Ten Rules for Health System Boards of Directors to Follow to Reduce the Risk of Fraudulent Outcomes Reporting and Scientific Misconduct

Enjoying a good spin

Are you on the Board of Directors for a large health service provider, population health vendor, integrated delivery system, managed care organization or other care corporation? 

If so, your company is likely collecting, analyzing and publicly reporting quality and cost data. Not only do superior results in journals, meetings, splashy web sites and glossy marketing materials present a competitive advantage, achieving superior outcomes is part and parcel of your organization's mission.

The Disease Management Care Blog reminds Board members that intentionally or unintentionally misrepresenting outcomes is an existential threat to health care organizations.  Having to retract a publication, correct a white paper, meet with grumpy regulators, confront claw backs, deal with a whistle-blower, respond to allegations of interpretation spin, uncover suppression of bad results or defend the integrity of your brand is something no Board wants to deal with.

To the DMCB's knowledge, this hasn't happened to any ACOs, risk contracting systems, managed care organizations or population health or wellness vendors.

Yet. 

It's just a matter of time.

While the risk of allegations of scientific misconduct can never be reduced to zero, the DMCB offers up ten best practices for Boards to follow:

Reduce opportunities by:

1. Exhibiting healthy skepticism regarding all outcomes reported by your management team, especially if the results seem to be too good to be true.

2. Insist that your management team has two persons with access to any data base, and that they have separate reporting relationships.

3. Insist that your management team has two persons independently involved in any data analysis, and that they have separate reporting relationships.

4. Be familiar with and insist that the rules on research on human subjects be followed.

5. Maintain a low threshold for conducting internal or external audits of any databases and any interpretations of those data.

Combat any rationalizations that fudging outcomes is OK by:

6. Recruiting Board members with research expertise.

7. Explicitly engage the Audit Committee and any other Board member or committee with oversight of risk to view "outcomes" with the same level of scrutiny as your company's financials.

8. Maintain an ethical "tone at the top" when it comes to research.

9. Have a disaster plan ready to go.  For starters, train your Board on how to deal with hostile media inquiries.

Reduce incentives by:

10.  Asking your CEO if any compensation plans including bonuses or unwittingly promoting unethical or fraudulent behavior.

The Latest Health Wonk Review Is Up!

A festival of bright wonky bloggery awaits you, courtesy of Health Wonk Review host Hank Stern over at his InsureBlog.  In it, you'll find links to health policy insights and viewpoints that you simply can't find anywhere else.

Mazel tov!

The Curious Case of the Medical Device Tax

Some medical devices

The Disease Management Care Blog continues to welcome blog posts from outside authors. This is another one courtesy of Erik Tollefson, who works in the health policy field. He can be reached at erikDOTmDOTtollefsonATgmailDOTcom.

During the political maelstrom of the October government shutdown that enraged Americans and enraptured Tea Party alike, a curious proposal emerged as a possible eleventh-hour savior: a repeal of the medical device tax. 

The medical device tax, a substantial revenue source for ACA funding, was seen as a compelling political bargaining chip. Although not achieving a full “repeal” of the ACA, the vitiation of the tax would have given Republicans a symbolic victory (political cover) and the medical device industry a reprieve. Although the tax remained in force, it still serves as a potent symbol of how health care reform will need to align long-term financing mechanisms that also promote a more efficient health care system. 

A 2.3% excise tax on all medical devices was included in the ACA as a main financing stream for health care reform. Indeed, according to CBO estimates, the tax is estimated to bring in $29.1 billion in revenue from 2012-2022.  A repeal of the medical device tax would not cripple the ACA’s implementation; however, it would make it difficult to move forward, and perhaps more importantly, reopen the bill to legislative scrutiny (Note: President Obama’s announced  administrative fix for health insurance in the individual market assiduously avoided legislative action for similar reasons). 

Some supporters of the tax argue for the concept of “shared responsibility.” Building on the fiscal architecture of Massachusetts’ 2006 health reform legislation, proponents posited that stakeholders who potentially benefitted from health care reform should lend fiscal support.  The ACA followed a similar funding model: hospitals, insurers, and pharmaceutical companies all decided to participate; the medical device industry, although more obstinate, was ultimately written in the legislation.

More sophisticated repackaging of this argument has also emerged. Topher Spiro argued that the medical device tax served as a bulwark against the industry’s egregious pricing and anticompetitive practices. Although, to his credit, Spiro lays out more commonsense policies to increase transparency and address monopolistic concerns besides taxation, he ultimately adopts an odd “the ends justify the means” policy prescription.

Opponents of the medical device tax adopt a well-known line of reasoning: taxation on medical devices will hurt domestic innovation, eliminate jobs in research and development, and have a negative economic impact. This is textbook economic analysis. While some of these points are apposite, much like pharmaceutical companies, medical device companies could arguably make up lost revenue through discriminatory pricing abroad, although this may be (increasingly) difficult in areas such as “austere” Europe. 

Overall, one may be agnostic regarding the substantive points of both supporters and detractors and still be dismayed at the misalignment between the medical device tax and its intended purpose. Granted, medical device providers are leveraging the opportunity to lobby and maximize the industry’s interests in the ACA tumult. However, the tax is not ultimately intended to discourage purchase of medical devices, many of which have substantially improved quality of life for patients. Rather, it functions as a defacto “windfall” tax clawing back excess profits from an industry seen as anticompetitive and opaque with oligopolistic pricing power. 

This narrative works only so far: Medicare, a publicly funded entity, is one of the largest purchasers of medical devices.  However, Medicare is not able (or is politically prevented) from exercising greater pressure on medical device providers through conducting cost-effectiveness analysis or lowering payments on devices that have a suboptimal cost-quality profile. It is true that Medicare is developing bundled payments that will subsume the cost of the device as part of the total procedure; this move away from fee-for-service charges may reduce the “economic rents” (profits) of medical device firms over the long-term. Until then, however, the misalignment between financing mechanisms and policy incentives will likely continue, along with the distortions of second and third-best policies in an already bloated system. 

Medical image from Wikipedia

Dr. Berwick Discovers Toxic Politics Too Late

Dr. Berwick listens to Ms. Sebelius

If you're interested in a post-mortem of Dr. Donald Berwick's failure to be confirmed as CMS Administrator, check out his November 13 JAMA article on "The Toxic Politics of Health Care." 

He identifies six causes of our national discontent, which the social media-minded Disease Management Care Blog has boiled down into 140 character or less tweetable summaries:

Money: there are too many entities making too much money to give up on the status quo. "Reducing costs" means cutting into someone's income.

Unorganized majority latent interests: the majority of Americans can't see or translate their interests into effective political action.

The Silence of Professions: Organized medicine has been all about the SGR and tort reform.  They should advocate for health reform.

Suspicion of Science: public trust in science is eroding because of its elitism. That, in turn, feeds into fear of rationing.

Duality of self interest: a lot of people work in the health care industry. Cutting costs will add to U.S. unemployment woes.

Ambivalence about Federalism: it's difficult to develop a coherent national health policy when power is shared with the states.

Ambivalence about the poor: it's difficult to convince the U.S. electorate that disadvantaged populations deserve public support.

For the record, the DMCB openly supported Dr. Berwick's nomination and still feels that he would have ably served his country as CMS Administrator.  That being said, one cause for his undoing was his failure identify these issues before he was forced to leave Administration. 

Docs like Dr. Berwick - and that includes the DMCB - unfortunately think that all they need are the facts to win the day. Not so: they need to address the money, catalyze coalitions, nudge stakeholders, reconcile multiple interests, cut deals and still do what's right.

He was the wrong guy at the wrong time.

Stuff Their Mouths with Gold

The Disease Management Care Blog uncovered this confidential memo, presumably authored by a health insurance CEO to the company's senior management team. Any resemblance to reality or perception is purely intentional.

DATE: November 18, 2013

TO: Senior Management

FROM: The Office of the CEO

RE: Our recent White House meeting on the individual mandate

As many of you are aware, I and other commercial insurance CEOs visited White House to barnstorm over ways to help President Obama out of his latest political pickle.  While, like you, I was caught off-guard by the President's "I hear you loud and clear" proclamation, our trade association CEO, Karen Ignagni, was once again masterful in helping us understand the big picture.  I wish to share that information with you.

1. Remember that the Affordable Care Act (ACA) is a commercial insurance gold-laying goose. Millions of Americans are being forced to buy our products, and a lot of them will be subsidized by the faith and credit of the Federal government. While the President will use every opportunity to deflect any blame on us, we must remember: eye on the prize, people!

2. While we would naturally prefer that, effective January 1 2014, our customers move from the skimpy lower margin individual plans to the richer and more profitable "essential health benefit" plans, Ms. Ignagni anticipated that the amateurs advising the President would lead to him to having to make stuff up on the fly.  Think of this as the price of doing business.
 
3. While many of you will be working long hours through the upcoming holidays to un-disenroll the hundreds of thousands of insureds that got our cancellation nastygrams, let me assure you that getting it right most, not all of the time is our new business mantra.  Sure, thousands of persons will allege that that they thought they were covered with X deductible for Y condition, but we can clean that up after the fact through the standard appeal process.  Hey, it's right there on the White House web site.

4. It's no accident that Ms. Ignagni described our White House meeting as "very productive."  While the details cannot be shared with you, as many of you know, the ACA allows for certain "risk corridor offsets" to be made if there are early death spirals in the mandated minimum benefit plans.  While opponents of the ACA will attempt to undermine those costly offsets in the upcoming government budget battles, we're hopeful that politicians on both sides of the aisle will ultimately recognize that it's not our fault that the White House's insights on health insurance is about as deep as Toronto Mayor Rob Ford's awareness of the perils of crack.

5. We must remain quiet and outside the public eye. While all of us are appalled at the Administration's blunders, the last thing we want to do is to remind our Democratic allies about the "public option."  If we are approached by the media, let's recall that Aneurin Bevan, the founder of the National Health Service, neutralized the opposition of Britain's doctors by "stuff[ing] their mouths with gold." The ACA is our gold and let's keep our dismay out of sight and our mouths silent. 

Three Population Health Management Principles for Reconciling Quality-Based Pay for Performance and the Doctor-Patient Relationship

Writing in the New England Journal, Robert Berenson and Deborah Kay of the Urban Institute say a linchpin of Washington DC's pursuit of quality is a "policy overreach [that] could undermine the quest for higher-value health care."

Yikes.  The Disease Management Care Blog turns to population health management to ponder their unhappiness.

The authors' concern is over Medicare's "Physician Quality Reporting System" or "PQRS."  As the DMCB understands it, PQRS rewards (and penalizes) physicians for outcomes that are calculated from a set of quality "modifiers" that are submitted as part of the Medicare billing statement (an example can be found here).  The amount of money at stake is in the range of 1%-2% of the Medicare reimbursements.

Berensen and Kay point out that while the system has been ramping up over 6 years, 70% of Medicare participating physicians do not submit any modifiers.  In their opinion, that's because:

1) the loss of 1% of any payment is practically meaningless,

2) physicians distrust the metrics and

3) there is a fundamental disconnect between the modifiers and the complex world of clinical practice. 

As examples, radiologists are being dinged for total x-ray exposure while surgeons are being held accountable for pre-op antibiotic administration. While these and other quality measures are important, they fall far short of recognizing what keeps docs up at night, like reading the x-ray correctly and getting a patient through surgery and out of the hospital.

"Hear hear!" says the Disease Management Care Blog.  In the course of a normal day, it is job of doctors to do "doctor stuff" involving one patient at a time. 

But, you ask, isn't that contrary to being accountable to the health of populations? 

The DMCB doesn't think so, because state-of-the-art population health management (PHM) agrees that:

A. Physicians need to be immunized from disruptions their "customer facing" (i.e., the patient) activities.  Otherwise known as the doctor-patient relationship, that's the part of the health care system that relies on the seven or more years of undergraduate and graduate training that turns smart people into exquisitely trained physicians.  Let the doctors be doctors, says the DMCB, and let them worry about their patients.

B. High performing systems - as much as possible - need to be configured around those customer-facing activities, further enabling the doc to focus on the patient who is right here and right now. 

From time to time, PHM might have to intrude.  When it does, the DMCB suggests policymakers recognize that they should proceed:

1) only when it's really important

2) only infrequently and

3) whenever possible, when it reduces physician work by outsourcing (an example in primary care can be found here) those things that don't require the personal involvement of a doc.

It would seem that Medicare's PQRS failed to recognize the fundamentals.

Image fromWikipedia

"Down Jobbing" to Primary Care Technicians?

Heard of "down-jobbing?"

Your PCT will see you now.....

The Disease Management Care Blog first became aware of the term years ago when it was pointed out that primary care docs can take on some specialty care responsibilities, while nurses can take on primary care roles, while office assistants can take on nursing roles. A parallel phenomenon is the movement of surgeries and other medical procedures from the inpatient to the outpatient surgi-center to the physician's office.

Naturally, the ultimate down-jobbing target is the patient. Examples include the reasonable innovation of self-service kiosks as well as emergency or wacky "self surgery."

Which naturally prompts the DMCB to offer it's own definition of down-jobbing: the historical movement of medical treatment from higher to lower levels or locations of health care services.

Of course, the major driver of down-jobbing is economics. DMCB readers are well aware of our national obsession with transitioning from "fee-for-service" (FFS) to more "value-based" reimbursement arrangements. These include pay-for-performance as well as shared-risk, global or other capitated approaches.

Since traditional FFS is notoriously linked to medical necessity as well as provider credentialing (examples are not hard to find), physicians have had little incentive to go along with down-jobbing. As FFS allegedly goes the way of the dinosaurs (a perspective likewise not hard to find), health care providers in these new value-based payment systems are looking for cost-effective ways to service their patients within a fixed budget or fixed payment system. One way to do that is to down-job.

So it was only a matter of time until someone thought of the option of "primary care technicians" ("PCTs") as a value-based and down-jobbed solution to the nation's physician shortage. As Kellermann et al point out in the November 2013 issue of Health Affairs, the pipeline for primary care docs, physician assistants, nurse practitioners is not only expensive, it's unlikely to meet future demand.  They argue that PCTs can be to primary care providers like emergency medical technicians (EMTs) are to emergency care rooms.  Like EMTs, PCT training to handle preventive care, treatment of minor illnesses and monitoring chronic conditions needn't be extensive. That's especially true if PCTs are armed with a health IT safety net that provides tablet-based decision-support algorithms that are ultimately tethered to (or teamed with?) a primary care physician.

So there you go: a few questions, a cursory exam and a recommended treatment plan for millions of healthcare hungry Americans is well within reach.  All it takes is some additional down-jobbing.

The DMCB thinks that, on paper, it's not a bad idea and no accident that it would appear in the academic health policy literature.  Whether this could gain any traction in the real world of patients remains to be seen.  Perhaps the next step is a randomized controlled clinical trial comparing the outcomes of patients seeing newly minted PCTs to those receiving usual care.

The DMCB has two additional concerns:

1. The promise of the expansion of access to health insurance under the current iteration of health reform was that patients would be able to access the current health care system, including doctors and hospitals.  Even if this system of primary care meet outcome expectations, this will hardly burnish American's ambivalent views of Obamacare.

2. Liability concerns are significant. Allegations of malpractice are inevitable with PCTs and their supervising docs will naturally worry about being ensnared in even more lawsuits by a very nimble plaintiffs' bar.

Image from Wikipedia

Health Information Technology and the Patient Centered Medical Home: Seven Additional Caveats

The Disease Management Care Blog is scheduled to participate in a November 12 PCPCC webinar on the timely topic of population health management (PHM).  We'll be focusing on the October 2013 PCPCC report "Managing Populations, Maximizing Technology." Readers can download it here and refer to page 2 where the DMCB, among other luminaries, is acknowledged for its thoughtful review.

The PCPCC report effectively reminds health system architects and policymakers that the electronic health record (EHR) is necessary - but nowhere near sufficient - for a high performing patient-centered medical neighborhood.  Other information technology (IT) components include intelligent shared decision making, registries, health information exchanges, analytics, referral tracking, telemonitoring, automated outreach, patient communications, mobile apps, decision support and risk stratification.

And that's just for starters. 

The good news here is that while Washington DC's EHR weenies remain focused on the dreary stages "meaningful use," innovative health systems with medical homes and neighborhoods are really using IT to make a thousand PHM flowers bloom.   

Naturally, during the PCPCC webinar, the DMCB isn't going to stop there. If given a chance, it will also point out:

1. Build vs. buy: While health systems generally believe that PHM - with or without its IT  trappings - can be built using local resources, a better answer may be to buy it from a vendor.  Why own it when you can rent it?

2. And speaking of outsourcing: While its physician-colleagues prize the stature that comes from "quarterbacking" a medical home team, what is less appreciated is the distinct possibility that a quarterback is often not the most important position.  Get out of the way and let the IT-empowered and enabled non-physicians do their thing.

3. The EHR gone wrong: "Portals" are preferred by EHR vendors because they push patients toward their products, often run by lawyers who fear HIPAA and typically programmed by IT geeks who only think about code. It's time to put patients first.

4. "This is not my patient!": While predictive modeling generates lists of patients that annoy physicians with multiple inaccuracies, the science is getting better.  That being said, many other tests like EKGs and chest x-rays are notorious for false negative and false positive results.  It's all part of being a doctor.

5. Apply a filter.... please!: The biggest threat from health IT is a data glut of numbers, labs, tests, surveys, messages, alerts, prompts, readings, alarms, vitals and figures that overwhelm medical home team members. That's going to involve setting thresholds and priorities.

6. It's not about the revenue: Forget about using health IT to justify additional payment. In a health system without anymore money, the purpose of health IT is to generate savings.  That means it has to pay for itself.

7. Watch out! The under-appreciated health IT event that is going to change the relationship between insurers and providers: the move from using paid insurance claims to submitted EHR claims to assess population outcomes.

Image from Wikipedia

The Latest Health Wonk Review is Up!

Wright on Health is hosting the latest Health Wonk Review with an interesting line up of bloggers on either side of the President's assurances about keeping your health plan.  Given the spectrum of insights and opinion, the Disease Management Care Blog declares this latest Review .....a keeper!

Enjoy!

A Medical Education Bubble Portends Lower Health Care Cost Inflation?

The Disease Management Care Blog spent part of its day in front of its internet enabled World Headquarters' computer screens. As a result, it was able to tune into todays dreary Sebelius Senate Finance Committee testimony.

It wish it hadn't. Between the spin, gotcha's and speechifying, it's obvious that the political rancor is here to stay. And in the end, it makes little difference who is "wrong" or "right" about Presidential reinterpretations of the history about "keeping your plan" or some regulation about "grandfathering." What is more disconcerting is how the partisan divide is gumming up the gears of a well-intentioned if flawed piece of legislation that is now hitting one fifth of the U.S. economy.

Which makes this New England Journal article on the possibility of a "medical education bubble" so timely. According to David Asch et al, "bubbles" occur when a product (in this case the training to be a practicing physician) far outstrips the underlying economic demand (i.e., physician services). Based on this chart that trends medical educational debt to income, student debt has gone up, while future income potential is stalling. In other words, there is a growing disconnect between what physicians can charge patients and what medical schools are charging their students.

The DMCB was not surprised at the rising cost of medical school and financial sacrifices necessary to do a residency, but it was less aware of how slowing health care costs are playing out in our nation's medical schools.

The good news is that this bubble is another indication of slowing health care inflation.

Most agree that the individual insurance market was broken, Medicare's expenses remain ultimately unsustainable and Obamacare will continue a long-established trend of making consumers assume a greater share of health care costs thanks to significant out-of-pocket expenses. The bubble phenomenon suggests we may be getting a handle on that.

Bad for medical schools, but good for the country - especially since the tenor of today's hearing suggest Congress is unlikely to come up with any new solutions in the near term.

Does Diet and Exercise Prevent Diabetes or Help Persons with Diabetes Live Longer?

It's such a no-brainer, right?  If persons at risk for diabetes would only eat right and exercise more, they'd avoid the disease.  And for those who develop diabetes, diet and exercise will reduce death rates and complications.

Yes and no, say Elizabeth Sumamo Schellenberg and colleagues at the University of Alberta.  Their review of the mixed published scientific evidence on the topic appears in the October 15 issue of the Annals of Internal Medicine.  The purpose of their study was to ascertain the impact of diet and exercise on the prevention of "Type 2 diabetes," as well as lowering complications among persons with who had established Type 2 diabetes. 

To be included, studies had to be prospective and compare the outcomes from an intervention versus a randomly selected control group. The study could only be included if it examined the impact of exercise plus diet and "one other component," such as "counseling, smoking cessation and behavior modification."  The outcomes had to include the development of Type 2 diabetes (in the prevention trials) or complications (in the treatment trials).

1289 candidate studies were found but only 20 made the grade. Nine were prevention trials and 11 were treatment trials.

For the prevention trials:

The interventions lasted from 6 to 72 months, with follow-up going for 3 to 20 years for between 39 to 3234 participants.  The counseling varied and included group and/or individual with or without tobacco cessation, telephony, goal setting, cooking classes or pills involving a range of physician and non-physician professionals.

Results?

Seven of the nine studies showed that diabetes can be delayed. When the results were pooled, compared to the control patients, the risk of developing diabetes over 10 years was only a third and the difference was statistically significant.

But, there was no detectable impact on cardiovascular disease events or on eye, kidney or nerve damage. That may have been due to not all the studies including these outcomes as well as the time it takes for these complications to occur once diabetes develops.  With more patients or more time, a difference could have become apparent.
 
For the treatment trials:

The interventions lasted from 6 to 48 months with follow-up for 6 to 93 months. The counseling was as varied as the prevention trials but included glucose and blood pressure monitoring as well as stress management and, in one instance, a three day residential retreat. There was likewise the range of professionals who provided the interventions.

Results? 

Compared to the control patients, there was no statistically significant difference in all-cause mortality.  Some individual studies had beneficial outcomes involving cardiovascular events or diabetes complications, but they included the aggressive use of medications.  There were no sustained impacts on weight or dietary intake.  And if pills were not included, there was also no real improvement in measures of blood glucose control.

The Disease Management Care Blog's take?

The good news is that there is good evidence that exercise and diet can prevent diabetes.  The bad news is that it takes years for that "return on investment" to declare itself and typically involves interventions that fall outside the traditional health care delivery system.  It's unlikely, thinks the DMCB, that current iterations of payment reform (value based purchasing, bundled payments or upside risk) can be marshaled to make this a reality.  That being said, population health management (PHM) companies like Omada Health are making their evidence-based services available to, for example, employers who have a longer term commitment to the well being of their "human capital" outside of the traditional insurance market.

The bad news is that once diabetes declares itself, diet and exercise don't result in life extension, and control of complications as well as overall blood sugar levels is more a function of pills than lifestyle. Accordingly, expectations need to be realisitically shared with patients and PHM should emphasize taking the pills as prescribed.

Image from Wikipedia

The Magnificent Carnac Again Speaks to Health Care Reform!

Visitated once again by the astral, magnificent, all-knowing and soothsaying Carnac, the Disease Management Care Blog has divined his answers to the questions swirling around the healthcare.com roll-out debacle.

As Tonight Show Johnny Carson fans know, the prescient Carnac can foretell answers before the questions have even been asked by Congress and its allies in the punditosphere! By merely holding an hermetically sealed envelope containing the question, the mighty Carnac would provide astounded observers with the answer.

Behold the wisdom of Carnac's answers:

"Six"....

That is NOT the number of individuals securing insurance on the first day of the website! Rather, it is the answer to the question:

"How many million lines of computer code need to be changed to fix the Healthcare.gov web site?"

"Healthcare dot gov and the DMCB spouse"....

The question: "Name one thing that won't work and one person who won't twerk."

"Grits, Glitz and Glitch"....

The question: "Name an excuse for breakfast, zirconium and a government sponsored website."

"Burger King, Viagra dot com and the misstatements surrounding the Affordable Care Act"....

The question: "Name three homes for "The Whopper."

"Zero Dark Thirty"....

The question: "Name three descriptions of what happened to President Obama's approval ratings following the roll out of healthcare.com."

More information on the image can be found here.