The Hippocratic Math

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.

60 Minutes, Glaxo’s Bad Day & Why Compliance is So Terribly Important

In case you missed it: 60 Minutes segment with whistleblower Cheryl Eckerd, a former manager of global quality assurance for GlaxoSmithKline. She describes her experience inspecting Glaxo subsidiary, Cidra, in Puerto Rico. It views like an in-house counsel’s nightmare and a PR professional’s worst day. CBS states:

“But in November, we found out just how much could go wrong at one of the world’s largest drug makers. A subsidiary of GlaxoSmithKline pleaded guilty to [a felony] distributing adulterated drugs.

“There was reason to believe that some of the medications were contaminated with bacteria, others were mislabeled, and some were too strong or not strong enough.”

Ms. Eckerd brought suit under the Federal Whistleblower Act, with the government ultimately recovering $750 million; Ms Eckerd who was “downsized” by Glaxo, received $96 million as her share of the recovery. In addition, when Ms. Eckerd made the information she had gathered about the plant in Puerto Rico available to the FDA, federal agents executed a search warrant and seized drugs worth “hundreds of millions of dollars.”

Of Phones and Dogs and Wonders

In yesterday’s post we talked about the recent conference convened by Health Affairs entitled “Innovations Across the Nation in Health Care Delivery.” More specifically, we looked at the keynote address of Dr. Richard Gilfillan, the acting director of the Center for Medicare and Medicaid Innovation, and a decidedly low-tech example he gave of a program which produced marked savings in hospitalization costs for patients suffering from chronic disease (the patient in his specific example suffered from diabetes and COPD), while also improving the quality of life for the patient. The innovation in that instance involved not much more than providing the patient (and the patient’s daughter) with a hotline phone number to a particular nurse familiar with the patient’s case history. Simple, but effective. The particular patient quoted attributed to the service, sine qua non, her life– and her hospitalizations, and the major expense which accompanies such, were down. A phone and someone who knows– go figure.

If that’s not low-tech enough for you, the Wall Street Journal ran an article on the benefits of the use of dogs in doctors’ offices– surgeons, neurologists, pyschiatrists, psychologists, therapists and even hospital staff are said to have all have derived benefit from the use of dogs. The Journal writes:

Research shows that a few minutes of stroking a pet dog decreases cortisol, the stress hormone, in both the human and the dog. It also increases prolactin and oxytocin, hormones that govern nurturing and security, as well as serotonin and norepinephrine, neurotransmitters that boost mood. One study found that five minutes with a dog was as relaxing as a 20-minute break for hospital staffers.

“It’s chemical, not magical,” says Rebecca Johnson, who teaches a popular course in animal-human interaction at the University of Missouri and has conducted much of the research.

and that

Experts speculate that people give off tell-tale scents under certain physical or psychological conditions that only dogs can detect.

That acute sense of smell also enables specially trained service dogs to recognize when seizures, diabetic comas or heart attacks are imminent in humans. Some dogs can even detect the presence of cancer cells in lab specimens—much like detecting traces of contraband or explosives in luggage.

Regular readers of this blog and others like it in the health reform world are regularly treated, by necessity, to the complexity of medical science as it intersects with law– often in an attempt to ascertain ways to enhance patient well being while implementing cost control and what one hopes ultimately amounts to a sustainable health care system. Can some of the answers really be this easy? A phone line and a dog?

On a personal note, having lost our Great Pyrenees, Molly, two years or so ago, the picture above is of the newest addition to our family– a six month old female Eskimo Spitz named by my son (it’s at least nominally his dog), “Doctor Wiggles.” I’m not all that happy about the name, and it can be somewhat arduous to acclimate a puppy–but it is somehow superbly comforting to live again with a dog. And if nothing else the name affords me the opportunity to walk into the house after a long hard day and say “Paging Doctor Wiggles. Paging Doctor Wiggles.” And she comes. Happy as can be to see me as we prepare get down to the most serious business of rubbing her belly and throwing her ball.

I’d be lying if I said I wasn’t better for it.

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.

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

  • 

    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.

Balancing Patient Demands and Physician Orders for Radiation Tests at the ER and Elsewhere

[Ed. Note: We are pleased to welcome Jennifer Jascoll to HRW. She is a second-year evening student at Seton Hall Law and a Research Assistant for the school’s Healthcare Compliance Certification Program.  She received her bachelor’s degree in Political Science from Bryn Mawr College and her master’s degree in Comparative Politics (Empire) from the London School of Economics and Political Science.]

Falling down stairs.  Hitting my head on a bowling ball.  Breaking my ankle and tearing two ligaments.  These are a few of the incidents that have landed me in the emergency room with a CT scan or an X-ray.  The AP has recently run four thought-provoking articles about the problems of balancing necessary and unnecessary tests administered during visits to the ER and elsewhere.

When should a person go to the ER? The American College of Emergency Physicians Foundation and other sources provide “tips” about the necessity of an ER visit when a person experiences symptoms such as:

• Difficulty breathing or shortness of breath
• Chest or upper abdominal pain or pressure lasting two minutes or more
• Loss of consciousness or sudden dizziness and weakness
• Confusion or changes in mental status

Fair enough.  The Foundation further advises patients to lower costs and “avoid unnecessary tests and procedures” by asking:

• Is this the best test or treatment?
• What are its costs, benefits, and risks?
• Are there alternative tests that are cheaper or less risky?
• Why do I need this test now, and what would happen if I don’t get it now?

Seems like common sense.  But just how many of us question the tests and procedures we undergo at the local ER?  Probably as many who think to ask whether our attending ER physician, in addition to the ER itself, is covered by our insurance.  After all, if a person is experiencing dizziness and confusion after hitting her head on a bowling ball, I doubt she will haggle over the necessity of a CT scan (or whether her attending physician is covered, which my father later tackled with the insurance company).

These tips may not get patients very far, however, as many ER physicians are said to overtest and overtreat for fear of malpractice lawsuits.  Lindsey Tanner, an AP reporter, writes that:

[t]he fear of missing something weighs heavily on every doctor’s mind.  But the stakes are highest in the ER, and that fear often leads to extra blood tests and imaging scans for what may be harmless chest pains, run-of-the-mill head bumps, and non-threatening stomachaches.

Maybe there shouldn’t be too much surprise here.  According to Dr. Angela Gardner, president of the American College of Emergency Physicians, ER physicians are among the 10 specialists most likely to be sued:

Our society puts more weight on technology than on physical exams….  In other words, why would you believe a doctor who only examines you when you can get an X-ray that can tell you something for sure?

Increased patient demand for imaging tests coupled with a concern that not placating that demand will create unhappy and litigious patients would also seem to play a role.

Overtesting doesn’t just apply to ER visits.  AP medical writer Marilynn Marchione reports a trend in this country favoring imaging tests over physical examinations, in particular the CT scan which requires radiation (as opposed to the ultrasound or the MRI which does not).  You can receive 10-20 millisieverts (measurement for radiation dose) from a single chest or abdominal CT scan.  Compare that number to the 2 millisieverts you receive from exposure to the sun and soil every year.  Have one or two CT scans in a year and you’re looking at 20-40 millisieverts or 10-20 times your annual exposure to natural background radiation.  (For a list of other comparisons, click here.)

Our citizens receive more medical radiation than those in any other country and no one — neither physicians nor patients — really seems to be keeping track of the dose accumulation.  At least for the moment.  Marchione writes that:

[d]octors don’t keep track of radiation given their patients — they order a test, not a dose.  Except for mammograms, there are no federal rules on radiation dose. Children and young women, who are most vulnerable to radiation harm, sometimes get too much at busy imaging centers that don’t adjust doses for each patient’s size.

That may soon change….  FDA officials [have] described steps in the works, including possibly requiring device makers to print the radiation dose on each X-ray or other image so patients and doctors can see how much was given.

The FDA also is pushing industry and doctors to set standard doses for common tests such as CT scans.

There are efforts to educate patients on the risk of side effects from unnecessary radiation exposure in order to curb demand.  AP medical writer Lauran Neergaard reports on a Minnesota health cooperative which displays national radiology guidelines in a patient’s electronic medical records whenever a physician orders a scan.  The guidelines help physicians deal with patient pressure and determine whether a radiation scan is necessary.  The cooperative estimates it prevented 20,000 unnecessary tests and saved $14 million through this process.  Archives of Internal Medicine, an American Medical Association journal, also started a “Less is More” feature which, according to editor Dr. Rita F. Redberg, offers articles “that document cases in which less health care results in better health and offer[s] commentary on the specific implications.”

Patients are advised to question the necessity of a radiation scan and physicians are advised to reconsider ordering one, but just how many will do so and what will it really take to get people to listen on a national scale?

Comparative Effectiveness Research Under Health Reform, “The Institute”

“Bend the cost curve” has been the mantra of many students of health care reform. The Dartmouth Health Atlas has shown that up to 1/3 of care may be unnecessary. But how do we find out what care is unnecessary? One tool that holds promise is comparative effectiveness research.   Now that health reform has been signed into law, there is greater certainty as to the future of comparative effectiveness research (CER). The Stimulus bill had already allocated $1.1 billion dollars to investigate CER. The newest health reform law continues to build on that start. So what about HR 3590, also known as the Patient Protection and Affordable Care Act? Will they ration care? Pull the plug on your grandmother? Get between you and your doctor? To start answering these questions, I will provide a brief overview of CER under the new law, and describe the law’s vision for a new institute for CER research.

Part D of  H.R. 3509 is entitled “Comparative Clinical Effectiveness Research.” Section 1181 of  Part D defines CER as: “research evaluating and comparing health outcomes and the clinical effectiveness, risks, and benefits of 2 or more medical treatments, services, and items described in subparagraph (B).” Subparagraph B goes on to describe various services and goods associated with health care.

The Institute
Section (b) of 1181 is where the rubber hits the road. Under this this section, the law creates a nonprofit corporation to be called the “Patient-Centered Research Institute,” known as “the Institute,” which is neither an agency nor establishment of the United States. This is rather interesting, and I did not know that our federal government created such corporations, but I suppose it could be compared to a nonprofit Amtrak.

Funding
The Institute will be backed by a Trust Fund created by money transferred from the Medicare Part A and B trust fund. It will receive, for year 2013, an amount equal to 1$ multiplied by the number of individuals entitled to benefits of Medicare Part A or enrolled under Part B. For years 2014 through 2019 the multiplier is $2.

The Purpose and Duties of the Institute
The purpose of the Institute is stated as what amounts to the typical reason for CER: making better health care decisions based on the evidence.

The duties of the institute are listed as:

1. Identifying and adopting (by majority vote within the Institute) research priorities and establishing research project agenda
2. Carrying out research project agenda by doing
   1. Systematic reviews of previous (and future) research (often known as meta-analysis), and
   2. Primary research including randomized clinical trials. The primary research the Institute conducts can be subcontracted to other institutions, under certain constraints.
3. Data collection from various electronic sources like those at the Center for Medicare and Medicaid Services.
4. Appointing expert advisory panels for clinical trials
5. Supporting patient and consumer representatives
6. Establishing a methodology committee to study new ways to measure and conduct CER.
7. Providing a peer-review process for primary research conducted by the Institute. Notably, if the Institute subcontracts, they can use the peer-review process of the organization to which they contract with.
8. Release of research findings to clinicians, patients, and the general public. The Institute must also release an annual report.

Governing in the Institute
The Institute will be run by a Board of Governors. The breakdown of the Board of Governors is quite interesting, and possibly telling:

• The Director of the Agency for Healthcare Research and Quality
• The Director of the National Institute of Health
• 17 members appointed by the Comptroller General of the U.S. The 17 members must be composed of:
  • 3 members representing patients and health care consumers.
  • 5 members representing physicians and providers, including at least 1 surgeon, nurse, State-licensed integrative health care practitioner, and a representative of a hospital.
  • 3 members representing private payers, of whom at least 1 member shall represent health insurance issuers and at least 1 member shall represent employers who self-insure employee benefits.
  • 3 members representing pharmaceutical, device, and diagnostic manufacturers or developers.
  • 1 member representing quality improvement or independent health service researchers.
  • 2 members representing the Federal Government or the States, including at least 1 member representing a Federal health program or agency.

This very well may be one of the handouts that the Senate provided Big Pharma and device manufacturers to get them on board. Remember that CER may very well show that a drug that a company has invested hundreds of millions of dollars in turns out to be ineffective when compared to its competitor. Thus, it is not surprising, for the cynics among us, that the Board has at minimum 3 industry reps from pharma and devices while there is a minimum of only 1 doctor. You start to wonder why the AMA supported the bill if physicians are only guaranteed 1/17th of the positions. After all, it is undeniable that physicians will be interacting with the CER data more than anyone, and they have on the ground experience using CER and related decision aids like Clinical Practice Guidelines.

Why Primary Care in Medicare Matters

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Little Beds and Little Help at Jfk Hartwyck at Edison Estates

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

I’ll keep you posted.

Cost, Choice, and Value

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Does the VA Cost Less Than Private Health Care?

Taking a break from law, this post is about whether the Veterans Health Administration provides care more efficiently than the private sector.  Paul Krugman and others have held the VA out as a shining example of the government’s ability to provide high quality care efficiently, as well as the private sector’s need to lower costs and improve quality through electronic medical records, comparative effectiveness research, reduced overhead, salaried physicians, and integrated delivery systems — all issues that are central to current health reform debates.  It would be a huge blow if it turns out none of this is true — but that’s precisely what’s suggested by an article published by VA researchers earlier this year.

Wm. Weeks, MD (at Dartmouth and the VA’s regional  center) reported that, from 2001-2006, the VA cost 33% more than equivalent care in the private sector, and its quality was not notably better.  Here, I focus on the cost findings, since they diverge dramatically from the prior, state-of-the-art, study by Nugent, Hendricks et al (also from the VA), which found that, in 1999, the VA cost about 20% less than Medicare.  Since Medicare itself costs 25-30% less than the private sector, Dr. Weeks reports the VA costs about twice what Dr. Nugent and other VA colleagues  previously reported.  What makes this discrepancy even more remarkable is that Weeks did not even cite this prior work of VA colleagues, published in multiple articles in leading journals.

What gives?  I’m not expert, but its clear their methods differed sharply.  Nugent et al. took all care delivered at 6 VA centers and valued the services at actual Medicare fee-for-service rates, comparing the total with costs borne by the 6 VA centers.  Thus, the measures and comparison are direct, apples-to-apples.  Weeks, on the other hand, compared total VA medical costs (excluding nursing homes) per user with per person costs reported by VA users in the Medical Expenditure Panel Survey (MEPS), which values those services at private sector rates.  MEPS is a national survey that contains only a small subsample of 500 VA users, about 1 of every 50,000 VA user.  Extrapolating from such a small sample is a much more indirect comparison, so merits closer scrutiny, which reveals many potential flaws:

1. The 500 VA users in MEPS  are probably not an accurate reflection of 5 million total users.  MEPS surveys people living at home who respond to surveys.  This entirely excludes people who are homeless, institutionalized, or have died earlier in the year, and it under-represents mentally ill or substance abusers.  All of these categories have worse health, and regrettably are prevalent among vets, so MEPS almost certainly omits vets who reflect the highest burden of illness.
2. This sample may lacks much statistical validity, even for the vets it does include.  MEPS weights responses to make them nationally representative for demographic characteristics, but not for veteran status.  Without this weighting, the chance of random error is much greater.  This is suggested, for instance, by the fact that the value of VA care reported over this six-year study ranged two-fold from year to year, with no discernible pattern (the sixth year was twice the fifth year, which was half the third year, etc.)
3. Even for those whom MEPS does represent, it underreports actual health care costs.  Exactly how much and why is somewhat unsettled, but what seem to be the most recent studies conclude that MEPS underreports by 14% - 19%, in large part because reports of both utilization and costs are understated.    Weeks acknowledges these possible flaws, but asserts that studies he and others have done show MEPS is reasonably accurate — again without citing any of the leading studies to the contrary.

Moreover, even Weeks’ self-selected cites do not fully support his accuracy claim.  For instance, he says a RAND study reports that “MEPS expenditure estimates ‘agree quite well’ with estimates from other databases.”  But, the RAND study (p. 34) spoke in that phrase only to utilization, not to expenditures, and even for utilization it said MEPS underreports by 85% for outpatient hospital use.  For expenditures (use X price), RAND (on the very next page) said that MEPS underreports hospital costs by 21% and physician costs by 54%.

What is this Journal of Health Care Finance that would publish a flawed use of MEPS?  It is hardly a leading health research journal.  According to its website, it is

devoted solely to helping you meet your facility’s financial goals. . . . Make easier, better decisions, with advice from industry experts. . . .  Experts in the field share their experiences on successful programs, proven strategies, practical management tools, and innovative alternatives, . . . including hospital/physician contracts, alternative delivery systems, generating maximum margins under PPS, improving productivity, taxation management, health care insurance, employee benefit cost-containment, joint ventures, mergers and acquisitions, employee incentive systems, and more.

An e-mail from its editor states that most articles are reviewed only internally, by its editorial board whose members are drawn primarily from industry.

It appears the Weeks article did not receive peer academic scrutiny, but what about scrutiny from the study’s own coauthors, who are affiliated with Dartmouth and Washington & Lee?  The second author happens to be Weeks’ wife, and the third appears to be their son.  As for Weeks himself, he is deeply embroiled in two serious legal controversies with the VA.

On balance, the Nugent, Hendricks et al. study remains unrebutted. In my view, the Weeks study suffers from too many serious flaws, and is too lacking in objective critique, to hold much or any credence in this important debate.

Originally posted at the O’Neill Institute for National Global Health.

Mammography, Cervical Cytology Screens, and Rationing

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

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

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

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

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

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

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

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