Posts filed under ‘Evidence Plans’

Woes of a Disjointed Healthcare System


As we all know, the cost of healthcare in the United States is high and growing.  Expenditures surpassed $2.3 trillion in 2008, more than three times the $714 billion spent in 1990, and over eight times the $253 billion spent in 1980. Stemming this growth has become a major policy priority, as the government, employers, and consumers increasingly struggle to keep up with health care costs. (Source: Centers for Medicare and Medicaid Services, Office of the Actuary, National Health Statistics Group, National Health Care Expenditures Data, January 2010.)

The healthcare industry, patient advocates and governmental bodies are pursuing many solutions.  These include, but are not limited to:

  • Investment in information technology
  • Improving quality and efficiency (e.g., encouraging evidence-based medicine, reducing unnecessary variations in care) – Some experts estimate that up to 30% of health care is unnecessary, emphasizing the need to streamline the health care system and eliminate this needless spending.
  • Adjusting provider compensation (e.g., sharing cost savings)
  • Government regulation (e.g., recent Medicare initiatives to control costs)
  • Encouraging prevention
  • Increasing consumer involvement in purchasing
  • Altering the tax preference for employer-sponsored insurance

One of the strengths of our current healthcare system, as well as one of its weaknesses, is that it is a market-based system.  We have multiple providers competing against each other.  The strength is that competition leads to innovation if not the low cost we might expect.  However, a market-based, competitive system also leads to a system that can make it difficult for providers to work together.  The resulting lack of coordination can have a negative impact on patient care and lost opportunities for reducing costs.

For example, MedSpan has a client that provides patient care in all 50 states.  They considered developing a unique program that could extend the reach of physicians’ care between visits, enhance patient-physician relationships, encourage therapy compliance and afford the opportunity for earlier identification of disease progression.  However, one of the challenges the program faces is that without coverage of the program by all health plans in a geographic region, physicians do not easily know which patients they can refer to the program.

Assume that only a few health plans provided coverage for our client’s program.  A physician would need to 1) determine that a patient would benefit from the program, 2) determine if the patient’s health plan provides coverage for the program and 3) refer the patient to the provider (my client), 4) develop a relationship with the provider and 5) exchange information to monitor progress, thereby ensuring a benefit for the patient and physician.

That’s a lot of work for physicians who, typically, do not have the time available.  This is especially true if only 5 or 10 patients might benefit from the program and only a few might have coverage.  As a result, a potentially beneficial program falls through the cracks due to a disjointed healthcare system.

A system integrated through better information systems would address some of the challenges the above program faces, but not all.  An extreme solution would be a single-payer system.  While facilitating coordination of care, a single payer system would engender a host of other issues.  For example, the innovation that competition generates may diminish.  Therefore, the question to address is how close should we move to a single payer system while maintaining the competitive, free market that is the foundation of the American economy?

That’s an issue we’ll address in a future entry into our blog.

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November 14, 2011 at 8:27 AM Leave a comment

What are Accountable Care Organizations (ACOs)?


Hello again!

Since our last blog post, the leaves have turned green, the summer months have passed, and we have just begun to enjoy the crisp autumn air.

Lately there has been much debate surrounding the launch of Accountable Care Organizations (ACOs) under President Obama’s Patient Protection and Affordable Care Act. ACOs are one of the key provisions in the 2010 health reform law designed to help reduce the cost of medical care. There is so much talk about this concept, but what exactly are ACOs?

An ACO is a network of providers and hospitals that share responsibility for delivering healthcare to a minimum of 5,000 Medicare beneficiaries for at least three years. It is based on the idea that hospitals, doctors, and other health care providers should work together to coordinate care for their patients. By coordinating care, the ACO will reduce costs by avoiding unnecessary tests and procedures. Those organizations that produce better outcomes will be rewarded, and for those that don’t, financial penalties will be incurred. In a recent study of ours, we found that with the development of ACOs, providers will take on responsibility for not only delivering actual medical care, but also providing some level of medical management between appointments.

Sounds like a great idea however, a lot skepticism has surrounded the development and launching of ACOs. First, there are very few providers that truly understand the ACO concept. In a recent survey conducted by Beacon Partners, only 15% of 200 provider organizations are “very familiar” with ACOs. Of those 200 surveyed, 92% are in the development stages for an ACO, and nearly all respondents’ budgets are not yet established.

Second, the Centers for Medicare and Medicaid (CMS) have yet to issue the final rules, which will affect the application process that prospective participants have to go through. Prospective participants will need to review the final rules before entering the application process in order to demonstrate their ability to comply with the eligibility requirements. Then, CMS will need to review all applications and offer contracts before the January 2012 launch deadline.

Lastly, the systems that were considered to be the models for a new health care delivery system, namely the Mayo Clinic, the Cleveland Clinic, Geisinger Health System and Intermountain Healthcare, have all declined to apply for the ACO program. Hospital and physician groups complained that the program created more financial risks than rewards and imposed burdensome reporting requirements.

Given the series of events surrounding the development of ACOs, it is no wonder that there is skepticism and doubt. Too much confusion and too many barriers surround the development of ACOs, including high start-up costs and regulatory issues. Add to that the refusal by health system role models to apply to the ACO program and you have a complicated situation.

Referring to our last post, this is one way to reduce the cost of care, a much needed move in our unstable economy. As prices for healthcare keep increasing over the year (health insurance is expected to rise 5.4% in 2012), patients deserve access to affordable healthcare. We urge ACO development leaders to address the barriers that health systems are encountering in order to aid in launching a successful ACO program.

Author:  Nicole Victoria

Editors:  Ken Chiang and Robert Kaminksy

 

October 26, 2011 at 3:52 PM Leave a comment

Healthcare reform and the quality of care


One of the most significant aspects of healthcare reform is its emphasis on improving the quality of care.  Many aspects of the law seek to improve the quality of care as a way of reducing cost.  The healthier we all are, the less we’ll spend on doctors and tests.  Now, if only the law could help every American lose 10 pounds!!  That would be the best ways to reduce the cost of care.

We cannot really discuss the quality of care until we know how to measure it.  There needs to be a consensus as to what constitutes good care.  The simpler these measures are to understand, the more providers and patients can focus on them and achieve success.

We also need a system for measuring the quality of care.  Quality measures also need to be simple so that they can be implemented and data collected cost effectively.  Of course, to do that, we need widespread use of electronic health records.

The U.S. government announced in February of 2009, the American Recovery and Reinvestment Act (ARRA). The ARRA act included $19 billion under the portion of its HITECH Act to promote the adoption of Electronic Health Record (EHR) technology in healthcare. Starting in 2011, medical providers can receive up to $44,000 or more by demonstrating what has termed as “meaningful use” of certified EHR technology to be eligible for government funds. 

Back to healthcare reform — the Patient Protection and Affordable Care Act (PPACA).  To drive improved quality of care, PPACA requires the identification and publication of a core set of quality measures for Medicare and Medicaid adults.   PPACA also requires Medicaid to establish a quality measurement program. 

PPACA requires the integration of reporting on quality measures with reporting for the meaningful use of electronic health records.  By focusing on the effective use of EHRs with certain capabilities, the HITECH Act makes clear that the adoption of records is not a goal in itself:   it is the use of EHRs to achieve health and efficiency goals that matters.  HITECH’s incentives and assistance programs seek to improve the health of Americans and the performance of their health care system through “meaningful use” of EHRs to achieve five health care goals:

  • To improve the quality, safety, and efficiency of care while reducing disparities;
  • To engage patients and families in their care;
  • To promote public and population health;
  • To improve care coordination; and
  • To promote the privacy and security of EHRs.

In the context of the EHR incentive programs, “demonstrating meaningful use” is the key to receiving the incentive payments. It means meeting a series of objectives that make use of EHRs’ potential and related to the improvement of quality, efficiency and patient safety in the healthcare system through the use of certified EHR technology.

Stage 1, which begins in 2011, the criteria for meaningful use focus on electronically capturing health information in a coded format, using that information to track key clinical conditions, communicating that information for care coordination purposes, and initiating the reporting of clinical quality measures and public health information.

The final rule reflects significant changes to the proposed rule while retaining the intent and structure of the incentive programs.  Key provisions in the final rule include:  

  • For Stage 1, CMS’s proposed rule called on physicians and other eligible professionals to meet 25 objectives (23 for hospitals) in reporting their meaningful use of EHRs. The final rule divides the objectives into a “core” group of required objectives and a “menu set” of procedures from which providers can choose.  This “two track” approach ensures that the most basic elements of meaningful EHR use will be met by all providers qualifying for incentive payments, while at the same time allowing latitude in other areas to reflect providers’ varying needs and their individual paths to full EHR use.
  •  In line with recommendations of the Health Information Technology Policy Committee, the final rule includes the objective of providing patient-specific educational resources for both EPs and eligible hospitals and the objective of recording advance directives for eligible hospitals.

Healthcare reform will fund the implementation of medication management services by pharmacists.  Medication therapy management (MTM) is a partnership of the pharmacist, the patient or their caregiver and other health professionals that promotes the safe and effective use of medications and helps patients achieve the targeted outcomes from medication therapy.  MTM includes the analytical, consultative, educational and monitoring services provided by pharmacists to help consumers get the best results from medications through enhancing consumer understanding of medication therapy, increasing consumer adherence to medications, controlling costs, and preventing drug complications, conflicts, and interactions.

Healthcare reform requires the public reporting of physician performance on quality and patient-experience measures through a website that will be called Physician Compare.  What begins with the implementation of EHR and the development of quality measures that are evaluated through data supplied by the EHR ends in public reporting of the results.  This will enable patients and hospitals to work with the physicians that provide the highest quality of care.  While high-quality of care might cost more up front, the (hoped for) decrease in hospital readmissions, adverse events and co-morbidities will (hopefully) reduce costs in the long term.

Implications for Healthcare Manufacturers

The emphasis on quality measures will more and better opportunities for healthcare manufacturers to demonstrate how their products and applications drive improvements in the quality of care.  Such demonstrates need to be based on clinical data that demonstrate how the product or application performs compared to the quality measures that Medicaid and Medicare adopt.  Medical groups and hospitals will look to healthcare manufacturers and government agencies to provide data that cut across multiple settings of care.  However, the growing availability of sophisticated EHR systems could enable medical groups and hospitals to develop data that are specific to their own patient demographics and mix.  It is in the best interest of healthcare manufacturers and government agencies to help coordinate these efforts.  Healthcare manufacturers will be encouraged to develop data for patient niches so that they are ready to address data that medical groups and hospitals gather that might demonstrate different results than those generated by the healthcare manufacturers.

The government and healthcare community (ie, providers and payers) will develop the quality measures.  The medical groups, hospitals and other payers will implement the EHR systems required to collect data relevant to those measures.  There is an opportunity for healthcare manufacturers to play a role in connecting the two endpoints.  That is, healthcare manufacturers can develop algorithms for analyzing the data so that the results comply in an appropriate way with the outcomes measures that Medicare and Medicaid establish.

Today, retail pharmacies are a secondary or tertiary contact for those drug companies and medical device suppliers that distribute product through this channel.  The growing importance of MTM programs will increase the importance of retail pharmacies for select disease states (eg, hypertension, dyslipidemia, diabetes).   Healthcare manufacturers will need to develop programs at the corporate levels of the retail pharmacy companies as well as the neighborhood pharmacies to educate the pharmacists and encourage and support the appropriate implementation of the MTM programs.  More effective MTM programs will encourage therapy compliance and higher quality care.

As the above evaluation demonstrates, the ARRA and PPACA will provide numerous new avenues for healthcare manufacturers to work with physicians, hospitals and other providers to drive an improved level of care.  The time is now to plan for these initiatives and start their development.

September 29, 2010 at 11:01 AM Leave a comment

Upping the ante for comparative effectiveness data


One aspect of healthcare reform is the importance of and need for comparative effectiveness data.  The following article appeared in the NY Times today regarding the role of mammograms and new therapies for breast cancer.  The article illustrates how comparative effectiveness data will cut across alternative modalities for treatment and diagnosis.    Manufacturers of diagnostic imaging, diagnostic assays and therapies are not limited to demonstrating the value of their products within their own silos.

By GINA KOLATA

A new study suggests that increased awareness and improved treatments rather than mammograms are the main force in reducing the breast cancer death rate.

Starting in their 40s or 50s, most women in this country faithfully get a mammogram every year, as recommended by health officials. But the study suggests that the decision about whether to have the screening test may now be a close call.

The study, medical experts say, is the first to assess the benefit of mammography in the context of the modern era of breast cancer treatment. While it is unlikely to settle the debate over mammograms — and experts continue to disagree about the value of the test — it indicates that improved treatments with hormonal therapy and other targeted drugs may have, in a way, washed out most of mammography’s benefits by making it less important to find cancers when they are too small to feel.

Previous studies of mammograms, done decades ago, found they reduced the breast cancer death rate by 15 to 25 percent, a meaningful amount. But that was when treatment was much less effective.

In the new study, mammograms, combined with modern treatment, reduced the death rate by 10 percent, but the study data indicated that the effect of mammograms alone could be as low as 2 percent or even zero. A 10 percent reduction would mean that if 1,000 50-year-old women were screened over a decade, 996 women rather than 995.6 would not die from the cancer — an effect so tiny it may have occurred by chance.

The study, published Thursday in The New England Journal of Medicine, looked at what happened in Norway before and after 1996, when the country began rolling out mammograms for women ages 50 to 69 along with special breast cancer teams to treat all women with breast cancer.

The study is not perfect. The ideal study would randomly assign women to have mammograms or not. But, cancer experts said, no one would do such a study today when mammograms are generally agreed to prevent breast cancer deaths. In the study, which is continuing, women were followed for a maximum of 8.9 years. It is possible that benefits may emerge later.

Nonetheless, the new study is “very credible,” said Dr. Barnett Kramer, associate director for disease prevention at the National Institutes of Health.

“This is the first time researchers used real populations to compare the effects of treatment and mammography in the modern era of treatment,” Dr. Kramer said. “It shows the relative impacts of screening versus therapy in an era in which therapy has been improving.”

Dr. Otis Brawley of the American Cancer Society said in a statement that the investigators used “careful methodology.” The society, Dr. Brawley said, “believes that the total body of the science supports the fact that regular mammography is an important part of a woman’s preventive health care.”

Dr. Carol Lee, a radiologist at Memorial Sloan-Kettering Cancer Center and chairwoman of the breast imaging commission of the American College of Radiology, said the new study affirmed that mammography saves lives.

“Mortality from breast cancer is decreasing, and I have to believe that screening mammography has played a part,” Dr. Lee said.

In their study, the investigators analyzed data from all 40,075 Norwegian women who had received a diagnosis of breast cancer from 1986 to 2005, a time when treatment was changing markedly.

In that period, 4,791 women died. And, starting in 1996, Norway began offering mammograms to women ages 50 to 69 and assigning multidisciplinary treatment teams to all women with breast cancer, similar to the teams at many major medical centers in the United States. The question was, Did the program of mammograms and optimal new treatment with coordinated teams of surgeons, pathologists, oncologists, radiologists and nurses lower the breast cancer death rate?

The investigators found that women 50 to 69 who had mammograms and were treated by the special teams had a 10 percent lower breast cancer death rate than similar women who had had neither.

They also found, though, that the death rate fell by 8 percent in women over 70 who had the new treatment teams but had not been invited to have mammograms. And Dr. Kramer said he knew of no evidence that breast cancer was more easily treated in women over 70 than in women ages 50 to 69.

That means, Dr. H. Gilbert Welch of Dartmouth wrote in an additional analysis in an accompanying editorial, that mammography could have reduced the breast cancer death rate by as little as 2 percent, an amount so small that it is not really different from zero.

Two percent is an estimate, Dr. Welch said. But, he said, whatever the effect of mammograms is, “all the signals here are that it is much smaller than we believed.”

Dr. Laura Esserman, a professor of surgery and radiology at the University of California in San Francisco, said it tells her that “if you get the same treatment and the outcome is the same if you find it earlier or later, then you don’t make a difference when you find it early.”

And screening has a cost, Dr. Welch said. Screening 2,500 50-year-olds for a decade would identify 1,000 women with at least one suspicious mammogram resulting in follow-up tests. Five hundred would have biopsies. And 5 to 15 of those women would be treated for cancers that, if left alone, would have grown so slowly they would never have been noticed.

When the study was planned, the scientists expected that screening would be even more effective than it was in studies from decades ago. After all, mammography had improved and, in Norway, each mammogram was independently read by two radiologists, which should make it less likely that cancers would be missed. The researchers expected mammograms to reduce the breast cancer death rate by a third.

“We were surprised,” said Dr. Mette Kalager, the lead author of the paper who is a breast surgeon at Oslo University and a visiting scientist at the Harvard School of Public Health.

Marvin Zelen, a statistician at the Harvard School of Public Health and the Dana-Farber Cancer Institute, who was a member of the research team said even though the mammography benefit is small, if he were a woman he would get screened.

“It all depends on how you approach risk,” Dr. Zelen said. His approach, he says, is “minimax” — he wants to minimize the maximum risk — which, in this case, is dying of a cancer.

Dr. Kalager came to the opposite conclusion. She worries about the small chance of benefit in light of the larger chance of finding and treating a cancer that did not need to be treated.

“Since I’m a breast cancer surgeon, I know what being treated is like,” she says. The decision to be screened, she says, “is a matter of personal preference. Is it worth it to risk becoming a patient without it being necessary?”

Many women may still want mammograms, she says, and that is fine.

“I think we have to respect what women want to do.”

September 23, 2010 at 11:25 PM Leave a comment

Evidence-based radiology — a concept on the cusp


For some years now, payers, academics and clinical practitioners have had concerns about the justifications for clinical practice patterns.   The need for evidence-based practice ranges from formulary design to clinical care to radiology.

“Medical practice is largely based on clinical anecdotes, uncontrolled investigations and expert opinion. The demand for scientific evaluation to guide patient care is increasing because financial resources are limited and because practice based on such influences may be inappropriate. In radiology, the situation is especially problematic…. Few radiology programs address and encourage critical thinking skills.” (Source: Hillman BJ, Noninterpretive skills for radiology residents. Critical thinking: deciding whether to incorporate the recommendations of radiology publications and presentations into practice. AJR Am J Roentgenol 2000; 174 (4):943-946.)

For example,  when clinicians, such as radiologists, health plan administrators, and others try to decide between imaging and interventional options, they may find that textbooks are out of date, guidelines are not specific enough and there are conflicting or apparently unreliable reports in the literature. Expert opinions and policies vary and even the definition of ‘evidence’ is unclear.

Some experts recommend using the ‘consensus of experts’ approach.  However, the reliability and reproducibility of this type of evidence is questionable.  Others recommend the use of guidelines that are based on expert appraisal of the literature.  These are roughly equivalent to a consultation with experts but may not answer our specific question well, be based on strong evidence or take into account new developments and local circumstances.  However, when clinicians and health plan administrators go to the literature, the first problem encountered is the volume of literature being published and, perhaps, a lack of training in how to separate the good studies from the weak ones.  Another problem is determining whether specific clinical decisions and medical policies should be based on the general consensus illustrated by the evidence or following a minority opinion that better applies to a specific situation or sub-group of patients.

One of the issues facing healthcare manufacturers is how to best support clinicians and administrators as they address these challenges.  For healthcare manufacturers, the key questions are 1) What type of data will my customers find most compelling?  2) How will that data best support my marketing efforts and support appropriate adoption of my product? 3) How can I develop the data most cost effectively?  Is a retrospective study or an observational study sufficient?  Is a costly prospective study with a randomized design necessary?  4) What return will I realize from the data I develop?

The first step for healthcare manufactures is to realize the data are necessary.  As comparative effectiveness research becomes more prevalent and clinical decisions are increasingly scrutinized, data is all that clinicians and administrators will find relevant and compelling. 

The next step is to develop an evidence plan early in the product development process.  To the extent possible, the time to develop such data is when drugs are going through clinical trials or diagnostic assays and imaging equipment and applications are under development.   Developing data after FDA approval and product launch could burn the limited commercialization time available before a competitor arrives or patent protection expires.

The evidence plan should be based on the expected return on investment.  If less-costly retrospective and observational studies will drive adoption, though perhaps not optimally, they might optimize ROI.  Potential market blockbusters might warrant costly prospective, multi-center studies that support a lasting and profitable competitive advantage.

The design of specific studies within the evidence plan should be based on the intended audience.  Payers (eg, health plans and hospital administrators) are looking for value.  That is the expected improvement in quality of care, based on specific and measurable outcomes, divided by the impact on cost.  Cost includes that of the drug, device or imaging application as well as any cost offsets (eg, reduction in hospitalizations) directly due to the product.  Providers are more focused on improvements in clinical care and outcomes and, to a lesser degree, cost impact. 

As today’s discussion begins to illustrate, the development of an evidence plan is a complex undertaking that should be well thought out.  Today’s environment and its emphasis on comparative effectiveness, cost management and access to appropriate therapies and procedures makes the development of the evidence plan more critical than ever before.

July 23, 2010 at 12:49 PM Leave a comment

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