Does Insurance oversight of clinical practice improve either quality of care, or patient outcomes?

Posted on August 30, 2017 by Ted

There appear to be no data to confirm this proposition[i],[ii].

I admit that I have a bias when it comes to the evaluation of quality of care and use of guidelines. I believe that measuring quality of care is close to impossible. Quality, as Justice Potter Stewart might have suggested, is almost always in the eye of the beholder. Nonetheless, we should try to come up with some agreed upon markers of quality. Otherwise, we will be without data and then, as Demming says, “just another person with an opinion”. I also believe that heterogeneity in the delivery of care for a single condition is often inappropriate. In general, use of guidelines will allow average practitioner help more patients more effectively.

Evidence Based Guidelines are, however, analogous to a magnetic compass which points to magnetic north, not true north. As long as the journey is going well and you don’t need help near the end of a journey, following the guidelines will most often help with decision-making. As you get nearer the pole and the journey isn’t going as easily as you had predicted, the compass, or the guidelines, may no longer be helpful. At the point when the patient hasn’t responded as had been predicted by the guidelines, specialist care is often invoked. At this point, a specialist/consultant may recommend variations from guidelines, driven now by clinical experience/judgment: the best assessment of evidence, other than that which drove the guidelines; consideration of the patient’s individual values and goals; as well as ethical and family considerations are appropriate.

Sometimes variations from guidelines suggest that utilizing a more expensive therapy may be appropriate. Sometimes using an “older” therapy that has generally been supplanted by “newer” therapies may be better for an individual patient. Not all patients will respond to “Guideline Driven Therapies” the way that had been predicted or hoped for. In these cases an expert is often asked to help with the therapy.

In patients covered by some Pharmacy Benefit Management (PBM) programs, there is often a “peer review” process that looks at a diagnosis and a therapy to see if they “match”. If they don’t, then the prescribing physician is often asked to justify the course. When the prescribing physician is an experienced, well-trained practitioner, who generally hasn’t misused the system, some of this oversight is onerous. Two examples come to mind:

One friend of mine, an experienced rheumatologist had been treating a middle-aged man employed as a general contractor with severe DJD of the knees with intraarticular hyaluronic acid injections on a six to nine month basis for over 5 years. With this therapy, the patient didn’t require more than occasional NSAIDs for comfort, thus avoiding opiates and knee replacement surgery, and was able to work without missing a day. While the therapy was included in the original Guidelines issued by the patient’s insurance company, the most recent edition rescinded approval for the use of hyaluronic acid due to equivocal evidence of efficacy based on a single, new meta-analysis. Because the therapy was not recognized in the revised guidelines, the rheumatologist was challenged by a physician reviewer (who happened to be a pediatric intensivist) working for the PBM. When the rheumatologist asked to discuss the issue with a rheumatologist or at least an adult internist, the pediatrician balked. Eventually, the therapy WAS approved, after about 90 minutes of discussions over multiple phone calls.

Another friend also discussed potential difficulties in getting an effective therapy approved in a complex patient. In this situation, a young woman with long QT syndrome who had been treated with diphenylhydantoin, a well recognized antiarrhythmic drug from the 1970’s to1980’s. The drug had controlled the patient’s symptoms in the past, and when it was stopped, the symptoms returned and were found to be related to the Long QT associated ventricular fibrillation. Other drugs may not have been effective, and when Dilantin was restarted the symptoms disappeared.

In both these instances, an experienced physician deviated from current Guidelines, because they suggested therapies that were thought to be outdated or were otherwise not applicable, even though in the individual patient they did work,. If PBMs could keep a database of physicians and their level of training, in addition to how often they deviated from usual therapies without good reason, they could avoid potentially unnecessary conflicts with physicians. This would save time and could save overall health care costs. In addition, time spent pleading with non-peer physicians could be better spent caring for more patients. This would likely improve physician satisfaction with practice. In addition, patients would likely be happier, being able to be seen more rapidly and not have to discuss insurance “interference” with therapy recommendations. Primary Care physicians would be happier because the specialist could see his/her patients sooner and likely be given better service as well.

References:
[i] Lyles, A.: Pharmacy Benefit Management Companies: Do They Create Value in the US Healthcare System?: PharmacoEconomics: 2017, 35, 493–5003

[ii] Shrank, W.H; Porter, M.E.; Jain, S.H.; Choudhry, N.K.: A Blueprint for Pharmacy Benefit Managers to Increase Value: Am J Managed Care: 2009, 15, 87-93

Posted in effectiveness/efficacy, General Interest, Guidelines, Quality, Quality in Medicine, treatment options | 2 Comments

Cook County’s Sweetened Beverage Tax of November 2016 – It’s A Matter of Choice!

Posted on July 5, 2017 by Ted

In early November of 2016 the Cook County Board passed a one cent per ounce tax on sweetened beverages. Almost from the day the ordinance was passed, organizations from the beverage industry and small business have publicly opposed the tax. There were organized protests in front of the County Building on June 27, 2017. At the last minute, the Illinois Retail Merchants Association, which is affiliated with the Illinois Beverage Association, filed an appeal asking for a Temporary Restraining Order against collecting the tax.

As the battle lines between purveyors of Sweetened Beverages (SB) and the County government became drawn, one might question the wisdom of such a tax. The County position in favor of the tax was supported by every health related public interest organization. Sugar has been a part of dietary intake since the eighteenth century, but was used mostly as a “spice” until its production was more recently made easier and some cane sugar substitutes became readily available (including beet sugar). Like most spices, sugar has no documented intrinsic nutritional value. The nutritional labels on foods have no “recommended daily intake”, because the Food and Drug Administration hasn’t found one. However, several organizations worldwide have suggested that there is a level that should not be exceeded. They have suggested that a child of 7-10 years consume no more than 25 (20-30) gm daily[1]. The American Heart Association suggests that a woman take in approximately that amount, and that the average man take in no more than 36 gm.[2]

There have been multiple scientific reports that suggest increasing sugar intake is associated with obesity and its complications:

  • Diabetes
  • Hypertension
  • Heart Disease
  • Some Cancers
  • Arthritis

Thus, any initiative that will help dissuade people from consuming SB should help improve the public’s health. One estimate is that approximately a third of of the nation’s health care spending is related to complications of consumption of excess sugar.[3]

These observations would suggest that in addition to generating revenue by a tax, there would likely be a reduction of demand for sugar sweetened beverages. The reduction of demand should lead to enormous Public Health Benefits, potentially associated with a reduction in health care costs to the county upwards of $400,000,000.00 annually[4]. The cost reduction would likely take several years to realize, but should help decrease County costs over time that would result in a potential reduction in other taxes. One should understand that this type of tax is one of choice. Those who buy beverages that have added sugar or artificial sweeteners pay the tax. Those who substitute water, milk, or pure juices don’t pay it. Because it is a choice tax it is not inherently discriminatory. In fact, in one community the lower income residents had a greater decrease in SSB consumption than those with higher incomes, although in both income groups consumption decreased.

Overall, the Cook County SBT makes sense. Those selling these drinks claim that their business will be adversely affected. They will still make profits, perhaps a little less. This seems like a small price to pay for the potential public health benefits that disincentivizing SSB consumption should provide

Footnotes:
[1] A 12 ounce bottle of Sugar Sweetened Beverage provides between 30-39 gm of sugar (Aproximately 40%more than the recommended maximum).
[2] One Teaspoon of granulated sugar contains approximately 4 gm of sugar. (thus 6 tsp = 24 gm)
[3] Forbes Magazine in 2013 quoting a Credit Suisse report: https://www.forbes.com/sites/danmunro/2013/10/27/sugar-linked-to-1-trillion-in-u-s-healthcare-spending/#175314cb6ad1 accessed 7/3/2017
[4] Cook County Budgets $1,600,000,000.00 for Health Fund

Posted in General Interest, Health Information, Policy, Public Health | Leave a comment

Some thoughts on Health Care Legislation 2010 to 2017.

Posted on June 26, 2017 by Ted

The PP – ACA (PL 111-148), or “Obamacare” had the term “Patient Protection” in it, because of what were perceived by many to be inequities forced on people by insurance companies. These included, but were not limited to:

  • Pre-existing condition exclusions
  • Rescission (the revocation, cancellation, or repeal of a law, order, or agreement.)
  • So Called “Usual, Customary and Reasonable” (UCR) Charges which had no basis in empiric data, which drove payments to physicians and others down.
  • Limited benefits (supposed to be corrected by defining “essential health benefits” (sect 1302 (b))[1]
Ambulatory patient services Prescription drugs
Emergency services Rehabilitative and habilitative services
Hospitalization Laboratory services
Maternity and newborn care Preventive and wellness services and chronic disease management
Mental Health and substance use disorder services, … Pediatric services, including oral and vision care
  • Driving up profits that were not then used to improve health, which was hopefully addressed by creating and defining a minimal Medical Loss Ratio[2]
  • Providing policies that included so much legal language that no one could understand them, and didn’t read them. A component (Section 2715) of the bill, that mandated insurers make policies readable and no more than 4 pages of font that was ≥ 12 points, was aimed at this practice.

In addition, insurance was being unevenly provided. If provision of “Insurance” is to even out exposure to risk, then everyone who may be at risk should be carrying insurance, and they should have it “all the time” not just when an emergency comes about. There were provisions in the bill that were designed to have insurance for health care be just that. These included a clause under the rubric of “shared responsibility” which was also called the “individual mandate” that said that every person in the country must have health insurance. In addition, the bill stated that employers should participate in insurance pools and provide insurance to employees (this could be in place of higher wages, as happened during WWII when wage and price freezes were circumvented by giving health insurance to employees). This was especially irksome, for several reasons, to many people.

If insurance was to pay for care for people who have a health related issue, the debate about whether access to health care is a “right” or a “privilege” has to be entertained and resolved. In addition, the discussion of remuneration of those who provide care has to be agreed upon.

The PP – ACA also had a number of provisions to help improve delivery of health care by encouraging investigations into quality improvement. There were also a series of taxes in the bill, predominantly on industries that made profits in the delivery of care, to help defray the costs.

There are currently two proposals for changing the way that health care is being provided under the current law: The House of Representatives has considered and on May 4, 2017 passed a bill to submit to the Senate called “The American Health Care Act of 2017” (HR 1628)[3] (AHCA). The Senate has received this bill and has then developed a bill, of its own, called “Better Care Reconciliation Act of 2017 (BCRA). The senate bill was released to the public on Thursday June 22; two weeks after the house bill had been given a second reading on June 8. The two proposals are not dissimilar.

The three health care proposals are very different in structure

Bill

Number of Pages in PDF
PP-ACA (PL 111-148) 906 in bill form
AHCA of 2017 (HR 1628) 132 in markup form
AHCA of 2015 (HR 2653) 195 in markup form
BCRA of 2017 (Reconciliation of HR 1628) 142 in markup form

The two 2017 Bills are remarkably similar. They repeal all of the taxes that were included in the PP-ACA to help defray the costs of implementing components of the bill. They change the ways that people can get help in buying insurance (neither bill explicitly mentions exchanges – the ways that states were supposed to be able to get a viable insurance marketplace) by changing subsidies to tax credits[4]. Both bills penalize any insurance vehicle that contains provisions for abortion (with few meaningful exceptions – “other than any abortion necessary to save the life of the mother or any abortion with respect to a pregnancy that is the result of an act of rape or incest”)

Both bills make major changes in the way that Title XIX of the Social Security Act (Medicaid) is funded and administered. In addition, both bills allow states to apply for waivers from almost all of the mandates (both in Medicaid, and other insurance initiatives) that are included in the Social Security Act[5]. There are several components of both bills that will make Medicaid expansion for patients other than pregnant women, CHIP, over 65 years, or otherwise eligible for Medicare, would be ended. These provisions would cut the number of people eligible for Medicaid and essentially make them uninsured – again.

The house bill has a version of the individual mandate[6], allowing insurers to charge 30% more for people who have let their insurance lapse for more than 63 days. It does, however, give people the option of getting insurance before 2018 or 2019, without being subject to the penalty. The senate on Monday, June 26, included their own version of the individual mandate by would requiring a waiting-period of six months for insurance to become effective, if a person hadn’t had insurance before.

 

 

Some sources for helping understand the Code of Federal Regulations Social Security, and the IRS code.

  1. Code of Federal Regulations, which is the repository of all of the Laws of the United States http://uscode.house.gov/browse/&edition=prelim: accessed 6/26/17)
  2. Social Security Act of 1935 (https://www.ssa.gov/OP_Home/ssact/ acc 6/26/17):
    1. Remember that the SSA is also codified in the CFR under section 42 Public Health and Welfare
      1. Chapter 7 (which calls the “Titles” (eg XVIII, XIX, XX and XXI) Subchapters (with sections of CFR 301 to 1397 MM)
      2. Sections are within a Title of CFR (CFR Title 42 “The Public Health and Welfare” has a total of 160 Chapters and (18501 sections – many of which have subsections designated by letters.
    2. The Preface, which describes the origin and the organization of the Act is helpful. (https://www.ssa.gov/OP_Home/ssact/ssact-preface.htm: accessed 6/26/17)
    3. Volume II provides references to other acts that refer to the SSA
  3. Internal Revenue Code in CFR as section 26 (has 11 Subtitles (A-K) and 9834 sections) https://www.irs.gov/tax-professionals/tax-code-regulations-and-official-guidance#irc: accessed 6/26/17

Footnotes:

[1] One might debate whether all of these services should be applied to everybody. Including them all is, however, in the spirit of insurance.
[2] In most of the statements on MLR the minimum of premium dollars spent on care was 85%
[3] The AHCA of 2017 is a modification of a prior bill introduced to the house in 2015, also called the AHCA, but of 2015 (was HR 2653), which began with a statement “To Repeal the Patient Protection and Affordable Care Act, and related reconciliation provisions, to promote patient-centered health care, to provide for the creation of a safe harbor for defendants in medical malpractice actions who demonstrate adherence to clinical practice guidelines and for other purposes.”
[4] Tax credits are an interesting method of providing financial support. There is no statement on how people who don’t pay taxes would get support for buying insurance.
[5] Chapter 7 (Social Security) of Title 42 (Public Health and Welfare) of the Code of Federal Regulations
[6] Sec. 133: Continuous Health Insurance Coverage Incentive
Posted in Affordable Care Act, American Health Care Act, General Interest, Patient Protection Act, Policy | Leave a comment

Rolf McMillan Gunnar, MD, MACP, MACC 1/22/1926 – 3/18/2017 – An Appreciation.

Posted on March 28, 2017 by Ted

Dr. Rolf M. Gunnar died after a battle with Cancer. The Chicago medical community and the world lost a compassionate, and brilliant man.

I met Dr. Gunnar when I was an intern at Cook County Hospital in 1966. My resident, Julio Ortiz, MD, learned of my passion for cardiology and so invited me to go with him on Friday afternoons to Cardiology/ECG/VCG conferences, at the Heart Center in the Durand Building. At the time, Julio and I were on the Northwestern service at “County”. Dr. Gunnar was on the U of I service, but more importantly was with John Tobin, of the Loyola service, the co-head of the Cardiology section. There were other luminaries in medicine surgery and other specialties at “County” and in the West Side Medical Center.

As I was finishing my medicine rotation, Dr. Gunnar stopped me one day in the cafeteria at Karl Meyer Hall and asked if I might want to be his fellow in shock research after my residency in medicine. I had a friend in Vancouver who had done shock work himself and because of him, shock became my over riding passion.

I outlined the reasons why I would have to leave Chicago for a couple of years: First, I would need to do a medical residency before becoming a Cardiology Fellow – Dr. Gunnar said, “Don’t worry, we’ll look after that. I can get you into the U of I program”; Secondly, my “green card” was only for one year, my internship, and so I would have to go back to Canada to renew it – Dr. Gunnar said, “Don’t worry, we’ll look after that”. There may have been a couple of other “Don’t worry, …’s”. So I stayed in Chicago to continue my training as an internist and a cardiologist. While I was doing my medicine residency, I contracted Tb from doing CPR on a patient at the West Side VA Hospital. That was before I had any health insurance, and certainly no unemployment insurance. When I told Dr. Gunnar that I wasn’t going to be able to leave my apartment to work and so would not have any income, again he said, “Don’t worry, we’ll look after that”, and he did.

By that time he had developed a great division of Cardiology at the U of I and Cook County Hospital. He brought Willard Harris, MD, a basic researcher who also did research into Systolic Time Intervals to help non invasively evaluate Left Ventricular Function. He hired John Naughton, MD who did research into exercise testing and training as well as Cardiac Rehabilitation. Dr. Gunnar had also brought Shahbudin Rahimtoola, MD as a general cardiologist and researcher and Kenneth Rosen, MD one of the first cardiologists to do intracardiac diagnostic studies (The “His Bundle Study”) to the Cook County section of Cardiology.

Dr. Gunnar left “County” and the U of I and went to Loyola in 1970. I wanted to follow him, but he asked me to stay at U of I and work with Ray Pietras, MD who became head of cardiology in the division that Dr. Gunnar had built. I stayed for 4 years. Then I went to Illinois Masonic Hospital to apply my skills as a shock researcher and intensivist. My career diverged from Dr. Gunnar’s then, but not his influence. I always kept a picture of him in my office, watching over everything I did. I never wanted to disappoint him! I like to think that he did watch over almost everything I did in medicine.

When I asked him for a recommendation for fellowship in the American College of Cardiology, he was supportive – after I made a contribution to the ACC Heart House development fund. He was always a little impish like that. Like many of the rest of us who were at his 90th birthday party in January, 2016, I have myriad stories about his sense of humor and his drive to make us all better.

Dr. Gunnar influenced many young people in cardiology and academic medicine. He was gender blind – many of his trainees were women in a time when women often couldn’t get academic training. He continued to fine tune his skills as an amazing teacher. He heard things on cardiac auscultation that almost no one else could hear. He claimed his hearing was more accurate than a phonocardiogram, because he knew that a phonocardiogram could be manipulated.

From his early days at County, he believed that Chicago could and should be a renowned center of medical research and training, as it had been in the early 20th century. He organized the Chicago Cardiology Group. Many of the first meetings were held at the Swedish Club of Chicago on North LaSalle St where, as a member, he was well known and respected. Subsequently the meetings moved to the Rush Professional Building, Suite 500. He had hoped that by getting the cardiologists and their fellows together there would be cross-fertilization of thought, and perhaps there would be development of multicenter studies done in Chicago institutions. Later, when he was Governor of the American College of Physicians for Illinois, he tried to get the Chiefs of Medicine together for breakfast meetings to discuss common problems both administrative and academic. Again, he tried to engender cooperation. When the Chicago Heart Association tried to establish the Inter Institutional Cardiovascular Center, Dr. Gunnar was an ardent supporter. I think that he was disappointed that members of the Chicago medical community couldn’t be as collegial and cooperative as they may have been when he was in practice with his father, Dr. Herman P. Gunnar. RMG told me a story about how he tried to set up a CCU at McNeil Hospital in the early 1960s, but the practicing physicians there didn’t want RMG “stealing” or treating their patients. I wonder whether this was not in fact a presage of what was to come, with physicians not trusting each other and not wanting to work together?

Dr. Rolf Gunnar loved medicine. After his internship at Cook County from 1949-1950, and after his military service in Korea, he practiced with his father, Herman P. Gunnar, until he went to Boston to train in Cardiology. After that he returned and again practiced with his father, doing Medicine and Cardiology at McNeil Hospital in Berwin, before he became full time at Cook County. He published at least 3 papers with his father in 1962 & 1963 and subsequently began researching with Cook County associates again. The first papers from Cook County were done in collaboration on with Rimgaudas Nemickas and John Sutton in 1964.

Dr. Gunnar was always open to trying to improve Cardiology in Chicago. Dr. Joseph V. Messer recounted a time when Dr. Gunnar was trying to recruit him to improve the practice of cardiology at the Hines VA hospital and brought Dr. Messer to Chicago for an interview. At the time he knew that Theodore Schwartz, MD was looking for a Chief of Cardiology at Rush. Dr. Messer came to Chicago to look at Dr. Gunnar’s VA position. Dr. Gunnar invited Drs. Messer and Schwartz join him for dinner. Even though Dr. Messer eventually went with Rush. Dr. Gunnar, I am sure, felt that he had done the right thing by getting Dr. Messer to come and help lead the Chicago cardiology community.

I was once taken aback to learn that such a compassionate, sensitive man was a Republican (it was just after the Goldwater era). I believe that he may have been the first to tell me something to the sense of, “If you aren’t a liberal when you’re young, you have no heart, but if you aren’t a middle-aged conservative, you have no head.”. Dr. Gunnar certainly had both a heart and a head.

Posted in General Interest | Leave a comment

What is Quality in Medicine? – It Isn’t Easy!

Posted on January 12, 2017 by Ted

I remember quality once being referred to as a paraphrase of Justice Stewart Potter’s statement referring to pornography as , “something I can’t define, but, I’ll know it when I see it”. When applied to medicine, this type of definition is, unfortunately, completely unsatisfactory. Quality should be something that can be defined and measured. However, even today, quality is largely in the eye of the beholder. Some of the stakeholders who may have a unique perspective on what comprises medical quality include:

  • Physicians
  • Patients
  • Other caregivers (extenders)
  • Nurses
  • Families
  • Employers
  • System/Hospital Administrators.
  • Researchers and other Academics
  • Payers (Governmental or Private Insurers)

A patient may view quality in terms of the way he or she gets to see a provider including such factors as: ease of getting appointment, attitude of para professional staff, whether the physician or staff are on time (how much leeway is acceptable is defined by the individual), the provider’s manner and personality, among others. A physician, on the other hand, is likely to view quality in terms of his/her training (specialist or generalist), his use of scientific evidence as it is published, his knowledge and familiarity with the most recent innovations, and perhaps in some instances his outcomes. Most physicians have probably not been rigorous in keeping track of their individual outcomes, in spite of Feinstein’s admonition to keep such records[1] A third group, outside bodies such as the federal government’s Centers for Medicare and Medicaid Services (CMS), or the Joint Commission (JC – previously the Joint Commission on Accreditation of Healthcare Organizations – JCAHO) often look at individual processes (drugs, counseling, and some procedures) that are done for specific conditions (often called by hospital personnel as “core measures”). Nurses often view quality as how promptly patients are seen and how their complaints are addressed. They always have an opinion on the quality of care provided by physicians, hospitals and other providers. It has been my experience that in the short run, nurses are more often “spot on” than not.

These, often subjective, measures can be quantified and made comparable between organizations and providers. One of the early attempts at defining quality was proposed by Avedis Donabedian in his construct that Quality was related to 1.) Structure (physical plant, institutional culture, and others); 2.) Process (what was delivered/performed) and 3.) Outcomes (mortality, morbidity, quality of life)[2],[3].

Q = S*P*O

The Institute of Medicine, in 2001defined six domains of an effective health care system, which is a surrogate for quality: Safety, Effectiveness, Patient Centricity, Timeliness, Efficiency and Equity[4].

As a physician, I have often been asked about the quality of another physician’s or surgeon’s practice. I often give an answer, but have become increasingly uneasy about the empiric basis of my recommendation. I almost never know a surgeon’s mortality rates (early or late), infection rates, or even his/her long-term efficacy rates. What I do know is how I think her/his judgment seems to be like (how often it improves my own judgment/recommendation), her/his personality (how we get along), what others of my compatriots seem to think, and whether he has had more than rare run ins with the hospital staff quality/practice review committees. My own patients’ encounters with the other physician/surgeon make up a small portion of his/her patient experience and as such may be biased either in favor or against that practitioner. I would like to think that my assessment of competence and quality of another doctor is valid, but I really have no easily available robust, concrete basis upon which to base my opinions

Who else is looking at quality and quality measures?

There are many groups looking at some measure of hospital or practitioner quality. For hospitals, the Joint Commission has its ORYX process measure tool; the CMS has its “Hospital Compare” data base[5], which provides information on utilization of process measures and outcomes such as mortality, 30 day readmission rate as well as some cost measures – but these are only for some clinical conditions (Acute Myocardial Infarction (heart attack), Congestive Heart Failure (CHF), pneumonia and Surgical Infection). There several coalitions of purchasers of healthcare (often employer groups) that look at their measures of quality: The Leapfrog group[6], a business purchasing group, just released results of a survey of quality metrics for approximately 1,200 hospitals,[7]. Some of the data on these measures were from publicly available sources and some from questionnaires filled out by some branch of the many of the hospitals. When a group of hospitals “failed” the leapfrog card they immediately questioned the methodology [8] . Many lay publications (Consumer Reports adn US News and World Reports among others) also have their own construct of what they call quality.

it would be ideal if many of the at least 9 stakeholder groups that look at quality could agree on a standard set of measures that may be revised periodically (but not too often). Thus, physicians, hospitals/systems, and other providers could keep a single series of quality measures that would satisfy the myriad people who want to report and depend on reports for making judgments on whom to use as a referral. Some groups such as the American Heart Association (through their Get with the Guidelines program [9] for some heart conditions, The American Board of Internal Medicine (with its Maintenance of  Certification) among others are trying to standardize process measures. If these are adequate, then other groups (like CMS and state licensing boards) should be able to incorporate satisfaction of these measures into their own requirements without “tweaking” them, which often leads to redundancy and increasing difficulty in keeping up with reporting.

Sources:

[1] Feinstein, Alvin R: Clinical Judgment; 1967 Williams Wilkins Co, Baltimore.

[2] Donabedian A. Evaluating the quality of medical care. Milbank Memorial Fund Quarterly 1966; 44:166-206

[3] Donabedian, A. The Quality of Care: How Can It Be Assessed?  JAMA 1988; 260; 1743-1748

[4] www.nap.edu/html/quality_chasm/reportbrief.pdf
http://www.nap.edu/openbook.php?record_id=10027&page=5

[5] http://www.medicare.gov/hospitalcompare/

[6] www.leapfroggroup.org/

[7] http://www.leapfroggroup.org/news/leapfrog_news/4810593

[8] http://www.ama-assn.org/amednews/2012/12/31/prsa1231.htm

[9] http://www.heart.org/HEARTORG/HealthcareResearch/GetWithTheGuidelinesHFStroke/Get-With-The-Guidelines—HFStroke_UCM_001099_SubHomePage.jsp

Posted in General Interest, Policy, Quality | Tagged , | 4 Comments

How Can We Align Incentives As We Move From Volume to Value?

Posted on May 19, 2016 by Ted

The adage that “One person’s cost is another’s Revenue or Income” comes to the fore, when we are discussing changing payment models for health care over the next decade.

As the 21st Century has begun, and health care costs in the US are escalating, Dr. Donald Berwick coined the concept of the “Triple Aim” in Healthcare: Better Care for Patients; Better Health for Communities and Lower Costs. These are laudable goals, but can they be achieved?

Currently, the majority of health care payments are based on “Fee for Service”. Everything that any provider does is paid for on a piecemeal basis. The incentive, even if not intended, then is for Hospitals, Physicians, Home Health Agencies, Drug Manufacturers, Device Manufacturers and others to do as much as possible. Payers, on the other hand, want to have less done (Medical Loss Ratio considerations may blunt this incentive, however). It has been variously estimated that there has been between $210 Billion ($210,000,000,000) and $750 Billion wasted on delivery of unnecessary or harmful care in the US annually.

There are initiatives in various legislative packages (PP-ACA – PL 111-148; MACRA – PL 114-10) to try to change financial incentives to improve the quality while reducing the cost of health care. One potential stumbling block in these initiatives is that if we spend less on health care, somebody is going to have their current incomes reduced. We then must question how will reduction in income change incentives? How will we “share” the savings in health care expenditure that could be realized from decreasing readmissions, shortening inpatient care stays, and doing less “routine” testing as suggested by the “Choosing Wisely” initiative that was begun in April 2012.

In the early 1900’s the Ford automobile company, when it was able to cut costs of production of the Model-T, actually cut the cost to the consumer by a significant amount. Ford and his employees still enjoyed a reasonable income and life style. It is difficult to imagine that a modern hospital manager, after improving processes and potentially cutting down on staff that might decrease costs of delivering care, would subsequently decrease billings. Physicians, who might stop doing some procedures, might see their fee for service payments decrease, decreasing their income. Would either the hospital employer or insurance payer that they are dependent on reward them with enough of a proportion of the savings to the health care system to keep up their lifestyle, even though they might not have to work as many hours a week? If the costs of care decrease, will an insurance company cut staff (they would certainly lose in the process) and pass the savings to the purchasers of the insurance product, rather than “pocket” the savings and continue with business as usual? Providers of drugs and devices are expected by investors to have their companies grow, to satisfy demands for return on investment to stockholders and other stakeholders.

In none of these brief examples is there any real incentive to continue to work to decrease the costs of providing medical care or treatments. The challenge to policy makers, health care systems, and physician groups will be to work together in order to ensure that none of the stakeholders in the healthcare system will feel unduly put upon. Can we do this?

Posted in General Interest, Operational effectiveness, Quality | Leave a comment

How Do We Use Statistics?

Posted on March 23, 2016 by Ted

How we utilize Statistical Inference is indeed a critical piece in the evaluation of new information in the Biomedical Literature.

Many researchers today believe that a “statistically significant” P-value is the primary justification for publication of the findings of their studies. In the first two weeks of March 2016, two articles on the use of the “p-value” were published. The first was highlighted in the British Journal, Nature, summarizing a statement released by the American Statistical Association on the misuse of the p-value [i]. The ASA issued a strongly worded statement cautioning against the over reliance on a p-value that is “statistically significant” in driving major changes in concepts or public policy. The second article, published in the American journal, JAMA, discussed how the use of the p-value has increased in medical literature over the last quarter of a century[ii]. Both articles caution that use of a p-value, by itself, to drive a change in scientific thinking is potentially misleading. Indeed often a study with results that are “statistically significant”, as evidenced by the p-value, cannot be reproduced.

A p-value is supposed to tell us whether an observed difference in ratios or other numbers is potentially related to chance or may be “real” allowing one can reject the “null hypothesis” that the numbers are similar. It is easy to find a computer program that will do the arithmetic to calculate a mean and standard deviation, from which a p-value can be calculated. However, one would be well served to remember that classical statistics depend on “normally distributed” values, and that the sample must not be biased. If the collection of the sample to be studied is biased then the “statistical significance” will also be biased. Finally, we must be aware of the “pragmatic significance” of a difference in means or ratios. Who cares if the difference in the average height of a class of 11-year-old children is 4 feet, 3.5 inches or 4 ft, 3.25 in, even if the p value is less than 0.001? This would be a case of a highly statistically significant, but pragmatically unimportant difference.

One really inopportune use of statistical inference is when the sample sizes are very small. In this instance it is indeed likely that the samples are not normally distributed and that they have a high likelihood of being biased. Here any p-value can potentially lead us down a garden path to nowhere.

The increasing volume of research papers (from just over 400,000 in 1990 to almost 1,200,000 in 2014, an almost trebling in volume of papers over 25 years) often depend on “statistical significance” to get published. The exact proportion of irreproducible results among these millions of papers, unfortunately, isn’t clear.

One message that has been proposed is that before we change our perspective the first paper to show a difference/correlation really needs an independent confirmation. Perhaps the second paper is potentially more important than the first. In addition, we might be well served to ask, “So what? Is this a meaningful result, regardless of the p-value?”

[i] http://www.nature.com/news/statisticians-issue-warning-over-misuse-of-p-values-1.19503?WT.mc_id=FBK_NatureNews

[ii] Chavalarias, D; et al: Evolution of Reporting P Values in the Biomedical Literature, 1990-2015: JAMA, 2016, 315, 1141-1148

Posted in General Interest, Guidelines, Health Information, Statistics and Decision Making | Leave a comment

What Happens to my medical information? Where is it?

Posted on December 14, 2015 by Ted

In this week’s MedPage, a medical information website, there is a post, by Dr. Leonard Lichtenfeld, about sharing personal health data. He was asked to sign a consent for information sharing that may have essentially taken away from him any control over how his personal health or Protected Health information (PHI)[1] could be shared.  I too had a screening colonoscopy and did sign the consent, because I thought it was a necessary evil of getting the procedure done. This unfettered sharing of Protected Health Information (PHI) may be frightening. On the other hand, not sharing information may hinder delivery of optimal care. Tomorrow, a relative of our family is going to a new physician for an evaluation. She has been getting care for urinary and skin infections at a urgent care center near her home. One of her caregivers asked me whether the new physician could access her records to see whether any of the meds that she is getting may relate to her recent health status deterioration. This brought up the question of sharing health information and how it happens, or doesn’t.

When I was in training, each person who saw a patient did a History and Physical (H&P). The format was fairly well prescripted. [2]After doing my H&P, I went to a room and wrote my findings on paper that was incorporated in the hospital chart for that patient for that admission. We then wrote progress notes daily or more often. After the patient left the hospital, I was required to dictate a Discharge Summary that hopefully went to the PCP and/or referring physician. All the paper from that admission was bound into a hospital chart some of which often ended up being over a foot and a half tall.  Many times, when I was seeing a patient, and asking the same questions again he/she would say something to the effect of, “Isn’t this all in my chart?” or “Get this from my chart”. I often would reply, “Yes some of it is, but I just want to be sure that I get it all right”. In the early 1990’s, my partner and I began to keep much patient information on our desktop computers in a flat file database (AppleWorks®)[3]. Our computer records migrated to disks that we would carry home, then to a lap top and then to our own intranet site. Having these data available made phone calls easier, and often allowed us to rapidly answer consultants questions. In the mid 1990s, we were introduced to the EPIC(r) EMR. It seemed wonderful, even if it slowed us down a bit. We were able to access our complete records immediately in the office (no more asking someone to “pull a chart” from the storage area), from the hospital when we were making rounds, and even from home at nights or on weekends. Having the chart available anywhere at any time, allowed us to provide more comprehensive care. We felt that, while it wasn’t perfect, this was an improvement in  the way we kept patient information for ourselves. Patients, themselves,  couldn’t access what we had though.

In his State of the Union Address on Jan 20, 2004, President Bush proposed computerizing medical records to help “avoid … medical mistakes reduce costs, and improve care”[4]. There was little other substance at that time. However, later that year his White House page proposed an ambitious goal that “Within the next 10 years, electronic health records will ensure that complete health care information is available for most Americans at the time and place of care, no matter where it originates. Participation by patients will be voluntary.”[5]

The EMR was supposed to help us share information between health care providers more easily. To date this hasn’t happened.

2009 brought ARRA[6] and HITECH[7] to help with info sharing. Health Information Exchanges were supposed to allow sharing of information between physicians and other caregivers and between hospitals and physicians. There was a flurry of activity to try to establish HIEs in cities and States. As of December 2015, none of these have really succeeded. This is at least in part because of inertia and also because there appears no incentive for any providers to share medical information.There is no financial advantage to having institutions/systems share information. In fact, one motive not to participate in an HIE might be that keeping the information confined to one hospital/system will encourage the patient to come back to that site(s) for care. There are no other incentives for physicians or systems to share patient data. A disincentive the privacy issue (often called HIPAA[8]). Sharing PHI is restricted by Federal Mandate[9]. At the minimum, someone has to sign a consent or release for information to be shared (Dr. Lichtenfeld didn’t sign a blanket release).

Equally important, there are almost no data supporting HIE use in decreasing healthcare costs.

So, where are the caregivers for my relative left? To get the information from the convenience clinic to the new provider will require she, or a person with her Power of Attorney to go to the clinic and sign a release of medical information. Hopefully the clinic will then release the data about her care so that any potentially important information can be shared with the new physician group that will be evaluating an entirely different aspect of her illnesses. It is unlikely that this information will be electronically available.

For the who are inclined to be more proactive, keeping a Personal Health Record (PHR) on a mobile device[10] should allow better continuity of care. The PHR has the potential advantage that individuals can keep records themselves and can then allow which providers can actually access their PHI. There is a website that can help us all understand some of the issues on PHR activities[11]. Alternatively, many hospitals and physician practices have a patient portal that allows patients, or those designated by patients, to access most, if not all, of the data that exist in that provider’s EMR. These data may then be shared with other providers.


[1] PHI is defined in HIPAA (see below)
[2] In the 1970s the way that we acquired and recorded information was modified by Larry Weed:  Weed, LL: Medical Records that guide and Teach; N Engl J Med. 1968;278:593-600.
[3] This was in addition to our charting in the office paper chart.
[4] State of the Union address, published in Washington Post (http://www.washingtonpost.com/wp-srv/politics/transcripts/bushtext_012004.html)
[5] http://georgewbush-whitehouse.archives.gov/infocus/technology/economic_policy200404/chap3.html
[6] American Recovery and Reinvestment Act of 2009
[7] Health Information Technology for Economic and Clinical Health – a component of the ARRA
[8] Health Insurance Portability and Accountability Act (Kennedy Kassebaum Act of 1996
[9] history of Kennedy Kasselbaum?)
[10]  There are over 7 potential PHR APPs:

   1.    Microsoft HealthVault (https://www.healthvault.com/us/en)
2.    WebMD Health Manager (http://www.webmd.com/phr)
3.    My Medical (http://mymedicalapp.com/)
4.    Capzule PHR (iOS only)
5.    iBlue Button (http://www.ibluebutton.com/)
6.    NoMoreClipboard (https://www.nomoreclipboard.com/)
7.    Track My Medical Records

[11] https://www.healthit.gov/patients-families/maintain-your-medical-record

Posted in General Interest, Health Informtion Exchange, Medical Records, Personal Health Record | 1 Comment

We have “Information Overload” in Clinical Guidelines.

Posted on November 11, 2015 by Ted

There is an increasing push for physicians to practice “Evidence Based Medicine”. However, the “evidence” is getting harder and harder to come by. The creation of “Guidelines” by expert bodies may be of little help.  There are simply too many of them.

Alvin Feinstein, MD (1925-2001) and David Sackett, MD (1934-2015) began to consider how evidence might be applied to clinical decision-making (Clinical Judgment) in the late 1960’s and early 1980’s, respectively. One of Sackett’s students introduced the term EBM to the medical profession in the 1990’s. Sackett graduated from the University of Illinois Medical School and practiced of Internal Medicine and Clinical Epidemiology at McMaster University in Hamilton, Ontario.

In the 1970’s, the randomized clinical trial (RCT) came into favor as the preferred way to determine the efficacy of treatments. Since then the types of papers published have changed markedly. No longer do we have many case reports, small studies or “reviews of the literature”. Most medical publications are now replete with RCTs of various size and complexity. The number of papers published in biomedicine has increased by 5-6 times from the approximately 50,000 a year in 1970. Keeping this published information straight has become harder and harder, some might say almost impossible. Sometimes a series of RCTs or observational studies are combined into a “Meta Analysis”. One might say that a MA is simply a more structured “review of the literature”, with a somewhat stronger mathematical bent.

Until the 1970’s, guidelines rarely existed. Some documents proposed schemes to help with diagnosis. These were initially the work of a single expert clinician[i]. Today guidelines are frequently produced to help clinicians in the care of chronic diseases[ii] or for the use in imaging and diagnostic testing[iii].

One of the very first sets of standards for provision of one form of patient care was the “Standards for cardiopulmonary resuscitation (CPR) and emergency cardiac care (ECC)”, published in 1974[iv]. In the next edition[v] the guidelines were specifically designated NOT be a legal document and were NOT to be construed as evidence in legal proceedings.[vi]

Dr. Sackett always regarded the evidence base as one of several components of patient care. He once said that EBM had “… three arms: very good evidence, seen by a very good clinician and integrated with patients’ expectations.”[vii]

A review of data at the National Guideline Clearing House  (NGCH), a service of the Agency for Health Care Research and Quality, revealed over 2,400 unique guidelines sets (GS). There are 111 unique agencies that participated in the development of more than 5 GS each. There is frequently significant overlap with several organizations collaborating on several sets of guidelines. The table shows that there are MANY sets of guidelines for 7 chronic cardiac conditions. It also illustrates how rapidly the guideline numbers are being changed:

Table:         Some Cardiac Conditions with Guidelines at NGCH

Number of Guidelines

September ‘15            October ‘15            November ‘15

Hypertension                            442                          468                               486
Heart Failure                           369                           515                                517
Myocardial Infarction            201                           230                               230
Peripheral vascular disease   151                            151                                188
Atrial Fibrillation                    108                           108                                129
Angina                                         78                             78                                 86
Aortic Aneurysm                       53                             53                                  59

It may strain one’s sense of credibility to imagine that any single physician would be able to evaluate 442 sets of guidelines for the evaluation and management of hypertension, or for any heart failure clinic to have evaluated and combined the recommendations of 369 sets of guidelines for heart failure.

Looking at Heart Failure alone, I found 486 sets of guidelines that relate to heart failure. Of those 113 have been published or revised since 2000. Of those 113, 30 are primarily related to diagnosis or treatment of Heart Failure or CHF. The remainder has statements regarding the place that the presence of heart failure may modify the recommendations in that set of guidelines.

The American College of Radiology leads the list of GS, having collaborated in creation of  239 sets. The National Institute for Health and Care Excellence (NICE) in Great Britain was the next most prolific organization publishing 211 sets. One hospital has developed 112 GS, which they called “best evidence statement” or BEST.

In an effort to be thorough, medical organizations and societies may have actually complicated the job of the clinician in his/her quest to remain up to date on what is “the most appropriate” strategy for diagnosis and treatment.

This leads to the question, “Why is this guideline group promulgating this set of guidelines?” It would appear that at least some groups are trying to give a “distinctive voice” to a unique subset of stakeholders in any specific clinical condition.

What are we to do with this “Tower of Babel” of guidelines?
The clinical system or clinician, who might want to use summaries of available evidence to help with clinical judgment, would be well served to ask if each source of available guidelines is relatively unbiased, and associated with a nationally recognized leader in the field[viii]. Governmental sources are frequently relatively unbiased[ix]. National Medical Associations[x] are generally considered reputable organizations with minimal biases. Recommendations published in the journals sponsored by them should be well rounded.. Finally, another filter to help find reliable guidelines would be where they are published. Guidelines published in well-recognized journals with as good a rigorous peer review process as possible are more likely to be reliable. Whether a provider group should accept a published series of guidelines or try to synthesize an analysis of others may be up to the group. However, in spite of the best intentions of the guideline writing groups, payers, lawyers and quality review organizations most often refer to a published set of guidelines. This makes trying to create an individual set of guidelines often counterproductive.

Notes:
[i] The Jones’ Criteria for Diagnosis of Rheumatic Fever published in 1944 is one example   – the problem with these often is that there was no “gold standard”
[ii] Hypertension, Heart Failure, Diabetes, Asthma are some conditions for which guidelines may be necessary.
[iii] ACC – Appropriate Use Criteria – the first set of AUCs appeared in 2005
[iv] JAMA, 1974, 227 Suppl: 833-868
[v] JAMA,1980, 244, 453-509
[vi] ibid p 505.
[vii] J of Undergraduate Life sciences; 2010, 45, 66-67
[viii] In cardiovascular disease some relatively unbiased sources might include the American College of Cardiology, American Heart Association, and the European Society of Cardiology
[ix] United States Public Health Service (USPHS), the National Institute for Health and Care Excellence (NICE) in the United Kingdom are examples
[x] British Medical Association, American Medical Association, Massachusetts Medical Society among others

Posted in CV, Guidelines, Policy, Quality | Leave a comment

Helping our Patients and Ourselves Navigate the Internet for Reliable Health Information.

Posted on July 7, 2015 by Ted

In June 2015 Dr. Arthur Caplan opined on Medscape that physicians should be prepared to help patients in some way as they try to navigate the morass of medical information that is available on the Internet[i]. One oft quoted study from the Pew Research Institute (2013) suggests that over half of US adults have looked for health information on the internet and that up to 80% begin at a commercial search engine. What is less clear, however, is how many people get their attention waylaid by some other web based source of medical information, but it is likely a large number. Caplan suggests that at least several of these sources may have “Evil People” behind them.

There is generally some skepticism about information on the Internet, but this degree of skepticism is likely not as prevalent as would be desirable. In 2012 the State Farm Insurance Company sponsored a TV ad that began with the skit that ran:

“ ‘Where did you hear that?’; ‘The Internet’; ‘And you believed it?’; ‘Yeah, they can’t put anything on the internet that isn’t true.’; ‘Where did you hear that?’; ‘The internet’.”                                                                                      

 

If we are to be able to help our patients navigate the Internet, it would be helpful to determine what is easily available. There are several search engines, or search engine groups. One website posited at least 12 sites in addition to Google, which seems to be the de facto market leader, with upwards of 65% of searches beginning there.

In order to see what was available, I looked for health related information, in the top 4 commercially available search engines (Google, Bing (a Microsoft site), Yahoo, and Ask). I used the initial search term “Health Information Websites”. There are well over 180,000,000 active sites identified by each of the search engine sites (Yahoo claimed over 480,000,000 sites).

Some sites that may be helpful in finding reliable information include two on evaluating websites:

  1. https://nnlm.gov/outreach/consumer/evalsite.html accessed 7/6/15.

This one page site with an easy to read and follow process map on evaluating a webpage, is from the National Network of Libraries of Medicine, and may be among the most important sites available.

 2. http://caphis.mlanet.org/consumer/index.html accessed 7/6/15

This is a website of the: Consumer and Patient Health Information Section of the Medical Library Association, Inc (https://www.mlanet.org/ ) , which has an interesting “User’s Guide” for finding and evaluating health information on the web (https://www.mlanet.org/resources/userguide.html)

 They then have a list of “top 100 health websites you can trust”, which refers to NIH and other governmental websites as well as websites for many of the major disease specific professional organizations. This may be a good approach, but would likely be frustrating to a person who has a simple question to answer.

 Evaluating Information on the Web:

In looking at a website to estimate reliability, most sources suggest looking at the site itself for its “professionalism”. Secondly one should ask whether there is an evident bias in the material – especially if the site is trying to sell something or asking for money. Thirdly, a searcher should ask whether the information that is being purported as real, is backed up with information from other sites. Finally, if the information on the site is supported by references or hyperlinks, it is more likely to be reliable. Evaluating these four characteristics: Professionalism, Bias, Uniformity through several sites, and provision of References should allow a person looking for health information to find reliable information upon which to make decisions.

Perhaps the easiest site to use and find reliable information is the Website of the National Institutes of Health: http://health.nih.gov/

My interpretation after spending time on the site is that it s well organized and has a robust search window, as well as directions to topics of interest, such as clinical trials, Medicare, and others. It was rated as in the top 3 of all the search engines.

Another Governmental Site that has links to many useful concepts is:  https://www.nlm.nih.gov/medlineplus/

Other sites that were common to all the search engines were:

There are many more, often included in the website of universities, insurance companies or other large healthcare providers, but if we send our patients, friends and other associates to these six sites, they will have a very good head start on their journey through the minefields of getting health information.

 

 

[i] Caplan, A.L.: Are Evil People Influencing Your Patients? /Medscape, Jun 24, 2015

Posted in General Interest, Health Information, Health Informtion Exchange, Literature | 11 Comments