HealthLawProf Blog

Editor: Katharine Van Tassel
Concordia University School of Law

Friday, May 17, 2013

Evidenced Based Practice: When will Law Catch up with Medicine?

 Two widely reported studies this week about bed rest for women at risk of preterm delivery and reduction of salt consumption in order to promote heart health highlight two things we don’t think about enough—that a lot of standard medical practices are without any foundation in science and a lot of legal ones probably are too.    However, medicine has more and more taken the public health approach of examining the practices of individual doctors to see how effective they actually are in the general population.    For example, it is old news that prescribing bed rest to pregnant women at risk of preterm delivery is not effective.  But what this Obstetrics & Gynecology study found that “activity restriction”, such as quitting work, is still prescribed to one at three women at risk for preterm delivery.  The accompanying Bed Rest in Pregnancy: Time to Put the Issue to Rest makes an ethical argument that continuing to prescribe bed rest in the absence of evidence of its effectiveness violates the principles of autonomy and beneficence.

The Institute of Medicine just issued this report Sodium Intake in Populations: Assessment of Evidence “found no consistent evidence to support an association between sodium intake and either a beneficial or adverse effect on most direct health outcomes other than some CVD outcomes (including stroke and CVD mortality) and all-cause mortality.”

We have similar research in law- a lot of it coming from the Empirical Legal Studies movement, including work done at the Center for Empirical Legal Research at Washington University Berkeley Emperical Legal Research , the Centre for Emprical Legal Studies at UCL (formerly known as University College London) among many others, but it is not as well funded or coming from as well established sources as the studies which attempt to find an evidence basis for medical practices.  The salt reduction report was commissioned by the Institute of Medicine   In contrast, the ACLU supports its empirical argument that the death penalty does not deter crime on an opinion survey of police chiefs.  Translating information from research scientists to practicing physicians is still a slow process,—but no one questions the underlying principle that medical practice should be based on scientific evidence.

Part of the issue is funding.   Medicine as a whole is in a constant quest to contain costs and stopping ineffective practices is an important component of that effort.    But beyond a small number of progressive funders like the Robert Wood Johnson Foundation, there isn’t a lot of demonstrable interest, the kind supported by funding studies, in law making bodies in finding out what legal practices work and what do not.   

 This isn’t a new observation.  Bryant Garth outlined the problem in 1997 when he explained the importance of more social science research into the foundational principles of practices civil procedure.   But the steady flow of studies questioning conventional wisdom coming from the medical field has, as yet, no real counterpart in the world of law making.

Of course there will always be the problem of knowing the unknowable.  But it would be interesting for law makers to consider taking a lesson from public health in challenging assumptions about the human body and mind or even more generally the physical world that underlie both common law and statutes.  


May 17, 2013 in Bioethics, Comparative Effectiveness, Cost, Effectiveness, Health Care Costs, Health Law, Innovation, Policy, Public Health, Quality Improvement, Reform, Research | Permalink | Comments (0) | TrackBack (0)

Thursday, May 16, 2013

Guest Bloggers Professors Alice A. Noble and Mary Ann Chirba - The ACA’s Tobacco Use Rating: Implementation, Inconsistencies and Ironies

Noble-1 A 6 15 2012 (2)As the Affordable Care Act continues toward full implementation, the law’s complexity is on full display.  As we have noted in earlier writings, the ACA continues the federal tradition of using a fragmented approach to allocating oversight responsibilities among federal and state regulators, while maintaining the role of private actors in health care insurance and delivery systems.  The result is a dizzying array of plan types (self-insured, fully insured, small market, individual market, large market, grandfathered) subject to an equally dizzying blend of ACA, ERISA, and individual state requirements.  

Time will tell if this uniquely American system will achieve the goals of reform, i.e., expanding access to care while improving its quality and controlling costs.  Unexpected and unintended consequences, some fortunate and others not, will certainly flow from such a system.  This post will consider the insurance market reforms, specifically, PHSA § 2701, “Fair Health Insurance Premiums,” added by ACA § 1201 and some unexpected and seemingly unintended consequences related to the tobacco use rating provision.  

Chirbamartin2Section 2701, which takes effect beginning in 2014, prohibits discriminatory premium rates by limiting the variables that insurers in the small group and individual market may use in setting premium rates.  Prior to the ACA, insurers had greater  latitude in setting premiums based on personal factors such as gender or health status.  This often resulted in unaffordable insurance premiums for those most in need of health coverage: individuals with serious or chronic health conditions or small groups that included uch individuals.  The ACA prohibits this type of underwriting in the small group and individual markets by permitting insurers to consider only four factors when setting premiums in these markets:  1) whether the coverage is for self-only or family enrollment; 2) the geographic area; 3) the age of the insured  premiums may vary by a ratio of no more than 3:1 for adults); and 4) tobacco use (premiums may vary by a ratio of no more than 1.5:1).  

Individuals who use tobacco may be required to pay up to 50% more for their health insurance premiums. For the sake of this provision, tobacco use is defined as using tobacco products on average of four or more times per week within no longer than the past six months, excluding religious or ceremonial uses of tobacco. Permitting a tobacco-use premium is consistent with the ACA’s larger focus on individual responsibility:  because tobacco use is voluntary and offers no health benefit, tobacco users should bear a significant portion of the higher health care costs associated with that activity.  It is conceivable that over time, other voluntary activities, such as weight control, may be added to the list of permissible factors used to set premiums.  

Like so many other aspects of the ACA, implementing the tobacco-use premium provision is anything but straightforward especially in light of highly fragmented health insurance markets.  In addition to the type of plan or policy, grandfather status under the ACA, an insurer’s ability to employ tobacco-use rating also depends on state law and the application of federal wellness programs regulations.  

Several of the thornier aspects of this crazy quilt are especially deserving of attention, as follows:  

1.  Type of Insurance Coverage  

The ACA’s tobacco use rating provision does not apply to the following kinds of insurance plans: 

  • Self-insured employer-sponsored plans, whether large or small 
  • Grandfathered plans in all markets
  • Insured plans in the large group market through 2016
  • Insured plans in the large group market after 2016, but only if the state does not permit insurers to offer large group policies on the state’s health insurance exchange


These exceptions mean that, starting in 2014, and at least until 2017, the tobacco use premium applies only to individual and small group plans that are both insured and non-grandfathered, whether offered in or off state exchanges. As noted below, in 2017, upon the election of the state, large insurance issuers may also be subject to the provision.  

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May 16, 2013 | Permalink | Comments (0) | TrackBack (0)

HIPAA and the Medical Records of Deceased Nursing Home Patients

Warning: some of this post is HIPAA-wonky. But read on: the punch line is that HIPAA does not protect the living or the dead from blanket release of medical records to their personal representatives—unless state law provides otherwise or patients have thought to specify in advance that they do not want anyone to see the record or parts of it and state law gives them this opportunity. This means that the default position is that personal representatives may see highly sensitive health information, including mental health records or sexual or reproductive histories: veritable skeletons in family medical closets.

In an important recent decision, the 11th Circuit has held that the federal Health Insurance Portability and Accountability Act (HIPAA) preempts a Florida statute that gave spouses and other enumerated parties the right to request the medical records of deceased nursing home residents. Opis Management Resources v. Secretary, Florida Agency for Health Care Administration, 2013 U.S. App. LEXIS 7194 (April 9, 2013). The nursing homes had refused to respond to requests for records made by spouses and attorneys-in-fact, arguing that these requesters were not “personal representatives” under Florida law. The requesters filed complaints with HHS’s Office for Civil Rights, which determined that the refusals were consistent with HIPAA. The Florida Agency for Health Care Administration issued citations against the homes for violating Florida law, and the homes went to court seeking a declaratory judgment that the Florida statute was preempted by HIPAA.

The statute in question, Fla. Stat. § 400.145(1) (2013), requires nursing homes to release records to the spouse, guardian, surrogate, or attorney-in-fact of a resident or a deceased resident, unless the release has been expressly prohibited by the resident. Disclosures must include both medical and psychiatric records, with the exception of psychiatric progress notes and consultation reports. The Agency interpreted this statute to authorize release to personal representatives as permitted by the HIPAA Privacy Rule, 45 C.F.R. § 164.502(g)(4)(2013). This section of the Privacy Rule specifies that personal representatives have the same authority to access health information that individuals do, and that executors or others authorized to act on behalf of a decedent must be treated as personal representatives with respect to protected health information. The Privacy Rule also permits covered entities to disclose to persons involved in the deceased individual’s care or payment for care information relevant to that involvement, unless the disclosure is contrary to the known expressed preferences of the decedent, 45 C.F.R. § 164.510(b)(5)(2013).

HIPAA preempts contradictory state law and state law inconsistent with its purposes, 42 U.S.C. § 1320d-7 (2013). It does not preempt more stringent state privacy protections, 45 C.F.R. § 160.203(b)(2013). The 11th Circuit determined that the Florida statute provided less protection than HIPAA, because it allowed individuals to act as thought they were personal representatives without a proper HIPAA authorization in seeking records. HIPAA only allows a personal representative under state law to request records pursuant to a proper HIPAA authorization. The exception for individuals involved in care, or in paying for care, is a very narrow one, again not permitting the broad grant of authority found in the Florida statute. The court refused to read the Florida statute as in effect amending Florida law with respect to identifying personal representatives, leaving that task to the legislature.

In general, HIPAA defers to state law concerning the legal power of individuals acting for the person to access medical records. In many states, statutes simply give designated surrogates or proxies the authority to seek whatever records patients themselves would be able to request in accord with HIPAA. For decedents, the HIPAA requirement is simply that requests for records must come from the state-designated personal representative via a HIPAA authorization. (Custodians of health care records may, to be sure, refuse to release records under special circumstances such as danger to the person or others.)

The decision in Opis Management does not change the scope of this HIPAA deference; it simply insists that Florida comply with HIPAA authorization requirements. But there is a genuine problem here for states to consider regarding access to medical records, for both the living and the dead. Currently, the default position is access to the entire medical record, with limited exceptions. This means that unless patients have thought to specify otherwise under state laws that give them this opportunity, personal representatives may have access to veritable skeletons in the family medical closet: mental health records, sexual histories, reproductive histories, determinations of parentage, and much more that patients might have believed would be kept confidential. In the days of silo-ed paper medical records, records would have been difficult to find or obtain. But in today’s emergent world of interoperable medical records, the results for confidentiality may be serious indeed.


May 16, 2013 | Permalink | Comments (0) | TrackBack (0)

Tuesday, May 14, 2013

Hospital Billing Varies Wildly, Government Data Shows

Coming right on the heels of the story by Steven Brill, Why Medical Bills are Killing Us, Time (March 4, 2013), the federal Centers for Medicare and Medicaid Services released the data for 3,300 hospitals that covers bills submitted from virtually every hospital in the country in 2011 for the 100 most common treatments and procedures performed in hospitals, like hip replacements, heart operations and gallbladder removal.

Barry Meier, Jo Craven McGinty and Julie Creswell reported on this data release in their New York Times story Hospital Billing Varies Wildly, Government Data Shows (May 8, 2013):

[H]ospitals charge Medicare wildly differing amounts — sometimes 10 to 20 times what Medicare typically reimburses — for the same procedure, raising questions about how hospitals determine prices and why they differ so widely.

A hospital in Livingston, N.J., charged $70,712 on average to implant a pacemaker, while a hospital in nearby Rahway, N.J., charged $101,945.

In Saint Augustine, Fla., one hospital typically billed nearly $40,000 to remove a gallbladder using minimally invasive surgery, while one in Orange Park, Fla., charged $91,000.

In one hospital in Dallas, the average bill for treating simple pneumonia was $14,610, while another there charged over $38,000.

[B]illing records showed that Keck Hospital of the University of Southern California charged, on average, $123,885, for a major artificial joint replacement, six times the average amount that Medicare reimbursed for the procedure and a rate significantly higher than the average for other Los Angeles area hospitals. ... Centinela Hospital Medical Center, also in Los Angeles and owned by Prime Healthcare Services, charged $220,881 for the same procedure.

One of the many disturbing aspects of this billing morass is that those who are least likely to afford these high costs are the most likely to have to pay the highest amounts for bills that may bear little relationship to the actual cost of treatment.  

Medicare does not actually pay the amount a hospital charges but instead uses a system of standardized payments to reimburse hospitals for treating specific conditions. Private insurers do not pay the full charge either, but negotiate payments with hospitals for specific treatments.

Since many patients are covered by Medicare or have private insurance, they are not directly affected by what hospitals charge. Experts say it is likely that the people who can afford it least — those with little or no insurance — are getting hit with extremely high hospitals bills that may bear little connection to the cost of treatment.

“If you’re uninsured, they’re going to ask you to pay,” said Gerard Anderson, the director of the Johns Hopkins Center for Hospital Finance and Management.


May 14, 2013 | Permalink | Comments (0) | TrackBack (0)