance.
• Informative: It is critical to be clear, honest, and direct about what happened. At the same time, too much information can be overwhelming. The worst approach is evasion.
• In person: Communication should take place face to face. At a minimum, the conversation should be over the phone. Email, which omits emotional tone, is the wrong way to offer consolation or apology.
• In private: It is easier to speak in a place where the conversation will not be overheard (except by physician staff or colleagues who will be supportive witnesses in cases where litigation or complaints ensure).
• Informally: It is better to speak in closer proximity, on the same level (i.e. both sitting or both standing, without a desk or bed in between doctor and patient).
• Without delay: Physicians should not put off these talks. Patients (and families) need soothing and good communication most when their feelings are raw.
• Active listening: As important as what is said, is how it is said. Before speaking, it is essential to defuse emotional or grieving patients or family members with active listening, i.e. focusing attention on the speaker, paraphrasing back what you hear, clarifying what is being said in nonjudgmental, without agreeing, disagreeing, or being defensive, conveying that you hear and understand the speaker. Active listening creates a collaborative, emotionally supportive environment. Patients or family members are often as desperate for emotional support as they are for information about what happened and why. Before discussing anything about the medical issues, the physician must ask the patient (or family member) how he or she is feeling and, if appropriate, ask questions.
• Taking notes: It is important to document the communication and the patient (or families’) reaction and to note any witnesses in the patient medical records. Writing down what is said goes hand in hand with active listening. It also is a helpful record if there is any malpractice suit or complaint.
• Sincere: The most important thing is to speak from the heart. It can be a challenge to convey the right tone while staying on message (i.e. expressing that you are sorry for what happened, not for having done anything wrong), but the expression must be genuine.

Harry Nelson is a partner in Fenton & Nelson, LLP. Fenton & Nelson counsels healthcare providers on risk management and legal complaince matters. For additional information, please contact him at harry@fentonnelson.com

©Harry Nelson 2008

Can patients sue drug manufacturers for violating state law despite FDA approval?

As reported by Adam Liptak in the New York Times, the first case to be heard by the U.S. Supreme Court in its October 2008 term (October 6, 2008) addresses the legal effect of Food and Drug Administration (FDA) approval of drug labeling. Wyeth v. Levine involves a physician assistant (P.A.) error in 2000. Diana Levine, a professional musician, sought treatment for severe migraines. When the P.A. administered the treatment Levine had received in the past – Demerol for pain and Phenergan for nausea – the P.A. injected the Phenergan via “IV push,” thinking she was injecting into a vein, but missing and injecting intra-arterially. Although Phenergan is typically safe if administered intramuscular or through intravenous drip, it causes “swift and irreversible” gangrene when “exposed to arterial blood.” Ms. Levine lost her right hand and arm below the elbow to gangrene.

She sued both the clinic and Phenergan’s manufacturer, Wyeth on the basis that its label, approved by the FDA, did not disclose the risk of danger of administration by IV push. The label did warn that “inadvertent intra-arterial injection” could cause “gangrene requiring amputation,” but made no mention of IV push. Wyeth contended that the FDA rejected a proposed change, but Levine argued that Wyeth could still have supplemented the labelling. Although the clinic settled, Wyeth declined to do so, arguing that it claims of deficient drug labeling were preempted by FDA approval. The difference is that FDA regulations require only minimum safety standards, in contrast to state law, which imposed stricter warning requirements. A jury found in favor of Ms. Levine, and the Vermont Supreme Court upheld the decision , finding that FDA minimum safety labeling requirements “provide[d] a floor, not a ceiling, for state regulation.”

Recommended Action: Plaintiffs’ lawyers are concerned that pharmaceuticals may be insulated from inadequate drug labelling if the U.S. Supreme Court agrees with Wyeth and the FDA’s position that states are preempted from imposing additional safety requirements on medications. As reflected by the fact that the clinic settles with Ms. Levine even as the drug maker fights on, healthcare providers don’t have the same luxury as manufacturer of reliance on FDA labelling. A growing trend and “best practice” among physicians is the use of informed consents to advise patients fully of all risks associated with particular medications. We recommend that providers review the medications used in their practice and consider implementation of informed consents to avoid claims of inadequate disclosure of risks.

Harry Nelson is a partner in Fenton & Nelson, LLP, a law firm that counsels healthcare providers on FDA-related and other compliance issues. For additional information, please contact Fenton & Nelson at harry@fentonnelson.com

©Harry Nelson 2008

Consumer Spending on Healthcare Declines with Economic Downturn

Vanessa Fuhrmans reports in the Wall Street Journal on the impact that the economic slump is having on consumer healthcare spending. For the first time in over a decade, consumers are cutting back on healthcare expenses. Although attention has been focused previously on the declining demand for cosmetic medical services, the reduced demand is evident in healthcare spending across the board, ranging from skipping or splitting doses of prescription medication to foregoing tests, preventative care, and procedures based on financial pressure.

Recommended Action: These trends are forcing a revision of the conventional wisdom that health care is impervious to recession. As a business matter, providers need to be atturned to — and protect their businesses against — the risk of slumping demand for services. As a matter of clinical care, providers need to ensure patients understand that foregoing necessary tests and appointments will lead to increases in both medical compliactions and costs in the future. Providers need to communicate to patients the risk that delayed screening will lead to emergency room visits. In the words of Rand Corp. director of health economics, Dana Goldstein, “[o]nce you’ve had that heart attack and end up in the hospital, that’s when the expensive stuff begins.”

Harry Nelson is a partner in Fenton & Nelson, LLP, a law firm that counsels healthcare providers on business and compliance matters. For additional information, please contact Fenton & Nelson at harry@fentonnelson.com

©Harry Nelson 2008

Is criminal and Medical Board prosecution of pain medicine prescribers overstated?

Barry Meier reports in the New York Times that, between 1998 and 2006, the rate of prosecution of physicians (criminal and administrative, i.e. Medical Board) for inappropriate prescription of pain medication was roughly .1%. Although this number may sound low, based on the media attention and the climate of fear among physicians related to this issue, the statistic is of dubious comfort to California physicians, given that this remains a relative priority on the Medical Board’s enforcement agenda. Moreover, the study appears to ignore a significant, countervailing development in recent years: DEA enforcement. Using enhanced data-mining capacity to track unusual patterns (e.g. specialties not ordinarily treating pain) and high volume prescribers, the DEA has become increasingly aggressive in enforcing DEA regulations concerning recordkeeping, storage, prescription, and dispensation of narcotic pain medications. (California has distinct pain medication regulatory requirements as well, albeit ones that are subject to lower levels of enforcement.) With civil monetary penalties set at $10,000 per violation, physicians who prescribe pain medication cannot afford to take legal compliance lightly when it comes to pain medication.

Physician Compensation, Pay-for-Performance, and Outcomes Reporting

In an essay in the New York Times, cardiologist Saundeep Jauhar, M.D. describes the challenges inherent in linking physician compensation to performance. The problem, Dr. Jauhar writes, is that pay-for-performance programs (“P4P”) create incentives for particular therapies that result in their overuse: pay physicians for prescribing antibiotics, and patients will receive them even if they have no evidence of infection. In addition, P4P encourages “cherry-picking” and discourages physicians from treating the sickest patients for fear of negative statistics.

The same danger lies in many of the physician outcome reporting programs that are gaining in popularity: in the field of cardiothoracic surgery, for example, the California Coronary Artery Bypass Graft (CABG) Outcomes Reporting Program, CCORP, has given rise to a fear on the part of many surgeons of the implications of negative reporting on outcomes if they perform CABG on sick patients.

Recommended Action: Physicians are under increasing pressure – from both patients and payors – for more information about and incentivization linked to quality of care. Greater reliance on both pay-for-performance and outcome reporting metrics are inevitable, despite the manifest problems inherent in both. On an individual level, providers need to approach these trends and their challenges strategically. On a collective level, providers need to take part actively in establishing — and establishing limits on — meaningful quality guidelines before payors and government agencies impose them.

Harry Nelson is a partner in Fenton & Nelson, LLP, a law firm that counsels healthcare providers on business and compliance issues. For additional information, please contact Fenton & Nelson at harry@fentonnelson.com

©Harry Nelson 2008

Study questions efficacy of arthroscopic knee surgery

The New York Times reports on a new study in the New England Journal of Medicine that reflects negative scientific data for arthroscopic surgery for knee osteoarthritis. The study compared two groups of patients with arthritic knees; one group received arthroscopic surgery, physical therapy and medications, while the other received only physical therapy and medications. According to the study, over the subsequent two years, no difference in symptom was discerned.

Recommended Action: Arthroscopic surgery as a treatment of knee osteoarthritis and insurance reimbursement for the surgery are expected to decline as a result of the study. As with all procedures, providers who elect to continue performing the procedure should protect themselves by ensuring that patients are informed in making the decision to undergo surgery.

Harry Nelson is a partner in Fenton & Nelson, LLP. Fenton & Nelson counsels healthcare providers on business and regulatory compliance issues. For additional information, please contact him at harry@fentonnelson.com

©Harry Nelson 2008

Identifying and Avoiding Problem Patients

Camille Sweeney reports in the New York Times on on plastic surgeons’ growing attention to the art of identifying problem patients in advance. (“Skin Deep: A Face Not Even a Plastic Surgeon Could Love.”) Varieties of problem patients include:

• litigious patients
• plastic surgery junkies
• patients with unrealistic expectations
• patients who badmouth physicians online

The various categories of “problem patients” each carry their own hidden danger. Among other challenges are the risk of having to do extensive post-operative care and revisions to try to satisy people who ultimately are not capable of being satisfied. Physician staff who have preliminary contact with patients should be trained to spot and report red flags. Worst of all are the disgruntled patients who turn to the Internet to vent their fury, whether on ready-made ratings websites like RateMDs.com and MakeMeHeal.com or through the patient’s own personalized blog. Barring contractual limitations agreed to in advance by patients, it is nearly impossible to prevent angry patients from causing reputational harm online.

Recommended Action: Providers need to become more adept at spotting and steering clear of potential problem patients. Although there is no substitute for identification and avoidance of patients who will waste providers’ time and, worse, harm their businesses, Fenton & Nelson recommends that providers adopt intake agreement forms that condition the rendering of services on patients’ agreement not to participate in online defamation and other reasonable behavior. Requiring patients to sign such documentation will help identify reluctant future patient bloggers.

Harry Nelson is a partner in Fenton & Nelson, LLP. Fenton & Nelson review and counsels providers on practice management, including drafting of patient forms. In addition, Fenton & Nelson conducts audits and training programs for health care providers to
ensure effective risk management and compliance in medical practice. For additional information, please contact him at harry@fentonnelson.com

©Harry Nelson 2008