HealthLawProf Blog

Editor: Katharine Van Tassel
Concordia University School of Law

Friday, June 1, 2012

War on Disclosure: Recent Fronts in Health Care

Corporations are at war with disclosure in many important fields.  Two notable fronts have recently opened in health care: 

1) Fracking processes have become highly controversial because secret chemicals may end up compromising water supplies.  Pennsylvania has now limited doctors' ability to speak about their concerns: 

Under a new law, doctors in Pennsylvania can access information about chemicals used in natural gas extraction—but they won’t be able to share it with their patients. . . .Pennsylvania law states that companies must disclose the identity and amount of any chemicals used in fracking fluids to any health professional that requests that information in order to diagnosis or treat a patient that may have been exposed to a hazardous chemical. But the provision in the new bill requires those health professionals to sign a confidentiality agreement stating that they will not disclose that information to anyone else—not even the person they’re trying to treat.

Protection of property rights uber alles appears to be the guiding principle here.  If only the doctors wanted to market drugs, maybe their free speech rights would trump the frackers' trade secrecy privileges.  

2) FDA User-Fee Bills recently approved by the House and Senate could seriously limit access to clinical trial information.  The House bill is particularly worrisome:

The Food and Drug Administration Reform Act of 2012, H.R.5651 . . . would keep potentially important health and safety information away from the public. Section 812 would, according to a letter to leaders of the House Oversight and Government Reform Committee penned by several [advocacy] groups, deny the public access to information relating to drugs obtained by the U.S. Food and Drug Administration (FDA) from any government agency -- local, state, federal, or foreign -- if that agency has requested that the information be kept confidential.    

If that House provision survives the conference committee, there will be troubling implications for US patients and research subjects abroad.



June 1, 2012 | Permalink | Comments (0) | TrackBack (0)

Worth Reading This Week

Sunday, May 27, 2012

Health Law Program Updates: Hamline University's Health Law Institute

Health Law Prof Blog is starting a new feature to keep readers updated on some of the many changes in health law degree and certificate programs across the country over the past year or so. If you have health law degree or certificate program updates, please send them to me, Katharine Van Tassel at or, after June 30, at and I will post them for you.

As the new director of Hamline University's Health Law Institute (HLI), one of our two guest bloggers for the month of May, Thaddeus Pope, has agreed to kick-off this new column by posting this entry:    

Pope 3It is hard to believe that I am already more than halfway through my guest blogging visit, here, at the Health Law Professors blog.  I have written about my scholarship.  And, next week, I will write about combining scholarship with service and advocacy.  This week, I want to write about the program that I now direct:  Hamline University’s Health Law Institute(HLI).

At HLI, we offer specialized courses, clinics, and externships that instill real-life health law experience in our students.  Recently, we were excited to recognize 21 Hamline Law graduates who have earned their General Health Law Certificate and/or Health Care Compliance Certificate. 

Plus, through our National Speaker Series, Symposia, CLE events, and Online Health Care Compliance Certificate for working professionals, we take education beyond law students to the Upper Midwest’s stellar health care community of lawyers, managers, compliance officers, and policy makers.  The strengths of our program have not gone unrecognized.  HLI has again been ranked as a top 20 health law program in the U. S. News and World Report 2013 Edition. 

This summer, we are again offering five compact Health Law courses on our Saint Paul, Minnesota campus for both students and working professionals.  The courses are

     Health Care Compliance Summer Institute  (May 29 - June 7) 

  • Elder Law  (June 16 – 21)
  • Unhealthy Choices  (June 23 – 28)
  • Health Care Reform: Insurance, Exchanges, & Mandates  (June 8 – 10)
  • Health Care Reform: A New Age of Regulatory Enforcement  (June 11 – 14)

This summer, we are also excited to launch our Online Health Care Compliance Certificate Program, via iPad.  This is a one-year program designed for working professionals.  Once students complete this program they are eligible to sit for the Certified in Healthcare Compliance (CHC) Exam to demonstrate both that they have the requisite knowledge and that they meet the national standards set by the Compliance Certification Board (CCB).   

And beyond this summer, we have an exciting fall semester, including: (1) a panel discussing the Supreme Court decision in DHHS v. Florida (Sept. 12); (2) competing in the National Health Law Moot Court Competition (Nov. 2); (3) a law review Symposium on Legal & Medical Issues in End-of-Life Care (Nov. 9); (4) in conjunction with a special performance of Expiration Date at the Landmark Center (Nov. 8).

If you are going to be in Saint Paul during the upcoming academic year (or if you would like to visit), please let me know.  We are always looking for engaging speakers and diverse faculty visitors.  I look forward to hearing from you.

- Thaddeus Pope

May 27, 2012 | Permalink | Comments (0) | TrackBack (0)

Guest Blogger Nicole Huberfeld: Hidden Responsibilities for Hospital Boards in New Public Benefit Rules



New regulatory regimes often contain both intended and unintended effects.  The example I have in mind is PPACA section 9007, entitled “Additional Requirements for Charitable Hospitals,” which I discussed briefly in my first post.  This section requires tax-exempt hospitals to prove their public benefit by four mechanisms, described by the IRS thus:

Section 501(r)… imposes new requirements on 501(c)(3) organizations that operate one or more hospital facilities (hospital organizations). Each 501(c)(3) hospital organization is required to meet four general requirements on a facility-by-facility basis:

  • adopt and implement written financial assistance and emergency medical care policies,
  • limit charges for emergency or other medically necessary care,
  • comply with new billing and collection restrictions, and
  • conduct a community health needs assessment (CHNA) at least once every three years.

These requirements seem to respond to critiques from Senator Grassley and others that tax-exempt hospitals had stopped earning their subsidy from the federal government (which, arguably, had been a downward slope since the IRS issued Revenue Ruling 69-545 creating the ‘community benefit’ standard after Medicare and Medicaid were enacted in 1965).  The new §501(r) will begin to reattach the concept of free care for the poor to federal charitable status. 

In the wake of the JPMorgan Chase revelations (scandal?) and renewed discussion regarding the Volcker Rule, one can’t help but think that a collateral consequence of §9007 may be to place additional, potential conflict-creating duties on hospital board members.  Hospital boards will be responsible for implementing new financial assistance policies, reviewing charges for certain medical care, ensuring their hospital(s) do not improperly collect debts, and conducting community health needs assessments; but that’s not all.  The CHNA in particular seems to be a potential sticking point for boards, as the public health-driven concept could be at odds with the board’s drive to ensure the mission of the hospital is fulfilled. 

For example, what if the CHNA determines that untreated STDs are a major issue in the community and an educational campaign regarding “safe-sex” is warranted, but the tax-exempt entity is a Catholic hospital.  If the board ignores the CHNA, it may violate its duty of care if it does not adopt an “implementation strategy” as required by 501(r)(3)(A); but, if the board implements the strategy to conduct safe-sex education, it may run afoul of its mission as a Catholic hospital and violate its duty of obedience.  Either way, board members face potential liability, and the hospital faces potential excise taxes.  Though I think the new community benefit rule is generally a good idea, I wonder if we are asking too much of hospital boards.  Thoughts? 

- Nicole Huberfeld

May 27, 2012 | Permalink | Comments (0) | TrackBack (0)