July 13, 2012
Worth Reading This Week
Mark Smith, The Supreme Court’s Medicaid Surprise, JAMA Forum
Joel Ario & Lawrence Jacobs, In The Wake Of The Supreme Court Decision, Many Stakeholders Still Support The Affordable Care Act, Health Affairs
Julian Prokopetz & Lisa Soleymani Lehmann, Redefining Physicians' Role in Assisted Dying, NEJM
July 12, 2012
What will it take for Pharmaceutical Companies to Stop Offering Doctors Illegal Inducements to Prescribe Dangerous and Expensive Drugs—and for Doctors to Stop Accepting Them?
With all the excitement about the Supreme Court’s ruling on the Affordable Care Act, another remarkable event related to the rising cost of health care has gotten less attention than it deserves. On July 2, 2012, GlaxoSmithKline (GSK) pled guilty to three counts of a criminal information and agreed to pay $3 Billion to settle its criminal and civil liability for persuading physicians to prescribe powerful drugs to patients and for diseases not approved by the FDA. The Justice Department described the event as “the resolution is the largest health care fraud settlement in U.S. history and the largest payment ever by a drug company.”
Specifically, GSK has pled guilty to allegations of persuading doctors to prescribe dangerous, unproven drugs to their most vulnerable patients. This included promoting “Zofran, approved only for post-operative nausea, for the treatment of morning sickness in pregnant women.” The government also alleges that “GSK participated in preparing, publishing and distributing a misleading medical journal article that misreported that a clinical trial of Paxil demonstrated efficacy in the treatment of depression in patients under age 18, when the study failed to demonstrate efficacy.’ Worse than that, the government alleges that GSK “did not make available data from two other studies in which Paxil also failed to demonstrate efficacy in treating depression in patients under 18.”
GSK’s actions were illegal and they have been caught. Whether or not the penalty is sufficient to discourage other companies from engaging in similar activities remains to be seen. But the more interesting issue, to me, is why any doctor still thinks it’s OK to take any gift from a drug company? After all, the only reason why a drug company’s shareholders would tolerate the expenditure is if it made it more likely for the physician to use her medical license in a way that would benefit the company. According to the Justice Department GSK, “used a wide variety of gifts, payments and other forms of remuneration to induce physicians to prescribe GSK's drugs, including trips to Bermuda and Jamaica, spa treatments and hunting trips, and sham consulting fees.” How did it ever seem OK to a physician who accepted tax payer money in exchange for treating patients through the Medicaid and Medicare programs to accept a trip to Jamaica from a drug company?
Have we, I wondered, gotten past the point of being able to rely on either criminal penalties against the drug companies or common sense on the part of physicians in order to protect the safety of patients? Is it time to stop these attempts to evade FDA regulation by ending the era of the unregulated prescription pad?
I have written before about the dangers posed by the out-date practice of allowing any physician to prescribe any drug approved by the FDA for any purpose and to any patient. This ability to prescribe drugs “off-label” is in direct contrast to legal prohibition against a drug company’s marketing a drug for uses other than that approved by the FDA. In other words, although a drug company has to provide the FDA with proof that its drug is safe and effective for specific uses, at specific doses, for specific populations, one a drug gets FDA approval a doctor can prescribe it in any dose to anyone for any purpose. This asymmetrical legislative system invites exactly the kind of behavior that GlaxoSmithKline is only the latest company to be caught engaging in.
The current system invites pharmaceutical companies to do the least testing possible in order to get its products approved for use and then engage in a back-door effort to persuade doctors to prescribe it far beyond any proven use. The campaign launched by GSK to promote the use of Paxil in children and adolescents included, according to the Justice Department, sponsoring “dinner programs, lunch programs, spa programs and similar activities.”
In the face of the information brought forward in the Justice Department’s case against GSK, it is hard to imagine why physicians still agree to participate in these events. According to the organization “No Free Lunch” which is an organization devoted to ending the influence of pharmaceutical companies. It describes itself as “health care providers who believe that pharmaceutical promotion should not guide clinical practice. Our mission is to encourage health care providers to practice medicine on the basis of scientific evidence rather than on the basis of pharmaceutical promotion. We discourage the acceptance of all gifts from industry by health care providers, trainees, and students. Our goal is improved patient care.”
No Free Lunch further explains that “We believe that there is ample evidence in the literature--contrary to the beliefs of most heath care providers--that drug companies, by means of samples, gifts, and food, exert significant influence on provider behavior. There is also ample evidence in the literature that promotional materials and presentations are often biased and non-informative. We believe that health care professionals, precisely because they are professionals ,should not allow themselves to be bought by the pharmaceutical industry: It is time to Just say no to drug reps and their pens, pads, calendars, coffee mugs, and of course, lunch.”
No Free Lunch’s website contains extensive references to literature showing the effectiveness of drug company efforts to change doctors’ prescribing practices. One of the many studies No Free Lunch cites is one in JAMA from 2000 that reviewed 563 studies and that found “There was an independent association between meetings with pharmaceutical representatives and formulary addition requests for the drug of the representative's company, both with respect to control physicians who did not meet representatives and with respect to requests for other companies' drugs.” The article directly counters the argument sometimes made by physicians that the information they receive from drug companies actually helps their patients. Rather, “most of the requested drugs presented little or no therapeutic advantage over existing formulary drugs, but the merit of the requests was not related to interactions with the pharmaceutical industry. This, as well as the strength, consistency, specificity, and independence of the results, make it unlikely that the interaction occurred because the physician was already convinced of that drug's influence.”
It’s hard to imagine what more evidence is necessary for physicians to separate themselves from the illegal efforts of drug companies to influence them in ways that can cause direct harm to their patients. Maybe it’s time to take a more direct approach by providing direct oversight of physician prescribing privileges.
Some Old-Fashioned Letter Writing on a New Morass
The Court's fractured decision on Medicaid continues to generate confusion and discussion. And why wouldn't it? To recap, a total of seven justices voted that the Medicaid expansion was unconstitutionally coercive because HHS has the power to withdraw all Medicaid funds for non-compliance with the Medicaid expansion, but they were fractured into a three vote plurality and the joint dissent (which pointedly did not join the plurality). Two justices would have upheld the Medicaid expansion but voted with the plurality to make five justices voting to sever the penalty for state failure to comply with the expansion. And, the four dissenting justices would not have severed the penalty but instead would have struck down the whole law.
Today, what's more interesting is the flurry of letters on the Medicaid issue. The National Governors' Association meets this week in Williamsburg (starting today, actually), where the Medicaid expansion is guaranteed to be a hot topic. In anticipation of the meeting, the NGA sent a letter to HHS asking, in so many words, exactly how much wiggle room the decision in NFIB v. Sebelius gives governors.
Also this week, the National Association of Medicaid Directors' letter asked a more technical and better set of questions that hones in on the open questions resulting from separating the remedy for non-compliance from the Medicaid expansion.
Thus far, Secretary Sebelius has sent a general letter that encourages states to implement ACA, including the Medicaid expansion, but specifics have not been forthcoming. Undoubtedly, HHS will need time to answer the many questions that now confront CMS on the Medicaid expansion, as the Court's King Solomon decision has left many unintended openings in the ACA implementation.
To continue the letter theme, Republican Governors have also sent a letter to Sebelius seeking absolute flexibility in implementing exchanges. And, a small letter-writing war appears to have broken out between Governor LePage and Representative Pingree regarding Maine's maintenance of effort in Medicaid, which LePage says has been negated by NFIB and Pingree holds is untouched. Stay tuned for more acrimony...
Exiling the Poor from the Insurance Market
John Roberts’ jurisprudential wizardry in NFIB has been compared to the artistic genius of pro wrestlers and rappers. Poor Americans in states newly empowered to resist the ACA’s Medicaid expansion may need even more ingenuity to get themselves insured. Both Kevin Outterson and my colleague John Jacobi have observed the perplexing predicament imposed on the poor in states that keep Medicaid 1.0, and resist Medicaid 2.0. From Jacobi’s post:
The reform provides insurance subsidies through tax credits. The credits are calculated on a sliding scale, according to household level, for people with income up to 400% of FPL [the federal poverty line] — subsidizing more generously someone earning 200% of FPL, for example, than someone earning 350% of FPL. But, under 26 USC 36B(c)(1), credits will not be distributed to those with incomes below 100% of the FPL. Why? Because Congress assumed states would take up the Medicaid expansion, obviating the need for exchange-based subsidies for the very poor. . . .Bottom line: states rejecting Medicaid 2.0 will not only forego about 93% federal funding for the program between 2014 and 2022, but they could also be depriving the poorest of the uninsured from any shot at coverage — potentially affecting millions nation-wide.
Georgia hospitals are already worried about the “unexpected prospect of lower reimbursements without the expanded pool of patients” to be covered by the Medicaid expansion:
Last year, Georgia hospitals lost an estimated $1.5 billion caring for people without insurance. The promise of fewer uninsured is what led the national hospital industry to agree to the health law’s $155 billion in Medicare and Medicaid cuts over a 10 year period. The Medicaid curveball comes at a time when Georgia hospitals are already in the throes of a massive industry transformation to improve quality and efficiency driven by market forces as well as the new law. Hospitals face lower payments from insurers and pressures to consolidate. One in three Georgia hospitals lose money. All are busy preparing for new standards under the law that, if not met, could mean millions of dollars in penalties.
It’s hard to imagine how hospitals like Grady can continue to act as a safety net in that environment. The article notes that “Georgians already pay for the cost of care provided to people without insurance through higher hospital bills and inflated insurance premiums.” If that trend continues, all the states refusing Medicaid 2.0 may end up doing is shifting the cost of the Medicaid expansion population from national taxpayers to Georgians with insurance. The superwealthy Americans of Marin County and Manhattan ought to send Georgia Governor Nathan Deal a thank you note for keeping Georgians’ problems for Georgians themselves to solve. (A note to Rick Perry would be in order, too.)
X-Posted: Concurring Opinions.
The “CBO Canon” and the Debate Over Tax Credits on Federally Operated Health Insurance Exchanges
The latest fracas over health reform—the challenge to subsidies for the federal exchanges—offers a long-overdue opportunity to think about how particular features of modern lawmaking might lead to new interpretive presumptions for statutory interpretation. This is the first of series of posts in which I will flesh out that idea. Here, I will focus on the role of the Congressional Budget Office, and how the “budget score" (the budgetary estimate of the effects of legislation) might be a useful tool of modern statutory interpretation, and how it sheds light on the current debate over the federal exchanges.
In a forthcoming article based on an empirical study of congressional drafting (co-authored with Lisa Bressman), we have argued for a new “CBO canon”: An interpretive presumption that ambiguities in legislation should be construed in the way most consistent with the assumptions underlying the congressional budget score on which the initial legislation was based. Both our empirical study and numerous articles in the political science and popular literature substantiate the notion that Congress now drafts in the shadow of the score. In the context of health reform, there was widespread reporting to this effect. As just one of many examples, the New York Times reported in March 2010: “Democrats have spent more than a year working with the nonpartisan budget office… Whenever the budget office judged some element or elements of the bill would cause a problem meeting the cost and deficit-reduction targets, Democrats just adjusted the underlying legislation to make sure it would hit their goal.”
Indeed, I would suggest that the budget score offers better evidence of congressional “intent” than other commonly consulted non-textual tools, including legislative history. This is because, unlike some types of legislative history, the budget score is produced by a nonpartisan office, widely publicized, often debated and usually the focus of many members and staffers. This gives it indicia of reliability that critics of legislative history have often thought lacking for that tool, and yet to my knowledge the Court has never used the score to help resolve statutory ambiguities.
This brings us to the most recent ACA-related scuffle. The ACA’s opponents have raised a challenge to the IRS's interpretation that the Act allows subsidies not only for those who buy insurance on state-operated exchanges, but also for those who live in states with federally-operated exchanges. The dispute stems from what was most certainly sloppy drafting in the statute—in particular, the separation into two different sections of those provisions concerning the state exchanges and those provisions allowing the federal government to operate an exchange if states are unwilling or unable to do so. (This issue of how courts should construe such hastily-enacted and lengthy statutes is another one that we take up in our forthcoming article and to which I will return in a future post).
In my view, the overall structure of the Act and its legislative history, plus the confirmatory language in the health reform reconciliation bill, amply support the IRS’s position. If more is wanting, however, the CBO evidence makes it a slam dunk. Throughout the debates and reporting over health reform, legislators, the Administration and the media repeatedly discussed and debated the ACA’s CBO score, and at all times that score was based on the provision of subsidies to all qualifying purchasers on the exchanges, regardless of whether those exchanges were operated by the states or the federal government. The “CBO canon” clearly supports the agency’s interpretation.
July 11, 2012
AALS Section on Disability Law: Call for Submissions
The AALS Section on Disability Law program at the AALS annual meeting (New Orleans, Jan. 4-7, 2013) will concern the impact of the recent Supreme Court decision on ACA on disability discrimination in access to care under the Medicaid program. Before the ACA decision came down, we wrote the following program description:
With the ACA decision taking the form that it has, pressure on Medicaid funding at the state level can only be expected to intensify. Addressing cutbacks that have disproportionate effects on persons with disabilities is thus a matter of urgency. We are looking forward to a lively program at the AALS.
Abstracts of proposed presentations are invited and should be submitted to Leslie Francis, firstname.lastname@example.org. The officers of the Section on Disability Law will select three abstracts for presentation; authors will be notified by Sept. 15, 2012.
Trusted Identities in Health Information Exchange
One of the most vexing problems for the creation of functioning health information exchanges is verifying the identity of those who are to have access to the information. Identity management also is being addressed as part of a national strategy for trusted identities in cyberspace. Without careful identity proofing (making sure that the person establishing credentials is who they say they are) and authentication (making sure that the person seeking access has the relevant credentials), health information exchange could become a serious threat to individual privacy, security, and even personal safety. On the other hand, identity management techniques that are too cumbersome, inefficient, or expensive, may deter use of information exchange. These are pressing issues for establishment of nationwide health information exchange.
Trust issues about access to interoperable electronic health records are enormous, within and across providers and health care systems. The HIPAA security rule applies to covered entities, which must maintain adequate technical, administrative, and physical security. This includes identity management; Within their own organizations, providers need to be sure that access credentials are issued only to those who should have them. They must also make sure that authentication methods work to limit access only to those who have been issued credentials. For example, relying on passwords is fundamentally flawed; robust passwords are difficult to remember and even these are subject to sophisticated forms of cyber attack. But identity proofing and authentication are just the beginning. There are further problems of ensuring that credentials are used appropriately, are not shared, and are terminated when responsibilities change or employment ends. For example, some providers have instituted audit controls that check to see whether employees are accessing records of family members or neighbors--access that might well be inappropriate. These issues of in-house credentialing and monitoring are themselves highly complex; providers have been struggling to implement mechanisms to ensure that the wrong people don't have inappropriate access to patient information.
Health information exchange presents all of these problem--but across participating entities that may have very different in house policies and practices. There must be a way to identity proof and authenticate individuals seeking to access information outside of home organizations through health information exchanges. Whether to develop a new set of procedures for identity management, or to rely on participating entities to identity proof and authenticate, with the only exchange-level question being identifying the entity, is one issue. Different provider policies are significant: some providers may have far more stringent controls on within-organization access than others. To the extent that exchanges rely on participating organizations to identity proof, authenticate, and monitor in house, exchange raises the concern that information is only protected as well as it is protected by its weakest link. And all this needs to be accomplished in a way that makes business sense: that is standardized, efficient, and user-friendly. For example, it may not be realistic to assume that an entirely new authentication structure should be created for health information exchanges, adding to authentication for electronic health records, bank records, or any other system requiring authentication.
Today (July 11), the Health Information Technology Policy Committee and the Health Information Technology Standards Committee held a public hearing on Trusted Identity of Providers in Cyberspace. The hearing was organized by the HITPC Privacy and Security Tiger Team and HITSC Privacy and Security Workgroup. The hearing addressed these layered problems in assuring that providers seeking to access information available via exchanges are appropriately identified. (The hearing postponed for another day questions about patient access to their records through exchanges). There were four panels: the value of trusted identities for providers, the identity ecosystem, trusted identity solutions in the private sector, and trusted identity solutions in the federal government.
The provider discussion addressed both why it is important to providers to ensure that patient trust is not violated and how providers have addressed questions of access by those outside the entity: community physicians with privileges or research partners, for example. Complicating the matteer is that it is often staff members such as nurses or research coordinators rather than physicians who perform the access. At present, authentication systems can be cumbersome and inefficient, if there are different structures for access credentialing in each of these cases. Even worse, outside of the health care environment people face many different systems of access controls. Among other issues, the ecosystem discussion considered whether it might make sense to develop a single method for assuring trusted identity in cyberspace, be it for banking, for benefits, or for access to health information within or across organizations.
Questions of developing standards were addressed, too. For example, does it make sense to establish a single credentialing standard, what might that standard look like? Could that standard be developed and administrated in the private sector? Could there be one standard credential for "trusted identity" in cyberspace--so that the same credentials can be used for access to health information in whatever system it exists, and that credentials used for access to health information can also be used for access to other types of information (for example, financial information). Although the ATM method of identity proofing (questions seeking information only you might know, like what was the name of your first pet?) and authentication (two factor authentication: the card you have and the password you know) has often been held up as an example of success, discussion observed that with health care, the risks and liability issues are quite different: life, rather than "only" money, may be on the line (although it was noted that banks pay more attention to major transactions than to purchased of inexpensive items like flip flops).
Satisfactory solutions to identity management are essential for health information exchange to succeed. The Health IT Standards and the Health IT Policy Committees will be developing recommendations about identity management in the near future. The hearings were recorded and audio will be available on the ONC HITPC Tiger Team website.
July 10, 2012
A Health Care Rebellion in the South
Messing around with health care in Texas
Today brings the not-unexpected news that Texas, which has one of the highest rates of uninsured persons in the nation (about 27% of Texans have no health insurance), has refused to expand Medicaid coverage to poor adults without children under the Affordable Care Act, and will not create a state-run health care exchange where Texans can go to shop for health insurance when the Affordable Care Act's individual mandate kicks in. According to the Los Angeles Times, Governor Rick Perry is "proudly" refusing to bring in billions of federal dollars to Texas which would help the poorest citizens of the state, because of his concern that Texas would become "a mere appendage of the federal government when it comes to health care." But does Governor Perry have any alternative plan as to how he will get health care coverage for the one-quarter of his state that has none? Plenty of bluster, such as his statements that Texas has "some of the finest healthcare in the world," and "this federal government . . . doesn't like Texas to begin with," but no concrete plans to improve the situation. Some of the purveyors of that fine Texas health care have expressed concern over Perry's statements. The Texas Hospital Association President notes that while Medicaid is definitely not perfect, refusal to expand the program means that many Texans will remain uninsured, will seek care in emergency rooms, and thus shift costs to the privately insured and the hospitals. Perhaps Governor Perry should listen to the folks who actually know something about health care in his state, rather than watching Gone With the Wind again.
History Repeats Itself
Governor Perry has company in his Southern mini-rebellion. Florida, Louisiana, Mississippi, and South Carolina are also refusing to implement the Medicaid expansion. Apparently, Rhett Butler's statement, regarding the resources needed to win the Civil War amidst all the bravado he heard from his fellow Southerners, that all the South has is "cotton and slaves and arrogance" needs to be updated for the current ideological war on health care. Perry's statements about the ACA make it clear that the arrogance is still around. What would be most accurate statement about the current resources available in the South to improve the health of Americans? I'm open to suggestions. But what most amazes me about these statements and the positions of these states is how history seems to repeat itself. From the statutes that many states passed (all over the country, not just in the South) claiming that their citizens would be exempt from the requirements of the federal law, to the tough talk about being pushed around by the federal government, we have heard all of this before, albeit over different issues. And the outcome then wasn't pretty. Over 600,000 Americans died in the Civil War. How many Americans will die because of lack of access to health care before we end this ideological war?
(VJW) cross-posted on Healthy Interests
July 9, 2012
Consumer Reports Investigates Hospital Safety
Consumer Reports has for the first time rated hospitals for safety. Their ratings include information from government and independent sources on 1,159 hospitals in 44 states. In compiling their rankings, Consumer Reports also interviewed patients, physicians, hospital administrators, and safety experts; reviewed medical literature; and looked at hospital inspections and investigations.
As they explain in this article,
[h]ospitals should be places you go to get better, but too often the opposite happens.
Infections, surgical mistakes, and other medical harm contribute to the deaths of 180,000 hospital patients a year, according to projections based on a 2010 report from the Department of Health and Human Services. Another 1.4 million are seriously hurt by their hospital care. And those figures apply only to Medicare patients. What happens to other people is less clear because most hospital errors go unreported and hospitals report on only a fraction of things that can go wrong.
“There is an epidemic of health-care harm,” says Rosemary Gibson, a patient-safety advocate and author. More than 2.25 million Americans will probably die from medical harm in this decade, she says. “That’s like wiping out the entire populations of North Dakota, Rhode Island, and Vermont. It’s a man-made disaster.”
“Hospitals haven’t given safety the attention it deserves,” says Peter Pronovost, M.D., senior vice president for patient safety and quality at Johns Hopkins Medicine in Baltimore. Nor has the government, he says. “Medical harm is probably one of the three leading causes of death in the U.S., but the government doesn’t adequately track it as it does deaths from automobiles, plane crashes, and cancer. It’s appalling.”
That lack of information not only makes it difficult to define the extent of the problem but also makes it challenging for patients to know about the safety of the hospitals in their communities.
For these reasons, Consumer Reports has stepped in to rate hospitals for safety. To see if your hospital was included in the rankings, go to this interactive map.
July 8, 2012
Affordable Care Act Timeline
The New York Times has posted a nice timeline of the legal and political opposition to the Affordable Care Act from the day that President Obama signed it into law (March 23, 2010) through the Supreme Court's decision on June 28.