Action of Ohio Controlling Board on Medicaid Expansion

According to Professor Wilson R. Huhn of the University of Akron School of Law, the Ohio governor’s action expanding Medicaid in Ohio is valid. He writes:

On Monday, October 22, at the urging of Governor Kasich, the  Controlling Board of the Ohio Legislature voted 5-2 to accept $2.5  billion in federal funding to expand Medicaid in the State of Ohio.  Under the laws of Ohio this action was valid.

The Controlling Board is a state agency created by statute. The agency  has two principal powers: it can transfer funds and authorize purchases  by state agencies, and it can decide to accept federal funding on behalf of these agencies. Section 131.35(A)(5) of the Ohio Revised Code  states: “Controlling board authorization for a state agency to make an expenditure of  federal funds constitutes authority for the agency to participate in the federal program providing the funds ….”

Two advocacy organizations (the Buckeye Institute and the 1851 Center  for Constitutional Law) as well as several Ohio lawmakers have announced that they intend to challenge the legality of the action of the  Controlling Board. They contend that the action of the Board violates  Section 127.17 of the Ohio Revised Code, which provides that the Board  is bound by the intent of the Ohio General Assembly. The challengers  quite correctly point out that both houses of the General Assembly voted not to accept federal funding to expand Medicaid. Governor Kasich  vetoed this bill, but the challengers argue that despite the Governor’s  veto it’s clear that the General Assembly did not want the Controlling  Board to accept federal funding to expand Medicaid.

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Our Bodies, Our Cells: FDA Regulation of Autologous Adult Stem Cell Therapies

By Mary Ann Chirba, J.D., D.Sc., M.P.H. and Alice A. Noble, J.D., M.P.H.

Stem cells have been an endless source of fascination and controversy since Dolly the sheep was cloned in 1996. This month’s announcement of a cloned human embryo from a single skin cell [1] came on the heels of Sir John B. Gurdon and Dr. Shinya Yamanaka’s receipt of the 2012 Nobel for Physiology and Medicine for their work with induced pluripotent stem cells. Pluripotent stem cells can be embryonic or induced. Embryonic stem cells (ESCs) can generally be obtained from human embryos or by cloning embryos through somatic cell nuclear transfer (SCNT), as was done for Dolly.  Gurdon and Yamanaka demonstrated that pluripotent cells may also be formed by reprogramming adult cells to an embryonic state, resulting in induced pluripotent stem (iPS) cells without having to use eggs or cloning, or destroy embryos. However derived, pluripotent cells are capable of differentiating into virtually any cell type in the human body. This imbues them with great promise for scientific breakthroughs and medical advances, but also raises serious ethical, legal and safety concerns about their use.

Less controversial are “multipotent” adult stem cells (ASCs) which do not involve embryos or raise as many safety concerns as pluripotent cells.  ASCs are found throughout the body.  Their ability to differentiate is more limited than pluripotent cells but is vast nonetheless. The NIH’s clinicaltrials.gov site lists some 4500 ASC trials as compared with 27 for embryonic stem cells and 21 for induced pluripotent stem cells. Recent announcements of new stem cell treatments usually involve ASCs, such as last month’s news that a toddler born without a trachea received a new one made from her own adult stem cells.  It is therefore no surprise that ASCs have captured the attention of researchers, investors, physicians, patients and – increasingly – regulators, both here and abroad.

A growing number of physicians routinely offer treatments involving ASCs to their patients which can be performed in their offices.  Autologous adult stem cells, used to treat a variety of conditions, are harvested from the patient, processed, and returned to the same patient. It is no surprise that moving ASCs from laboratories to physician offices raises complex questions of law. We consider one of the more pressing ones: to what extent can the FDA regulate a physician’s ability to treat a patient with that patient’s own stem cells?  In the coming months, the D.C. Circuit Court of Appeals will hear oral arguments on this very issue in United States v. Regenerative Sciences.[2]

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DNA Art

According to an article in the NYT, an artist has collected DNA samples from litter on sidewalks, such as chewing gum and cigarette butts, and used those samples to extract and sequence DNA that she then used to make computer models of their owners’ faces. She then printed 3-D masks that she is showing at her upcoming exhibit called Stranger Visions. The artist hopes her exhibit will spark a dialogue over genetic surveillance.

The NYT article explains that

[w]hile staring at the wall of her therapist’s office, the artist Heather Dewey-Hagborg noticed a strand of hair stuck in a hanging print. Walking home, she noticed that the subways and sidewalks were littered with genetic material on things like chewing gum and cigarette butts, some still moist with saliva. Curious about what she could learn, Ms. Dewey-Hagborg began to extract and sequence DNA from these discarded materials. Then — and here it gets a little eerie — she began to make computer models of their owners’ faces, using genetic clues to print 3-D masks that she concedes “might look more like a possible cousin than a spitting image.” Hanging these portraits along with the original samples, she says, is “a provocation designed to spur a cultural dialogue about genetic surveillance.” After the June exhibitions, Ms. Dewey-Hagborg will show her work early next year at the New York Public Library. She has also collaborated on a tongue-in-cheek project called DNA spoofing, which purports to offer ordinary people some techniques to avoid detection by scrambling their genetic material.

Talk and exhibition at Genspace in Brooklyn on June 13. Exhibition at QF Gallery in East Hampton, N.Y., opens June 29.

[Cross-posted from HealthLawProf Blog]

A Decade’s Quest for Safer Drugs: Congressional Committee Green Lights Regulation of Drug Supply Chains and Compounding Manufacturers

By Mary Ann Chirba and Alice A. Noble

On May 22. 2013, the Senate Health, Education, Labor and Pensions (HELP) Committee unanimously approved S.959, “The Pharmaceutical Compounding Quality and Accountability Act,” and S.957, “The Drug Supply and Security Act,” (now incorporated into S. 959 as an amendment).  Congressional efforts to enact comprehensive legislation to improve drug safety and secure the nation’s drug supply chain have lingered for over a decade. The lack of federal uniformity has allowed a patchwork of state legislation to emerge, attracting the less scrupulous to those states with the lowest security. The issue finally gained traction among HELP Committee members when 55 people died and 741 more became ill after contracting fungal meningitis from contaminated steroid injections made by the New England Compounding Center (NECC). Committee member Sen. Pat Roberts (R-KS) stated that given prior reports of problems with NECC, this tragedy could have been averted but for a “shocking failure to act” by NECC, state and federal regulators, and Congress.

As NECC’s role in the meningitis outbreak came to light,gaps in regulatory oversight did, too. The federal Food Drug and Cosmetic Act (FDCA)[1] currently recognizes only two categories of pharmaceutical manufacturers: commercial pharmaceutical companies and compounding pharmacies. To qualify as the latter under federal law, the entity must make individual or small batch, patient-specific drugs and do so only with a physician’s prescription for that patient.  Compounded drugs must be either be unavailable in the commercial market or needed in commercially unavailable doses or combinations. The FDCA exempts such compounders from its pre-marketing requirements applicable to commercially manufactured drugs. Thus, federal law clearly covers commercial pharmaceutical manufacturers, state law just as clearly oversees and licenses pharmacies but as the NECC case demonstrates, there is nothing clear about the responsibility for inspecting, licensing or otherwise overseeing compounders that do not fill prescriptions on a per patient basis.

Instead of compounding in response to an individual prescription, the New England Compounding Center made large batches of drugs for institutional buyers such as hospitals. Many of its drugs were commercially unavailable but some were knock-offs of marketed FDA-approved drugs – a practice which is clearly unauthorized. NECC’s business model was certainly not unique; neither was the limited and erratic response of state and federal regulators to complaints about the facility’s unsafe manufacturing practices. Congress knew that large-scale compounders existed along with concerns about their safety. Several members of the Senate HELP Committee had worked on curative legislation for over ten years, but made few inroads until the NECC crisis prompted the  HELP Committee to shift from park into drive.

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Medical Malpractice, the Affordable Care Act and State Provider Shield Laws: More Myth than Necessity?

By Mary Ann Chirba and Alice A. Noble

Given the ambitions and reach of the Affordable Care Act, confusion about its intended and inadvertent impact is inevitable. Since its enactment in 2010, the ACA has raised legitimate and less grounded concerns among various stakeholders ranging from individuals and employers facing coverage mandates to States deciding whether and how to implement the Act’s Medicaid expansions. One item has received far less attention even though it weighs heavily on any provider engaged in the clinical practice of medicine: the ACA’s impact on medical malpractice liability. The Act does little to address medical malpractice head on. Nevertheless, physicians and other providers, the states and even some members of Congress have expressed concern that the Act will increase a provider’s exposure to medical malpractice liability.

In response, the American Medical Association has drafted model legislation to shield providers from newly created malpractice claims resulting from the ACA. It would prevent malpractice claimants from using federal or state practice guidelines, quality measures, reimbursement criteria and the like to establish or define the standard of care without expert testimony. In Congress, a version of this model, H.R. 1473, was introduced in the House of Representatives in 2012, and again in April of 2013 [link: http://beta.congress.gov/bill/113th-congress/house-bill/1473/cosponsors].

In April, the governor of Georgia signed H.B. 499 [link: http://www.legis.ga.gov/legislation/en-US/display/20132014/HB/499] into law, becoming the first state to pass legislation based on the AMA model act.

This came on the heels of a Medical Association of Georgia Advocacy Brief [link: http://www.mag.org/sites/default/files/downloads/issue-brief-provider-shield2-2013.pdf] stating that the ACA’s “guidelines” concerning health care quality measures; payment adjustments; hospital value-based purchasing; and value-based payment modifiers “will raise [the medical malpractice] standard to unreasonable levels by exposing physicians to a number of new liabilities….” [Emphasis added]

It is too early to tell whether states will follow Georgia’s lead and enact similar measures. What is clear is that such “standard of care protection” or “provider liability shield” legislation raises interesting questions about the ACA’s impact on state medical malpractice law.

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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 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.

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Tools for Teaching the Fungal Meningitis Outbreak

By Jennifer S. Bard

I’m sure many of us are talking about the contaminated steroid injections which have spread a fungal form of meningitis Exserohilum rostratum across the country.   The CDC, which as is usually the case is doing an excellent job of providing clear and current information,  reports that as of “October 17, 2012, a total of 47 patients have laboratory-confirmed fungal meningitis.”  They offer some reassuring information—that “this form of fungal meningitis is not contagious”  and some scary information—that  there are 257 cases and ten deaths in 15 states and that incubation periods last up to a month.

The most recent legal news is that the pharmacy was visited earlier this week by the FDA’s criminal investigative unit and that the first law suit has already been filed in Minnesota Federal District Court by a woman who received a vaccine from the pharmacy but who does not know yet if she has meningitis. Read More

Marijuana Initiatives in the Upcoming Election

By Leslie P. Francis

In a year of a presidential election, initiatives are likely to get lost in the shuffle unless they have implications for the race at the top–as did the state efforts to ban same-sex marriage did some years ago. This election season features a number of efforts to legalize marijuana.

Several of these would legalize possession of small amounts of marijuana, whether or not for medical use.  Colorado Amendment 64 is a constitutional amendment to legalize possession of less than an ounce of marijuana by state residents over the age of 21.  Oregon Measure 80, the Oregon Cannabis Tax Act, would legalize growing and selling marijuana.  Washington I-502 would create exceptions to state law enforcement for adults possessing less than an ounce of marijuana.  Growers and sellers would be required to obtain state licenses, and sales would be taxed–with revenue going to state drug prevention programs.It would also establish a 5 nano-gram/millileter of blood limit for adults driving and a zero tolerance policy for those under 21. Read More

The DOMA Petition You Should Be Following

By Nicole Huberfeld

You may be thinking “DOMA? Hello, this is HEALTH LAW.”  Please stick with me for a moment.  The Supreme Court appears to be collecting petitions for certiorari regarding the Defense of Marriage Act, likely to determine which circuit’s decision is the best vehicle for considering the constitutionality of this federal law.  One such petition results from the First Circuit’s decision in Massachusetts v. Department of Health and Human Services/Hara v. Office of Personnel Management, which held that section 3 of DOMA violated the Fifth Amendment’s Equal Protection Clause.  The court reasoned that promoting marriage is not rationally related to denying federal benefits to same-sex couples, thereby avoiding the creation of a new category of suspect class.  The twist is that the state of Massachusetts also claims that section 3 of DOMA, which denies federal economic benefits to same-sex couples, exceeds Congress’s Spending Clause authority and infringes the state’s 10th Amendment rights.  While the First Circuit did not agree with the state on these points, it did incorporate federalism concerns into its Equal Protection Clause analysis by noting that states traditionally have defined marriage, therefore the federal government cannot protect the state of Massachusetts from its own definition of marriage by promoting heterosexual marriage. Read More

Congressmen are Concerned that Meaningful Use Stage 2 is Too Weak

By Leslie P. Francis

On October 4, four Republican Congressman, all with powerful positions concerning health care, wrote Secretary Sebelius urging suspension of “meaningful use” Stage 2 payments until a stronger program is in place. The Congressmen, Dave Camp (Chair of the House Ways & Means Committee), Wally Herger (Chair of the Ways & Means Subcommittee on Health), Fred Upton (Chair of the House Committee on Energy and Commerce), and Joe Pitts (Chair of the Energy & Commerce Subcommittee on Health), expressed concern that the Stage 2 regulations are too weak to insure genuine interoperability of electronic medical records.  As a result, the Congressmen contended, a great deal of taxpayer money will be wasted on payments for electronic records that do little to improve care or reduce costs.

The Congressmen have a point, despite the apparant partisanship of the letter.  There is a history of apparent reluctance on the part of the Office of the National Coordinator for Health Information Technology, and with it HHS, to meet head-on industry complaints about the difficulty and costs of meeting standards or industry contentions that regulation will stifle innovation. Models of technology forcing that were employed in furtherance of environmental protection appear not to have been considered by ONC and HHS. The requirement to meet Meaningful Use Stage 2 was delayed by a year, from 2013 to 2014, to allow vendors more time to develop products. As I indicated in an earlier post, ONC has decided not to develop governance rules for health IT exchanges, out of industry concern for impact on innovation.   The stage 2 meaningful use requirements are not very strong, either, as the Congressmen point out. For example, core requirements are only that 50% of prescriptions be electronic, that only 50% of care referrals must be accompanied by electronic care summaries, that only 50% of patients must have access to health information (with 5% using it), and the EHR be capable of generating only one list of patients by condition. (For a handy comparison of stage 1 and stage 2 certification criteria, see here). All of these–and other–requirements are important to anticipated improvements in care to be garnered from the introduction of EHRs.  For example, generation of lists of patients with a specified condition (e.g. diabetes) may be an important way to ascertain the quality of patient management across a practice. Read More