Recent Comparative Studies of Health Systems

As America continues to wrestle with the thorny thicket of health care reform, there are a number of recent reports chronicling and comparing approaches to health care and health reform in different countries that are worth a read.  For example:

• The Organisation for Economic Co-operation and Development recently released Health at a Glance 2011: OECD Indicators, which provides “comparable data on different aspects of the performance of health systems in OECD countries.” The U.S. spends 2 ½ times more than the OECD average health expenditure per capita (which amounted to 17.4% of GDP in 2009). (OECD explores why in a separate addendum, “Why is Health Spending in the United States So High”.) Yet, with the exception of cancer care and acute care in hospitals, it is not clear Americans are getting improved quality for the greater expenditures. As reported by CQ HealthBeat and by the Commonwealth Fund, “hospital services cost much more in the United States and pharmaceutical prices are much higher compared to other countries;” “there are fewer practicing physicians per 1,000 population, fewer doctor consultations and shorter hospital stays;” “more CT scans, knee replacements, and Caesarean sections;” and “comparatively high hospital admission rates for preventable conditions like asthma, diabetes and hypertension.”

• Strengthening Primary Care: Recent Reforms and Achievements in Australia, England, and the Netherlands, a recent report by Sharon Willcox, Geraint Lewis, and Jako Burgers of the Commonwealth Fund, evaluates efforts to improve access to, and the quality of, primary care in these countries– and suggests what the U.S. can learn from these initiatives. These countries have been focusing on three primary care reform strategies: promoting coordination of care, reforming primary care payment, and improving quality and access. As the abstract summarizes, “[q]uality improvement strategies include postgraduate training programs for family physicians, accreditation of general practitioner (GP) practices, and efforts to modify professional behaviors–for example, through clinical guideline development. Strategies for improving access include national performance targets, greater use of practice nurses, assured after-hours care, and medical advice telephone lines. All three countries have established midlevel primary care organizations both to coordinate primary care health services and to serve other functions, such as purchasing and population health planning. Better coordination of primary health care services is also the objective driving the use of patient enrollment in a single general practice. Payment reform is also a key element of English and Australian reforms, with both countries having introduced payment-for-quality initiatives. Dutch payment reform has stressed financial incentives for better management of chronic disease.”

• Bradford H. Gray, Thomas Bowden, Ib Johansen, and Sabine Koch, also of the Commonwealth Fund, review the extent of adoption of “meaningful use” (as defined in federal regulations) in three countries with extensive experience with electronic health records, Denmark, New Zealand, and Sweden in Electronic Health Records: An International Perspective on “Meaningful Use.” Although these European countries have high levels of EHR adoption, they have not reached 100% meaningful use, with the greatest weakness being in information provided to patients. The authors suggest that the U.S. could learn from these experiences the value of “providing economic incentives to encourage adoption and designating an organization to take responsibility for standardization and interoperability.”

• International Profiles of Health Care Systems: Australia, Canada, Denmark, England, France, Germany, Italy, Japan, the Netherlands, New Zealand, Norway, Sweden, Switzerland, and the United States, edited by Sarah Thomson, Robin Osborn, David Squires, and Sarah Jane Reed and published by the Commonwealth Fund, provides an overview of the health systems in these countries– including “health insurance, public and private financing, health system organization, quality of care, health disparities, efficiency and integration, use of health information technology, use of evidence-based practice, cost containment, and recent reforms and innovations.”

• The Commonwealth Fund also recently released results of an international study of patients with complex care needs in eleven countries: Australia, Canada, France, Germany, the Netherlands, New Zealand, Norway, Sweden, Switzerland, the United Kingdom, and the U.S. Although it identified significant care coordination issues, it found that “patients who have a medical home reported better coordination of care, fewer medical errors, and greater satisfaction with care than those without one.” In addition, the study also found “that patients in the United States are much more likely than those in 10 other high-income countries to forgo needed care because of costs and to struggle with medical debt.” 27% “were unable to pay or encountered serious problems paying medical bills in the past year, compared with between 1 percent and 14 percent of adults in the other countries,” and 42% did not see a doctor, fill a prescription, or receive recommended care. The authors conclude that “[t]he United States in particular has opportunities to learn from abroad-including the use of purchasing power to lower prices, payment innovations, and the use of information systems and care system redesign efforts that are under way in several countries.”

Of course, there are a variety of reasons the experiences in other countries may not take root in the United States.  But we still should be aware of these efforts and critically evaluate whether we might transplant any of them as seeds of reform here.

Generic Drugs, Cost-Effectiveness, and Confidence

Smarter prescribing and better medication management are linchpins of current efforts to care for those with chronic medical conditions in a more consistent, coordinated, and, it is hoped, affordable manner.  A study reported in last month’s Health Affairs found that using medication to control patients’ blood sugar levels and lower their blood pressure and cholesterol is not just cost-effective, it can actually save money by reducing “downstream complications and the use of health services that outweigh the cost of the medications themselves.”  Notably, these cost savings can only be achieved if the medications in question are generics.  The authors conclude that “in a health care system strapped for resources, physicians will increasingly use generics, and patients will have to expect that most of their medications will be generic.”

As the authors also note, resistance to generics, on the part of both patients and their doctors, is longstanding and persistent.  Some of this can be chalked up to the intense and wide-ranging marketing campaigns that innovator companies mount on behalf of branded drugs.  Branded medications used to treat chronic conditions are especially heavily marketed, including through the use of free samples.  Numerous studies (here’s a recent one out of Vermont) show that physicians with sample closets in their offices are less likely than those without sample closets to prescribe generics where appropriate.

Interestingly, the Centers for Medicare and Medicaid Services announced earlier this year that Medicaid Part D prescription drug plans “may incur expenses related to distribution of and reporting on generic drug samples, provided to members within a physician’s office setting, under the plan’s administrative cost structure if doing so is consistent with a cost effective drug utilization management program.”  CMS explained that generic samples have the potential to reduce the government’s overall costs and to promote compliance with drug therapies by reducing enrollees’ current and future cost sharing expenses.  (George Van Antwerp argues here that CMS overstates the benefits of generic samples, but only because generic fill rates are rising so fast without them.)

Marketing is not the whole story behind lingering resistance to generics, though.  As the New York Times recently reported, most generic drugs are manufactured in “a shadowy network of facilities in China and India that are rarely visited by government inspectors, who sometimes cannot even find the plants.”  While plants in the United States are inspected at least once every two years, the Food and Drug Administration has historically lacked the resources to provide the same level of oversight to foreign facilities.  An “epoch-making” agreement between the FDA and generic drug manufacturers will, assuming it is approved by Congress, change this.  The manufacturers have agreed to pay $299 million in annual fees to, among other things, fund inspections of foreign plants on the same schedule that applies to domestic plants.  As the Times notes: “[T]he generic drug industry is no longer a motley collection of struggling mom-and-pop companies.  Years of consolidation have created giants like Israel-based Teva Pharmaceuticals that understand that their businesses depend on winning the confidence of patients and regulators alike, and they can afford to pay the fees needed to achieve that confidence.”

Can’t Teach an Old Doc New Tricks?

Reuters reports that,

According to findings in the American Journal of Medicine, patients whose doctors had practiced for at least 20 years stayed longer in the hospital and were more likely to die compared to those whose doctors got their medical license in the past five years.

The study, which was based in Montefiore Hospital in the Bronx, NYC, examined the records of over 6,500 patients of the teaching hospital from 2002 to 2004. Over the course of the study, there were 59 different attending physicians heading up 6 different teams, consisting of said attending, a medical student, and recent med school graduates.  A junior doctor randomly assigns patients to a team. The researchers grouped patients and according to length of practice for the attending– “five years or less,
six to 10 years, 11 to 20 years, or more than 20 years.”

Reuters reports,

At first glance, compared to patients with the newest doctors, those with the most experienced physicians had more than a 70 percent increase in their odds of dying in the hospital and a 50 percent increase in their odds of dying within 30 days.

However, when the researchers took into account how sick the patients were, they
found that only the sicker patients — those with complicated medical problems — were at higher risk in the hands of the more experienced doctors.

So… the good news here is that only sicker patients are at higher risk in the hands of the more experienced doctors. Those with complicated medical problems are more likely to die if seen by a more experienced doctor. Although I feel as though I should write this again, I fear it still won’t fully resonate. But let me try in simple, quasi-mathematic terms:  More sick + More Experienced Doctor = More Death.

No, it’s still not working for me, but Reuters spoke with Dr. Niteesh Choudhry of Harvard Medical School, who was not involved in the study but is said to have offered the following:

The problem, he said, is not with the capability of the more experienced doctors, but rather, their familiarity with more current guidelines and practices. The results suggest the need to rethink the way doctors are continually educated in the years after completing their certification, he added.

There’s more, and you can read it here.

Final Value-Based Purchasing Rule Released

On April 29, the Department for Health & Human Services (HHS) announced the launch of the Hospital Inpatient Value-Based Purchasing (Hospital VBP) program under the Medicare Inpatient Prospective Payment System (IPPS).  According to HHS, the Hospital HVP program “marks the beginning of an historic change in how Medicare pays health care providers and facilities-for the first time, 3,500 hospitals across the country will be paid for inpatient acute care services based on care quality, not just the quantity of the services they provide.”

As a part of the launch of the Hospital VBP program, authorized under § 3001(a) of the Patient Protection and Accountable Care Act of 2010 (ACA, codified at 42 U.S.C. § 1886(o)), the Centers for Medicare & Medicaid Services published the final rule outlining the measures, performance standards, scoring methodology, and methodology for translating hospitals’ Total Performance Scores into value-based incentive payments.

Why Should I Care?

Value-based purchasing has been called a “fast-approaching, mandatory competition with millions of dollars on the line.”  The program is aimed to fix two previously identified problems: (1) preventable medical errors and (2) resulting health care costs.  According to CMS:

One in seven Medicare patients will experience some “adverse” event such as a preventable illness or injury while in the hospital.  One in three Medicare beneficiaries who leave the hospital today will be back in the hospital within a month.  Every year, as many as 98,000 Americans die from errors in hospital care.

…

In addition to adding to the suffering of patients and their caregivers, these errors lead to significant unnecessary health care spending. Medicare spent an estimated $4.4 billion in 2009 to care for patients who had been harmed in the hospital, and readmissions cost Medicare another $26 billion.

The Hospital VBP program marks a shift in CMS reforms, from “pay-for-reporting” to “pay-for-performance.”  In 2003, the Hospital Inpatient Quality Reporting (IQR) Program introduced the core-measures concept.  Hospitals that did not successfully report data under the IQR program were penalized by a 2.0 percentage point reduction in their applicable percentage increase.   The Hospital VBP program continues using payment incentives and takes the next logical step “in promoting higher quality care for Medicare beneficiaries and transforming Medicare into an active purchaser of quality health care for its beneficiaries.”  The Hospital VBP program now directly ties payment amounts to a hospital’s performance score.  CMS will begin measuring hospital performance for incentive payments this July.

To fund the Hospital VBP incentive program, CMS will reduce the base operating diagnosis-related group (DRG) payment by 1% in FY 2013 and increase withholding by 0.25% each year until it peaks at 2% in FY 2017.  As a result, approximately $850 million will be allocated for the Hospital VBP program in FY 2013.  Since overall Medicare spending for inpatient stays at acute care hospitals will remain constant, the new payment scheme will benefit some hospitals and hurt others.  As the Hospitalist writes, “[i]t’s also a zero-sum game. That means there will be winners and losers, with the entire cost-neutral program funded by extracting money from the worst performers to financially reward the best.”

How It Works

As summarized by our very own Kate Greenwood:

[§ 3001(a)], which applies to patients discharged on or after October 1, 2012, establishes “value-based purchasing,” meaning that the government will make “value-based incentive payments” to hospitals that provide care to Medicare patients that meets or exceeds certain performance standards to be established by the Secretary of Health and Human Services.  Initially the standards must relate to at least the following five conditions: heart attack, heart failure, pneumonia, surgery, and healthcare-associated infections.  Eventually (by fiscal year 2014) the standards are to incorporate “efficiency measures,” that is Medicare spending per beneficiary must be a factor.

Beginning in FY 2013 (October 1, 2012), hospitals will receive incentive payments “based on how well they perform on each measure or how much they improve their performance on each measure compared to their performance on the measure during a baseline performance period.”  The final rule adopts twelve clinical process of care measures and one patient experience measure, the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey.  These measures overlap or align with the Hospital Inpatient Quality Reporting (IQR) Program measures.

FY 2013 Objective Measures

Acute Myocardial Infarction
AMI-7a	Fibrinolytic Therapy Received Within 30 Minutes of Hospital Arrival
AMI-8a	Primary PCI Received Within 90 Minutes of Hospital Arrival
Heart Failure
HF-1	Discharge Instructions
Pneumonia
PN-3b	Blood Cultures Performed in the ED Prior to Initial Antibiotic Received in Hospital
PN-6	Initial Antibiotic Selection for CAP in Immunocompetent Patient
Healthcare-associated Infections
SCIP-Inf-1	Prophylactic Antibiotic Received Within One Hour Prior to Surgical Incision
SCIP-Inf-2	Prophylactic Antibiotic Selection for Surgical Patients
SCIP-Inf-3	Prophylactic Antibiotics Discontinued Within 24 Hours After Surgery End Time
SCIP-Inf-4	Cardiac Surgery Patients with Controlled 6AM Postoperative Serum Glucose
Surgical Care Improvement
SCIP-Card-2	Surgery Patients on a Beta Blocker Prior to Arrival That Received a Beta Blocker During the Perioperative Period
SCIP-VTE-1	Surgery Patients with Recommended Venous Thromboembolism Prophylaxis Ordered
SCIP-VTE-2	Surgery Patients Who Received Appropriate Venous Thromboembolism Prophylaxis Within 24 Hours Prior to Surgery to 24 Hours After Surgery

In FY 2014, CMS will add thirteen more measures.

FY 2014 Objective Measures

Acute Myocardial Infarction
Mortality-30-AMI	Acute Myocardial Infarction (AMI) 30-day Mortality Rate
Mortality-30-HF	Heart Failure (HF) 30-day Mortality Rate
Mortality-30-PN	Pneumonia (PN) 30-Day Mortality Rate
Hospital Acquired Condition Measures
	Foreign Object Retained After Surgery
	Air Embolism
	Blood Incompatibility
	Pressure Ulcer Stages III & IV
	Falls and Trauma:  (Includes:  Fracture, Dislocation, Intracranial Injury, Crushing Injury, Burn, Electric Shock)
	Vascular Catheter-Associated Infections
	Catheter-Associated Urinary Tract Infection (UTI)
	Manifestations of Poor Glycemic Control
AHRQ Patient Safety Indicators (PSIs), Inpatient Quality Indicators (IQIs), and Composite Measures
	Complication/patient safety for selected indicators (composite)
	Mortality for selected medical conditions (composite)

Hospitals will be scored according to achievement (compared to all other hospitals) and improvement (over each hospital’s baseline) for each applicable measure.  Achievement points will be awarded if the hospitals performance during the measurement period (quarterly) exceeds the 50^th percentile of hospitals measured during the baseline period (the “threshold”).  Improvement points will be awarded to the extent that a hospital’s current performance exceeds baseline period performance.

Baseline scores for improvement measurement have already been set, during the period from July 1, 2009 to June 30, 2010.  The FY 2013 performance period for clinical process of care measures will be July 1, 2011 through March 31, 2012.  July 1, 2011 will also mark the beginning of a 12-month performance period for the FY 2014 30-day mortality measures.

The Total Performance Score (TPS) is calculated “for each hospital by combining the greater of its achievement or improvement points on each measure to determine a score for each domain, multiplying each domain score by the proposed domain weight and adding the weighted scores together.”  In 2013, clinical measures will account for 70% of a hospital’s performance score and the HCAHPS survey for 30%.  Over time, scoring methodologies will be “weighted more heavily towards outcome, patient experience, and functional status measures.”

Future Changes

Moving forward, CMS will implement other ACA provisions designed to improve care and reduce costs.  For instance, hospitals will begin receiving reduced payments in FY 2015 if they are unable to prevent certain hospital acquired infections or if the hospital fails to “meaningfully use information technology to communicate within the hospital to deliver better, safer, more coordinated care.”  Check prior posts to learn more about HITECH’s “Meaningful Use” Rule.

Do I Need 9 Lives Just to Get a Cat Scan?

Tonight’s post will be relatively brief, as I wish only to call attention to another post and a particularly disturbing number contained therein. The post was published over at The Health Care Blog by Robert Wachter, MD, a leading figure in the modern patient safety movement. It is entitled “A Game-Changing Statistic: 1 in 250.” It is. Or at least it should be. You should take a minute or two to read it– it’s provoking, and not in a good way.

The 1 in 250 refers to the odds of getting cancer from a single CT scan.

Wachter writes:

Last month, my colleague Rebecca Smith-Bindman, professor of radiology, epidemiology, and ob/gyn at UCSF and one of the nation’s experts in the risks of radiographs, gave Medical Grand Rounds at UCSF. Her talk was brimming with amazing statistics, but this is the one that took my breath away:

A 20-year old woman who gets an abdominal-pelvic CT scan (i.e., just about any young woman coming to the ED with belly pain) has a 1 in 250 chance of getting cancer from that single scan.

Did that fully register? One CAT scan, which until recently most of us ordered with no more restraint than we exhibit when asking the Starbucks barista for a tall latte, will cause cancer in one out of every 250 patients. Two-hundred fifty: that’s the number of students in my college Bio 101 class. Wow.

Wachter adds fuel to that disturbing fire and reports that his above mentioned colleague found both increased radiation dosage (66% greater than that which is the usually quoted dose) and wide variation in dosage among different scanners in 4 Bay area hospitals.

If the variation and increased dosage isn’t scary enough, perhaps this nugget from Wachter regarding the usual dose is:

• A multiphase abdominal/pelvic CT scan has the same radiation wallop as 500 transcontinental flights, 450 chest radiographs, and 74 mammograms.

The effects? Well, there’s the 1 in 250 number, but Wachter is kind enough to give us an aggregate estimate:

• The best estimates are that radiation from CT scans causes 29,000 excess cancers each year in the U.S., mostly in women.
• Researchers estimate that 15,000 people will die from the direct effects of the 72 million CT scans performed in 2007 alone.

And if that weren’t enough, it seems the death and danger are accompanied by widespread ignorance–

• A 2004 study found that less than 50 percent of radiologists, and 9 percent of ER docs, were aware that CT scans could increase the subsequent risk of cancer.

Unfortunately, quite a few CT scans are done each year. And the number has risen dramatically over the last few decades–a more cynical man (or perhaps just a man who has read Atul Gawande and Adam Smith) might think the increase in usage might bear some relationship to the high cost of purchase for a CT scan machine-Buy it and they will come. Wachter tells us that

• One in five Americans will receive a CT scan in any given year; some experts suggest that at least one-third of those scans are unnecessary.

Even if only one-fifth were unnecessary, with a 1 in 250 chance of getting cancer from a single scan, the odds are ugly– and at least in some cases, amount to a dire risk without any merit whatsoever. In other cases, we risk greatly for minimal gain–and, perhaps, most disturbingly, that risk is often called for by doctors and radiologists who are sans knowledge of the risk. Yes,  a 1 in 250 chance of getting cancer from a single scan–when you perform 72 million of them per year–should be a game changer.

Recommended Reading: Recent Legal Scholarship on Health Reform

In recent months, the first law review articles on the Patient Protection and Affordable Care Act (PPACA) have begun to appear. I highlight here two very recent contributions to the legal literature that are well-worth reading.

In Setting National Standards for Health Plans Under Healthcare Reform (published in the October 2010 issue of the UCLA Law Review) Jessica Mantel argues persuasively that the notice-and-comment rulemaking procedure set forth in PPACA for defining “essential health benefits” will result in politically-driven decisions that do not serve the broad public interest, using as one case study the controversy over the U.S. Preventive Services Task Force’s recommendations regarding routine screening mammograms.  Professor Mantel proposes that the power to define essential health benefits be vested not in the Secretary of Health & Human Services, as PPACA provides, but instead in an independent commission — modeled on the Base Realignment and Closure Commission — that “could give more careful consideration to the relevant empirical evidence on clinical efficacy and cost-effectiveness, showing sensitivity to the concerns of all individuals impacted by its decisions, correct for fallacies or biases in public opinion, and exercise moral powers of persuasion in evaluating the various policy options.”  The commission’s proposed package of essential health benefits would be subject to an up-or-down vote in Congress and any subsequent changes Congress wished to make would be subject to an “actuarial offset requirement,” i.e., if Congress wanted to expand coverage in one area it would have to contract it in another.  Professor Mantel considers the possibility that the resultant benefits package would tilt in favor of well-organized, wealthy special interest groups but ultimately discounts it, in part because “groups defending the status quo have important advantages over those seeking new mandated benefits legislation.”  Even if Professor Mantel’s proposed reform to healthcare reform is not adopted, her article’s thoughtful analysis of the potential for politics to interfere with the establishment of fair and reasonable national coverage standards is a very valuable contribution.

Richard Saver’s Health Care Reform’s Wild Card: The Uncertain Effectiveness of Comparative Effectiveness (forthcoming in the University of Pennsylvania Law Review) similarly addresses a weakness in PPACA — in this case, its “fail[ure] to bet smart and play the [comparative effectiveness research (CER)] wild card effectively.”  Professor Saver highlights a number of what he calls “translation barriers” that “jeopardize making productive use of governmentally funded CER.”  Included among these is vagueness in the statutory definition of comparative effectiveness that leaves unclear the extent to which cost effectiveness can or should be evaluated and creates the potential for “misson-creep.”  Other barriers include the fact that comparative effectiveness studies are (1) costly, (2) pose design and execution challenges, (3) may raise more questions than they answer, (4) fail to account adequately for patient and provider differences, and (5) fail to keep pace with innovation.  Surpassing all these in importance, Professor Saver argues, is the simple fact that physicians lack “strong incentives . . .  to adapt to CER.”  He concludes his article by laying out a number of concrete steps to address these translation barriers, including rewarding physicians who follow evidence-based practice recommendations with enhanced reimbursement and liability safe harbors, deploying academic detailers to persuade physicians to conform their practices to CER, and systematically studying what implementation methods work and what do not.   I recommend this article for its comprehensive and insightful analysis of the comparative effectiveness research component of health reform and also for its fascinating discussion of the reasons (some legitimate and some less so) underlying practicing physicians’ resistance to CER.

Accountable Care Organizations: Landmark Report from California

Earlier this week the Integrated Healthcare Association (IHA) released an important whitepaper entitled “Accountable Care Organizations in California — Lessons for the National Debate on Delivery System Reform.” (Click here for a pdf of the whitepaper). The IHA describes itself as: “a statewide multi-stakeholder leadership group that promotes quality improvement, accountability and affordability of health care in California. “

ACOs have been discussed before at HRW in the context of reforming the health care delivery system. Unfortunately, ACOs are relatively new and untested. This is what makes California — a tried-and-true state policy laboratory — a valuable laboratory for health reform, particularly for models like the ACO that the reform law attempts to leverage. The tables provided in the whitepaper make it easy to appreciate California’s experience with ACOs:

The upshot of IHA’s report are the ten lessons that they have distilled from the 285+ physician organizations that together display many of the characteristics of ACOs. These lessons are as follows:

Lesson One: A variety of organizational structures are effective at delivering high quality coordinated care; at least as important to success as structure are an organization’s capabilities, culture and infrastructure, as well as the alignment of goals between the organization and its individual physicians.

Lesson Two: In California, a range of relationships exist between physician organizations and hospitals. Alignment of incentives between physician organizations and hospitals offer important opportunities for performance improvements across the entire continuum of care.

Lesson Three: As a method of payment, capitation can be effective at encouraging coordinated care, but payment methods should vary across ACOs depending on an organization’s ability to assume risk.

Lesson Four: Health plans acting in concert on payment methods and performance measurement helped facilitate the growth of California’s provider organizations, and should also play an integral part in fostering ACO development nationally.

Lesson Five: ACOs are not a panacea for healthcare spending control.

Lesson Six: ACOs must be agnostic to insurance type; most provider organizations in California have focused on commercial, Medicare and Medicaid HMO plans for their patients, but for ACOs to be viable across the country, mechanisms must be found to encourage PPO and traditional Medicare and Medicaid patients to use their services.

Lesson Seven: Balancing patient choice with the desire to decrease costs and effectively coordinate care is difficult. California’s experience underscores the challenge of promoting care coordination in an environment of unrestricted provider choice.

Lesson Eight: Regulation of the financial solvency of provider organizations is important to ensure market stability.

Lesson Nine: Consumer protections from capitated provider organizations need to be balanced, not overburdening.

Lesson Ten: Special attention must be given to establishing ACOs in areas with social and economic challenges.

There is a common thread that runs through many of these lessons: the tension between new organizational models and the payment models that currently exist:

In California, provider organizations have developed hand-in-hand with HMO products, and have been largely unsuccessful in their attempts to diversify into serving PPO patients. This has been driven in part by regulatory restrictions at both the State and  Federal  level  surrounding  providers  accepting capitation  and  FFS  payments. Downward trends in HMO enrollment in California have meant that this failure to diversify has limited the impact of the state’s physician organizations. In order for ACOs to flourish, laws and policies must allow for innovative provider payment arrangements, regardless of insurance type, and internal organizational changes will be needed to adapt to different payment methods.

As the report goes on to describe:

The greatest challenge and greatest opportunity facing ACOs in California and elsewhere is the potential for integrating the coordinated care programs developed originally for HMO and other narrow network insurance products into PPO and other broad network products.

The managed-care backlash of the 1990s is a reminder that past is prologue.  Increased consumer choice through products like PPOs is likely here to stay for quite some time. What remains to be seen is how the future regulations governing ACOs will promote greater collaboration in the delivery of care while embracing the payment models that consumers have come to appreciate and expect.

Office of the Inspector General Releases 2011 Work Plan

On October 1, the Office of the Inspector General (”OIG”) of the U.S. Dept. of Health & Human Services (”HHS”) released its Work Plan for Fiscal Year 2011 (”Work Plan”).  Each year, the OIG briefly outlines activities that OIG “plans to initiate or continue with respect to the programs and operations” of HHS.  Various offices within OIG conduct audit, evaluation, investigation, enforcement, and compliance activities.

Continuing Work Within OIG

Many of the topics outlined in the Work Plan were included in last year’s plan.  Although the repeated inclusion of these areas of focus makes compliance easier for facilities, audits should still be conducted in the following areas:

• Provider-based status
• Observation services (as part of an outpatient visit)
• Part A hospital capital payment
• Critical access hospitals
• Medicare disproportionate share payments
• Duplicate graduate medical education payments
• Hospital readmissions
• Hospital admissions with conditions coded present-on-admission
• Inpatient rehabilitation facility transmission of patient assessment instruments
• Medicare excessive payments

New Issues to be Targeted

“What we’re really looking at are four or five really brand new issues,” said Stephen Miller, JD, chief compliance and privacy officer for Trenton, NJ-based Capital Health System, Inc. for HealthLeadersMedia.com.

• Brachytherapy reimbursement
• Replacement of devices received at no cost or reduced cost
  • According to Debbie Mackaman, RHIA, CHCO, regulatory specialist for HCPro, Inc., in Marblehead, MA, “Since the medical devices replacement issue can be a difficult billing procedure to comply with, facilities should certainly do an in-depth process audit in this area.”
• Safety and quality of intensity-modulated radiation therapy (IMRT) and image-guided radiation therapy (IGRT)
  • Indicates a responsiveness on the part of OIG to headlines regarding quality concerns.  In March, the Nuclear Regulatory Commission fined Philadelphia Veterans Affairs Medical Center $227,500, its second largest fine ever against a medical institution, after “unprecedented number” of radiation errors in treating prostate cancer patients.
• Hospitals’ application of the “three-day rule” and “one-day rule” under the Preservation of Access to Care for Medicare Beneficiaries and Pension Relief Act of 2010
  • Many hospitals have had difficulty in billing under the new rules, which redefined what services are related to the admission, and therefore not eligible for Medicare payment within the defined window.  According to Mackaman, “IPPS facilities should be vigilant about reviewing the current three-day rule, and the non-IPPS hospitals should review the addition of the one-day rule.”  CMS guidance on this topic can be found here.

OIG Review of FDA Administration

As HealthReformWatch previously reported, nine Food & Drug Administration (”FDA”) scientists from the Center for Devices and Radiological Health (”CDRH”) sent a letter to President Obama stating, in relevant part, that:

the scientific review process for medical devices at the FDA has been corrupted and distorted by current FDA managers, thereby placing the American people at risk. Managers with incompatible, discordant and irrelevant scientific and clinical expertise in devices…have ignored serious safety and effectiveness concerns of FDA experts. Managers have ordered, intimidated and coerced FDA experts to modify scientific evaluations, conclusions and recommendations in violation of the laws, rules and regulations, and to accept clinical and technical data that is not scientifically valid.

These scientists also wrote to Congress in 2008, accusing the top FDA officials of “serious misconduct” in ignoring scientist concerns and “approving for sale unsafe or ineffective medical devices,” according to the N.Y. Times.

According to Washington G-2 Reports, OIG also stated on September 29 that “it would re-examine the concerns of those FDA reviewers, and broaden the scope of its inquiry.”

This coming year, OIG intends to investigate CDRH “policies and procedures for resolving scientific disputes about approval of devices.”  The Work Plan states that OIG will:

review a sample of administrative files for disputed device decisions and assess the extent to which regulations, policies, and procedures were followed during the dispute resolution process. We will also assess whether CDRH managers and staff are aware of and trained on policies and procedures for resolving scientific disputes.

Additionally, OIG will continue to review FDA oversight of investigational new drug applications, the process for device approval, and oversight of postmarketing surveillance studies of medical devices.

Health Care and Disparity in a “Post-Racial” Era

Seton Hall Law School recently hosted the Third National People of Color Conference, which was convened to “address critical national and global issues through the lens of legal scholarship that explicitly and implicitly examines contemporary racial context.”

The conference brought together over 400 judges, law professors, lawyers and students to our campus over the course of  four days and featured panels and speeches by people such as the Reverend Jesse Jackson; the Honorable Cory Booker, Mayor of Newark, New Jersey; Professor Derek Bell, Visiting Professor at New York University School of Law; Kathleen Martinez, Assistant Secretary of Labor for Disability Employment; The Honorable Joseph A. Greenaway, U.S. Court of Appeals, Third Circuit; Gay McDougall, United Nations Independent Expert on Minority Issues; Keith Harper, former Appellate Justice of the Mashantucket Pequot Tribal Nation; and just too many other smart and interesting people to list here. (A good account of the Conference in Diverse Magazine can be found here).

Involved in some of the on site prep work, I was unable to attend nearly as much as I would have liked. But I did have the opportunity to listen to a number of thought provoking presentations, including speeches by Jesse Jackson, Mayor Booker, Keith Harper and Katleen Martinez.

In considering the theme of the conference, “Our Country, Our World in a ‘Post-Racial’ Era,” it was made clear time and time again that despite the rhetoric that has bounced about our nation since President Obama took office, when looking at numerical indicators for well being in the United States racial identity, ethnicity, gender, sexual identity, and disability status matter.

I realize that I am saying nothing new here–nor am I saying it as well as I heard it. But I think it also bears repeating.

It is also worth noting, when looking at the disparity in health care access, utilization, and quality of received care, that here in New Jersey as a response to a budget crisis, the state recently summarily stripped over 12,000 legal immigrants of their right to health care through Medicaid. Our Center for Social Justice here at Seton Hall Law has sued the State of New Jersey for doing so as a violation of both the state and federal constitutions as a matter of, among other things, equal protection. Such actions by the state assuredly do not bode well for the health care variance numbers below; and maybe, when considering the disparities in health care, “equal protection,” in the largest sense of the word, is the appropriate lens through which to view this.

But it is also, within the context of anyone’s verbal meanderings about a supposed “post-racial” society, important to note that news of the suit was featured in the Wall Street Journal, Star Ledger, Asbury Park Press, The Record, The Daily Record, The Courier Post, Home News & Tribune, The Jersey Journal, MSNBC, PolitickerNJ, Newsday, Immigration Prof Blog and other media throughout New Jersey, New York, Pennsylvania, and Connecticut.

Reader’s comments were decidedly not kind. Having done a great deal of work with and for immigrant communities, the urban disenfranchised, Guantanamo Detainees, and others unpopular and unjustly treated, we’re used to it here at Seton Hall Law. But I invite anyone entertaining delusions about a “post-racial” era to take a look at the comments. Or, for that matter, the comments on almost any newspaper article that deals with immigration– or race.

Having said that, I also invite you to take a look at the following numbers and study results from HHS’ Agency for Healthcare Research and Quality. Below that, you’ll find a really interesting lecture from a Health Care Disparities Class at Case Western Reserve University from Professor Insoo Hyun. The video is courtesy of the Case Center for Reducing Health Disparities and their well produced blog and resource center.

As for the studies and numbers, though just a small sampling, I’ll let them speak for themselves:

Identifying Disparities in Care

Access to Primary Care

Primary care is the underpinning of the health care system, and research studies have shown that having a usual source of care raises the chance that people receive adequate preventive care and other important health services. Data from AHRQ’s Medical Expenditure Panel Survey (MEPS) reveal that:

• About 30 percent of Hispanic and 20 percent of black Americans lack a usual source of health care compared with less than 16 percent of whites.
• Hispanic children are nearly three times as likely as non-Hispanic white children to have no usual source of health care.
• African Americans and Hispanic Americans are far more likely to rely on hospitals or clinics for their usual source of care than are white Americans (16 and 13 percent, respectively, v. 8 percent).

Diagnosis and Treatment

Race and ethnicity influence a patient’s chance of receiving many specific procedures and treatments. Of nine hospital procedures investigated in one study, five were significantly less common among African American patients than among white patients; three of those five were also less common among Hispanics, and two were less common among Asian Americans. Other AHRQ-supported studies have revealed additional disparities in patient care for various conditions and care settings including:

• Heart disease. African Americans are 13 percent less likely to undergo coronary angioplasty and one-third less likely to undergo bypass surgery than are whites.
• Asthma. Among preschool children hospitalized for asthma, only 7 percent of black and 2 percent of Hispanic children, compared with 21 percent of white children, are prescribed routine medications to prevent future asthma-related hospitalizations.
• Breast cancer. The length of time between an abnormal screening mammogram and the followup diagnostic test to determine whether a woman has breast cancer is more than twice as long in Asian American, black, and Hispanic women as in white women.
• Human immunodeficiency virus (HIV) infection. African Americans with HIV infection are less likely to be on antiretroviral therapy, less likely to receive prophylaxis for Pneumocystis pneumonia, and less likely to be receiving protease inhibitors than other persons with HIV. An HIV infection data coordinating center, now under development, will allow researchers to compare contemporary data on HIV care to examine whether disparities in care among groups are being addressed and to identify any new patterns in treatment that arise.
• Nursing home care. Asian American, Hispanic, and African American residents of nursing homes are all far less likely than white residents to have sensory and communication aids, such as glasses and hearing aids. A new study of nursing home care is developing measures of disparities in this care setting and their relationship to quality of care.

Looking Beyond Income and Insurance

Disparities in health care are often ascribed to differences in income and access to insurance. Research has shown these to be important, but by no means the only factors. For instance, the proportion of Hispanic Americans with a usual source of care has declined substantially over the past decade (from 80 percent in 1986 to 70 percent in 1996). Insurance coverage has also declined, and the lack of insurance in some groups is dramatic (among Hispanic men, for instance, 37 percent have no health insurance). Nonetheless, declines in insurance coverage explained only one-fifth of the change in access to a usual source of care.

In another recent study, AHRQ-funded researchers in Boston examined the quality of care provided to hospital patients with congestive heart failure or pneumonia. Quality of care was measured both by physician review and by adherence to standards of care. The researchers found no difference in quality of care for patients from poor communities compared with other patients, after adjusting for other factors. They did find, however, that African American patients received a lower quality of care than white patients.

Physician Decisionmaking

A small study of physicians’ decisions about whether to refer patients for cardiac catheterization, a diagnostic procedure for heart disease, provides supportive evidence that factors other than insurance and income can influence the quality of care people get. This study, which used actors portraying similar economic backgrounds, found that black women were significantly less likely than white men to be recommended for referral, despite reporting the same symptoms. (Differences between other groups studied were not statistically significant.)

Hospital Characteristics

In the Boston study of the quality of care, quality for African American patients was lower in nonteaching than in teaching hospitals. In another study, white patients were more likely than Hispanic and African American patients to receive invasive cardiac procedures in hospitals performing a high volume of such procedures, a factor strongly associated with the quality of cardiac care.

Petitioners Ask OSHA to Regulate Resident Physician Work Hours

On September 2, Assistant Secretary David Michaels for Occupational Safety and Health received a petition requesting that OSHA regulate resident physician and subspecialty resident physicians.  “Depending on the type of residency, physicians-in-training can work anywhere from 60 to 100 or more hours a week, sometimes without a day off for two weeks or more.”  The petition requests that OSHA exercise the authority granted under §3(8) of the Occupational Safety and Health Act to implement the following federal work-hour standard:

(1)   A limit of 80 hours of work in each and every week, without averaging;

(2)   A limit of 16 consecutive hours worked in one shift for all resident physicians and subspecialty resident physicians;

(3)   At least one 24-hour period of time off work per week and one 48-hour period of time off work per month for a total of five days off work per month, without averaging;

(4)   In-hospital on-call frequency no more than once every three nights, no averaging;

(5)   A minimum of at least 10 hours off work after a day shift, and a minimum of 12 hours off after a night shift;

(6)   A maximum of four consecutive night shifts with a minimum of 48 hours off after a sequence of three or four night shifts.

More information about the petition can be found at the Public Citizen-run website, WakeUpDoctor.org.

Present Accreditation Standards

The Accreditation Council for Graduate Medical Education (ACGME), “[a]s the accrediting body for more than 8,800 medical residency programs,… is charged with setting and enforcing standards for supervision and resident duty hours for graduate medical education.”  In 2002, OSHA denied a petition by Public Citizen, the Committee of Internists and Residents (CIR), and American Medical Student Association, citing the voluntary adoption of standards by ACGME.  In 2003, the ACGME set standards that restricted resident work hours to 80 hours per week when averaged over four weeks and no more than 30 consecutive hours of work.  (A breakdown of the differences between the OSHA petition and ACGME 2003 standards can be found here.)

In 2007, the Institute of Medicine (IOM) evaluated resident work standards pursuant to a request from Congress. The resulting report, “Resident Duty Hours: Enhancing Sleep, Supervision, and Safety” found, among other things, that considerable scientific evidence demonstrates that “30 hours of continuous time awake, as is permitted and common in current resident work schedules, can result in fatigue, and that adjustments to the 2003 rules are needed.”  In response, the ACGME proposed revised standards for resident work hours and supervision.  The comment period ended on August 9 and the changes will be implemented after July 2011.

The Substance of the Petition

According to petitioners, the ACGME revised standards are not sufficient.  A study by Landrigan et al. found that even after implementation of the ACGME’s 2003 standards:

• The average work week was 66.6 hours (95% confidence interval [CI] 66.3-66.9);
• The mean length of an extended shift was 29.9 hours (95% CI, 29.8-30);
• 29% of all work weeks were more than 80 hours in duration, 12.1% were 90 or more, and 3.9% were 100 hours or more;
• 83.6% of all interns reported hours of work in violation of the professional self-regulations that were established and are being monitored by the ACGME. This number far exceeds the rates of violations reported by resident physicians and residency programs to the ACGME, indicating both that widespread under-reporting exists, and that the ACGME’s enforcement has been ineffective.

According to the petition, these numbers of hours are among the highest in the professional world and negatively affect personal health and safety.  Despite the previous rejection of a similar petition in 2002, the petitioners have changed their strategy in appealing to OSHA:  “Whereas previous appeals to limit resident physicians’ work hours have focused on the well-documented risks patients face due to tired physicians, this petition concentrates on the often-overlooked health risks faced by the resident physicians who endure those long hours.”  These risks include:

• Motor Vehicle Accidents — In addition to anecdotal evidence that resident fatigue after long work hours has resulted in physical injury and death, the petition offered the following research:
  • A Journal of the American Medical Association (JAMA) informal survey found that “[o]f seven surgical residents in our hospitals who we interviewed, six fell asleep while driving to or from work during their internships and three were involved in motor vehicle accidents.”
  • A New England Journal of Medicine (NEJM) study found that “risk of a motor vehicle crash was increased significantly following a work shift of 24 hours or greater,” as well as the risk of a near miss.
  • Sleep deprivation researchers at John Hopkins Hospital found that “[f]orty-nine percent of resident physicians [questioned] reported falling asleep at the wheel (not necessarily at a stop light), and 90% of these events occurred after the resident physicians had worked an extended duration (> 24-hour) shift.”
  • An Anesthesiology abstract reported that 17% of survey respondents reported post-call automobile accidents and 72% reported near misses.
• Mental Health

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    Capricho No 43, "The sleep of reason produces monsters." Francisco de Goya (1746–1828)

    One study described “house officer stress syndrome.” Caused in large part by sleep-deprivation and excessive work load, physicians-in-training may suffer from (1) episodic cognitive impairment, (2) chronic low-grade anger with outbursts, (3) pervasive cynicism, (4) family discord, (5) depression, (6) suicidal ideation and suicide, and (7) substance abuse.

  • Four studies demonstrated that residents are unhappy, face high levels of stress, and suffer “major problems” in their personal relationships with others.
  • Three studies demonstrated that on-call residents reported greater mood disturbance and increased negative mood than those who were rested.
  • One study found that as many as 30% of residents experience depression during their residencies.
  • A study published in the Archives of Internal Medicine found that 21% of residents reported depressed scores on the Center for Epidemiological Studies-Depression (CES-D) scale and that depressed responses increased with longer work weeks. Two other studies also found increased rates of depression among residents that correlated with high work hours.
• Pregnancy
  • A NEJM study reported that premature labor and preeclampsia or eclampsia was twice as common among pregnant residents as the wives of male residents and that residents working more than 100 hours per week in the third trimester were twice as much at risk for preterm delivery than those that worked fewer than 100 hours.
  • The pre-term labor and preeclampsia risk was validated by a study published in Obstetrics and Gynecology.
  • One study found that infants born during residency significantly more likely to be born with intrauterine growth restriction.
• Percutaneous Injuries (such as needlestick injuries)

  • 

    Saint Sebastian, Carlo Crivelli (1490-91)

    A JAMA study of self-reported percutaneous injuries in residents found that substantially increased risk during day shifts after overnight call as compared with day shifts not preceded by overnight call.

  • “An Annals of Surgery study from 2005 found that 20 to 38% of all procedures in one urban academic teaching hospital involved exposure to HIV, HBV or HCV.”
  • A NEJM study found that 99% of all residents had suffered a needlestick injury by their final year of study. Fatigue was the second most common reason given for the injury.

Additionally, this petition has more public support than the one submitted in 2002.  Petitioners include:

• Public Citizen, a consumer and health advocacy group with 150,000 members and supporters;
• the Committee of Interns and Residents/SEIU Healthcare (CIR/SEIU), a housestaff union, part of SEIU, representing over 13,000 resident physicians;
• the American Medical Student Association (AMSA), a national organization representing over 33,000 physicians-in-training;
• Bertrand Bell, M.D., Professor of Medicine at Albert Einstein College of Medicine and author of New York State Health Code 405 restricting resident physician work hours;
• Charles A. Czeisler, Ph.D., M.D., Baldino Professor of Sleep Medicine, Harvard Medical School;
• Christopher P. Landrigan, M.D., M.P.H., Assistant Professor of Pediatrics and Medicine, Harvard Medical School;
• Plus forty-five health-related organization and over 1,000 individuals.

Response to the Petition

In order to fulfill OSHA’s mission “to send every worker home whole and healthy every day,” the petition argues that OSHA must “act now to address the dangers that extreme work hours pose for resident physicians and subspecialty resident physicians.”

In a statement released the same day, Assistant Secretary Dr. David Michaels recognized the concerns raised by the petition:

We are very concerned about medical residents working extremely long hours, and we know of evidence linking sleep deprivation with an increased risk of needle sticks, puncture wounds, lacerations, medical errors and motor vehicle accidents. We will review and consider the petition on this subject submitted by Public Citizen and others.

The relationship of long hours, worker fatigue and safety is a concern beyond medical residents, since there is extensive evidence linking fatigue with operator error… All employers must recognize and prevent workplace hazards. That is the law. Hospitals and medical training programs are not exempt from ensuring that their employees’ health and safety are protected.

However, ACGME believes that the revised rules under development are adequate.  According to medpagetoday.com, the ACGME said the following in a prepared statement:

As the Occupational Safety and Health Administration reviews a petition from three special interest groups requesting federal regulation of resident duty hours, the Accreditation Council for Graduate Medical Education stands ready to share with OSHA the many studies, evidence, and documentation that substantiate the standards proposed by the ACGME Task Force on Quality Care and Professionalism.

We May Need More Than A Spoonful Of Sugar To Help Our Medicine Go Down

Today CNNMoney reports that drug recalls quadrupled from 426 in 2008 to a record 1,742 in 2009.  The recalls have been attributed to “manufacturing lapses” in raw material quality, labeling and packaging, and contamination.  Generic and over-the-counter drugs have been affected the most.  CNNMoney notes that the race to put generic products on the market and the pressure to cut costs have caused drug companies to

sometimes fail to spend enough time learning how best to make the drug….  And since generic and over the counter drugs aren’t as lucrative for drugmakers as prescription drugs, companies may not be investing enough resources to make high-quality, safe products.

One such cost-cutting measure involves outsourcing production to foreign manufacturing sites and this measure seems to have received the most attention.  (Check out fellow blogger Jae W. Joo’s post on outsourcing.)

Earlier this month, Senator Michael Bennet (D-Colorado) introduced the Drug and Safety Accountability Act of 2010 which seeks to ensure the safety and efficacy of drugs sold in America, regardless of their manufacturing location.  The bill would require, among other things, that:

• manufacturers have quality management plans which the FDA can inspect;
• manufacturers maintain supply chain documentation;
• the Secretary of Health and Human Services track facilities manufacturing drugs or active ingredients for the American market; and
• the FDA be given more power to ensure drug safety, including the authority to enact mandatory recalls for batches of drugs that pose risks and to assess civil penalties for violations of the Federal Food, Drug, and Cosmetic Act.

Click here for more details about the bill and here for Sen. Bennet’s own promotion of it.  Sen. Bennet has lamented how:

[f]or too long, the FDA has lacked the proper authority to adequately safeguard our drug supply.  Americans need to be able to trust that the drugs in their medicine cabinets are safe, no matter where they’re made.

A father of three, Sen. Bennet has said that the recent McNeil recall of over-the-counter children’s medicine spurred him into action.

Pharmaceutical Research and Manufacturers of America (PhRMA) Senior Vice President Ken Johnson has issued a statement in response to the bill, saying that:

[t]he lifeline of America’s biopharmaceutical research companies is the safety and integrity of the products they develop.  Brand-name pharmaceutical companies make tremendous investments in quality control systems and take extensive measures to help protect patient safety and to help prevent adulterated ingredients from entering into America’s prescription drug supply.

In addition, drug manufacturing for the U.S. market — regardless of where it occurs — is regulated under Good Manufacturing Practices (GMP) by the Food and Drug Administration (FDA).  These GMP requirements help to assure the safety, quality and purity of drug ingredients that are used in the U.S. prescription drug supply.

The U.S. regulatory system for prescription drugs is the toughest and safest in the world….

Okay.  But other people here don’t think so.  (Click here to read a good opinion by Dr. Lynn Parry, Chair of the Colorado Prescription Project, on why this bill should pass.)

According to a recent Pew Prescription Project poll, less than 10% of Americans feel confident about medications manufactured in India and China.  89% of Americans support Congressional action to introduce new drug safety measures.  How many of those people realize that approximately 80% of the materials used to make or package drugs sold in America comes from foreign sources?  I didn’t, but then, is such high a percentage really that surprising?

Reading through the CNNMoney report, I was reminded a little of a scene from a seventh season episode of Friends:

Phoebe: It’s amazing! My headache is completely gone! What are those pills called?
Monica: Hexadrin.
Phoebe: Oh, I love you, Hexadrin!  Oh look!  It comes with a story!
Monica: No, Phoebe, those are, like, the side effects and stuff.
Phoebe: Say what?
Monica: You know, the possible side effects.
Phoebe: Oh my God!  Dizziness, nervousness, drowsiness, facial swelling, nausea, headache…  Headache! Vomiting, stomach bleeding, liver damage!  Now, okay, I don’t recall any of this coming up when you gave me these little death capsules! Oh, I’m sorry, extra-strength death capsules!

Admittedly, the scene concerns how potential side effects can be worse than the problem being treated (and that’s a whole other blog post).  Yet it’s also a reminder of how we can forget about the other potential hazards of these potent drugs, delivered in easy-to-swallow capsules/tablets/liquids, if there are quality control or other manufacturing issues.  It’s as easy to forget as it is to pop them, well, like candy.