ACOs: OIG Guidance, CMS regulations, and Interpretive Tasks

Tim Greaney has already posted on the FTC/DOJ Joint Policy Statement on antitrust scrutiny of ACO applicants, and Jordan Cohen posted on the  CMS’s draft regulations on the Medicare Shared Savings Program (”MSSP”) for ACOs.   In this post, I’ll describe some interesting structural issues presented by the OIG’s notice on proposed waivers, which cross-references the CMS MSSP draft regulations. The fundamental issue for the OIG is how “virtual organizations” — those not fully integrated in a corporate or financial sense — can serve the integrative goals of the Affordable Care Act while staying on the right side of the web of federal laws prohibiting physician self-referral, kickbacks, and payments to reduce care to Medicare beneficiaries.  The OIG notice proposes to square this circle in two steps.

The OIG two-step; Step One

The Fraud & Abuse problem with ACOs is that they are intended to achieve the efficiency and quality gains of formally integrated delivery systems (Geisinger, Mayo Clinic)  through contract-based aggregation of providers.  This less formal integration, of course, implicates the dealings generally prohibited by the Physician Self-Referral Law (”Stark”), Anti Kickback Statute (”AKS”), and the Prohibition on Hospital Payments to Physicians to Induce Reduction in Services law (which provides for civil money penalties for violations) (”CMP”).  The OIG notice proceeds very incrementally.  In large part, the OIG proposes to affirm that a CMS determination that an ACO qualifies for participation in the MSSP signifies the adoption of quality and fiscal protections sufficient to allow a waiver of Stark, AKS, and CMP enforcement for purposes of the distribution of shared savings.  In addition, and to the extent “necessary for and directly related to” the ACOS’s participation in the shared savings plan, the OIG proposes to waive enforcement under the AKS and CMP provisions with respect to conduct that falls within a Stark exception.  In outline form, then, the OIG proposes as its initial waiver guidance:

• Stark. The OIG proposes to waive enforcement of Stark for
  • The actual distribution of MSSP to and among ACO participants, and ACO providers/suppliers for conduct during a year in which shared savings were earned; and
  • “activities necessary for and directly related to the ACO’s participation in and operations under the” MSSP.

• AKS. The OIG proposes to waive enforcement of AKS under two scenarios:
  • The distribution of shared savings under the MSSP
    • to and among ACO participants, and ACO providers/suppliers for conduct during a year in which shared savings were earned; and
    • for any financial relationships between ACO participants and ACO providers/suppliers necessary for and directly related to the ACO’s MSSP participation that implicate Stark, but fall within a Stark exception.

• CMP. The OIG proposes to waive enforcement of the CMP provisions under two scenarios:
  • Distribution of shared savings from a hospital to a physician so long as
    • “the payments are not made knowingly to induce the physician to reduce or limit medically necessary items or services”; and
    • the hospital and physicians were ACO participants or providers/suppliers during the year in which the shared savings were earned.
  • In the context of financial relationships among ACO participants and/or providers/suppliers necessary for and directly related to the ACO’s MSSP operations, that implicate Stark but that fall within a Stark exception.

The OIG two-step; Step Two

In Step One, the OIG proposes waivers for arrangements that are central to the MSSP gain distributions, or that are central to the ACO enterprise and are structurally within Stark exceptions.  The OIG goes on to solicit input on the need for additional waiver guidance, for conduct that is “beneficial” to ACO participation in the MSSP, but that also protects “patients and programs from harms caused by fraud and abuse.”  The OIG solicits input on:

• Arrangements related to establishing the ACO;
• Arrangements between or among ACO participants or providers/suppliers related to ongoing operations of the ACO and achieving ACO goals;
• Arrangements between the ACO, its ACO participants and/or providers/suppliers and outside individuals or entities;
• Distributions of shared savings or similar payments from private payers;
• Other financial arrangements for which a waiver would be necessary;
• Miscellaneous: duration of waivers, scope of the waivers listed above in “Step One,” and additional safeguards; and
• Arrangements in which providers are subjected to risk, particularly in the “two-sided risk model” in the CMS draft regulations on the MSSP.

“Necessary for and directly related to”

It is pretty clear that the lion’s share of the OIG’s waiver work will be done by determining whether or not an ACO has been qualified by CMS for the MSSP.  There will be waivers, however, even under Step One, that will require the OIG to evaluate the proposed arrangements.  Stark enforcement regarding the actual distribution of shared gains, for example, will be waived under the proposal for CMS-qualified ACOs.  But Step One proposes additional waivers “for activities necessary for and directly related to the ACO’s participation in and operations under the” MSSP.  Similarly, AKS and CMP waivers are proposed for dealings between ACO participants that are within Stark exceptions so long as they are “necessary for and directly related to the ACO’s MSSP participation.”  A standard based on what is “necessary for and directly related to” an ACO’s MSSP participation will, then, do a lot of the waiver work.  It is not a self-defining standard, and further elaboration from the OIG (by providing examples, perhaps) will lend clarity to the OIG’s waiver guidance.

Attribution, assignment, and patient notice

ACO commentators (here (subscription required) and here)  have observed that the method by which patients are “attributed” to ACOs is central to ACOs’ financial and structural planning.  Attribution was the term used in the literature to refer to the formal determination that a particular Medicare patient should “count” for assessing the gain (and possibly the loss) experienced by the ACO.  The CMS draft regulations on the MSSP, consistent with the terms of the Affordable Care Act, use the term “assignment” rather than attribution.  The CMS proposal’s treatment of assignment, or attribution, will engender much discussion here and elsewhere in the coming weeks.

One important issue, however, seems to have been resolved.  In the literature on ACOs, it has not been clear whether Medicare beneficiaries would know whether or not they had been assigned or attributed to an ACO; consistent with continuing commitment to beneficiaries’ right to choose providers within the Medicare fee for service system, the discussion contemplated the possibility that ACOs would organize a beneficiary’s care, gain payments as a result of efficiencies, but never inform the beneficiary of his “attribution” to an ACO.

Donald Berwick highlighted the requirement of patient notice in his Perspective published in the New England Journal of Medicine on the day of the regulations’ release.  The CMS draft regulations on the MSSP explain the requirement of patient notice in the following terms:

[W]hile the statute refers to the assignment of beneficiaries to an ACO, we would characterize the process more as an “alignment” of beneficiaries with an ACO as the exercise of free choice by beneficiaries in the physicians and other health care providers and suppliers from whom they receive their services. . . .  Therefore, an important component of the Shared Savings Program will be timely and effective communication with beneficiaries concerning the Shared Savings Program, their possible assignment to an ACO, and their retention of freedom of choice under the Medicare FFS program.

That piece of consumer protection regulation was absolutely essential.  It would be odd indeed, after decades of struggle with patient protection in managed care systems, were patients to be engaged without their knowledge in a system built on economic incentives to providers directed to care management.  We’ll post more about assignment and other ACO issues in the coming weeks.

Navigating Vaccine Policy in New Jersey

[Ed Note: This article was originally published in print and online by The Record, New Jersey's most awarded newspaper.]

NEW JERSEY’S immunization law attempts to strike a balance between protecting public health and the accommodation of religious observance. Children must be vaccinated as a condition of school attendance, but the requirement is waived if the vaccination “interferes with the free exercise of the pupil’s religious rights.”

Last summer, the Department of Health and Senior Services amended its regulations to simplify the process for obtaining this exemption. Several legislators, pointing to New Jersey’s drop in childhood immunization rates, have filed a resolution to force the withdrawal or amendment of this relaxed standard.

Emotions on this topic run high. New Jersey can, however, craft a policy that protects the public health while accommodating those who feel most passionately about avoiding childhood vaccinations.

Under such a policy, permissible exemptions could fall into three categories: medical exemptions for children with conditions, such as immune disorders, that render vaccinations inappropriate (the department estimates that about 0.2 percent of children fit this category last year); exemptions for those with genuine religious reasons to refuse vaccinations (the department estimates that about 0.8 percent of children fit this category last year), and exemptions for those who categorically oppose vaccines on non-religious principles. The first two categories combined amount to only 1 percent of children.

Fueling fears

It is, then, growth in the size of the final category that fuels fears that childhood immunizations could drop to levels threatening population health. The adoption of two practical steps can allay those fears.

First, some factual background. New Jersey’s immunization rates have been dropping. The department’s figures show that the rate of children under 3 with complete age-appropriate vaccinations has dropped from about 80.5 percent in 2007 to about 67.2 percent in 2009. The drop is significant, and may pose a threat to our “herd immunity” - the level of population vaccination necessary to block outbreaks of infectious diseases.

Public health officials recommend vaccine levels at least in the mid-80 percent to low-90 percent level to protect “herd immunity.” This is important stuff: children who are not immunized because they’re too young or medically compromised are at risk if overall rates drop to unsafe level.

Routine vaccinations are safe

Almost all medical and public health experts believe that routine vaccinations are safe and appropriate for almost all children. Even so, we can reach safe levels of childhood immunizations while respecting the strongly felt contrary views of vaccine deniers. Two steps are necessary.

1) Primary care focus. The American Academy of Family Physicians has encouraged primary care providers to remind parents of immunization schedules, provide accurate vaccine education and open their scheduling to encourage primary care visits.

Here in New Jersey, Summit Medical Group has reported that such programs raised its patients’ childhood immunization rates from 84 percent to 97 percent from 2008 to 2010. If primary care providers focus on the reminders, education and open scheduling that achieve such dramatic level of improvement, we’re mostly there.

Restricting exemptions

2) Tightened process for non-medical exemptions. This step is more controversial. Let’s be candid and admit that religious exemptions are sometimes employed by those with strong non-religious objections to vaccinations.

Further, let’s admit that it is uncomfortable for the state to pass judgment on the sincerity of claims of sincere religious belief. A 2001 study published in the American Journal of Public Health provides a way out of this conflict.

It found that non-medical vaccine exemptions can be minimized when states take minor steps as requiring parents to file annually, and at that time to receive accurate information on risks and benefits of immunizations. Such processes can tip the balance toward immunization for two groups of parents.

First, parents without strong objections but for whom doctors’ appointments for vaccinations were inconvenient may find that it is now easier on balance to comply with the law. Second, those confused by the controversy may have their fears addressed by public health information provided.

The article found that these simple steps can increase the level of immunization, while respecting the views of those parents with implacable objections to vaccinations. Objecting parents can simply accept the information, and file the annual reports.

These two steps could raise immunizations to safe levels without the need to force the hands of parents with strong religious or other principled objections. If, as the studies suggest, vehement objectors are relatively few, population health and personal beliefs can be accommodated.

Jonathan Blum, CMS Deputy Adminstrator, Speaks on ACOs

We’re waiting for the Department of Health and Human Services to release proposed regulations on Accountable Care Organizations.  This site has previously discussed the potential good and bad of ACOS (see here, here, and here).   I attended a conference last week at which an innovative model of “Medicaid ACO” was discussed.  The Medicaid ACO would be authorized in New Jersey under a bill pending before the NJ Legislature.  It is an exciting idea that will attempt to reach the poor and vulnerable who often lose out in health reform programs.  The godfather of the Medicaid ACO project is Jeff Brenner, about whom Atu Gawande recently wrote in the New Yorker.   (subscription required)    I’ll be blogging about the New Jersey bill in a future post.  The conference was funded by the Nicholson Foundation and presented  by the Health Care Quality Institute.

Speaking at the conference was Jonathan Blum, Deputy Administrator and Director of the Center for Medicare at CMS.  In discussing “Accountable Care Organizations and the Affordable Care Act,” Blum was in the difficult position of speaking about a topic of great interest, while not being able to discuss the contents of draft regulations that are no doubt nearing completion. Nevertheless, he made some interesting points that I’ll pass along.

Blum’s talk focused on policy positions that are driving HHS as it drafts the regulations.  The overriding policy positions he described included:

• The ACO regulations will not be “one size fits all.” He emphasized that CMS will be looking for innovative models, with different payment systems, and with different “on ramps” to formation and approval. He emphasized that CMS is interested in models that serve “safety net populations,” as CMS wants to ensure that the poor and underserved get the same opportunities as “suburban” folks. The primacy (at least in order of presentation) was welcomed by the NJ folks, whose model is directed to Medicaid recipients.
• The orientation, consistent with much of the ACO literature, is “patient first.” He distinguished this orientation from one that would see ACOs as a means for powerful interests to gain market share. That tension is, of course, evident in the ACA’s ACO provisions, as has been pointed out most eloquently by Tim Greaney. Blum described CMS as being focused on care systems’ sensitivity to patient and family concerns, and with payment programs oriented to health care “journeys” and not episodes.
• Clinical quality is key. CMS will focus on outcomes measurements “much more” than in the past. It will be interested in particular in quality measurements and patient experience.
• He spent a fair amount of time emphasizing that CMS does not regard the ACO program as static. CMS will constantly review payment and quality issues, with an eye toward updating oversight and program requirements. It will use payment incentives to drive quality improvements. He indicated that there is some tension between CMS’s interest in having quality be data-driven in ACOs with its insistence on protecting patient confidentiality and privacy issues. CMS is interested in encouraging patient advocacy efforts to support continued emphasis on patient privacy and confidentiality.
• In response to a question, Blum recognized the substantial tension between the ACO model’s emphasis on improving quality and reducing cost through organization of care on one hand, and the ACA’s continued embrace of patient choice of provider on the other. He indicated that this tension might best be addressed by ACOs and their constituent providers creating a sufficiently attractive delivery model that patients will want to be involved — exclusively. (Reaching this goal would clearly require unprecedented patient education efforts.)

The Q & A following Blum’s presentation was predictably frustrating on both sides, as could be anticipated in connection with a talk about not-yet-finalized regulations.  He recognized several outstanding issues that he was not at liberty to discuss, but which had been occupying those drafting the regulations, including:

• Will physicians be able to join more than one ACO? CMS is apparently considering different rules for primary care physicians and specialists, although Blum acknowledged that such overlapping provider networks will make the computation of “gain” difficult when gainsharing is implemented.
• Blum, although asked, would not bite on the question of “who will lead” (physicians or hospitals). He anticipates a variety of models, but stressed that no ACO would flourish without physician buy-in.
• The question of geographic exclusivity for ACOs engendered a similarly noncommittal response. Blum acknowledged the conceptual difficulties presented by such overlap, but also pointed to the negative implications of exclusivity on the robustness of competition.

So, it was an interesting discussion of general principles, whetting our appetites to see how HHS will “square the circle” — or circles — in the upcoming regulations.

Getting Mental Health Coverage Wrong

Thanks to Frank for inviting me to review Barak Richman, Daniel Grossman, and Frank Sloan’s chapter,  Fragmentation in Mental Health Benefits and Services, in Our Fragmented Health Care System: Causes and Solutions (Einer Elhauge, ed. 2010).  The book is important and provocative.  The chapter on the fragmentation of mental health care couldn’t address a more timely issue.

People with serious mental illness, more than most other patients, struggle with health system fragmentation. As the Institute of Medicine described it,

Mental and substance-use (M/SU) problems and illnesses seldom occur in isolation. They frequently accompany each other, as well as a substantial number of general medical illnesses such as heart disease, cancers, diabetes, and neurological illnesses. *** Improving the quality of M/SU health care-and general health care-depends upon the effective collaboration of all mental, substance-use, general health care, and other human service providers in coordinating the care of their patients. *** However, these diverse providers often fail to detect and treat (or refer to other providers to treat) these co-occurring problems and also fail to collaborate in the care of these multiple health conditions-placing their patients’ health and recovery in jeopardy.

By some estimates, formerly institutionalized people with serious mental illness experience about 25 fewer years of life, mostly due to the effects of treatable physical illnesses such as cardiovascular, pulmonary and infectious diseases.  The effects of this health system fragmentation are experienced notwithstanding parity legislation, and they are felt also by people in the community with less serious mental illness, often because their primary care providers can’t find mental health providers to whom they can refer.

In Fragmentation in Mental Health Benefits and Services, the authors approach mental health system fragmentation by telling a story of the relationship between health insurance structure and income redistribution. The authors address the interrelationship between insurance “carve-outs” for mental health care and the growth of mental health parity laws. They assert that the carve out of behavioral health coverage from medical insurance provokes states to pass mental health parity laws. According to the authors, these parity laws fail to help their “intended” beneficiaries, and instead serve to redistribute resources away from low income and non-White employees.

To make their case, they mine a database of claims data for privately insured North Carolina patients. These claims data allow them to track employees’ (and, presumably, their dependents’) use of mental health services. Along the way, they raise several important issues. For example, they suggest that care provided by mental health providers may not be particularly efficacious. (299) Few would disagree that in most areas of health care — including mental health care — comparative effectiveness research is essential.   In addition, they suggest that access to and benefit from covered services varies by income and race. (298-99) It is undoubtedly true that there are class-based and race-based disparities in access to health care; this is so much discussed, in fact, that it somewhat puzzling that the authors would characterize as a “regularly overlooked question” the fact that “equal insurance and access does not translate into equitable consumption.” (279)

On some points, the authors seem to go a bit beyond their data. First, the authors assert (without citation) that mental health parity is “often” pursued “to benefit low-income and traditionally vulnerable populations.” (284) Many advocates (myself included) have argued for parity as a civil rights matter: as people with physical illness have access to insurance coverage, so should people with mental illness.  Certainly, insurance coverage is most valuable for those without the means to pay for care out of pocket, but that is as true for cardiac care as for mental health care. From this perspective, parity legislation seems no more a redistributive move than any other form of health insurance.

Second, and to distinguish parity legislation from other forms of insurance, the authors establish that the people of color and low-income insureds are less likely than others to take advantage of access to mental health practitioners. (298) Other researchers have pointed out the difficulty vulnerable populations have had gaining access to covered mental health outpatient care, even when their physicians attempt a referral, so this finding is uncontroversial. Does it follow from a finding that low-income people and people of color experience unequal use of and benefit from a covered service, that the coverage is illegitimate and should be curtailed? The logic of this assertion would call into question the continued coverage of cardiac services.  It might, rather, be wise to address the observed shortcomings in access to outpatient services for non-White and low-income patients and to seek the elimination of disparities here as elsewhere in the health finance and delivery system.

Third, the authors examine whether outpatient mental health treatment (as opposed to mental health treatment by primary physicians) is associated with a reduction in the rate of hospitalization for mental health services. They conclude that care from outpatient mental health providers does not reduce the rate of hospitalization for mental health care. (294) The authors here seem to argue that it would be unwise to “fix” the observed inequalities in access for the disadvantaged group, as the lack of association between outpatient mental health care and reduced hospitalization is weak. The authors, however, candidly acknowledge the limitations on using claims data to draw clinical conclusions, noting “unobservable heterogeneity of underlying health status” (294) and the possible “problem of unobserved severity.” (297) That being the case, it might be that the race and income disparities observed in access to outpatient mental health providers has carried though to other aspects of the mental health care system. For example, vulnerable low-income patients and patients of color might be unengaged in care, and therefore suffering with untreated mental health symptoms. Some employees or their dependents might be treated by the parallel public mental health system. It may be, in other words, that low-income people and people of color are poorly served by the mental health care system for reasons that have little to do with the efficacy of outpatient mental health care, notwithstanding their location in a university town.

The fragmentation of care for people with mental illness is an enormous public health and health finance problem. Much research needs to be done to approach the problem from all angles. The authors have done substantial work with an interesting set of claims data, and have creatively drawn links between patterns of usage and mental health outcomes.  As can be said of many forms of mental health treatment, their analysis fails to address the core issues.  But in such a difficult area of research, any advances are welcome.

Cross Posted at Concurring Opinions

Medicaid Cuts: Where’s the Outrage?

If Medicare services or provider rates were cut, or threatened to be cut to balance the budget, the firestorm would be epic.  Republicans would accuse Democrats suggesting such cuts of stealing from the elderly.  Democrats would accuse Republicans suggesting such cuts of trying to abolish Medicare.  AARP would express outrage, and if it didn’t do so loudly enough tea partiers would urge seniors to burn their AARP cards in an incongruous support of a government health care program.  So where’s the outrage when states faced with budget cuts look first to cut Medicare’s sister program, Medicaid?

A front page story in the New York Times on Tuesday describes cuts in Michigan’s Medicaid budget, resulting in the elimination of some services and reductions in provider fees.  As Medicaid fees were already absurdly low in Michigan, as in many states, the predictable response was that the pool of doctors available to Medicaid beneficiaries shrank even further.  Those lucky enough to find a doctor willing to take the low Medicaid reimbursement must be willing to travel long distances, and give up days of work to get necessary care for their sick children.  The Times described one such case:

Medicaid enrollees in Michigan’s midsection have grown accustomed to long journeys for care. This month, Shannon M. Brown of Winn skipped work to drive her 8-year-old son more than two hours for a five-minute consultation with Dr. Mukkamala. Her pediatrician could not find a specialist any closer who would take Medicaid, she said.

Later this month, she will take the predawn drive again so Dr. Mukkamala can remove her son’s tonsils and adenoids. “He’s going to have to sit in the car for three hours after his surgery,” Mrs. Brown said. “I’m not looking forward to that one.”

Those who can’t locate a participating physician either do without or wait for the condition to become emergent, at which time they seek more expensive hospital care.  How can this program be so dysfunctional?   The Kaiser Family Foundation, in a report posted last month, described the countercyclical nature of Medicaid’s finance structure:

During an economic downturn, unemployment rises and puts upward pressure on Medicaid. As individuals lose employer sponsored insurance and incomes decline, Medicaid enrollment and therefore spending increase. At the same time, revenue losses make it more difficult for states to pay their share of Medicaid spending increases. Specifically, a 1 percentage point increase in the national unemployment rate is estimated to result in 1 million more Medicaid and CHIP enrollees and an additional 1.1 million uninsured at the same time as state revenues are projected to fall by 3 to 4%.

So, states need to increase funding for Medicaid just when they are losing tax revenues and are facing pressures in other public service settings.  As KFF describes in the report, the problem this year was lessened somewhat by the addition of federal stimulus funding; the funding was apparently not enough to support the program in Michigan, and in any event will not persist nearly as long as states’ projected budget problems.

This is not a new problem.  It has often been noted that a health care system for poor people is a poor health system.  The reasons are, unfortunately, quite clear.  Medicare serves (mostly) the elderly of all income groups.  This is a politically powerful bloc: its members vote, and enough of them are financially and socially powerful to protect their turf.  Medicaid covers low-income people, including our lowest wage-earners, poor children, and people with permanent disabilities.  They have little social clout, by definition little money, and not much in the way of a lobby.  So, when times get hard, their programs are on the line.

That brings us to health reform.  The current bills rely heavily on Medicaid to bring coverage to the uninsured.  That is, as the above discussion makes clear, a risky proposition.  In its several forms, current reform bills have promised some increases, often temporary, to the federal share of states’ Medicaid costs.  And in a letter to Congressional leaders following a summit earlier this month, the President acknowledged the precariousness of the network of providers on whom we’ll rely to render that expansion more than a charade:

At the meeting, Senator Grassley raised a concern, shared by many Democrats, that Medicaid reimbursements to doctors are inadequate in many states, and that if Medicaid is expanded to cover more people, we should consider increasing doctor reimbursement. I’m open to exploring ways to address this issue in a fiscally responsible manner.

That would be a good step.  So would increasing the federal share of Medicaid’s costs.  If the current fiscal crisis has shown us anything about our federalist system, it is that the federal government, with its ability to borrow,  is much better at responding to emergencies than are the states, with their obligations to balance budgets annually.  But ultimately, a program for poor people will always have political, and therefore fiscal problems.

For reform to stick, for expansion of coverage to the poor and near-poor to genuinely serve their health needs over time, we have to tend structurally to our funding system.  The achievement of expansion to near-universal coverage would be a statement of solidarity, proclaiming that we’re all in this together.  To make that stick, we have to be in our health care financing system together.  There will be a list of clean-up work and next steps if and when reform passes.  High on that list should be the repair of Medicaid’s shaky fiscal foundation, integrating the interests of Americans across class and income levels.  When they’re considering reductions in access to health care, legislators should be just as cautious about harming kids in Flint as they are about harming elders in Scarsdale.

Why Primary Care in Medicare Matters

Why should we care about primary care in Medicare?  Early in the reform discussions, preventive and primary care was emphasized; in addition to extending medical care to all, reform would also implement preventive measures to keep them well.  In the current reform scrum, some are back peddling pretty fast, and in the course of finding “consensus” points (often focusing on cost-savings), we might lose conceptual coherence.

Ken Thorpe’s new Health Affairs article on chronic care patients in Medicare offers sound research and helpful analysis.  Thorpe’s data point toward a subtle explanation for health inflation keyed not to the increased cost of high-tech interventions, but to a shift in the conditions for which treatment is provided:

Our results highlight important changes in the medical conditions accounting for the rise in spending among beneficiaries over time. The most notable changes were in spending on a handful of chronic conditions: diabetes, kidney disease, hyperlipidemia, hypertension, mental disorders, and arthritis.

Thorpe has long argued that our health care delivery and finance system is stuck in a 20^th Century of acute care, while our 21^st Century needs have migrated toward chronic care.  As he has argued previously, these chronic care needs call for care at a human scale, including care management and supportive community-based care.  But he also points out that many chronic conditions are at least partially preventable, and that attention and resources should not be directed only to treating these conditions, but also to forestalling their incidence.

Prevention is, then, vital to any health care system.  But haven’t studies repeatedly shown that preventive care is not cost-effective?   Sorting this out requires that we step back and assess not only what “prevention” means, but also what we value in health care.

Preventive care can usefully be separated into three categories, as Ron Goetzel  (an Emory University colleague of Thorpe’s) has described.

• Primary prevention: Health promotion measures focus on lifestyle and simple interventions such as vaccinations to keep people from developing sickness; often cost-saving.
• Secondary prevention: Targeting people with preconditions for illness, including genetic or lifestyle markers, with screening technology, maintenance drugs, in order to forestall or prevent the manifestation of the condition; rarely cost-saving, in part because it is often applied to low-risk populations. Worth it? That depends on the design of the intervention and one’s metric for assessing health care value.
• Tertiary prevention: In this context, coordinated care management for those with chronic illness.  Properly implemented, chronic car management could “flatten the curve,” but is unlikely to be “cost-saving.”

So, whether “prevention” can save money (a claim Thorpe’s paper doesn’t make) is a complicated question.  In addition, it is often a poorly framed one. Explicitly or implicitly, cost-based objections to prevention often suggest that preventing one illness simply means that the person will die of something else, or less simplistically, that keeping people alive longer is cost-increasing, not cost saving.  Steven Wolf has elegantly responded to both objections:

[S]keptics of prevention argue that everyone dies of something; preventing demise serves only to allow a different disease to generate illness and spending. However, the aim of health promotion and disease prevention is not to prevent the inevitable but to “compress” morbidity, maximizing health until death.

Another common criticism is that prevention rarely saves money; it costs society if people live longer. The same applies to disease treatments. Health is a good; it is not purchased to save money. Health is a good that costs too much under the current medical care system, a problem of inefficiency that calls for wiser resource use, such as spending less per health unit gained (lower cost-effectiveness ratio). Disease prevention offers a way to improve health with low cost-effectiveness ratios and to also modulate disease rates. To reject health promotion and disease prevention because they do not save money (i.e., cost-effectiveness ratios are not negative) misses the point. (citations omitted)

Advocates who would shift our systemic emphasis to prevention and management of chronic illness, then, are not naïve about cost implications.  To the contrary, they address the issue head-on, with a three-step argument:

• The purpose of our system is or should be the maintenance of or restoration to high levels of functioning consistent with a fulfilling life.
• Our needs have largely shifted from acute to chronic interventions, and our system should shift to meet those needs.
• In preventing or managing chronic illness, as with all interventions, we should carefully examine the capacity of methods to meet our needs, and to demand value for those being served.

Applying this sort of argument to primary care, Goetzel elsewhere advocates skepticism of attempts by medicine to turn prevention into a high-tech enterprise:

We have medicalized prevention and health promotion in this country so that most people believe that only doctors in clinical settings can deliver these services. Although effective in many cases, this approach is the most expensive method of delivering prevention. If we expand our arsenal of potential interventions to include environmental, ecological, and policy changes, in addition to individually focused counseling and coaching programs, we can change the cost-effectiveness equation.

Thorpe’s article has garnered much-deserved attention, although it is tempting to think of his data in only cost-benefit terms.  That is not true to Thorpe’s conclusion, which is consistent with efforts to redirect attention from the business enterprise of health care to the health needs of Americans:

The U.S. health system remains predicated on providing acute, episodic care that is inadequate to address the altered patterns of disease now facing the American public. Our results highlight the need for prevention and care outside doctors’ offices and hospitals designed to address the changing needs of patients at risk for or living with chronic disease and, often, multiple comorbidities. As [reformers] continue their efforts to reshape the U.S. health system, they must address these changed health needs through evidence-based preventive care in the community, care coordination, and support for patient self-management.

Use of APRNs in Primary Care Settings

Some health care problems must be addressed whatever happens with reform. High on the list is the supply of primary care professionals.  Shortages have been reported in Massachusetts, and primary care access concerns have been raised in national reform discussions.  The shortage of primary care physicians is often tied to their low income, compared to specialists, and the consequent diversion of medical graduates to specialties.  The shortage of primary (and in some areas, specialty) physicians has prompted recommendations for increased medical school enrollment and residency slots for all areas of medical practice.

The wisdom of pumping up physician supply has been questioned.   It has been noted that, beyond a low threshold, increasing specialty physician supply is poorly correlated with better outcomes, and that previous efforts to increase supply has made the rich richer and the poor poorer, as graduates have flocked to locales and specialties already well-served by physicians.

So what is the proper policy response to a shortage of primary care physicians?  Physicians claim exclusive control of a broad swath of professional practice.  They dominate primary care, and exclusively control a more and more finely differentiated series of specialty fields.  With power comes responsibility, one might think.  Richard Cooper, a leading analyst of physician supply, commented in 2002 (at a time when many saw a surplus, not a shortage, of physicians) in an article with colleagues on the ramifications of this broad near-monopoly in a profession with falling production and fixed supply:

The sociologist Andrew Abbott has observed that “a profession whose jurisdiction is excessive must increase its productivity or expand its numbers.” Conversely, “when a powerful profession ignores a potential clientele, paraprofessionals appear to provide the needed services.” These statements characterize the dilemma that physicians now face. Their ability to increase their productivity is limited by their declining work effort. Their ability to grow their numbers is hostage to the belief that surpluses exist. And organized medicine has embarked on a vigorous campaign to thwart expansion of the NPC [non-physician clinician] disciplines. Yet it was shortages in the past that motivated state legislatures to remove the barriers to licensure for NPCs and to enlarge their range of privileges, and it is perceived professional opportunities that stimulated the creation of new disciplines and the expansion of existing ones. (footnotes omitted)

So, health reform efforts have emphasized access to primary care for its beneficial effects, while the supply of primary care docs has suffered a flight to specialty practice.  Is it, as Cooper suggested, time to rethink the place of non-physician caregivers on the front line of primary care?  As advanced practice registered nurses (”APRNs”) have gradually increased their scope of practice, studies and meta-studies have found that outcomes are equivalent when services are provided by a physician or APRN, and patients satisfaction measures may favor nurse practitioners.

But what about the nursing shortage?  It may be that expanding the profile and responsibilities of APRNs could further efforts to recruit and retain nurses.  Talented, hard-working nurses have long been concerned that their career path is limited; their salary steps are few and shallow, and they are unable to gain responsibility and autonomy commensurate with their training and experience.  Facilitating RNs’ graduate education to allow licensure as advanced practice nurses would enrich their career paths and encourage then to remain in the profession.   To move in this direction, those states that have not done so could expand the scope of licensure of APRNs to permit more fully independent primary care practice options.   The length of time needed for education and training would be long, but not as long as for physicians; compensation would have to be increased to reflect a higher level of training and responsibility, but not to the compensation level of physicians.

The path to regularizing the scope of practice for APRNs is described in a 2008 consensus document endorsed by 39 national general nursing and nursing specialty organizations.  A 2009 report from the Connecticut Office of Legislative Research described that state’s APRN scope of practice:

Advanced practice registered nursing is defined as the performance of advanced level nursing practice activities that, by virtue of postbasic specialized education and experience, are appropriate to and may be performed by an APRN. The APRN performs acts of diagnosis, and treatment of alterations in health status and must collaborate with a Connecticut-licensed physician. In all settings, the APRN may, in collaboration with a licensed physician, prescribe, dispense, and administer medical therapeutics and corrective measures and may request, sign for, receive, and dispense drug samples.

The required “collaboration” with physicians was also described:

The law defines “collaboration” as a mutually agreed upon relationship between an APRN and a physician who is educated, trained, or has relevant experience that is related to the work of the APRN. The collaboration must address a reasonable and appropriate level of consultation and referral, patient coverage in the absence of the APRN, a method to review patient outcomes, and a method of disclosing the relationship to the patient.

The physician oversight rule is typical, and has been the source of tension with APRNs.   Physicians can be suspicious of APRNs, and it has even been suggested that physicians may avoid working with them as APRNs gain more autonomy — a reaction that could be fueled by concerns with APRNs’ competency and training, or by a desire to weaken a source of competition for control of the profession.

APRNs might fill the primary care end of the physician practice spectrum, should physicians continue to flee primary care for more remunerative specialties.  There are genuine professional competency issues to work out, but they ought not be resolved by physicians as a matter of naked market power.  In addition, the terms of appropriate collaboration between physicians and APRNs need to be ironed out, to protect patients while avoiding the possibility of anti-competitive refusals to deal with APRNs.  Many researchers and physicians welcome the emergence of APRNs as partners in primary care practice.  Further research on the proper autonomous practice settings for APRNs will serve the interests of patients, and can guide planning for the future of primary care.

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.

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.

Haitian Earthquake Aid through Partners in Health

Those looking for means to get help quickly to the people of Haiti, devastated by an earthquake, should consider an emergency donation to Partners in Health.  PIH has a long track record of providing excellent health care directly to the people of Haiti.  It has personnel in the country, and facilities available to provide help.  From a recent bulletin on the PIH web site:

In an urgent email from Port-au-Prince, Louise Ivers, our clinical director in Haiti, appealed for assistance from her colleagues in the Central Plateau: “Port-au-Prince is devastated, lot of deaths. SOS. SOS… Temporary field hospital by us at UNDP needs supplies, pain meds, bandages. Please help us.”

With our hospitals and our highly trained medical staff in place in Haiti, Partners In Health is already mobilizing resources and preparing plans to bring medical assistance and supplies to areas that have been hardest hit. In Boston, our procurement and development teams are already fielding numerous offers of support and making arrangements to deliver resources as quickly as possible to the places where they are needed most.

Donations can be made on-line through the PIH web site.  PIH has a long history of providing health care directly to the neediest in Haiti.   Some background from the web site:

PIH was founded in 1987, two years after the Clinique Bon Sauveur was set up in Cange, Haiti, to deliver health care to the residents of the mountainous Central Plateau. PIH co-founders had been working in the area for years. The Clinic was just the first of an arc of successful projects designed to address the health care needs of the residents of the poorest area in Haiti. In the 20 years since then, PIH has expanded its operations to eight other sites in Haiti and nine additional countries and has launched a number of other initiatives.

If you’re looking for a trustworthy organization able to immediately turn donations into direct assistance to Haitians, think of PIH.

Rebalancing Long-Term Care

Will efforts to modernize home health programs survive insurance reform’s end game?  Providing insurance coverage to as many low-income uninsureds as possible has been an organizing principle in 2009’s health reform discussions, and reconciliation of the House and Senate versions will require satisfying some members that sufficient subsidies will be available to permit the promise of extended coverage to reach the neediest.  The ripple effects of those discussions may reach other reform issues, as leadership attempts to meet budgetary targets.  It would be a shame if this process led to a retreat from the current bills’ innovative long-term care provisions.

As I’ve described previously, the reform effort has contemplated an interesting mix of Medicare and Medicaid improvements to expand access to community based care for people with disabilities and chronic illness.  And the CLASS Act’s inclusion in the mix gives some hope  to those with needs for assistance with Activities of Daily Living (ADLs), as well as their family caregivers.  Those involved in caregiving for a chronically ill family member can testify that they’re not looking to dodge responsibility; to the contrary, they’re hoping to gain assistance to continue providing assistance in the community, to avoid the need for isolating and expensive institutional care for their loved ones.

Health Affairs’ January 2010, Volume 29, Number 1 — “Advancing Long-Term Services & Supports” - (subscription required for some content) is a welcome source of information and analysis in this area.   H. Stephen Kaye and coauthors provide timely data filling out our understanding of who is served, and where.  It is clear that people in need of nursing and personal care assistance prefer to live at home rather than in a nursing home.  About 8.4 million people of all ages with ADL difficulties receive services in their communities, while about 1.6 million receive services in nursing homes.  The median monthly cost in the home care setting, in 2009 dollars, is $928, compared to $5,243 in nursing homes.  About 75% of those in the community live with relatives.  90% have mobility impairments, 55% have cognitive impairments, and 31% have sensory impairments.  Other articles shed some light on programmatic and financial barriers to improving access to home services.

• Terrence Ng and coauthors describe the gaps, overlaps, and regional variation in long term care coverage provided by Medicaid and Medicare. In particular, they report wide variation in states’ adoption of Medicaid waivers and other mechanisms for extending community-based home care. For example, Iowa’s participation rate in Medicaid home and community-based care is 16.8 per 1,000, while Virginia’s rate is only 3.21 per 1,000. The authors also highlight the effects of the failure to coordinate Medicare and Medicaid for long-term care, and the cost-increasing effect of hospital readmissions, traceable in part to Medicare’s poor coverage of long-term care. The current Senate bill, at Sections 2401- 2406, would encourage expansion of Medicaid rebalancing efforts.
• The Public Policy Institute’s Susan Reinhardt discusses programs supporting the community preference of people with nursing and home care needs. She describes diversion and transition programs. Transition (”downstream”) programs are dedicated to moving to appropriate community settings those who would like to leave nursing homes. Diversion (”downstream”) programs fund home and community based services, to forestall or prevent institutionalization in the first place. She points to the reform bills’ support for the Community Living and Money Follows the Person Demonstrations.
• Two pieces do an excellent job of introducing us to those who provide home care. Carol Levine and others describe the plight of family caregivers, traditionally thought of as “informal” caregivers, but clearly the foundation of home health care.  Howard Gleckman provides case studies of non-family member home care workers, highlighting the physical and financial difficulties under which they labor. As needs for chronic care in general and home care in particular increase in coming years, the long-neglected needs of these family and non-family caregivers will have to be addressed. Congress is famously solicitous of the financial concerns of physicians, our most highly compensated caregivers. It is time to focus on the needs of those millions of direct caregivers who every day provide compassionate personal services to our most vulnerable friends and family members.

The January issue of Health Affairs helps to highlight the growing importance of the financing of long-term care.  As we age, and as our needs shift from acute to chronic care, we must wean ourselves from a financing perspective that emphasizes dazzling high-tech interventions and instead embrace the human-scale care offered by home health aides, visiting nurses, and physical therapists.  The pending bills don’t make this shift, but they nudge the battleship a bit.  They leave long-term care financing fragmented among various public and private programs, but they do support some promising programs.

The CLASS Act (Senate bill Section 8002) is a voluntary, opt out social insurance program that would provide some support for home care services.  For the reasons described last year by Howard Gleckman, the CLASS Act is incomplete; among other things, its voluntary nature could create selection problems.  It is a start, however, and would put a useful if imperfect patch on a torn system.  I’ll cite to one final article from the Health Affairs issue to point to a better way.  John Creighton Campbell and coauthors‘ discussion of public long-term care insurance in Germany and Japan contains the germ of a solution to the woes our system suffers.  Both the German and Japanese systems have universal coverage, support family caregivers, and accord beneficiaries a large degree of control over services received.  And they do so at a cost roughly comparable to that experienced by American public payers (Germany a bit less, Japan a bit more).  Organizing long-term care financing through one social insurance program yields efficiency dividends, eliminates stigma concerns, and encourages care at the level and location preferred by recipients.  Maybe it’s too early to be pushing for the next step in long-term care reform, but why can’t we do what the Germans and Japanese have done?  At the very least, let’s not cut back on the progress made in the current bills as we strain for the finish line.

Supporting Family Caregivers

Many of our hardest-working caregivers are not professionals, but parents, spouses, and children of people with serious chronic conditions, limited in their ability to engage in activities of daily living (ADLs) or instrumental activities of daily living (IADLs).  A new report from the National Alliance for Caregiving and the AARP opens up this informal, but absolutely essential, world of unpaid caregiving (h/t: Howard Gleckman ).

Some basic facts on the caregivers:

• They’re usually (66%) women;
• On average, they provide over 20 hours of care each week;
• They’re of all income levels, with an average income of about $60,000
• About one-third care for more than one person.

Some basic facts about those receiving the care:

• They’re mostly over 50 years of age, and 44% are over the age of 75;
• Most (51%) live in their own homes;
• Most (69%) require care due to long-term physical condition;
• 34% receive informal caregiving for 5 years or more.

In many cases, informal caregivers enable people with significant care needs to avoid nursing home or other institutional care.  Patients are better off, and so is the health budget: the avoided costs of expensive hospitalizations and nursing home care are enormous.   I have previously described the reform bills’ provisions that would support in-place care for people with chronic illness and disabilities.  Medicaid amendments would expand home care services, including such Cash & Counseling programs that give consumers substantial control over the mix of home services, and permit support for kinship caregiving.  And the Senate bill incorporates the Community Living Assistance Services and Supports Act (the “CLASS Act”), which provides for a new source of funding for personal assistance services for those not Medicaid-eligible.  A move supported by the insurance industry to strip it from the reform bill was narrowly defeated on December 4^th.

The insurance industry, of course, is vigorously trying to protect its own nascent long term care insurance business.  The long term care insurance industry has faced its share of horror stories about bureaucratic double-talk, denied claims, high prices, and limited benefits. The CLASS Act would provide an optional source of coverage, creating a voluntary program of member-supported public insurance for home care costs.  Like Medicaid’s Cash & Counseling system, it provides consumers with flexibility to choose the mix of supportive care when his or her health status triggers eligibility for coverage.

Why do we need such a program?  After all, there are many willing attorneys ready to help people spend down their assets — achieving “Medicaid impoverishment” — in order to qualify for Medicaid’s richer coverage.  Georgetown scholar Judy Feder was asked just that question for a recent Time Magazine article on the CLASS Act.  Her response was dead-on:

“Medicaid is invaluable,” says Judy Feder, a health policy expert at Georgetown University and a senior fellow at the Center for American Progress. “But it’s not insurance. It doesn’t protect you from catastrophe. It takes care of you after catastrophe.”

The long-term care financing mix in the Senate bill is far from perfect.  As a panel of experts surveyed by the Commonwealth Fund overwhelmingly agreed last year, the best solution would be to add a premium-financed long-term care component to Medicare, allowing the cost to be shared by government and consumers, without the trouble or expense of creating a new programmatic structure.  In the alternative, Congress could cobble together a better integrated “system” of long term/home care financing.  Such a system could virtually integrate a long-term care financing continuum, including Medicaid, Medicare, and voluntary insurance (such as that created by the CLASS Act) that could support consumers with chronic illness in the most appropriate setting for supportive care, reducing the discontinuities in coverage, perverse incentives for institutionalization, and counterproductive limits on services.  Either actual integration of all long term care services in Medicare, or the virtual integration (through smooth eligibility and service interfaces) in Medicare, Medicaid, and CLASS Act coverage could improve care and reduce costs.  But that won’t happen this year.

Instead, the best hope for expansion of access to personal assistance services will be the strengthening of Medicaid’s home care provisions and the creation of the CLASS Act program.  The overwhelming reform focus has been on very traditional “medical” insurance run through private, risk bearing insurance companies.  Only at the margins will the reform address the growing need for financing  appropriate health care for chronic illness.  Keeping the CLASS Act is a small step, but it at least acknowledges the obligation to support the personal assistance needs of those with serious chronic illnesses or disabilities, who are not (yet) impoverished, and who prefer to remain in their communities.  The CLASS Act will provide a new funding source for patient-directed personal assistance services.   Family caregivers will continue to devote themselves to their loved ones, but they need help.

Consumer Protection Under the Health Reform “Deal”

News of the Senate “deal” on the public option is trickling out.  It appears to comprise a swap, in which the public option will be dropped in favor of the creation of a nationwide program mimicking the Federal Employees Health Benefits Plan (FEHBP) (along with a Medicare buy-in for people 55 years of age or older).  Will the FEHBP model (for those under 55) accomplish what the public option would have done?  Tim Greaney’s post here yesterday raises well-founded concerns that it will be less likely to increase competition in concentrated markets.   But we had additional hopes for the public option.  I’ve previously argued that the public option could help assure adequate coverage of people with chronic conditions.  They’re the most vulnerable and increasingly the most costly; sound coordination of their care is necessary to serve their complex needs and to contain costs.   Whether this nascent deal will do that work depends on how the FEHBP model translates to an open exchange model, and in particular on benefits design and process rights components.  The new enrollees are likely to be more vulnerable than the FEHBP’s membership, and sound consumer protections are necessary to assure that their needs are met.  Two components of the program will be critical here: benefits design and process rights.

The FEHBP is mostly a mechanism for contracting with and managing private health insurers.  This deal would, therefore, likely create a form of private health insurance exchange, piggy-backing on private plans’ benefits design.  Congress should be aware of private insurers’ history with coverage of chronic care services.  It is widely documented, for example, that children with special health care needs have more sharply restricted access to necessary therapies through private than public coverage.  Ruth Benedict, of the University of Wisconsin, described access problems for children with functional limitations in 2006:

Public health insurance predicted greater use of supportive services and therapeutic services outside the school setting, a finding that may be attributable to the commitment of public programs to serve vulnerable populations such as children with special needs.  * * *   In contrast to public insurance, private insurance provided children no advantage in accessing therapeutic and supportive services relative to their uninsured counterparts.

The Office of Personnel Management (OPM) has historically addressed benefits design with a broad brush, negotiating and contracting directly with insurers, and balancing premium level against benefits richness.  Unless the bill directs OPM to incorporate the needs of people with chronic illness — physical and speech therapy, home care services, and case management, for example — the sickest of the newly covered will find only coverage that poorly matches their needs.  And state law that would otherwise benefit the private insurers’ benefits design is specifically preempted in the FEHBP statute:

The terms of any contract under this chapter which relate to the nature, provision, or extent of coverage or benefits (including payments with respect to benefits) shall supersede and preempt any State or local law, or any regulation issued thereunder, which relates to health insurance or plans.

Unless the bill mandates that the OPM protect vulnerable populations in its benefits design contracting, people with chronic illness will likely be left without coverage for vital services that they might have obtained through a public option.

What of process rights under the FEHBP?  Suppose a plan participating in the new national exchange were to deny coverage for a service with the benefits design on, say, medical necessity grounds.   As Nan Hunter described in her 2006 article, Managed Process, Due Care: Structures of Accountability in Health Care, the process by which covered persons may vindicate their rights of access to covered health care is fractured and often frustrating to participants.  Two features of the FEHBP bear note in this regard.  First, it allows participants “an independent system of external review,” which Nan Hunter argues can assist individuals and society by improving plans’ accountability and enhancing the deliberative process by which coverage decisions are made.  She also identifies, however, the pervasive lack of effective member notice of review options.  Second, judicial appeal from the administrative and independent review process is quite limited.  It is available only after exhaustion of internal plan review, external review independent review, and OPM review, and the scope of the judicial review itself is quite limited:

A covered individual may seek judicial review of OPM’s final action on the denial of a health benefits claim. A legal action to review final action by OPM involving such denial of health benefits must be brought against OPM and not against the Carrier or the Carrier’s subcontractors. The recovery in such a suit shall be limited to a court order directing OPM to require the Carrier to pay the amount of benefits in dispute.

The adequacy and accuracy of the administrative process, then, must be protected by thoughtful and specific statutory and regulatory language.

Insurance coverage does not equate to access to care.  Necessary benefits must be contractually covered, and the insurer must follow through where required.  The benefits design and due process provisions in the FEHBP in many ways mirror those of large, self-funded employers.   The population newly covered by this bill will, however, not be employees of large firms and federal agencies, and instead will be a more economically and medically marginal population with a higher percentage of people with disabilities and chronic illness.  The bill should, then, anticipate the issue directing OPM to set benefits design and review standards serving all, including those with chronic conditions.   If Congress hopes to contract out the responsibility of serving a vulnerable population, it needs to ensure that its contracting partners are charged clearly on the nature of their responsibilities.

“You’re Going to Die”: the “Paranoid” Style of Reform Opposition

An AP story on Wednesday quoted Tom Coburn, a Republican Senator and former obstetrician, addressing the reform bill’s Medicare cost-containment provisions, and delivering a message to seniors:  “I have a message for you: you’re going to die sooner.”  Some Democrats, such as Senator Pat Murphy, are clearly frustrated that Republican Senators, having opposed many recent Medicare improvement measures (see MIPPA 2008, which expanded primary care and suspended a scheduled cut in physician reimbursement), now cast themselves as the pro-Medicare party.  And standing with Coburn was Senator McCain, whose ‘08 presidential campaign argued for health reform financed in part with savings from Medicare and Medicaid.

The health reform bills contain interlocking provisions concerning coverage, finance, and delivery reform.  I doubt that any two thoughtful people would agree on every aspect of the current bill.  Comments of two sorts seem in order under these circumstances  (and hopefully are reflected in the posts on this site):  specific comments providing reasoned support or opposition to particular provisions and/or proposing amendments thereto, or general and reasoned comments supporting or opposing the overall package.  Coburn’s comment fits most nearly into the second category, but “reasoned” it ain’t.  It made me think of the classic Richard Hofstadter essay, The Paranoid Style in American Politics. (H/t to CBC’s Ideas, broadcast on November 28, podcast available here.)  Hofstadter, a Pulitzer Prize-winning Columbia University historian and commentator on American anti-intellectualism, wrote in his 1964 essay of the dark tradition in American politics of outrageous argumentation calculated to see “how much political leverage can be got out of the animosities and passions of a small minority.”  He was clear that he was not using “paranoid” in a clinical sense, but instead as a label to evoke a “sense of heated exaggeration, suspiciousness, and conspiratorial fantasy.”

Hofstadter was clear that the “paranoid style” was not used only by one movement, or even by only one slice of the American political spectrum.  He argued that examples could be found on the left and the right, and on both sides of many major issues.  It is not Coburn’s position that harkens to Hofstadter’s characterization of irresponsible speakers.  Rather, it is the style of his speech.  Hofstadter explained it this way:

Of course this term is pejorative, and it is meant to be; the paranoid style has a greater affinity for bad causes than good. But nothing really prevents a sound program or demand from being advocated in the paranoid style. Style has more to do with the way in which ideas are believed than with the truth or falsity of their content.

American history is filled with examples of political spokespersons resorting to this sort of extreme speech:

In the history of the United States one finds it, for example, in the anti-Masonic movement, the nativist and anti-Catholic movement, in certain spokesmen of abolitionism who regarded the United States as being in the grip of a slaveholders’ conspiracy, in many alarmists about the Mormons, in some Greenback and Populist writers who constructed a great conspiracy of international bankers, in the exposure of a munitions makers’ conspiracy of World War I, in the popular left-wing press, in the contemporary American right wing, and on both sides of the race controversy today, among White Citizens’ Councils and Black Muslims.

Joining all of these examples together are several factors: extreme overstatement; the use of specific “facts” as the basis for factually unsupportable positions; and the apparent intent to inflame rather than reason.  There are of course, examples of such political speech today on the right and left.  It is no longer surprising — although regrettable — to hear simplistic and hateful comments from “entertainers” and “commentators” on cable news and talk radio programs.

But Colburn is not an entertainer.  He is in a leadership position in the United States Senate.  He might speak factually — rhetorical flourishes and all — about aspects of the bill with which he disagrees.  He might forcefully explain why he believes Americans should decide that we’d be better off without this version of health reform.  Instead, he has taken himself out of the discourse, and has used “factual” arguments for the purpose of misleading and inflaming.  He has, in short, removed himself from reasoned debate and embraced the demagoguery decried by Hofstadter.  Americans deserve better from our Senators.

Mammography, Cervical Cytology Screens, and Rationing

The recent recommendations on mammography and cervical cytology screens by the US Preventive Services Task force and ACOG (American College of Obstetricians and Gynecologists), respectively, have added a new dimension to reform discussions.  Some are inclined to say “gotcha,” suggesting that the recommendations are evidence of a creeping denial of needed care that would follow governmental insinuation into health finance and benefits design.  Others see the reports as serendipitous irrelevancies, unconnected to reform discussions.  The truth is, not surprisingly, more complex.  The irony is that consumers will be more represented in health technology assessment in a public plan than they have been in private insurance.

It seems inevitable that any future health finance system will rely on evidence-based assessments of new (and old) technologies for both quality and cost purposes.  Our experience with the widespread use of affirmatively harmful (e.g., hormone-replacement therapy) and apparently useless treatments (e.g., knee arthroscopy for osteoarthritis) points to the possible risks of rapid  or uncritical adoption of new technologies.  As Sara Rosenbaum and others have pointed out,  (subscription required) we don’t want to confuse population data with individually-applied diagnostic and treatment judgment.   Both reports, to their credit, got this part right, and advised individual patients and physicians to assess each case in context, notwithstanding the general population-level guidance.  But evidence-based population data on the efficacy and comparative benefit of new and expensive interventions will be of enormous assistance in future treatment and funding decisions.

How should such health technology assessment be done, if not by expert panels?  As Bill Sage has observed, private health plans were opaque and inconsistent when they were in the technology assessment business.  (They have pretty much gotten out of that field, leaving cost control to others.)   One criticism of the mammography and cervical cytology reports has been that they should have included a more public process before issuing recommendations.  As the reports are merely advisory, it is not clear that post-publication comment doesn’t get the job done.  Where, as may be the case in the future, such expert analysis has instrumental effect, pre-implementation public process is essential.   Two guides for public health technology assessment advise as much.  The Institute of Medicine, in guidance issued earlier this year for comparative effectiveness analysis funded by the stimulus bill, observed that,

Clinicians and patients do not always consider the same factors when weighing the tradeoffs posed by important health care alternatives.  To ensure that the fruits of CER support consumers’ health care decision making, the CER Program should focus on the questions of patients as well as their health care providers.

Similarly, a health technology assessment guide created by the European Observatory on Health Systems in 2008 describes well-functioning technical assessment as consultative and transparent:

Social accountability permeates the whole knowledge production and is reflected not only in the interpretation and diffusion of results but also in the definition of the problem and the setting of research priorities.

We don’t want a health system — public or private — that is blind to either sound evidence-based technology assessment or the particular health needs of individual patients.  One advantage to a public system is that the assessment of technologies can and should include a robust public process.  We didn’t get that with private managed care.  The mammography and cervical cytology reports should call our attention to the opportunity for public process in decision making in publicly-funded coverage, and the need for close attention to the implementing regulatory processes if and when a bill is signed.

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