Training Doctors, The Importance of Tx Intensity and Patient Preferences?

The Dartmouth Atlas of Health Care recently published a report entitled, “What Kind of Physician Will You Be?: Variation in Health Care and Its Importance for Residency Training.” (2012; http://www.dartmouthatlas.org/pages/residency).  Briefly, this report analyzes Medicare data to create indexes and variables used to describe varying levels of treatment intensity, particularly at the end of life, for 23 top U.S. medical centers. This report is targeted to medical students who are choosing their residency programs, hoping that prospective residents look at a wider-array of factors, including: how well these hospitals utilize effective, proven health care interventions; to what extent the care they provide is dependent on supply-induced demand; and how well the hospitals allow for patient preferences in treatment plans.

This report grabbed my attention given that I conduct research in end-of-life (EOL) care, and I am sympathetic to efforts to improve the quality of care provided to people with advanced and terminal diseases. I am also quite interested in how our medical system can change the culture of medical care to provide higher-quality EOL, and to reduce the use of often ineffective and invasive medical interventions, particularly through hospitalization and ICU admissions. The education of residents seems like a good place to start in changing the current intensity and specialty-driven culture.

However, the gaps in this report compromise its arguments and potentially reduce its effectiveness. I will only highlight two here.

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Pharmacy Compounding: Federal Law in Brief

by Jonathan J. Darrow

Until recently, most ordinary people had never heard of “pharmacy compounding.”  Then, a number of deaths and illnesses caused by a drug that was compounded in a Framingham, Massachusetts pharmacy propelled drug compounding to the national spotlight (see, e.g., Denise Grady et al., Scant Oversight of Drug Maker in Fatal Meningitis Outbreak, N.Y. Times, Oct. 6, 2012).

Compounding is the practice of preparing a drug for an individual patient’s needs, and is used when those needs cannot be met by a mass-produced drug.  See Thompson v. Western States Medical Center, 535 U.S. 357, 360 (2002).  For example, if a patient is allergic to a particular excipient (inactive ingredient) in an FDA-approved medicine, a doctor may order a special compounding pharmacy to prepare the medicine without that excipient. Because of the very small scale of compounding, Congress in 1997 attempted to exempt (via 21 U.S.C. § 353a) the industry from a number of provisions of the Food Drug and Cosmetic Act, including the requirement to submit a new drug application prior to interstate sale (21 U.S.C. § 355), the requirement that the drug labeling bear “adequate directions for use” (21 U.S.C. § 352(f)(1)), and the need to strictly follow good manufacturing practices, or GMP (see 21 U.S.C. § 351(a)(2)(B)).  A number of controls on compounding were included, however, such as the requirement that there be a valid prescription from a licensed practitioner (21 U.S.C. § 353a(a)(1)), that the drug be compounded by a licensed pharmacist (or physician) (21 U.S.C. § 353a(a)(1)), and that the drug be compounded from ingredients that meet certain quality standards (21 U.S.C. § 353a(b)(1)(A)–(B)).

However, § 353a—and with it, all of the provisions and exemptions just mentioned—was held unconstitutional in its entirety in Western States Medical Center v. Shalala, 238 F.3d 1090 (9th Cir. 2001), aff’d 535 U.S. 357 (2002), on the basis of certain restrictions on free speech that were also contained within the statute and which, according to the Ninth Circuit, could not be severed from the remaining provisions because “Congress intended to exempt compounding from the FDCA’s requirements only in return for a prohibition on promotion of specific compounded drugs.” See 535 U.S. at 366. Thereafter, the FDA promulgated a policy by which it would primarily “defer to state authorities regarding less significant violations” but would enforce a number of provisions relating to ingredient standards, unapproved substances, commercial scale production, adulteration, and promotion.  The FDA made clear that its enforcement activities “need not be limited to” these or any particular areas, however, thus negating any expectations that Congress’ now-invalidated exemptions might nevertheless provide a safe harbor through the weight of influence, if not law. Since then, the FDA has in fact exercised oversight of compounding pharmacies, as is evident from the handfuls of warning letters that it sends to non-compliant facilities each year.  These letters have addressed, for example, promotion that made unsubstantiated efficacy claims, contamination, and the large-scale manufacture of what were essentially copies of FDA-approved drugs.

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Legal Implications of the Meningitis Outbreak

If you’ve been following the fungal meningitis outbreak and wondering about the legal implications, take a listen to this audio interview with Glenn Cohen and personal injury lawyer Michael F. Barrett, hosted by Legal Talk Network’s Lawyer2Lawyer.  They discuss the litigation likely to stem from this outbreak (and some already pending), as well as the role of FDA and CDC in regulation.

FDA Reprimands Genentech for “Drastically Overstat[ing] the Efficacy of Tarceva”

by Jonathan J. Darrow

On October 3, 2012, the FDA’s Division of Professional Drug Promotion issued an untitled letter to Genentech in connection with its cancer drug Tarceva.  Tarceva (erlotinib) was approved in 2004 for the treatment of non-small cell lung cancer, and has since been approved, in combination with Gemzar (gemcitabine), for the treatment of pancreatic cancer. Its approval letter reported a tumor response that was 9 times greater with Tarceva than with placebo (0.9% in placebo versus 8.9% in Tarceva), but relatively modest improvements in 1-year survival rates: approximately 8 of 10 patients on placebo did not survive 1 year, while about 7 of 10 patients on Tarceva did not survive (see page 6, line 102 of the approval letter).  A 2005 New York Times article was less than enthusiastic about Tarceva’s efficacy, noting that it (along with several other cancer drugs that were new at the time) “help[s] most patients only marginally . . . .”  Despite its modest efficacy, Tarceva was reported in the same New York Times article to cost almost $31,000 per year.  A number of patents are listed in the FDA’s Orange Book as covering Tarceva until 2020.

The recent untitled letter accused Genentech’s promotional materials of misleadingly indicating that Tarceva in combination with gemcitabine extended overall survival by 3.7 months in comparison with gemcitabine alone, when the actual increase in survival was only about 12 days.  The FDA characterized the discrepancy as “drastically overstat[ing] the efficacy of Tarceva.”  (The figure of 3.7 months was derived, according to the FDA, “from a retrospective, exploratory subgroup analysis that does not provide substantial evidence to support the efficacy claims cited . . . .”). In addition, the front cover of one of the promotional materials in question contained an image of an hourglass positioned on its side, presented with the claim: “Extending survival for moments that matter.”  Although the claim with its associated image may be literally true (“moments” is left undefined), the FDA characterized the image and claim as “drastically overstat[ing] the overall survival benefit for patients” because it “strongly suggests that time is standing still for the cancer patient because of Tarceva therapy.”  The FDA noted a number of other instances of misleading overstatement of efficacy or minimization of risk.

The October 3 Tarceva letter brings to 23 the total number of Drug Marketing and Advertising Warning Letters (and untitled letters) listed by the FDA’s Office of Drug Promotion as having been sent this year.

Art Caplan: Many needlessly getting steroid injections for back pain

In his latest MSNBC column, Art Caplan addresses a different angle of the fungal meningitis outbreak:

Many needlessly getting steroid injections for back pain, bioethicist says

The quest for relief from pain has now resulted in the deaths of 19 people and a total of 247 confirmed infections of fungal meningitis from tainted steroid injections. Thousands more who got the injections, made by the New England Compounding Center in Massachusetts, are worried that they too may wind up sick or dead.

The horrific outbreak has resulted in the outrage about a lack of oversight of the compounding pharmacy.

But, this tragedy has another aspect that is not getting sufficient attention. Why are so many Americans getting spinal injections?

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Quality Control on the Back-End via the ACA and on the Front-End via Tort Litigation

By Vickie J. Williams

I am back after a brief hiatus for the Jewish holidays. L’Shanah Tova to all my readers who have just celebrated the Jewish New Year.

The first Monday in October is, of course, a special day for all of us legal eagles–the Supreme Court is back in session. The other significant thing about October 1 for those interested in health law is that hospitals will now be fined if too many of their Medicare patients are readmitted within 30 days of discharge due to complications. As reported by the Associated Press, this is part of the Affordable Care Act’s push to incentivize quality improvement while trying to save taxpayers money. Right now, admissions for only three medical conditions are subject to the penalty: heart attacks, heart failure and pneumonia. Penalties are held to a maximum of 1% of the hospital’s Medicare payments for now, but will rise to a maximum of 3% of Medicare payments over several years. This attempt to control quality of care on the back-end constitutes a marked contrast with the way reimbursement policy has worked over the last several decades to discourage hospitals from keeping patients in beds for “social” reasons, such as having nobody to care for them at home if they are discharged. Many Medicare hospital readmissions are due to non-compliant behavior by fragile patients with few resources to help them once they leave the hospital, something that is not really subject to the hospital’s control, and says nothing about the hospital’s quality of care for the patient. For decades, Medicare payment policy, which generally pays hospitals the same amount for caring for a patient regardless of how long he or she is in the hospital, has encouraged speedy discharges. This is touted as a way to save costs. Apparently, the new policy on payments for readmission is an acknowledgement that there is both a financial and a human cost to treating medically and socially fragile people in the express lanes of health care. It remains to be seen whether the penalties result in better quality care, or significant savings, but surely they will result in increased work for hospital social workers and discharge planners. Read More

Would you rather medical school train your PCP to have good hands or a good bedside manner?

Last week NPR covered a story highlighting how medical education is morphing in order to adapt to the unmet demand for primary care physicians driven (at least in part) by the increased access to primary care that will be ushered in under the ACA.  It may be surprising to some to learn that many of the most prestigious medical schools like Johns Hopkins and Harvard do not have a primary care program; however, as reported by NPR, medical schools may soon rethink this hole in their curriculum in the face of changing demands upon the health care system and its accompanying incentives for young physicians to enter primary care.   Mount Sinai School of Medicine is leading the way in this regard by launching a new department of family medicine in June.

Intuitively, changing the medical education system to produce more primary care physicians will further goals of the ACA by increasing access to primary care, and therefore improving overall public health and diminishing cost by decreasing emergency room care for conditions that could have been treated less expensively or avoided altogether by increasing access to preventative services.  These are the arguments we’ve heard repeatedly by the champions of the ACA and by the Obama administration, particularly through its vision for the Prevention and Public Health Fund which was intended to bolster the pipeline of primary care physicians before being gutted earlier this year.

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Will ACA Create a Doctor Shortage–And If So, What Should We Do About It?

By Jennifer S. Bard

Being in my native land of Connecticut reminds me that Mark Twain is famously, if inaccurately, quoted as saying that everyone talks about the weather but no one ever does anything about it.  Nowhere is this concept more true today than in the handwringing over the coming shortage of physicians following the passage of Affordable Care Act.  We hear dire predictions that the patients who now have access to health care will flood the system resulting in poor care not just for them, but for those among us who were lucky enough to already have health insurance.  The American Academy of Family Physicians has recently expressed its concern that the shortage will be made up by nurse practitioners rather than physicians.

This is a situation where the shortage, if it exists, has nothing to do with fear of law suits.  Applications to U.S. medical schools have been steadily increasing.  Moreover, the shortage isn’t of doctors in general, it is of primary care physicians.  There are still a fair number of dermatologists and plastic surgeons, but not so many physicians who provide the kind of primary and preventive care that actually improve the public’s health.

Uwe Reinhardt, the Princeton health care economist, has been following this issue closely and in a series of posts for the New York Times’ Econmix Blog has been aggressively skeptical about the existence of the shortage as well as the actions taken so far by the Federal Government to address it.  He also questions the need both for the residency system as currently structured and for the benefit to the public of subsidizing it through Medicare given what a poor job it does in producing the primary care doctors the public really needs.  Last week, he undertook an extensive analysis of medical school debt which showed that by charging students intending to be high paid specialists the same as those who might go into primary care has created a loan burden that makes it difficult for any but the most dedicated to turn away from training for the most lucrative specialty for which they can qualify. Read More

The Use of Electronic Health Records Is Increasing Medicare Billing: Is It Also Increasing the Amount of Care Physicians Provide?

 By: Katie Booth

The New York Times recently reported that the switch to Electronic Health Records (“EHRs”) may be contributing to rising Medicare costs. The Times described two hospitals where the portion of patients billed at the highest reimbursement rate rose by over 40% when the hospitals adopted EHRs. The Times also reported that in hospitals that switched to EHRs between 2006 and 2010, Medicare payments rose 47%. Medicare payments for hospitals that did not adopt EHRs rose 32%.

There are several potential explanations for this increase in billing. One is that doctors are simply doing a better job electronically recording the same care they’ve always given, leading to higher Medicare billing. Another is that some doctors are abusing the EHR system by upcoding patients or copying and pasting examination histories, fraudulently increasing Medicare billing.

A third explanation is that EHR systems actually change the way doctors practice medicine. In the process of asking doctors for particular data points, EHR systems may remind doctors to look for particular symptoms or to provide particular treatments that doctors may not have considered otherwise. It is thus possible that EHRs have led to higher Medicare bills because they have increased the amount of time doctors spend diagnosing and treating patients.

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NEJM: Cutting Family Planning in Texas (and more)

Our friends over at the New England Journal of Medicine just alerted us to a new perspectives piece addressing the impact of cutting family planning funds in Texas (the piece was also picked up by Politico).  The authors interviewed 56 leaders of organizations throughout the state that provided reproductive health services using public funding before cuts went into effect, and what they found was disturbing:

  • Most clinics have restricted access to the most effective contraceptive methods because of their higher up-front costs (choosing pills over IUDs or subdermal implants).
  • Clinics have started to turn away those who canot pay, when previously their visits would have been covered by public funds, and women who can pay the newly instated fees are choosing less effective methods and fewer tests to save money.
  • A number of clinics have lost their exemption from Texas’ law requiring parental consent for teens under 18 who seek contraceptives.

Overall, the authors conclude that laws intended to defund Planned Parenthood in an attempt to limit access to abortion (even though federal and state funding cannot be used for abortion anyway) have resulted in policies limiting women’s access to range of preventative reproductive health services and screenings.

Alta Charo weighs in via a NEJM podcast, discussing the future of reproductive health care for women in the US, particularly in light of upcoming elections (as well as the article we discussed last week on conscientious action, and other general issues in reproductive health policy).  Take a listen!

And one more NEJM plug for now: our Bill of Health blogger Kevin Outterson also has a podcast online discussing the record-breaking settlements of pharmaceutical fraud cases and the need for further regulation.