Health Affairs

“A child is not a small adult,” but an adolescent is not a large child.  Adult oncologists, reluctant to care for cancer patients under the age of 16, believe that adolescent and young adult (AYA) cancer patients should be within their purview.  We believe younger cancer patients are a special group needing special attention, even as the arbitrarily selected AYA age-break point is debated by clinicians, hospital administrators, attorneys, federal regulators, institutional review boards and the pharmaceutical industry.

We have two concerns about the participation of young cancer patients in clinical research.  First, as difficult as the regulatory environment has become for investigators, sponsors, and human subjects in adult oncology, it is more complex for the pediatric and adolescent populations and their physicians.  Second, the degree to which consideration must be given to the human subject protection issues surrounding informed consent in this population requires discussion, debate, and resolution.  As Morgan et al. point out, “open and frank communication is necessary to create opportunities for two-way information exchange between patient and professional”. Read the rest of this entry »

On November 8, 2011, the Centers for Medicare & Medicaid Services (CMS) solicited the public for feedback on Medicare’s controversial coverage with evidence development (CED) policy. Although CMS did not finalize the CED policy until 2006, the agency first applied the CED concept in 1995 through a national coverage determination (NCD) on lung volume reduction surgery (LVRS).  At the time, CED represented one of the few mechanisms that the agency had to ensure the development of necessary evidence to confirm the clinical benefit of technologies for Medicare beneficiaries.

To date, there have been 15 national coverage determinations (NCDs) that have resulted in the use of CED.  Since 2007, over one in five NCDs has ended with requirements for additional data.

The environment in which CMS initially formalized its CED policy has changed dramatically over the last five years.  CMS was once the only voice technology developers were required to listen to in order to ensure their products were commercially successful in the U.S. market.  The agency outlined its demands of what was needed to understand the real-world effectiveness of FDA-approved products not only by applying CED, but also by hosting Medicare Evidence Development & Coverage Advisory Committee meetings, and commissioning technology assessments by the Agency for Healthcare Research and Quality. Read the rest of this entry »

As every reader knows, the Supreme Court has agreed to consider challenges that have been brought to the constitutionality of two provisions of the Affordable Care Act (ACA) by twenty-six states, the National Federation of Independent Businesses, and individual plaintiffs.  The Court has scheduled the case for five and a half hours of oral arguments in late March.  It will probably decide the case early in the summer.

In the meantime, the Supreme Court is accepting written arguments, called briefs, from the parties.  The Supreme Court has established a briefing schedule for the four issues it has agreed to hear: the constitutionality of the minimum coverage requirement of the ACA; the constitutionality of the ACA’s Medicaid expansion provisions; whether the Anti-injunction Act (AIA), which prohibits federal courts from enjoining the assessment or collection of a tax, precludes the Court from deciding the constitutionality of the minimum coverage requirement at this time; and whether additional provisions of the ACA must be struck down if the Court decides that the minimum coverage requirement is unconstitutional.  The Court has also appointed two independent lawyers to argue two positions that none of the parties are taking: that the AIA precludes the Court from considering the minimum coverage requirement until a penalty is actually assessed in 2015; and that the minimum coverage requirement can be held unconstitutional without striking any other provisions of the ACA.

In general, the briefing schedule allows each party and the two appointed attorneys to argue their position, those opposing this position to respond, and the original proponent to reply. It also allows amicus briefs to be filed in support of any brief seven days later, and there will be dozens of these.  The briefing schedule lasts through the middle of March. The first four briefs were due on January 6, including the brief of the United States on the merits of the minimum coverage requirement, the state and NFIB briefs on severability, and the appointed counsel’s brief on the application of the AIA.  This post will discuss the Justice Department’s brief on the merits at some length and briefly summarize the arguments of the other three briefs. Read the rest of this entry »

With little fanfare and little attention from the media, the Obama Administration recently issued proposed rules to crackdown on health insurance scams that use ERISA to avoid state law enforcement and regulatory actions.

Since the 1974 enactment of ERISA — the federal law governing employee pension and health benefit plans — crooks have used it to promote health insurance scams. There have been bipartisan Congressional attempts to address this problem, e.g., the passage of the 1982 amendments to clarify state authority and the 1996 HIPAA amendments to increase penalties for health fraud.  But until the passage of the Patient Protection and Affordable Care Act (ACA), the federal government has had limited administrative authority to fight health insurance scams.

One little known provision under ACA, section 6605, gives the U.S. Department of Labor (DOL) new administrative tools to combat health insurance scams and insolvencies of Multiple Employer Welfare Arrangements (MEWAs).   Once final, these new tools will mean less fraud, and, most importantly, fewer individual and employer victims.  Many, including me, believe that when health insurance coverage becomes available and affordable for all Americans and small businesses in 2014, there will be fewer scams.  Nonetheless, some scams will exist, and,between now and 2014, it is critical to crackdown on scams that take advantage of vulnerable people and small businesses seeking insurance. Read the rest of this entry »

With the passage of the HITECH Act, there has been a push towards the broad and meaningful use of electronic health records.  Critics argue that electronic health record systems are not yet adequately developed.  The systems are ill-designed and clunky; poorly integrated into clinical workflow; and often times create more work without improving the quality of care delivered to patients.

While, as daily users of EHR systems, we sympathize with these concerns, every so often a clinical situation presents that underscores the value of electronic health systems and electronic health information exchange.  The following events took place recently at a small community hospital where we both rotate as resident physicians.

The scene begins with an outpatient nephrologist phoning a hospital resident in connection with the admission of one of his patients to the hospital. Read the rest of this entry »

Editor’s note: See additional posts discussing Pioneer accountable care organizations by Debra Ness and William Kramer and Douglas Hastings.

The December 19 announcement by the Centers for Medicare and Medicaid Services (CMS) of 32 Medicare Pioneer ACOs underscores the transition of “shared savings” and “accountable care” from policy concepts to implementation.

Perhaps more than any other delivery system-related reform enacted in the Affordable Care Act of 2010, ACOs have generated enormous interest.  One recent Leavitt Partners study found announcements of 164 ACOs in 41 states.  Even though “scored” as generating only modest savings, proponents believe ACOs have the potential to lower costs while improving accountability and quality by transforming the organization and delivery of health care.  Implementing Pioneer ACOs raises two critical questions:  will they succeed and, if they do, can their success be generalized to less well-organized and experienced entities?

Despite analysts using Medicare data to explore shared savings and ACOs, more recently Medicare has lagged the private sector in implementing ACOs.  The private sector had commercial ACOs operating for the under-65 population in 2010; one example is the Norton Healthcare/Humana ACO, which is a Brookings-Dartmouth pilot site.  In contrast, the first Medicare ACOs will begin in January 2012 under the Pioneer program.  As Douglas Hastings discusses, the final CMS regulation issued on October 20, 2011 envisions Medicare ACOs beginning in either April or July 2012. Read the rest of this entry »

The recent CMS bulletin on the essential benefits package (EBP) required for certain types of coverage under the Affordable Care Act has been described in greater detail in earlier Health Affairs Blog posts by Tim Jost and Kavita Patel.  The bulletin is a pragmatic document, seemingly driven by the overall exigency of implementing the ACA and not by specific considerations of policy or politics with respect to benefit design.

CMS’s approach refrains from making the federal government a watchdog for specific benefits that either consumers or health care providers might desire, and seems to benefit business and insurance interests within each state that are concerned primarily about cost in the individual and small-group markets.  The bulletin grants states considerable flexibility to select a benchmark plan based on those now serving their residents, and allows insurers to meet federal EBP requirements by offering benefits “substantially equal” to those in the benchmark plan.   Moreover, by choosing a benchmark plan from among those it currently regulates, each state will in effect be able to include its own mandated benefits in the initial EBP. Read the rest of this entry »

In the recently released bulletin from HHS on the essential health benefits (EHB), the administration answered a major question on the minds of many critical healthcare stakeholders: Will the administration be specific in their guidance and create a definition of what constitutes “essential?”  The answer, is no, they will leave the bulk of the decision-making to the states, thus increasing the likelihood of variation in benefits and access to elements of care.

Details of the bulletin were reviewed in an earlier Health Affairs Blog post, but this post will review the implications of the guidance for various healthcare stakeholders and will note areas that will likely require further guidance from the administration.

First, a brief review in Table 1 below (click to view) of populations affected by the EHB Bulletin, from the perspective of the insurance markets in which the populations would be purchasing health insurance: Read the rest of this entry »

Editor’s note: See additional posts discussing Pioneer accountable care organizations by Steven Lieberman and Douglas Hastings.

We have commended the Centers for Medicare and Medicaid Services (CMS) on this blog in the past for actions regarding Accountable Care Organizations (ACOs) – but we’ve also noted the need to establish strong enough criteria to ensure that this new model will be implemented in ways that deliver on the promise of better coordinated, more patient-centered care that gives us improved value for our health care dollars.  That is why we applaud the launch of the Pioneer ACO program by the Center for Medicare and Medicaid Innovation (CMMI).  It exemplifies the kind of innovation and testing we need to forge a path out of the current dysfunctional system.

Certainly, the nation has few higher priorities than to leave behind a health system that often fails to coordinate patient care, bringing poor clinical outcomes, miserable patient experiences, duplication, waste, errors and skyrocketing costs.  The financial security of families and the economic viability of our nation depend on replacing the current payment system, which rewards volume of services regardless of whether those services are appropriate or beneficial to patients.

We need a fundamental transformation, and Pioneer ACOs have the potential to significantly change the way providers coordinate, collaborate and share accountability for the patients they serve.   But the true test of whether these ACOs deliver on their promise will lie in both the spirit and specifics of how they are implemented. Read the rest of this entry »

Editor’s note: See additional posts discussing Pioneer accountable care organizations by Steven Lieberman and Debra Ness and William Kramer.

With the announcement by the Centers for Medicare and Medicaid Services on December 19 of the Pioneer accountable care organization (ACO) model participants, CMS and its Centers for Medicare and Medicaid Innovation (CMMI) conclude a year of robust activity on the ACO front.  One can understand why Don Berwick has said that working on the Medicare ACO program was his best experience at CMS.  There was significant inter-agency collaboration to implement complex statutory provisions as well as a comprehensive dialogue with a broad set of stakeholders to produce a final set of requirements.

If the goal of this next period of payment and delivery reform is to test multiple models and achieve reasonably broad participation so that the best practices can be identified and brought to scale, the roll out of the Pioneer model, along with the Medicare Shared Savings Program, signals the real start of this testing period for Medicare ACOs.  At the same time, we see the blossoming of much accountable care and value-based purchasing activity in the commercial market.

Some argue that private market programs will be more successful and have more impact.  Only time will tell, but it does not really matter. What matters is that we make progress directionally in addressing the challenges that our health care system faces, particularly given the relentless budgetary pressures that will exist in the months and years ahead.  Reasonable progress in both the public and  private sectors is essential.  And the actions and programs of the federal government, as the largest purchaser of health care services, will have a huge impact, like it or not. Read the rest of this entry »