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Unpacking the 21st Century Cures Act

President Obama signed the 21st Century Cures Act into law this week.  It’s the largest piece of health legislation since the Affordable Care Act.   No doubt you’ve heard or read that—and it’s true. 

But while the legislation was three years in the making and much hyped, it became the best recent example of that old saying that passing federal laws is akin to sausage making:  You don’t really want to watch what goes into it.

(An aside:  I made venison and bacon sausages from scratch for the first time this year and can attest to the “visceral” nature of that exercise.) 

There’s something for almost everybody in this new law.   That’s one reason it was the most lobbied health bill since the ACA.  In particular, the pharmaceutical and medical device industries were big winners.  Fifty-eight drug companies, 24 device companies and 26 biotech companies lobbied the bill, spending close to $200 million altogether, according to a Kaiser Health News analysis of lobbying data compiled by the Center for Responsive Politics.

What they got:  a big nudge to the FDA to find ways to approve drugs and devices faster.

For example, one change in the law allows FDA to accept as proof of safety and effectiveness less rigorous clinical trials, as well as other types of studies and data—both for the initial approval of drugs and to authorize new uses for drugs already on the market. 

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MedPAC: Medicare Advantage and ACOs Can’t Cut Costs And We’ll Never Know Why

What would you do if you were a member of the Medicare Payment Advisory Commission (MedPAC) and you were told Medicare Advantage and Medicare’s ACO programs are losing money and there’s no way to determine why they’re losing money? That is what happened over the course of two MedPAC meetings, one in October and another in November. At the morning session of the October 6, 2016 meeting, MedPAC staff reported data on the Pioneer and MSSP ACO programs indicating that the two programs together raised Medicare’s costs slightly in 2015. And at the morning session of the November 3, 2016 meeting, staff reported that Medicare Advantage (MA) raised Medicare costs by 5 percent in 2016 (which is down from 14 percent in 2009) and, moreover, that it’s extremely unlikely anyone will ever know why MA plans and ACOs are raising costs.

If you were a commission member, wouldn’t you at least inquire why the staff thinks it’s impossible to determine the causes of the MA and ACO programs’ failure to cut costs? And if you confirmed that it really is impossible to know why they’re failing, wouldn’t you say it’s high time to terminate those programs? Not one of the 16 commission members present at those meetings did that. Many of the commissioners expressed frustration with the poor performance of the ACO programs (for some reason they spared the MA program from similar criticism). But not one demanded to know why the commission knows so little about what goes on inside HMOs, PPOs and ACOs, nor why the staff thinks the information vacuum will go on forever. Surprisingly, two commissioners (Buto and Gradison) did suggest it was time to terminate the MSSP ACO program. But they received no support from any other commissioners or staff.Continue reading…

Does Life Expectancy Matter?

U.S. life expectancy declined in 2015 for the first time in more than two decades, according to a National Center for Health Statistics study released last week. The decline of 0.1 percent was ever so slight ― life expectancy at birth was 78.8 years in 2015, compared with 78.9 years in 2014.  However, this reversal of a long-time upward trend makes these results significant.

While many researchers are scratching their dumbfounded heads in utter astonishment, I hypothesize the decline in life expectancy is partly due to the decrease in the primary care physician supply.  Studies have shown the ratio of primary care physicians per 10,000 people inversely correlates with overall mortality rate.  It is a well-known and reproducible statistical relationship that holds true throughout the world.  In the U.S., increasing by one primary care physician per 10,000 population, decreases mortality by 5.3%, ultimately avoiding 127,617 deaths per year.

Headlines last week highlighted how much these unexpected results left the researchers baffled.   Jiaquan Xu, a lead author of the study told The Washington Post, “This is unusual, and we don’t know what happened…so many leading causes of death increased.”   Age-adjusted death rates went up by 1.2 percent, from 724.6 deaths per 100,000 people in 2014 to 733.1 in 2015.  Death rates increased for eight of the ten leading causes of death, including heart disease, chronic respiratory illness, unintentional injuries, stroke, Alzheimer’s disease, diabetes, renal disease and suicide.  Differences in mortality were most prevalent in poorer communities, where smoking, obesity, unhealthy diets, and lack of exercise are ubiquitous. 

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The HIT Emperor Has Never Had Any Clothes

Over the last several months, I have worked to make the following the official policy of the Massachusetts Medical Society:

That the MMS will advocate to our State and Federal Representatives to end all legal constraints and financial inducements arising from the use or non-use of Office of National Coordinator (ONC) Certified EHR Technology.

That the MMS will encourage our Massachusetts Federal Legislators to introduce legislation to end the ONC’s EHR certification program, and will ask the President of the United States to immediately request that such legislation be introduced.

While the MMS’s Committee on Information Technology voted unanimously to support the above proposal, the MMS rejected the above and choose instead to make the following official MMS policy:

That the MMS will work with appropriate government entities to foster EHR innovation, affordability, and functionality by modifying the certification process for EHRs to improve patient care.

Without a doubt, ONC’s EHR certification program has stifled innovation in EHRs in particular and in health information technology (HIT) in general. In addition, the data accumulated to date has shown these ONC’s Certified EHRs have failed to have a meaningful impact on either the cost or quality of healthcare.

The 6 December 2016 issue of Annals of Internal Medicine has an article which shows that for every hour a physician is involved with direct patient care results in an additional 2 hours of EHR work (in the office/clinic) and then more EHR work from home. No wonder MDs are so dissatisfied with the practice of medicine. The accompanying editorial (Ann Intern Med. 2016;165:818-819) concludes “Now is the time to go beyond complaining about EHRs and other practice hassles and to make needed changes to the health care system ”

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Lead Time Bias and Court Rooms

By SAURABH JHA MD

In 2014, a jury in Massachusetts awarded $ 16.7 million in damages to the daughter of a Bostonian lady who died from lung cancer at 47, for a missed cancer on a chest x-ray. The verdict reminds me of the words of John Bradford, the heretic, who was burnt at the stakes: “There, but for the grace of God go I.” Many radiologists will sympathize with both the patient who died prematurely, and the radiologist who missed a 15-mm nodule on her chest x-ray when she presented with cough to the emergency department few months earlier.

The damages are instructive of the tension between the Affordable Care Act’s push for both resource stewardship and patient-centeredness, and between missed diagnosis and waste. But the verdict speaks of the ineffectualness of evidence-based medicine (EBM) in court. If EBM is a science, then this science is least helpful when most needed, i.e. when trying to influence public opinion.

EBM tells us that had the patient’s cancer been detected thirteen months before it actually was, it would have made little difference to her survival, statistically speaking. Researchers from Mayo Clinic examining the impact of frequent chest x rays in screening for lung cancer in a large number of smokers found that the intensively screened group knew about their cancers earlier, had more cancers removed, but did not live longer as a result. This is known as lead time bias, where early detection means more time knowing that one has the cancer, not more time one is actually alive. This means had the nodule been seen on the patient’s initial chest x-ray she would probably, though not certainly, not have survived much beyond 47.

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Could Price Be Right?

If confirmed as Secretary of HHS, Tom Price will oversee a $1 trillion budget – roughly one-third of all health expenditures.  His proposed legislation “Empowering Patients First” seeks to control costs by giving patients more choices and providing the information required to make them. He calls for publicly available standardized information on the price and quality of physicians, hospitals and other health care institutions.

It sounds like Dr. Price is prescribing a single data system. 

Medicare has had a single data system on the over-65 population for decades.  Since 2005, these data have informed Hospital Compare, a consumer oriented website comparing the quality of over 4000 hospitals.  And while prices in Medicare are relatively fixed, these same data have shown substantial variation in costs because the quantity of service – the number of hospital admissions, procedures and physician visits – varies substantially from place to place.

But Medicare is only one piece of the data puzzle.  A National Bureau of Economic Research report[nber.org] added another piece last year with data from large insurance companies like Aetna and United.  For the under-65 commercially insured population, it’s not just the quantity of services that are all over the map – it’s also the prices. 

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The Case For a Medicare Buy In

Here is why we need a Medicare buy-in:

Take the case of a male age 62, in Omaha Nebraska , whose Income is $50,000 a year

His only offers of ACA-qualified health insurance are from Medica and Aetna.

With Medica, he can choose a bronze plan that has a monthly premium of $1,242, a deductible of $6.850.

What an awful policy! For a premium that equals about 35% of his after tax income, he gets no benefits until he paid over $20,000 a year. The insurance company is essentially trying not to cover this person- they are just offering the worst policy they can.

The ultimate solution is simple — this man should be on Medicare.

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A Different Kind of Meaningful Use Penalty

Our clinic is worried about qualifying for this year’s Meaningful Use incentive payments. We have this hastily purchased EMR that was supposed to make life easier and quality better for all of us. The EMR vendor got paid a long time ago but we are still dealing with the administrative burdens imposed by our new system.

By attesting that we can use this thing reasonably properly, we can receive some Government incentive monies, which even under the best of circumstances don’t even begin to make up for all the extra expenses and productivity losses we have incurred through going digital.

What we are up against is a product that doesn’t do, or doesn’t easily do, what we were told it could.

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Moonshots, Opioids and Incentives

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Major disparities in health outcomes have stubbornly persisted throughout both democratic and republican administrations.  If you have diabetes and you live in a predominantly African-American neighborhood of Chicago, you have a two-to-five times higher risk of having your leg amputated than if you live in one of the city’s white neighborhoods.  If you are a Hispanic child with asthma, you are 50% more likely to be admitted to the hospital than if you are white. And if you are a Vietnamese woman, you are five times more likely to develop cervical cancer than your white counterpart. The incoming Trump administration’s vow to repeal the Affordable Care Act presents a great danger for vulnerable populations.  However, incentive principles that underlie Republican Party health policies could be designed to encourage health care organizations and clinicians to reduce health disparities.

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Does It Matter If You Get Along With Your Doctor?

Seems like a silly question, right? 

No one ever asks if you get along with the cashier at the grocery store or the barista at your neighborhood coffee shop.  For most folks choosing a doctor means finding someone in your area who’s taking new patients with your insurance, which usually isn’t too many. 

Simply getting an appointment is hard enough, so expecting a pleasant experience and a good relationship with the doctor seems to be an unreasonable request, like asking for a unicorn who also speaks fluent Spanish. Many people don’t think patient-physician relationship is particularly important; they’re looking to the doctor for medical advice, not to be a friend.  In these days of electronic medical records and 15 minute appointments, many physicians simply don’t have the time to get to know patients and find out their motivations, goals and fears.  It’s even harder for patients with language and cultural barriers; for example, physicians talk more and listen less to black patients than to white patients

So why do we care? 

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