HealthLawProf Blog

Editor: Katharine Van Tassel
Akron Univ. School of Law

A Member of the Law Professor Blogs Network

Monday, February 25, 2013

Does the Omnibus HIPAA Rule Endanger "Free" EHR Business Models?

Many commentators have worried that medical privacy laws aren't keeping up with new devices and business practices. It appears that the Omnibus HIPAA rule released last month may put some concerns to rest.  For example,  argues that EMRs based on certain types of information exchange and use may prove to be impractical or unworkable under the rule: 

The HIPAA updates impose new limitations on marketing. For the first time, it requires providers to obtain patient authorizations "for all treatment and healthcare operations communications where the covered entity receives financial remuneration for making the communications for a third party whose product or service is being marketed."  The authorization can't be buried in the provider's notice of privacy practices. . . .

So if a physician is reviewing the chart after hours and a pop up ad recommends some new drug, and he or she doesn't have an authorization from the patient, does he or she have to wait until the next face-to-face visit before suggesting it to the patient? Does she ask the patient to come in before her next visit?

As Duben Hirsch suggests, these are tough questions, and guidance is necessary.  It would be very disruptive for a physician to learn an EHR system, only to find that the funding model behind it was rendered obsolete by privacy regs.

[FP]

February 25, 2013 | Permalink | Comments (0) | TrackBack (0)

Friday, February 22, 2013

Call for Papers and Panelists - Beyond Roe:Reproductive Justice in a Changing World

Throughout 2013, five law schools in the Delaware Valley will hold events exploring various aspects of reproductive justice in the 40 years post-Roe v. Wade. The final event in this series is a conference sponsored by the Rutgers School of Law – Camden that will take place on Friday, October 11 on the Rutgers campus in Camden, New Jersey.* You can find more information about the conference here.  

We are now pleased to invite proposals for papers and panels. The conference theme is Beyond Roe: Reproductive Justice in a Changing World. We welcome submissions on any topic related to the law, policy and reproduction, including avoiding reproduction, public policy related to reproduction, and reproductive regulation post-Roe.

Paper abstracts should be no more than 500 words, accompanied by a descriptive title for the paper proposed. Proposed panels should include a description of the overall topic, as well as a panel title and the titles of all the papers and panelists to be included in the panel.  Panels should include no less than 4 proposed panelists. Panel proposals should also be no more than 500 words. All submissions must include the names, e-mail addresses, and full affiliations of all authors.  In the case of panels and co-authored papers, please identify a corresponding author and provide sufficient detail in your abstract or proposal so that reviewers can fully assess your proposal and determine how it will fit with other proposals being reviewed.  

Continue reading

February 22, 2013 | Permalink | Comments (0) | TrackBack (0)

Penn Health System to Stop Hiring Smokers

Right on the heels of Frank's thought-provoking post yesterday "Get Wellness Soon--Or Else," comes this story from The American Journal of Bioethics:

The University of Pennsylvania Health System will no longer hire smokers and other tobacco users, starting in July.  The system, which includes the Hospital of the University of Penn., said the policy would improve the health of its workforce and reduce the cost of health-care benefits.

[KVT]

February 22, 2013 | Permalink | Comments (0) | TrackBack (0)

Health Insurance Market Rules Published

Its been a busy week for ACA implementation. A few days ago we saw the Essential Helath Benefits rule, here. Today, HHS issued the final regulations for health insurance markets, here. As noted in the Executive Summary, "Beginning in 2014, health insurance issuers will be prohibited from denying coverage … because of a pre-existing condition, and from charging individuals and small employers higher premiums based on health status or gender. In addition, health insurance issuers will no longer be able to segment enrollees into separate rating pools in order to charge high-risk individuals more than low-risk individuals." The final regulation has the following components:

  • (1) provides that health insurance issuers may vary the premium rate for health insurance coverage in the individual and small group markets only based on family size, geography, and age and tobacco use within limits
  • (2) directs health insurance issuers to offer coverage to and accept every employer or individual who applies for coverage in the group and individual market, subject to certain exceptions
  • (3) directs health insurance issuers to renew or continue in force coverage in the group and individual market, subject to certain exceptions
  • (4) codifies the requirement that issuers maintain a single risk pool for the individual market and a single risk pool for the small group market (unless a state decides to merge the markets into a single risk pool)
  • (5) outlines standards for enrollment in catastrophic plans for young adults and people who cannot otherwise afford health insurance.

[NPT]

February 22, 2013 | Permalink | Comments (0) | TrackBack (0)

Thursday, February 21, 2013

Get Wellness Soon--Or Else

There is a good debate in the WSJ on the wellness programs recently promoted by PPACA. Market-oriented thinkers have long promoted the “nanny corporation” to exertinfluence over workers’ lives. But as Lydia Mitts notes, this may be disadvantaging certain people:

A workplace wellness program in Wisconsin increased overweight employees’ premiums by more than $100 a month if they didn’t meet goals such as losing weight, which evidence shows can be very challenging. That kind of increase creates a real cost barrier for many families. The last thing a wellness program should do is make health coverage less affordable for those with greater health risk factors and whose health could most benefit from certain health services. Studies have found that being uninsured or underinsured leads people to delay or forgo needed care, making them sicker—and their health care costs higher—down the line.

On the other hand, it could be quite rational for an individual corporation to alienate and browbeat the people whom it sees as most likely to drive up its health care costs, as long as it can avoid running afoul of disability laws. The higher health care costs “down the line” may then rest on the balance sheet of the next employer—or the government.

[FP]

February 21, 2013 | Permalink | Comments (0) | TrackBack (0)

Wisdom from an Oncologist

I recently came across blog posts of James Salwitz, an oncologist. Reflecting on end of life issues, he had this to say

There are obstacles to dignity at the end of life.  Disease inflicted pain and debilitation, cost and confusion, poor planning and fear, all aggravated by our societal ignorance regarding dying, result in unneeded suffering and isolation.  

We barely have enough time to take care of our families and get through our normal day-to-day existence. We spend our lives sprinting from fast food restaurants, down high velocity freeways, to hectic jobs, through rushed relationships and finally grab too little sedated sleep, before we pick up the race again.  Gaps, during which we might reflect, are filled with electro-grout via high speed Internet in dozens of shades, be it email, tweet, face or video. We live without self-reflection, life contemplation or honest communication. . . . Therefore, when a complex medical problem occurs and we have not taken the time to prepare, we must make decisions while exhausted and frightened.

The social acceleration of time has wrecked many contemporary institutions.  Salwitz is wise to suggest that, at the most critical moments of the caring process, health policy should promote more opportunities to reflect.  We are too prone to think about informed consent doctrine (or clinical decision guides) as "slowing things down" in a negative way.  Salwitz helps us see the positive side of slow.

[FP]

February 21, 2013 | Permalink | Comments (0) | TrackBack (0)

Wednesday, February 20, 2013

Lobbying by EHR Vendors

Also worth reading today--Julie Creswell's story in the New York Times about the profits being reaped by EHR vendors through government incentives.  Creswell documents "soaring profits" and "Wall Street style" paydays in the wake of the stimulus package.  One of her concerns is the extent to which larger--she argues, less innovative--companies have been able to crowd out smaller competitors, with the help of certification requirements.  Ironically, innovation has been used as the primary argument for flexibility as the requirements for meaningful use phase in.  It will be a shame if the promise of EHRs is another casualty of the role of profits in US health care.

[LPF]

February 20, 2013 | Permalink | Comments (0) | TrackBack (0)

Essential Health Benefits

HHS has published the final rule on essential health benefits, here. [NPT]

February 20, 2013 | Permalink | Comments (0) | TrackBack (0)

Sunday, February 17, 2013

RUC-rolled

A few years ago, I noted that the American Medical Association/Specialty Society Relative Value Scale Update Committee (RUC) has a dominant role in suggesting payment levels to CMS.  It raises hard questions about price-setting in the health care sector, many of which cannot be answered because its processes are opaque.  Now we know that judicial relief will not improve things any time soon.  As Brian Klepper reports, "On January 7, a federal appeals court rejected six Georgia primary care physicians’ (PCPs) challenge to the Centers for Medicare and Medicaid Services’ (CMS) 20-year, sole-source relationship with the secretive, specialist-dominated federal advisory committee that determines the relative value of medical services."  What was the complaint? 

The core of the ... physicians’ legal challenge was that the RUC is a “de facto Federal Advisory Committee,” and therefore subject to the stringent accountability requirements of the Federal Advisory Committee Act (FACA). This law ensures that federal bodies have panel compositions that are numerically representative of their constituencies, that their proceedings are open, and that methodologies are scientifically credible. In other words, FACA ensures that advisory practices are aligned with the public interest.

The RUC adheres to none of these and is an object lesson in how special interests can be insinuated into and capture regulatory processes, displacing the public interest. For example, when the legal challenge was first filed, only 3 of 29 RUC panelists (10 percent) represented primary care, even though some 30 percent of US physicians practice primary care. RUC meetings are closed to the public, unless an invitation is extended by the Chair, and admission is tied to the guest signing a nondisclosure agreement. Determination of a procedure’s value has been based on as few as 30 survey responses by physicians who know that their reimbursement will be linked to how they have answered the questions.

This is a sad example of opacity in health pricing. In ordinary markets, publicity would tend to narrow the price differential between similar quality services.  In health care, however, there is a triple layer of agency between care and patients whose physicians’ recommendations are often constrained by an insurer that is chosen by the patient’s employer or government. Even if we assume away the agency problems in such an arrangement, it is difficult for buyers and sellers to truly understand “market” dynamics, or even the governmental processes that underlie them.

[FP]

February 17, 2013 | Permalink | Comments (0) | TrackBack (0)

Wednesday, February 13, 2013

Teaching The Emperor of All Maladies

Our medical school took the bold step of assigning Mukherjee's The Emperor of All Maladies as required reading for all entering medical students.  I recently had the pleasure of leading two small group discussions about the book and commenting on the students' reflection papers.  I was absolutely delighted by the students' engagement with the book and by their reactions to it--as were my fellow discussion leaders.  Many of the students had read the book more than once.  Although they were often initially drawn in by the stories of heroism and conquest, nearly every student came away with understanding of the far more complex world of medicine--and cancer--that it is Mukherjee's goal to portray.  They engaged with his discussions of the social context of medicine and the need for cooperation.  They discussed the complexities of research ethics raised by experimental treatments and phase 1 trials.  They expressed the hope that they would be able to establish the kind of relationships with patients that Mukherjee weaves through his accounts of the science.  Some were surprised by how much science they learned from reading Emperor, too. And they were deeply impressed by his sense of the uncertainties and limits of medicine.

Ours is, to be sure, one medical school.  But our experience as discussion leaders was so overwhelmingly positive that I suspect other medical students might benefit from the experience.  And I profoundly wished that I had had the opportunity to discuss the book with a mixed group of law students and medical students.

[LPF]

February 13, 2013 | Permalink | Comments (0) | TrackBack (0)

Tuesday, February 12, 2013

A Tale of Two Stories - Growth in Health Care Costs is Down, but Nobody Knows How Much Things Cost

Two recent stories in the New York Times highlight the fact that our health care system is so dysfunctional, that we don't really have a clue as to how to fix it.  In a piece that has received a lot of media attention, a researcher discovered something that many of us already knew--that if you are trying to shop around for the best price for a health care service, you are out of luck.  Jaime Rosenthal, a student at Washington University in St. Louis, called more than 100 hospitals around the country, trying to get a price for a hip replacement for a 62-year-old (fictional) grandmother who would pay cash for the procedure.  Half of the hospitals would not provide any price estimate at all, while the other half quoted wildly divergent prices ranging from $11,100 to $125,798.  Some hospitals were willing to bargain, and lowered their prices for a self-pay patient when pressed.  For those who are proponents of "consumer-directed health care" (in which the consumer is given a certain amount of money to purchase health care, and is supposed to be able to shop around for the best price for the care), this points out the problems with assuming that anybody can be an"informed consumer" when it comes to health care services under our current system.  The inequity in bargaining power and the knowledge gap between the consumer and the provider is just too great.

So apparently, the cost of procedures currently depends solely on the amount of profit the provider thinks it needs to make.  Nevertheless, the New York Times today also reported a piece of good news regarding health care costs-- growth in health care costs is sharply and persistently slower than the Congressional Budget Office had expected.  Growth continues to be at the lowest rate in decades for a fourth consecuitive year.  The article says that the consensus is that doctors and hospitals are changing how they deliver health care to eliminate waste, insurers are no longer paying per procedure, and market forces are driving down costs.

The juxtaposition of these two pieces of news tells me that prices for health care procedures have been so inflated for so many years that providers can charge prices that are likely to exceed 10 times the cost of their services, while at the same time we can experience a slowing in the growth of health care costs.  I am usually a skeptic about plowing money into "demonstration projects" and research, but I am  beginning to think that any money we put into research on the actual costs of health care services and theamount of profits being made on such services will be money well-spent.  After all, we can't fix something we don't understand.

[VJW]

Cross-posted on Healthy Interests

February 12, 2013 | Permalink | Comments (0) | TrackBack (0)

Monday, February 11, 2013

Life Cycle of the Fight to Label Innovative Ingredients Introduced Into Consumer Products - A Suggestion for Producers of Lab Grown Meat

Manufacturers assert that they have no obligation to provide consumers with notice through labeling when ingredients created through innovative technologies are introduced into consumer products designed for human consumption. On the other hand, consumers take the position that they have the right to know what ingredients are in these products, especially when ingredients are novel and the risks associated with exposure to them are unknown. Recent events suggest that this problem may be developing a life cycle that savvy manufacturers should be watching.  The first in what may be a series of examples of this life cycle is the conflict over the labeling of genetically modified plant ingredients in food.

From the outset, food manufacturers using GMO ingredients have declined to provide consumers notice of GMO content. The FDA has not mandated disclosure as it takes the position that the introduction of GMO ingredients into food is not material. This lack of transparency resulted in consumer rights groups testing products for GMO use and disclosing that use to consumers.  As consumers have become aware of the extensive use of GMOs in their food, a rising number have expressed the desire that these ingredients be labeled.  A recent ABC poll suggests that 93% of consumers now support mandatory disclosure of GMO content on labels.

When industry ignored this consumer preference, a market was created for products that are “GMO-free.” Thus, the practice of “GMO-free” labeling was born. The growing consumer labeling movement also triggered repeated attempts to pass labeling laws. While these efforts have been unsuccessful to date, they are gaining traction –for instance, it cost industry 40 million dollars to block California’s prop 37 calling for mandatory labeling last fall. With more legislative proposals cropping up (a ballot initiative in Washington State and legislative proposals in Connecticut, Vermont, New Mexico and Missouri), a growing consumer boycott of some organic or “natural” brands owned by major food companies and a recently introduced popular mobile app by Fooducate that allows consumers to check for GMO content in a growing number of products, industry may be seeing the writing on the wall. Just this year, Ben & Jerry’s Ice Cream has decided to remove GMO ingredients from its supply chain. And the Meridian Institute, which organizes discussion of major issues, convened a meeting in Washington just last month that included executives from PepsiCo, ConAgra and about 20 other major food companies, as well as Wal-Mart and advocacy groups that favor labeling. See here.  Many are predicting that voluntary labeling may be right around the corner.

It appears that this life cycle of manufacturers’ refusal to disclose innovative ingredients with unknown risks and consumers’ reactive self-help measures may be repeating itself in the context of the use of nanotechnology in consumer products. The EPA explains that  

[n]anotechnology is the science of the very small. A nanometer is 100,000 times thinner than a strand of hair. … Nanomaterials can exhibit unique optical, mechanical, magnetic, conductive and absorptive properties different than the same chemical substances in a larger size. With these new properties, a world opens up for the development of innovative products and services that have the potential to change the world by offering new medicines, products and services.

According to the PEN, the Project on Emerging Technologies, nanotech materials are currently being used in 1317 consumer products which are being produced by 587 companies. The manufacturers of the vast majority of these products do not disclose these products’ nanotech content. It is projected that the nanotech product market will grow to 2.4 trillion dollars by 2015. As is the case with GMOs, the FDA does not mandate labeling as it states that there is insufficient evidence that nanotech ingredients, as a class, are harmful to human health. The FDA appears to indicate that, in the future, it will evaluate nanoparticle safety on a case by case basis.

Continue reading

February 11, 2013 | Permalink | Comments (0) | TrackBack (0)

Saturday, February 9, 2013

Tall People Are Celebrating the New BMI

Here's an interesting article on BMI from the UK: 

The body mass index has been around since Belgian scientist Adolphe Quetelet invented it in the 1830s and was designed to approximate whether people have a healthy weight.  Nick Trefethen of Oxford University's Mathematical Institute has identified a flaw in the basic formula for BMI, and has created a new calculation which he says better accounts for the relationship between height and weight.

According to Mr Trefethen, the current formula to calculate the score (weight/height2) is incorrect because "it divides the weight by too large a number for short people, and too small a number for tall people. So short people are misled into thinking they are thinner than they are, and tall people are misled into thinking they are fatter than they are."

Of course, even the new BMI isn't that great an indicator.  Dr. Robert Lustig argues for a more granular approach, focused on visceral fat. Expect more controversy over biomarkers and wellness programs, as well as the inevitable privacy concerns about close monitoring of weight, waistlines, and more.

[FP]

February 9, 2013 | Permalink | Comments (0) | TrackBack (0)

Wednesday, February 6, 2013

More ACA Proposed Rules

February 1st was another busy day for administrative action at HHS regarding ACA.  HHS issued the NPRM on religious exemptions and the mandate to provide preventive contraceptive services.  Less publicized was another NPRM on miscellaneous minimum essential coverage provisions.

The first NPRM is an effort to reconcile the commitment to access to contraception services with the beliefs of religious organizations.  As widely reported, it clarifies that exempt religious organizations do not lose their status if they engage in activities other than those designed to inculcate religious beliefs, employ persons who are not members of the faith, or serve clients who are not of the faith.  It suffices to be a non-profit entity under § 6033(a)(3)(A)(i) or (iii) of the Internal Revenue Code.  Thus a church would not lose the exemption because it ran a soup kitchen for the area poor.

More controversially, the NPRM proposes that non-profit organizations holding themselves out as religious organizations and opposing contraceptive coverage—church-owned hospitals, universities (and their student health plans), or charities—be permitted accommodations for the contraception mandate.  Organizations wishing accommodations would self-certify, maintaining their own records and filing them with their health insurer, and thus avoid any government entanglement in the certification process.  Insurers would be required to offer free contraception coverage to employees; HHS believes (with good evidentiary support) that the costs saved through improved women’s health would offset costs of the coverage.  For plans that self-insure, the third party administrator would arrange for the coverage; the entity providing the coverage would receive a rebate on federally-facilitated exchange fees, paying the administrator to offset administrative costs.  HHS seeks comments on the details of structuring such arrangements.  The NPRM does not consider the case of a self-insured plan not using a third-party administrator, judging that no self-insured plans are structured this way.  Another possibility, not mentioned in the NPRM, is a third party administrator that is also a religious organization. For-profit entities are excluded from the accommodation, such as the craft store chain Hobby Lobby which has brought suit against the mandate and delayed the start date of its plan year to avoid fines.  The comment period should be lively: HHs received over 200,000 comments in response to its ANPRM.

The NPRM about miscellaneous minimum essential coverage requirements establishes standards and processes for Exchanges to determine individual eligibility for exemptions from the requirement to maintain minimum coverage.  Individuals may apply for exemptions on multiple grounds. State-based exchanges (or federal substitutes) may make exemption determinations in 5 of the 9 specified categories; 

            Membership in a religious organization objecting to health insurance as specified by Treasury rule.  This exemption, once granted, continues until the individual applying for it informs the exchange of changed circumstances.  Children with exemptions must reapply on turning 18; exchanges are to provide them notice of the need to reapply.

            Membership in a health care sharing ministry.  This exemption requires annual reapplication and is only to be granted retrospectively.

            Incarceration.  This exemption is granted retrospectively and applies only to the months of actual incarceration.

            Membership in an Indian tribe.  This exemption is granted on a continuing basis until the individual gives notice that s/he is no longer eligible.

            Hardship.  Individuals qualify if they have significantly changed circumstances or if the purchase of health insurance would cause serious deprivation of food, shelter, clothing or other necessities; this is described in broad language and will be augmented by guidance.  They also qualify if they meet projected income standards specified by the Treasury.  The hardship exemption is also extended to individuals who do not qualify for Medicaid because their state has not adopted the Medicaid expansion provisions of ACA. The hardship exemption also applies if the total household cost of employer-offered self-only coverage for all employed household members exceeds 8% of household income.

Four of the exemptions will be handled through tax filings:  the hardship exemption based on reported income; not being lawfully present; short coverage gaps; and inability to afford coverage (other than the limited hardship exemption proposed for exchanges to grant).

This NPRM also addresses some types of coverage that may be considered to meet the essential minimum requirement but that are not included in ACA.  These are:  self-funded student health insurance, foreign health coverage, federally-funded refugee assistance, Medicare Advantage plans, the AmeriCorps plan, and state high risk pools.  HHS seeks comments on when high risk pools should be re-evaluated as meeting minimum coverage requirements.  HHS also seeks comments on developing a process for applications from other coverage types to qualify as meeting essential minimum standards.

[LPF]

February 6, 2013 | Permalink | Comments (0) | TrackBack (0)

“It’s like Yugoslavia, and Tito just died”

Interesting Times piece, here, on how Insurance companies are changing their business models in the face of ACA provisions. 

[NPT]

February 6, 2013 | Permalink | Comments (0) | TrackBack (0)

Friday, February 1, 2013

ACA Implementation: MLR & More

The Commonwealth Fund has recently reported on how states are lagging in implementing consumer protection aspects of the ACA.  In case you are looking for a comprehensive overview of the options open to a state as it implements the MLR provisisons of the ACA, check out my colleague Tara Adams Ragone's policy brief "The Affordable Care Act and Medical Loss Ratios: Federal and State Methodologies."  Though the piece focuses on New Jersey, its structure suggests the issues that will come up for many other states: 

As part of sweeping health care reform in 2010, Congress established MLR requirements for health insurance issuers offering coverage in the group and individual health insurance markets, including grandfathered but not self-insured plans, hoping to increase the value consumers receive for their premiums and to improve transparency. Medical loss ratio refers to a measure of the percentage of premium dollars that a health insurance company spends on health care as distinguished from administrative expenses and profit, including advertising, marketing, overhead, salaries, and bonuses. Prior to the ACA, some states but not the Federal government regulated loss ratios. The new Federal MLR law, which went into effect on January 1, 2011, for the first time established a national MLR standard, which varies from existing state MLR requirements in important ways. 

This Policy Brief analyzes the new Federal MLR requirements and how they intersect with and affect New Jersey law and its insurance markets. After providing background on medical loss ratios and highlighting the major similarities and differences between the existing Federal and New Jersey MLR regulatory schemes, this Brief examines several requirements and policy options that New Jersey must consider as it implements the Federal requirements. This Brief also includes appendices that provide more extensive details regarding the components of the Federal MLR requirements, New Jersey’s MLR legal structure, and research regarding experiences with loss ratios nationally and in New Jersey, pre- and post-the ACA.

My former student Ina Ilin-Schneider has also posted on the MLR, after authoring a very interesting paper on the state waivers granted (and denied) by HHS.  

Finally, a quick note to recommend Ann Marie Marciarille's several recent posts at PrawfsBlawg on ACA implementation and health policy generally.  It's hard to write about these topics gracefully and for a general audience, while conveying the expertise of a scholar.  I think of her posts as real models on both counts.

[FP]

February 1, 2013 | Permalink | Comments (0) | TrackBack (0)