Things You Wanted to Know About the New HIT Standards But Were Too Afraid to Ask

In a previous post I discussed the interim final rule (IFR) that was recently promulgated by the Office of the National Coordinator for Health Information Technology (ONC).  The previous post discussed two of the four categories of standards in the IFR. This post will look at the final two categories. In order to appreciate the purpose of the final two standards, it is worth recapitulating the basic framework upon which the IFR is based.

The ONC’s framework for the standards is to first start with the meaningful use objectives. From the broad objectives of meaningful use, the ONC establishes certification criteria for these objectives. Based on the certification criteria, the ONC has adopted standards that would allow for an objective determination of whether the criteria has been met.

An example will help: One of the meaningful use objectives is “the capability to exchange key clinical information among providers of care and patient authorized entities electronically.”  To achieve this objective, “Certified EHRs” will have to meet the following criteria: “[The EHR system must] electronically receive a patient summary record, from other providers and organizations including, at a minimum, diagnostic test results, problem list, medication list, immunizations, and procedures and upon receipt of a patient summary record formatted in an alternative standard specified in Table 2A row 1, displaying it in human readable format.”

In order to guide EHR vendors (and purchasers) in fulfilling the above criteria–and likewise the larger meaningful use objective–the ONC has adopted a number of standards that EHRs must utilize in order to be certified. These standards fall into 4 general categories.

1. Vocabulary Standards — The standardized nomenclatures and code sets used to describe clinical problems and procedures, medications and allergies.
2. Content Exchange Standards –  The standards used to share clinical information such as clinical summaries, prescriptions, and structured electronic documents.
3. Transport Standards — The standards used to establish a common, predictable, secure communication protocol between systems.
4. Privacy and Security Standards — Standards relating to authentication, access control, transmission security which relate to and span across all of the other types of standards.

My previous post provided a general overview of the first two standards, the first of which specifies the language of “EHR speak,” while the second specifies standards giving that EHR vocabulary a predictable organization so as to ensure that different EHR systems can interpret the data.

In the previous post I used the analogy of the Bluebook style of citation to explain the content exchange standard and vocabulary standard. As you can see, the following two citations share the same basic organization (e.g. case name in italics, followed by the reporter volume number, name of the reporter, starting page of case, etc).

Wilson v. Mar. Overseas Corp., 150 F.3d 1 (1st Cir. 1998)

Orange County Agric. Soc’y, Inc. v. Comm’r, 893 F.2d 529 (2d Cir. 1990).

The content exchange standard is analogous to the order of the different elements of the citation. Regardless of the case, all Bluebook citations to federal court of appeals cases have this same basic organization. The part that changes is the vocabulary. As you can see in the cases above, two different reporters (publishers) have been used: F.3d and F.2d.  There are still only limited options for the vocabulary of court reporters.  Likewise, even though the organization of a patient’s record will remain constant, it will obviously consist of different terms depending on, among other things, the patient’s diagnosis and test results. The possible terms within the chart are determined by the vocabulary standards.

Essentially, the signifier and syntax standards are meant to save us from constructing a costly high-tech Tower of Babel. A sign (word, letter, number, symbol) displayed in a particular way must have an agreed to and discernible meaning.

With these two standards in mind, a brief overview of the latter two standards is possible.

Transport Standards

Though the data is sitting on server A in a structured format–governed by the content exchange and vocabulary standards discussed above–there is more that needs to occur for the data to be useful. For example, Computer A must “know” how to send a request for that data in a way that Computer B can understand. Likewise, Computer B must “know” how to respond to Computer A’s request, i.e., how to structure the response it will give to Computer A. This is where the third category of “transport standards” becomes important.

Luckily for us, one of the transport standards (SOAP) adopted by the ONC is the same standard used by LexisNexis. This allows us to continue our analogy.

When I log onto LexisNexis, I have the opportunity to enter a citation. The citation must be entered in the same basic order that the Bluebook citation provides. Therefore, utilizing the first case cited above, I would type in:

150 F.3d 1

The name of the parties in the case is not necessary since only one case occurs at a given page (page 1) of a reporter’s (F.3d) volume (150). If I submit that citation and Lexis recognizes it, Lexis will then display the case. The beautiful thing about Lexis (and Westlaw) is that the case data, like the citations, has a specified organization–analogous to the organization specified by content exchange standards. One discrete element common to all Lexis cases is a field listing the parties’ counsel. Let’s say that I am an iPhone application developer and I want to create a simple application that would allow a user with a Lexis account to type in a citation like the one above, and in response the program would output the opposing counsel field (as opposed to the whole case). My application would need to know how to trigger Lexis’s server to go and find that information in the database. Likewise, the Lexis database must know how to package and send that data back to the client application. Thus, the fact that Lexis organizes data like citations and counsel into organized fields with specific vocabulary is not sufficient. Rather, there must be a standard governing the requests of specific information, as well as how that information should be formatted and transmitted. This is the role of the “transport standards.”

The ONC adopted two alternative standards–the SOAP standard and the REST standard–to govern requests and responses between client and server computers. As stated above, the SOAP standard is used by Lexis (and other Internet sites) to allow other applications and services to be able to interact with it. That Lexis uses the same standard as that adopted in the HIT interim final rule helps to illustrate the broad nature of  transport standards. Unlike the content exchange and vocabulary standards that are unique to the practice of health care, the transport standards ensure that services wishing to interact with a server have an agreed upon framework by which to accomplish the interaction.  As becomes obvious from this discussion, ensuring the proper implementation of the transport standards is critical to meeting the meaningful use objective described earlier that dealt with exchanging clinical information among providers. Additionally, having a specified standard for requesting and receiving the data is crucial for personal health record (PHR) services that seek to interface with the databases of health care providers in order to retrieve and display certain information to the consumer of the PHR.

Privacy and Security Standards

The fourth group of standards deals with privacy and security, and for the most part, this part of the IFR is straightforward. The reason for the straightforwardness is that the ONC has decided to model their privacy and security criteria off of HIPAA’s Privacy and Security Rules. Therefore, there are no real surprises. With that said, the HITECH Act does direct the various HIT committees as well as the ONC to look at capabilities beyond those specified in the HIPAA Security Rule. Thus, even though the IFR does not change the privacy and security landscape in any major way, there is no promise that things won’t change in the future.

Specifically,  the ONC has adopted standards for certain aspects of HIPAA but not others. For example, standards have been adopted for the encryption of data, but not for “access control” measures that are used to prevent unauthorized access at computer terminals connected to EHR systems. The ONC’s rationale is that the methods of regulating access are evolving at a rapid pace, whereas there are industry best practices available for encrypting information. As a result, the ONC requires all certified EHR systems to be capable of encrypting their data. This is somewhat remarkable given that HIPAA and HITECH do not require all entities to use encryption. The ONC believes that this capability will spur the use of encryption by making it available to all consumers of certified EHR systems. Furthermore, the implementation of encryption by HIPAA covered entities is important because it acts as a safe harbor, relieving them of the responsibility of having to report a data breach.

As Table 2B shows, the ONC distinguishes between the general encryption of stored data on the one hand and the encryption of transmitted data on the other hand. Please click on the thumbnail below to enlarge the table.

The ONC has stated numerous times that the IFR in no way changes the responsibilities of covered entities or business associates under HIPAA (and HITECH). Rather, it solely concerns the capabilities of certified EHR systems.

Reform Rodeo

1a. Health Reform Post-Brown: Kaiser Health News Staff Writer Jenny Gold discusses the Democrats’ seemingly new strategy of focusing on repealing health insurers’ antitrust exemption.

2. Bending the Curve, Success Story: Maggie Mahar over at Health Beat has a wonderful overview of  Maryland’s successful approach to reducing health care costs.

3. Comparative Effectiveness: Dr. Nortin Hadler offers a forceful and nuanced view on the role of comparative effectiveness research.

4. Medicare and Technology: The New England Journal of Medicine has an interesting piece on how Medicare determines which health-related technologies to reimburse.

5. Quack Attack: Over at Science-based Medicine, Dr. Steven Novella covers the retraction of Andrew Wakefield’s 1998 article that claimed to link autism with the mumps-measles-rubella (MMR) vaccine.

6. Neuro News: The New York Times reports on how new studies may question some bedside techniques used to diagnosis the degree of brain activity in severely brain-injured patients.

7. Bonus: For those interested in more health-related links, Joe Paduda at Managed Care Matters hosts the current Health Wonk Review

Medical Care for Haitians: US Announces Funding

This past Sunday, the White House resumed military airlift of injured Haitians into the United States.  The halt on incoming Haitian patients had happened just days earlier, springing from the economic and logistic fears of many state officials of Florida, where the majority of patients from Haiti were being sent for care.  After finding a solution to the hospital capacity issue in Florida,  and fully knowing that they could not keep certain patients in the medically hazardous environment which is Haiti, White House officials reopened U.S. hospital doors to  badly injured patients.  Yet, the resounding question “who is going to pay for this emergency care?” remains.

The costs are not insignificant.  One Florida hospital executive estimates costs to her hospital alone to be in the millions, and while she hopes some of this cost will be lessened through federal government assistance, other hospitals have already started to initiate reimbursement for the costs themselves through private donations.  In addition, many doctors and nurses are volunteering their services to help reduce the high cost of the care.

The U.S. Department of Health and Human Services announced on Monday that they would supply funding for the emergency care through the National Disaster Medical System, which is usually accessed only in times of domestic emergencies. As described in the announcement, “activation will allow U.S. hospitals that treat Haitian patients evacuated with life-threatening injuries due to the earthquake, to receive federal reimbursement for the costs they incur.”  The reimbursement for the care to Haitians is equal to 110% of Medicare rates.

Since the announcement of aid through the National Disaster Medical System, hospitals in other areas, such as Atlanta, are agreeing to treat patients.  Hospitals in the Atlanta and Florida area are able to provide assistance due to their proximity to Haiti and their “extensive medical resources.”  Other hospitals in the New York, New Jersey, Philadelphia, and Boston areas have been notified that their medical centers may also be tapped  for help in treating the Haitian patients.

Because some of the patients that are being treated at American hospitals are American citizens who were in Haiti when the earthquake hit, some of the medical care can be reimbursed through the insurance coverage that those patients may already have or be eligible to receive.  Interestingly, Haitians who are not legal residents of the United States might also qualify for insurance through Medicaid, but to qualify, the patients would have to be granted “Humanitarian Parole” by U.S. Citizenship and Immigration Services.  Up until this point, Humanitarian Parole visas, which last for a year, have mostly been granted to orphans who were already in the process of being adopted before January 12^th.  Only 50 Humanitarian Parole visas have been granted to those who were sent to the United States for health care; due to the difficulty in tracking patients after their care is complete, the Immigration Services is hesitant to grant more such visas.

While the federal government appears to have systems in place to aid Haitians who are in dire need of medical care for now, questions about long term help still linger.  International aid experts want to see systems of sustainability put into place so that Haiti can once again stand on its own after the foreign aid ends.  Maybe our nation’s leaders will be able to give to Haiti the health care reform it needs, even if they can’t give it to America itself.

Allergan v. FDA: Where Does Disseminating Safety Information End and Promotion Begin?

In the Fall of 2009, the drugmaker Allergan made waves when it sued the FDA alleging that the ban on off-label promotion was chilling its “First Amendment right to share truthful medical information with physicians about how to safely use Botox off-label [to treat muscle spasticity] to achieve a benefit while minimizing risk of serious adverse events.”  Allergan was back in the news last week when the LA Times reported that trial was set to begin in a case brought against Allergan by the mother of Kristen Spears, a seven-year-old girl with cerebral palsy who died after being injected with Botox to treat muscle spasticity in her legs.

Allergan manufactures two FDA-approved botulinum toxin products, Botox Cosmetic, the well-known anti-wrinkle treatment, and Botox, which is approved to treat, among other conditions, cervical dystonia, “a movement disorder that causes [the muscles of the neck and shoulders] to contract and spasm involuntarily.”  Botox is also frequently used “off-label” for conditions it is not approved to treat, including muscle spasticity.  Per the NIH,  locally-injected Botox “has become a standard treatment for overactive muscles in children with spastic movement disorders such as cerebral palsy.”  The FDA agrees.  An agency physician describes Botox as a “commonly used” and “very effective” treatment for spasticity, which he characterizes as a “significant disability[y.]“  Per the LA Times, Botox can “sometimes help young patients walk without surgery.”

While the NIH’s website states that the undesirable side effects of Botox are “mild and short-lived,” the FDA’s informs physicians that “a Boxed Warning has been added to the prescribing information to highlight that botulinum toxin may spread from the area of injection to produce symptoms consistent with botulism,” “that swallowing and breathing difficulties can be life-threatening and there have been reports of deaths related to the effects of spread of botulinum toxin,” and “that children treated for spasticity are at greatest risk for these symptoms[.]”

In addition to requiring the addition of the black box warning to the Botox label, the FDA has ordered Allergan and other manufacturers of botulinum toxin products to adopt a Risk Evaluation and Mitigation Strategy (REMS) which includes “a Medication Guide [for patients] and Communication Plan, including a Dear Health Care Provider letter, and a timetable for submission of assessments.”

In its complaint against the FDA, Allergan alleges that while “the boxed warning and REMS materials identify the risk of potential distant spread of toxin effect, … they do not give physicians using Botox for spasticity specific guidance about how to further minimize that risk while still obtaining an acceptable therapeutic effect.”  Allergan wants to provide physicians with specific information about treating spasticity including “proper dosing, patient selection, and injection technique.”  Allergan argues, with good reason I believe, that if it were to, say, develop a slide deck about dosing, patient selection, and injection technique in treating spasticity and present it to physicians it would be exposing itself to criminal liability for promoting an off-label use.  In its brief in opposition, the FDA disagrees — sort of — arguing that disseminating safety information about unapproved uses is “not necessarily” promotion and that Allergan has “ample room” “to disseminate truthful, non-promotional information about dangers associated with unapproved uses of Botox.”  (I will have more to say about the parties’ legal arguments in a subsequent post.)

In an interesting twist, the LA Times reports that Kristen Spears’ pediatrician and his nurse practitioner wife testified in depositions that they “learned to use Botox on children with cerebral palsy at Allergan-sponsored seminars in 2000 and 2001″ and that “Allergan’s sales agents discussed the use of Botox for juvenile cerebral palsy patients … repeatedly, visiting the practice about 50 times over several years.”  They also claimed that they were told by sales representatives that other doctors were using “in range of 10 to 15 units” of Botox per kilogram to treat their pediatric patients.  Dr. Mitchell Brin, Allergan’s Chief Scientific Officer for Botox, testified that fifteen units per kilogram, which is the dose given Kristen Spears, is nearly twice the maximum dose that the company considers safe for children.  He also testified that, because of the ban on off-label promotion, Allergan did not disseminate its maximum dosage information to physicians.  If it is true that Allergan’s sales force was providing doctors with dosing information gleaned from anecdotal reports from other doctors they called on while the experts in the company’s medical department kept their dosing knowledge to themselves, it is an example of an all-too-common disconnect between the field and headquarters that in this case may have had tragic consequences.

Excise & Healthcare Reform, Part II, or: “What Overall Effect Would the Cadillac Plan Tax Have?”

Part I of this series provided an overview of the excise on high-cost health insurance plans contained in the Senate’s healthcare reform bill, the Patient Protection and Affordable Care Act (PPACA).  This part summarizes the projected general effects of the excise provision.  The final part of this series will address the problematic and controversial consequences of the excise and possible alternatives.

Three governmental agencies have been primarily responsible for calculating the effects of healthcare reform legislation for Congress:  the Congressional Budget Office (CBO), the Joint Committee on Taxation (JCT), and the Center for Medicare and Medicaid Services (CMS).  Both the CBO and JCT operate under the auspices of Congress, while CMS operates within the Department of Health and Human Services (HHS).

Additionally, numerous private entities separately analyze legislative language to ascertain its effects.  As expected, private entities often issue findings that differ, in varying degrees, from those provided by governmental entities.  This post focuses on the government findings regarding the excise provision, upon which the Senate relied (presumably) in passing the PPACA.  This post is summarized from information contained in the following documents:

JCT letter to Representative Joe Courtney, Dec. 08, 2009

JCT letter to Representative Joe Courtney, Oct. 16, 2009

CBO letter to Senator Bayh, Nov. 30, 2009

CBO letter to Senator Reid, Dec. 19, 2009

CMS memorandum “Estimated Financial Effects of the ‘Patient Protection and Affordable Care Act,’ as passed by the Senate on December 24, 2009,” Jan. 08, 2010

Present tax law allows for the exclusion of employer-provided health benefits from individual income tax and contributions made by employers from FICA (Federal Insurance Contributions Act) tax. The excise would generate approximately $148.9 billion dollars in revenue from 2010-2019.  The excise tax itself would not be deductible from Federal income tax.

For each year after 2013, the actual excise tax collected would account for a smaller percentage of the total revenue collected as a result of the excise provision.  This would be the result of an increase in wages following shifts away from the high-cost insurance plans.  The JCT provided the following explanation:

[T]he Joint Committee on Taxation estimates that the excise tax would be mainly passed along [to consumers] through increases in premiums and that many consumers respond by reducing their demand for insurance above the excise cap.  As described above, because health insurance premiums are a component of compensation, which is not likely to fluctuate due to the excise tax, as consumers spend less on tax-excluded benefits, their taxable cash wages will increase.  Therefore, as the value of health insurance plans decline, the income tax base will increase in the long run.

The total number of health plans affected by the excise would increase from 2010-2019 due to the compounding difference between the inflation rate applied to the premium threshold and medical cost inflation.  The percent of active plans affected by the excise tax would increase during the 2013-2019 period from 14% to 27% and 9% to 22% for single plans and family plans, respectively.  The average premium for those affected plans would actually be lowered.  How?  CBO provides:

For policies whose premiums remained above the threshold, the tax would probably be passed through as a roughly corresponding increase in premiums.  However, most employers would probably respond to the tax by offering policies with premiums at or below the threshold; CBO and JCT expect that the majority of the affected workers would enroll in one of those plans with lower premiums.  Plans could achieve lower premiums through some combination of greater cost sharing (which would lower premiums directly and also lower them indirectly be leading to less use of medical services), more stringent benefit management, or coverage of fewer services.

The excise certainly generates a significant amount of revenue to fund other aspects of healthcare reform.  However, the excise is also expected to decrease the overall national health expenditures (NHE).  According to CMS, the excise “…would have an initial, significant impact on the overall level of expenditures.”  Furthermore, “In 2019, these impacts would reduce the total NHE by an estimated 0.3 percent.”   The current NHE projection for the year 2019 is $4.7 trillion.  That puts the savings at $14.1 billion.

The excise generates revenue, reduces affected premiums, and “bends the cost curve.” So, what is the problem?

Mental Health Parity and Health Reform

The Interim Final Rules on mental health parity were issued last Friday by the various agencies responsible for the administration of the  Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA).  The rules provide interim permanent answers to some of the interpretive questions raised by the MHPAEA.  I’ll provide a couple of early reactions to the rules, and briefly describe why the parity rules in no way lessen the need for broader reform for the benefit of people with serious mental illness.

MHPAEA, effective for large (over 50) public and private health coverage for plan years beginning after October 3, 2009, adds substantial protections for mental health and substance abuse (MH/SA) coverage.  For example, it:

• Prohibits covered plans from imposing deductibles, copayments, and out-of-pocket limits on MH/SA coverage higher than those imposed for medical/surgical coverage;
• Prohibits restrictions on days of hospital coverage and duration/scope of MH/SA treatment beyond limits imposed for medical/surgical coverage; and
• Prohibits exclusion of out-of-network coverage for MH/SA treatment if such exclusions do not apply to medical/surgical coverage.

Advocates have been looking to the rules for clarification of a number of ambiguities in MPAEA.  Two clarifications in the published rules are encouraging.

• Should insurers be permitted to set deductible amounts separately for MH/SA? Some insurers require their members to meet two different deductibles — one for MH/SA, and one for other treatments. The effect is to permit members without behavioral health needs to experience, say, a $500 deductible, while people with behavioral and other health needs experience two such deductibles, for a total of $1,000. These rules forbid this double hit. The agencies acknowledged the lack of guidance in MHPAEA on this question, and the power of arguments on both sides, but explain their determination to enforce a unitary deductible:

Given that the statutory language does not preclude either interpretation, the Departments’ view is that prohibiting separately accumulating financial restrictions and quantitative treatment limitations is more consistent with the policy goals that led to the enactment of MHPAEA.

Translation: the act did not dictate a result, but unitary deductibles advance parity, and dual deductibles continue inequitable treatment.

• How will plans be prevented from continuing disparate treatment through less obvious means such as medical management decisions? Advocates have long been concerned that coverage inequities between behavioral and other health care could persist if aggressively restrictive utilization review systematically restricted MH/SA services under the guise of “medical necessity” or “medical management.” It is relatively easy to prohibit differential copayments and deductibles. It is harder — and more controversial — to attempt to monitor the relative equity of medical management techniques. The agencies have spoken pretty clearly on this issue in requiring equitable use of “nonquantitative” management strategies:

Any processes, strategies, evidentiary standards, or other factors used in applying the nonquantitative treatment limitation to mental health or substance use disorder benefits in a classification must be comparable to, and applied no more stringently than [those] used . . . with respect to medical/surgical benefits in the classification.

The tools must be comparable both facially and in application:

Thus, for example, assume a claims administrator has discretion to approve benefits for treatment based on medical necessity.  If that discretion is routinely used to approve medical/surgical benefits while denying mental health or substance use disorder benefits and recognized clinically appropriate standards of care do not permit such a difference, the processes used in applying the medical necessity standard are considered to be applied more stringently. . ..  The use of discretion in this manner violates the parity requirements for nonquantitative limitations.

Translation: the parity requirement for medical management is not one merely of form, but also of substance.  While the enforcement of this substantive even-handedness may be messy, it furthers the principle of parity in a powerful way.

The parity rule, then, takes some strides toward the enforcement of true parity in health insurance for people with behavioral health needs.   But people with such needs are desperately in need of further health reform for many reasons, a few of which are outlined below:

• Most obviously, people with serious mental illness are often unemployed or underemployed, and therefore are less likely to have employment-based health coverage. If they do not qualify for Medicaid or Medicare, they are often uninsured. Health reform extending coverage to the uninsured is therefore a pressing need for people with MH/SA needs.
• People with severe mental illness also suffer disproportionately from the effects of physical illness. As I’ve previously described, a 2006 National Association of State Mental Health Program Directors report titled Morbidity and Mortality in People with Serious Mental Illness revealed that people with serious mental illness die 25 years earlier than peers without mental illness, and suffer from a great deal of excess illness while alive. Most of the excess mortality and morbidity is due to preventable physical illness, and their poor medical condition is often traceable to poor coordination of their mental and physical care. The care coordination provisions in pending reform bills would go some distance in addressing these coordination and coverage concerns.
• The reform bills, in addition to mandating and facilitating the expansion of insurance, would channel at least much of the expansion through insurance exchanges. Although the proposals vary, exchanges could, as Tim Jost has described be a force for regularizing health plan design, and for promoting transparency in plan offerings for the benefit of all consumers, including those with MH/SA needs.

Our current health insurance system serves people with behavioral health needs rather poorly.  The MHPAEA took beneficial steps for insured people with MH/SA needs, and the interim rules in at least some sections interpret the act rather robustly.  This good news should not blind us to the fact that more comprehensive health reform is absolutely necessary to provide for the broad range of health needs of people with mental illness or substance use disorders.

Little Beds and Little Help at Jfk Hartwyck at Edison Estates

We speak here of health care and health care reform, most often in the larger, policy sense. This weekend I had occasion to witness the beast up close. My younger brother had his knee replaced earlier in the week at JFK Medical Center here in Edison, NJ. By all accounts the operation was a success; although he is only 45 years old (which I’m told is considered young for a knee replacement) he has had a history of knee problems initially ensuing from his having been struck by a car while working a number of years ago. After the surgery, his doctor asked him how he had even been walking– there was, he said, no cartilage left to speak of.

Initially his insurance company balked (perhaps pro forma?) at the prospect of my brother entering a convalescent center for physical therapy and rehab, citing his relatively young age, but relented under the demands of the doctor. He was initially to have been transferred to the rehab center on Thursday, but was inexplicably delayed until Friday late afternoon. He was sent to Jfk Hartwyck at Edison Estates, which seems to function primarily as a Nursing Home– but not a particularly highly rated one.

On Saturday at around 1:30 pm, as I set out to see him, I called to a) make sure he had in fact been transferred and was there; and, b) find out his room number. After three call transfers and three fairly frustrating conversations I was finally able to confirm that he was there; I also learned that he was on the third floor. I gave up on the room number.

To say the place is a bit run down is not to engage in hyperbole; to say that there was an absence of care is merely to mimic the US News Report on the Nursing Home and Rehab Center.

My brother is a big man– 6′ 3″ or 4″ tall, and having lost some weight, scales in at about 295lbs. Despite the fact that his chart says such, provisions were not made to accommodate him. He did not fit in the bed: his head struck against the headboard and his feet crushed against the footboard if he tried to lay straight. Presumably, with his knee having just been replaced, this matters even more than it would normally. There is a contraption that he was supposed to put his leg and knee in– it would not fit on the bed. Furthermore, the foam mattress that came with his too-short bed was so old and beat up that he sunk into the bed’s metal slats tossing and turning (though not laying straight) while trying to sleep. In doing so,  he had actually been cut.

In addition, no one had thought to give him an elevated toilet seat; his knee precluded him from reaching a standard seat.

He had made these problems known to staff earlier, and was told that they would fix them. This did not happen.

After I arrived and reiterated these needs to various levels of staff, I was told of a number of different, but conflicting remedies and the schedules for such. They did not have a bed long enough but would  remove the footboard so that his feet would hang off the bed??? until they could fasten an extender or buy or rent a bed to fit him– which could take either a few hours or a few days.  I said I could live with a few hours, but that a few days was patently unacceptable. The contraption would have to wait.

He is 6′ 3″ or 4″ tall, he is not 7′ 2.” It is decidedly not a new facility. They have 280 beds. Surely, from time to time they get patients taller than 6′ 2″? They acted as though they never had.

The shoddy mattress was soon replaced, though, inexplicably, no one entered the room to assist my brother as he struggled to get out of the bed and hoist himself precariously onto the walker as the mattresses were exchanged. Throughout the four or so hours I was there, this absence of assistance was a recurring theme. Having been trained as a lawyer, this willingness on the part of staff to court, if not embrace, liability was, quite frankly, appalling. I assure you, somewhere there’s an in-house attorney prematurely gray.

As for the elevated toliet seat? I had to ask again, but urgently, as he had to go. The nursing assistant unable to find one elsewhere, ultimately snatched one from another patient’s room and hurried to clean it as my brother, the outcome uncertain, anxiously waited.

The truth is, they ultimately moved in response to my demands formulated in accord with my legal training. Otherwise, I imagine he’d still be lying there with a too-short bed, presumably covered in his own fecal matter as he vainly attempted to make his new knee bend and descend to an unprepared toliet.

In the end, they gave up on removing the footboard as they realized while taking it apart that it would actually disable the bed controls by doing so. When the rental bed came, they had no mattress to fit it but, tired of it all, we assented to pillows shoved in at the end. When the bed was set up, after the rental bed man told the nurse that she was going to want to go over the bed– which had different controls than the former bed– with my brother–and to make sure we set up the height of the bed to accommodate him–the nurse nodded her head and promptly walked directly out of the room. We managed without her.

I won’t bore you with more, but I will say that the attending doctor had briefly visited my brother earlier in the day and, without so much as asking him his relative pain level, apparently changed his pain prescription for the afternoon, but didn’t bother to actually tell my brother that she was doing so. Tentative about leaving the direct care of his surgeon, before he left the hospital my brother actually asked his surgeon if he would continue on this particular prescription that seemed to be working–the surgeon assured him that this prescription was “the law” and would remain in place wherever he went to combat the pain. Apparently, the rehab’s attending had not heard of the law and by the evening it became apparent that something was wrong. My brother, who is tough as nails and has worked a harsh blue collar job all his life, began to cry. The nurse informed us soon thereafter that his prescription had been changed. A lengthy explanation/argument with the nurses and phone call to the doctor filling in for the attending resulted in a reinstatement of “the law.”

It is also worth mentioning that although we were told by the nurses that standard protocol for incoming sub-acute was a physical therapy evaluation within at least, the very next day– that never happened. And although I was assured that although there must have been some form of communication failure which deprived him of his evaluation, he would be evaluated very first thing the next morning. That did not happen either. My brother was told this morning that “no physical therapy staff work on Sundays.” Obviously, he has received no physical therapy yet. At best, he will be evaluated for such come Monday morning– he got there on Friday. His knee and leg have further swollen. Insurance will only pay for so many days stay. It is also my understanding that the first few days of rehab are crucial to an effective recovery.

I routinely villify insurers (as they deserve it), but I can’t help but see at least one of their points here. My question is this: exactly what will this medical facility be charging the insurer for this weekend? Therapeutic Services? Rehab? He was warehoused– and poorly at that.

I’ll keep you posted.

An Overview of the New Federal Standards Governing Health Information Technology (Part 1)

Those hoping for health reform have recently had a bad stretch of luck. I am here to report that movement in the reform process is certain in one area: health information technology (HIT). It may not be the sexiest topic in health care, but as David Blumental, the director of the Office of the National Coordinator for Health Information Technology (ONC),  noted in his piece for the New England Journal of Medicine, “[i]nformation is the lifeblood of modern medicine. Health information technology (HIT) is destined to be its circulatory system.” The ONC recently released an interim final rule (IFR) for HIT standards. CMS released a notice of proposed rule making (NPRM) that describes how Electronic Health Records (EHRs) are to be put to “meaningful use.” The context of both of these rules is the incentive-based program that the federal government has created. The goal of this program is to spur the creation of a sustainable and interoperable nationwide network of EHRs.

As opposed to describing every detail of the ONC’s interim final rule, I think it would be more valuable to broadly discuss the general standards that the government has decided upon, and then describe those standards so that the reader has a general idea of what these standards are.

Two Tables are Primary Reference for Understanding the Rule

So what did the ONC determine? The easiest way to tease out the big picture is to refer to two tables (Table 1 and Table 2A) that are buried within the IFR.

The two tables have been extracted from the pdf for ease of reference. Table 1 can be found here (pdf). Table 2A can be found here (pdf).

For the full IFR, it can be found here in pdf or here in html.

Using the tables to decode the IFR

Table 1 has three columns. The column on the left consists of the stage 1 meaningful use objectives that were issued by CMS and which serve to govern the purpose and capabilities of EHRs at a broad level. (For background on CMS’s proposed guidelines for meaningful use, see my earlier post here). The two columns on the right of Table 1 are the ONC’s certification criteria. These criteria have been created in order to support CMS’s meaningful use objectives. The middle column corresponds to the criteria for non-hospital providers–referred to as eligible professionals–such non-hospital-based physicians. The rightmost column corresponds to the criteria for hospitals (referred to as eligible hospitals). These two groups, eligible professionals and eligible hospitals, are eligible in the sense that they are eligible for reimbursement in exchange for the meaningful use of EHR technology.

Table 2 is the final piece of the puzzle, laying out the standards that the ONC has adopted. The standards are the nitty gritty details of the broader certification criteria that support the even broader meaningful use objectives.  Thus, we have a framework for our standards: start with the meaningful use objectives, establish certification criteria for these objectives, and then specify the standards that would allow for an objective determination of whether the criteria has been met.

With these tables in hand, it is possible to delve a bit deeper into the ONC’s vision of HIT.

Three Important Phrases: “Certified EHR Technology”, “Complete EHR”, and “EHR Module”

The regulations utilize the phrases “Certified EHR Technology”, “Complete EHR,” and “EHR Module” in an effort to implement flexible standards that can evolve as the standards continue to evolve. This idea of the rules evolving is a common theme, and it cannot be stressed enough that the ONC has gone through great pains in balancing the predictability of constrained EHR standards with the dynamism of the evolving standards landscape.

Terms

• Qualified EHR: an electronic record of health-related information on an individual that:
  • (A) Includes patient demographic and clinical health information, such as medical history and problem lists; and
  • (B) has the capacity:
    • (i) To provide clinical decision support;
    • (ii) to support physician order entry;
    • (iii) to capture and query information relevant to health care quality; and
    • (iv) to exchange electronic health information with, and integrate such information from, other sources.’
• Certified EHR Technology: A Complete EHR or a combination of EHR Modules, each of which:
  1. Meets the requirements included in the definition of a Qualified EHR; and
  2. has been tested and certified in accordance with the certification program established by the National Coordinator as having met all applicable certification criteria adopted by the Secretary.
• Complete EHR: EHR technology that has been developed to meet all applicable certification criteria adopted by the Secretary.
• EHR Module:  any service, component, or combination thereof that can meet the requirements of at least one certification criterion adopted by the Secretary. Examples:  Interface or other software program that provides the capability to exchange electronic health information; An open source software program that enables individuals online access to certain health information maintained by EHR technology; A clinical decision support rules engine; A software program used to submit public health information to public health authorities; and, A quality measure reporting service or software program.

In order to allow for flexibility, the ONC does not require that “Certified EHR technology” is a complete “turn key” system. Rather, the ONC allows for two different types of “Certified EHR Technology.” On the one hand you have “Complete EHRs” which are  “turn key” solutions in that a complete EHR meets the broad functional requirements of a qualified EHR and all of the  certification criteria listed in Table 1 (see link to Table 1 pdf above). On the other hand, “Certified EHR Technology” may also consist of a combination of modules, as long as the combination of modules meets the broad functional requirements of a “Qualified EHR,” and the modules together satisfy all of the certification criteria. Thus, physicians and hospitals retain flexibility in how they implement technology to achieve meaningful use.

The Adopted Standards

The ONC has grouped the standards into four groups:

1. Vocabulary Standards — The standardized nomenclatures and code sets used to describe clinical problems and procedures, medications and allergies.
2. Content Exchange Standards –  The standards used to share clinical information such as clinical summaries, prescriptions, and structured electronic documents.
3. Transport Standards — The standards used to establish a common, predictable, secure communication protocol between systems.
4. Privacy and Security Standards — Standards relating to authentication, access control, transmission security which relate to and span across all of the other types of standards.

Content Exchange Standards

Table 2A describes the first 2 categories. It is actually most helpful to initially discuss the second category: the content exchange standards. The content exchange standard can be thought of as the rules that constrain the shape and form of the data. In other words, it concerns how the data is structured. A standardization  of the structure is necessary so that different computer systems can predictably send and receive data that is organized in a predictable format. A rough analogy can be made to the Bluebook citation standards which specify the organization of legal citations. Regardless of the court reporter being used, all bluebook citations to federal court cases have the same basic organization (e.g. case name in italics, followed by the reporter, starting page, etc). Whereas a law school journal may only accept the Bluebook standard, the ONC has decided to allow for two standards:  Health Level Seven (HL7) Clinical Document Architecture (CDA) Release 2 (R2) Level 2 CCD or ASTM CCR.  Again, the ONC has sought flexibility in the initial stage of the certification process by allowing for multiple standards to be used. As noted in Table 2A, the ONC will eventually decide on one of these standards. It should be noted that if HL7 is picked, the ASTM standard can be “mapped” onto HL7 so that systems using ASTM can become interoperable with HL7-based systems.

The first standard is referred to as HL7 CDA R2 CCD. Though the name is intimidating, it is not very difficult to explain. HL7 is an international health care standards organization. The Clinical Data Architecture part of the name serves to identify that we are dealing with HL7’s standards regarding the organization of clinical documents that are sent and received electronically. It is necessary to specify CDA because HL7 has released other standards. The R2 refers to the fact that it is a second version of the standard. The CCD stands for Continuity of Care Document, and identifies that the standard deals with a constrained amount of health information–specifically, the information necessary to create a summary of a patient’s medical history.

Vocabulary Standards

To go back to the Bluebook analogy, the Bluebook must do more than specify the organization of the information in a citation. Additionally, it must specify the actual content that can be represented. For example,  the vocabulary of the reporter of a federal appeals case consists of F. or F.2d or F. 3d. Likewise, the vocabulary of EHRs must be standardized. The standards adopted for the vocabulary are listed in Table 2A.  There are a variety of different standards that have been adopted, including ICD-9, SNOMED, and LOINC. Some of these standards are in competition, and as Table 2A shows, the ONC’s position on competing standards will change in Stage 2 of Meaningful Use. For example, the vocabulary for medications will become more restrictive in Stage 2. However, some standards are not in competition, but are independent and describe wholly different aspects of medicine. For example, RxNorm describes medications but says nothing about laboratory test results, which is the domain of the LOINC vocabulary.

Hopefully the above discussion of the ONC’s adopted standards offers a foundation that allows for closer inspection of the IFR. The second part in this series will detail the two additional categories of standards, as well as other salient details of the IFR.

For additional information on the ONC’s rules, the following resources may be of interest:

The ONC’s most recent meeting, including mp3s of the meeting, can be found here.

General information about the ONC’s efforts with respect to the new standards can be found here.

Information about Clinical Data Architecture can be found here.

A solid overview of the new standards can be found here.

Financial Remuneration of Clinical Study Investigators

In November 2009, the Center for Health & Pharmaceutical Law & Policy, in its White Paper, Conflicts of Interest in Clinical Trial Recruitment & Enrollment: A Call for Increased Oversight, explored payments to investigators — and other potential motivators — to conduct research.  A study in this month’s IRB: Ethics & Human Research explores the impact payments may have on researchers to conduct and complete studies.  In Motivated by Money? The Impact of Financial Incentive for the Research Team on Study Recruitment, Sharon Unger and her colleagues examine the effect financial remuneration has on researchers in a neonatal intensive care unit (NICU).

Taking advantage of a “fortuitous set of circumstances” in which two separate clinical trials with nearly identical inclusion criteria were conducted simultaneously in an NICU in Canada, the authors looked at two issues: 1) whether financial remuneration impacted the rate at which the research team approached parents about research participation, and 2) whether financial remuneration impacted the rate at which parents provided consent to participate.

In the first study (Study A), a placebo-controlled trial involving a medication that was the standard of care for treatment of newborns nearing extubation to prevent apnea of prematurity, members of the research team were financially compensated for their time if they were successful in obtaining parental consent (parents were unaware of this arrangement).  In the second study (Study B), which involved two different forms of noninvasive respiratory support following extubation, there was no financial compensation of the research team.  Both studies had the same recruiting team.  Study A was federally funded, multicentered and high-profile, while Study B was a single-center, unfunded trial.

The payments in Study A were per capita, which, while creating a direct incentive to recruit individual enrollees, is usually not problematic as long as the payment is not excessive.  The Center recommends “that the benchmark for compensation for physician services for research should be comparable payment for time and services for treatment. This will compensate physicians fairly for their time and services, and will assure that there are no hidden bonuses or incentives for physicians to recruit patients into research or to refer them to research rather than treatment.”  As noted in the study, finder’s fees are increasingly considered “ethically problematic;” the Center recommends a wholesale bar on finder’s fees because they can create conflicts of interest that can incentivize investigators to recruit and retain individuals who do not meet the study’s inclusion and exclusion criteria.

As the authors noted, and as acknowledged in the Center’s White Paper, potential enrollees are increasingly vulnerable as increasing numbers of individuals seek to participate in research either as a primary means of access to treatment or as a form of income.  The results of this study indicate a much higher likelihood of approach when there was a prospect of financial remuneration.  These results are concerning, and were anticipated by the Center’s White Paper, which noted the potential for poor compliance with inclusion and exclusion criteria and pressure to enter or remain in a clinical trial.

However, surprisingly, the authors found that, despite the much higher likelihood of approach for Study A than Study B, parents were much more likely to actually agree to enroll their newborn in Study B — for which there was no financial remuneration of the research team.  The authors explored various explanations for this result, including that the research team was overly cautious about giving the appearance that their approach for consent was motivated by financial compensation, or that parents chose to withhold consent  due to the research team’s  increased pressure.

The authors do acknowledge other potential factors — beyond financial remuneration –  that could have affected the study’s results.  For example, parents’ hesitancy to enroll their newborn in a placebo-controlled drug trial could explain the discrepancy between enrollment in the studies.  Likewise, the authors consider that parents may not have been able to differentiate between the two modes of support being investigated in Study B.  In addition, the recruiting team, when presented with the results of the study, did not recall feeling influenced by the financial arrangement of Study A, but did “recall being highly motivated to ensure the success of Study A as it was part of a high-profile, multicentered trial.”

The authors concluded by noting concerns that “there may be a point at which the amount of the financial remuneration or the manner in which it is assigned could negatively impact the ethical conduct of the researcher,” but cautions that these concerns should be balanced with the value of conducting research in patients’ best interests.  This balancing act is considerably important.  As the Center notes,

Research is critical to the advancement of medical treatment and health. It must be structured to produce high quality data that facilitates the assessment of safety and efficacy in the population for whom the treatment will be used. The good of the enterprise requires that the clinical trial system sufficiently balance the costs and benefits to physicians and prospec­tive trial participants to ensure the continued sufficient supply of researchers and subjects. The system must also be imbued with actual and perceived integrity — so that it produces scientifi­cally reliable results, participants are safe, and people trust the system sufficiently to be willing to participate.

Excise & Health Reform, Part I, or: “What is an Excise & How Would this Tax on Cadillac Plans Work?”

[Ed. Note: We are very pleased to introduce James Christiano to the blog. He is a law student here at Seton Hall Law and, after receiving his B.A. in psychology in 2002, worked from 2003 to 2008 as a District Adjudications Officer for the United States Citizenship and Immigration Services (USCIS), an agency within the Department of Homeland Security.  During his time with USCIS, James was primarily responsible for adjudicating applications for immigration benefits, including naturalization, lawful permanent resident status, and work authorization. As you might imagine, James has an eye for regulatory analysis, and will be offering a series of posts (to start) on provisions in the health reform bill regarding  "excise" along with analysis as to their potential impact.]

One of the many controversial aspects of healthcare reform is the Senate’s proposed excise on high-cost health insurance plans.  Such high-cost plans have often been referred to, arguably inappropriately, as “Cadillac plans.”  This post provides an introduction to the proposed excise on high-cost plans as provided in the Senate Bill.  Subsequent posts will address the ramifications and controversies of the excise.  (Note: The Senate Bill contains other excise provisions, including a 5% excise on elective cosmetic surgery procedures, which this post does not discuss.)

What is an excise?

Black’s Law Dictionary defines excise as “[a] tax imposed on the manufacture, sale, or use of goods (such as a cigarette tax), or on an occupation or activity (such as a license tax or an attorney occupation fee).”  Excises are commonly, and redundantly, referred to as “excise taxes.”

A quick skim of Subtitles D and E of Title 26 of the United State Code provides one an idea of the types of goods and activities that Congress has deemed deserving of an excise.  A few examples are luxury passenger automobiles, certain vaccines, communications services, authorized and unauthorized wagers (i.e., gambling), petroleum, firearms, cigarettes, and “excess expenditures to influence legislation.”

Excise currently imposed on group health plans

Federal law already subjects group health plans to an excise under certain circumstances.  For instance, 26 USC § 5000 imposes an excise on certain group and large group health plans deemed “nonconforming” — i.e., those that do not comply with the requirements of particular subsections of 42 USC § 1395y(b)(1) and (2).  Additionally, 26 USC § 4980B and D impose an excise (as a form of penalty) on group health plans that fail to meet HIPAA and COBRA requirements.

Excise on high-cost plans in the Senate Bill

The Senate Bill includes a provision imposing a 40% excise tax on high-cost, employer-sponsored health insurance plans.  High-cost plans would include those costing $8,500 for individuals and $23,000 for those other than self-only, beginning in the year 2013.  Starting in 2014, the threshold for high-cost plans would be increased annually by the change in the Consumer Price Index (CPI) plus 1%.  These thresholds are further increased for individuals employed (or previously employed) in certain high-risk professions or the repair or installation of electrical or communications lines.  Also, residents of states that rank in the top 17 among the highest-costing average employer-sponsored health insurance plans would be subject to more lenient thresholds for the years 2013, 2014, and 2015 (120%, 110%, and 105% of the threshold, respectively).

For each given high-cost plan, the coverage provider would be responsible for paying a 40% tax on the amount equal to the cost of the coverage exceeding the threshold.  For example, a coverage provider would be subject to an excise of $400 for a plan costing $24,000 in 2013 ($24,000 - $23,000 = $1,000; $1,000 x 40% = $400).  A coverage provider may be the insurance issuer, the benefits plan administrator, or the employer, depending on the coverage arrangement.

Medical Experts Say Haitians Will Need Health Care Help for Years to Come

The BBC recently reported that medical organizations with members serving the Haitian communities affected by the earthquake on January 12^th warn that one of the larger issues for Haitians will likely be the need for increased medical supplies, such as prosthetic devices and rehabilitation services.

Concerned about infection, doctors in Haiti have had to amputate the limbs of a great many injured patients.  In addition to the need for such resources as medical devices and prosthetic equipment, doctors are also still in need of simple medications.  Antibiotics are needed to prevent the spread of infections and painkillers to help damaged patients simply make it through the day.

Because many of the country’s hospitals were also destroyed by the earthquake, doctors in Haiti are performing most care in makeshift open areas.  And in such environments, infection spreads fast.  Though the few hospitals that are running are reported to be in relatively well-organized condition, many of the patients in those hospitals are not leaving as they have nowhere else to go, except perhaps the streets– where infections await their open wounds. So they stay,  Doctors are left with fewer and fewer areas to treat, and the number of patients increases. To remedy the situation, there are plans at present to quickly build a convalescent center.

The present medical needs are only the beginning.  The concerns of some medical experts extend to the years after the media eye has turned away from Haiti, after the NGOs have left the country, and after foreign doctors have returned to their home-countries.  These experts worry about how the Haitians that are being treated today will be able to continue with one less leg or one less arm in the future.  Without proper rehabilitation services or necessary follow-up medical care, many Haitians will lack the physical capabilities to rebuild their lives.  Mark Hyman, a doctor and volunteer with Partners In Health, calls these future medical needs of the injured Haitian community the “third wave,” and he finds that such aid is not yet realized:

Soon, very soon, there is the need for rehabilitation, helping the thousands with lost or broken limbs get back on their feet or foot again. There are no physical therapists, no facilities, and no place for them to go for care. As the immediate surgical needs are slowly addressed, the psychological needs explode magnified by each minor aftershock.

Some medical device companies have already donated supplies to aid the doctors’ efforts as well as money to support the other necessary aid efforts in Haiti.  While such donations are helping address an urgent need, they are being outpaced by the number of amputations being performed.  Hope lies in the idea that health care systems will be put in place before the external help exits; that prosthetic devices will ultimately be made available to the patients that need them; and that Haitian medical workers are trained to be able to properly care for those who cannot care for themselves.

The needs of the Haitian people are great, and the impact of this disaster will be felt for years to come.  Please give to help those who are working hard towards rebuilding Haiti.  Click here to find a list of the different organizations through which you can donate. And if you happen to be a part of a prosthetic device company which wants to do something amazing, we’d love to write the story.

Reform Rodeo

1a. Massachusetts: A blog post by Harold Pollock can be found here, discussing why 47 health policy experts have sent a letter urging the House to pass the Senate’s bill in the wake of Scott Brown’s upset victory.

1b. Interesting Poll of Brown Voters: As MoveOn.org’s poll reveals: “Nearly half (49%) of Obama voters who voted for Brown support the Senate health care bill or think it does not go far enough.”

2. Health Care Economics: David Herszenhorn at the New York Times discusses William J. Baumol’s theory of cost disease, and why it should give us pause in expecting too much from health care reform.

3. Health IT: Adrian Gropper M.D. describes the advantages of the OAuth system of linking electronic health record systems.

4. The Science Behind Reform: The NEJM has a short editorial describing the findings of a recent study that underscore the importance of lowering salt consumption; findings that associate reduced salt intake with public health benefits on the level of smoking cessation and weight reduction.

5. Individual Mandate Constitutionality Redux: At the O’Neill Institute, Mark Hall responds to the Constitutional argument that the individual mandate is unconstitutional because it regulates inactivity as opposed to activity.

6. Visualizing Health Care: Comments on  a National Geographic piece apparently spurred National Geographic to discuss why they chose the plot on the top instead of the plot on the bottom.

Click the images below to enlarge:

Cost, Choice, and Value

The Massachusetts Massacre has everyone stepping back a bit.  The President says that we should “coalesce around those elements of the package that people agree on,” but it is unclear just which elements those might be, given the extreme polarization that has defined the debate.  He suggests that points of agreement might center on insurance reform and cost containment, which are both important goals.  I’m skeptical that a sudden flowering of bipartisanship will allow such agreement, however.  Ezra Klein, on the other hand, has a paring proposal that goes in another direction, and reminds us of why we got into this in the first place: to extend coverage to the uninsured.  If we must narrow our focus, Klein says we should extend Medicare to those over 50, and expand Medicaid to those under 200% of poverty.  This would get lots of people insured, and could well be accomplished through budget reconciliation if no Congressional coalescing is to be had.

However the parsing, paring, and palavering goes, cost control is and will be at or near the health reform debate for years to come.  Two recent articles are worth a look for those interested in analysis of cost-containment strategies.

In his health care speech to Congress, the President suggested that one component of an effort to lower health care costs should be to empower a commission of “doctors and medical experts” to identify and,

encourage the adoption of  . . . common-sense best practices by doctors and medical professionals throughout the system. Wrapped up in that suggestion are notions of adhering to expert guidance in treatment decisions.

The stimulus bill passed in February pushed for scientific assessment of modes of care, providing $1.1 billion for comparative effectiveness research.  The current reform bills further emphasize CER, and would encourage the adoption of proven and promising treatments through professional education and some payment reform.  Harvard Medical School professor Jerome Groopman writes on evidence-based medicine in the latest New York Review of Books.   In his 2007 book, How Doctors Think, Groopman did a great job of explaining the complex and fraught process by which doctors make decisions, and he is fully on board with the notion that there is ample room for improvement.  His new article, however, cautions that the use of panels of experts with authority to impose or even recommend best practices is a dangerous way to go.

Groopman acknowledges the need for health policy folks to consider the bounded rationality of both doctor and patient.  He examines the Obama Administration’s policies on evidence-based practice by contrasting the views of two key advisors: Cass Sunstein, whose view of “libertarian paternalism” incline him to favor gentle “nudges” that may encourage certain behavior while leaving people free to reject the advice if they wish, and Peter Orszag, who is more inclined to employ forceful regulatory standards and financial incentives to achieve cost effective medical practice.  Groopman is compellingly  skeptical of expert claims of definitive standards on what “works” in health care, and cautions that such standards can result in harm to patients who fit uncomfortably into the hard categories defined in such best practices.

Groopman’s analysis seems incomplete for two closely intertwined reasons, and surely as a result of space constraints.  First, he suggests that the administration is faced with a stark choice between

aggressively pushing doctors and patients to do what the government defines as best, or [being] respectful of their own autonomy in making decisions.

Surely there is much middle ground between tying doctors’ hands and respecting complete clinical independence.  And it is not enough to say, as does Groopman, that

Most physicians seek data and views on treatments from peers and, as needed, specialists, and then present information and opinion to patients who ultimately decide.

Maybe so, but physicians are sometimes self-interested, and patients’ choices  are sometimes influenced by advertisements or other considerations disconnected from quality concerns.  For these and other reasons, spending decisions are no longer consigned to the doctor/patient dyad, but increasingly must accommodate the cost-containment interests of third party payers — government, employers, or insurers.

Second, Groopman describes two exclusive categories of procedures: “mechanical procedures” such as the  insertion an intravenous catheter (where he argues that enforcing standards to avoid infections is proper) and all other procedures, where the individual patient’s condition becomes relevant, and where he argues that coercing clinical choices is out of bounds.  It is not obvious that the universe of procedures is so divisible; it is even less clear that the dividing line between the two categories is uncontroversial.

Many questions remain.  Groopman is surely right that we must be cautious in enforcing categorical “best practices;” it is important to create public processes for vetting their accuracy and usefulness.  He is also surely right that public and private health finance rules must accommodate variation in medical needs, and must bend readily when a “best practice” is not suitable for a particular case.  But cost is relevant, and encouraging efficient practice can reduce the cost (and therefore the extent) of coverage.

So, how might a balance between financial constraints and patient protection work?  In a Health Affairs article posted  yesterday, Michael Chernew and coauthors examine the growing phenomenon of “value-based insurance” — a structuring of insurance co-payments responsive to the needs of people with chronic illness.  The co-payments imposed by insurers are, of course, intended to reduce demand for health care services (an Orszag, not a Sunstein tool, you might say).  Value based insurance reduces or eliminates these co-payments for services of “high clinical value.”  That is, if an insurer determines that it would rather not discourage utilization for a particular service, it reduces or removes the patient cost-sharing, presumably increasing usage, for cost as well as clinical reasons.  As the authors explain,

The belief that a value-based insurance program will lower health care spending rests on the recognition that the use of high-value health care services reduces the probability of adverse events related to chronic disease and that on a population basis, these events are much more costly than the services aimed at preventing them.

The authors found some evidence that such programs are cost effective, even in the narrow sense of reducing a plan’s health care expenditures.  They suggest that widening the economic lens to consider broader societal goals would only strengthen those conclusions.

The article acknowledges the reality of economic coercion in the clinical setting, and measures attempts to shape the tools of cost containment in a way that protects patients while maintaining cost containment.  One doesn’t have to accept the general wisdom of patient cost-sharing to value attempts to protect patients from untoward effects of its use.

The need to obtain “value” for health care spending and to take steps to restrain health inflation will persist however we come out of the current reform debate.  The discussion will benefit from both the erudite analysis of Groopman and others warning us away from answers that are too easy, and that of Chernew and others who can shine a light on the efficacy of particular cost containing measures.

Medical Marijuana Act Signed Into Law: Some Chronically Ill New Jerseyans Rejoice While Others Continue to Wait

As expected, on January 18, 2010, Governor Jon Corzine signed the New Jersey Compassionate Use Medical Marijuana Act into law, making New Jersey the 14^th state to legalize marijuana for medical use.  Seton Hall Law’s Center for Health & Pharmaceutical Law & Policy endorsed the Act in a position paper distributed to key lawmakers in June 2009.

The Act’s backers celebrated its passage with “hugs and tears,” while its opponents expressed continued concerns, including that the for-profit “alternative treatment centers” that the Act will allow to grow and distribute marijuana will have negative effects on the neighborhoods where they are established.  An interesting abcnews.com article by Susan Donaldson James highlights a third constituency: New Jerseyans with chronic illnesses that are responsive to treatment with marijuana but who are not considered to have debilitating medical conditions under the Act.

The article profiles Jack O’Brien of Laurel Lake, New Jersey who was born without fingers and toes and suffers from “crushing neuropathic pain.”  He wakes up to shooting pain in his arms and legs and can only walk short distances on his deformed feet.  According to O’Brien, smoking marijuana is “like having a valve on the forearm, turning it and having the coolness of relief through my extremities. … I try to walk on these feet and I can go four or five blocks, with my wife. With marijuana, I can go forever.”  State Assemblyman Reed Gusciora, who was a prime sponsor of the Act, explained that while he had empathy for O’Brien and others in his position, the legislature “had to do a measured approach,” citing fears that New Jersey could become another California, where medical marijuana “seemed to be spiraling out of control.”   Assemblyman Gusciora promised that in two years the legislature would “revisit the issue and add ailments.”

Addendum:

While Jack O’Brien’s case provides only anecdotal evidence of marijuana’s efficacy against neuropathic pain, as the Center noted in its position paper, “in the past two years, three placebo-controlled, randomized, double-blind clinical trials published in the medical literature have demonstrated that smoked marijuana is effective against neuropathic pain, including for patients who have tried the available conventional treatments and are still in pain.”   The existence of this evidence is remarkable because, as recent articles in the New York Times and Wall Street Journal explain, researchers must surmount formidable hurdles to study marijuana’s potential medical uses.

For those who are curious, under the compromise version of the Act which was signed into law January 18^th, “debilitating medical condition” is defined to include the following:

• Seizure disorder, including epilepsy, if resistant to conventional medical therapy;
• Intractable skeletal muscular spasticity, if resistant to conventional medical therapy;
• Glaucoma, if resistant to conventional medical therapy;
• HIV or the treatment of HIV, if it causes severe or chronic pain, severe nausea or vomiting, cachexia, or wasting syndrome;
• AIDS or the treatment of AIDS, if it causes severe or chronic pain, severe nausea or vomiting, cachexia, or wasting syndrome;
• Cancer or the treatment of cancer, if it causes severe or chronic pain, severe nausea or vomiting, cachexia, or wasting syndrome;
• Amyotrophic lateral sclerosis;
• Multiple sclerosis;
• Terminal cancer;
• Muscular dystrophy;
• Inflammatory bowel disease, including Crohn’s disease; and
• Terminal illness, if the physician has determined a prognosis of less than 12 months of life.

Brown Wins Kennedy’s Senate Seat, Health Reform Plot Thickens

This just in from the Washington Post:

Massachusetts state Sen. Scott Brown was elected to the U.S. Senate on Tuesday, winning a special election over two opponents, the Associated Press projected. Brown — the first Republican senator from the Bay State in 31 years — willgive the GOP 41 seats in the Senate, enhancing the party’s ability to demand changes in legislation.

“Enhancing the party’s ability to demand changes in legislation.” That is certainly one way of saying it. As we live under the yoke of the Senate’s filibuster rule, and the stated aim of soon-to-be (or maybe not so soon) U.S. Senator Brown is to put a halt to the health reform legislation currently poised for informal reconciliation between the two houses of Congress, it is dizzying to think that the life’s work of Senator Ted Kennedy may well be torn asunder by the man who’ll take his seat. It is a biting irony of classical greek proportions.

And I find myself wondering, honestly, “What would Ted Kennedy do?” A consummate politician and a superb tactician, I doubt, considering the stakes, he would be adverse to the Massachusetts Secretary of State’s position:

Secretary of State William F. Galvin, citing state law, says city and town clerks must wait at least 10 days for absentee ballots to arrive before they certify the results of the Jan. 19 election. They then have five more days to file the returns with his office.

Galvin bypassed the provision in 2007 so his fellow Democrats could gain a House vote they needed to override a veto of then-Republican President George W. Bush, but the secretary says U.S. Senate rules would preclude a similar rush today.

Ah! The Senate Rules. As that yoke of the modern filibuster draws nearer round the throat of health care reform, and the phrase “in the nick of time” begins to hang in the air like a concrete goal, these words to the opponents of health care reform seem apt:  Live by the sword….

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