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IndyCar Driver Kimball Races Past Diabetes

By PAUL NATINSKY
IndyCar driver Charlie Kimball says he is the first diabetic to start and finish the Indy 500. Legally, that is. Diabetic racer Howdy Wilcox II competed in the Indianapolis 500, finishing second in 1932, but he was disqualified before the 1933 race when diabetic symptoms revealed his secret.

Today’s racecar drivers travel much faster—in excess of 225 mph on oval tracks—than their compatriots of yesteryear. Consequently, the slowed reactions, vision issues and decision-making deficits characteristic of unmanaged diabetes are much more dangerous.

“Charlie needs to consistently keep track of before getting on the racetrack,” Michigan State University kinesiologist David Ferguson told MSU Today in 2017. “If his blood sugar is too low, it may take him too long to make the right decision. If his sugar is too high, his reaction time may be fine, but the likelihood of him making the wrong choice increases.” Ferguson works with Kimball to manage his diabetes and authored a study using data from his work with Kimball.

“Technically, since Charlie doesn’t have a functioning pancreas, all the other drivers have had an advantage over him,” Ferguson said. “We simply put him on a level playing field.”

Kimball, 33, thinks his heightened consciousness regarding his health and fitness gives him an edge. “Between my healthcare team, my training team and my race team, I feel like I’m probably a better athlete because of my diabetes rather than just leveling the playing field. I feel I understand my body as an athlete better than I ever would have without ever being diagnosed,” he said.

Kimball, who finished 23rd and 8th, respectively, in two Detroit Grand Prix races on Belle Isle June 2 and June 3, likens his disease management to the functioning of his IndyCar. “With good diabetes management, with good blood sugar control, there is no difference between someone who has a functioning pancreas and someone who has, as I like to call it, a manual transmission pancreas. I’ve always preferred driving a manual transmission car and my pancreas is just a manual instead of an automatic now.”

Kimball’s analogy extends to an actual symbiotic relationship with his race car. “My IndyCar is different than everyone else’s because my body is different. I wear a continuous glucose monitor, so I have a sensor on my body that transmits to a display that’s actually plugged into the car’s data system. On my electronic dash I have speed, lap time, oil pressure, blood sugar, water temperature—my car and my body data right there together.”

While the monitor keeps him alert to his blood glucose level, Kimball is not a candidate for an insulin pump to help him balance his glucose during races. Kimball uses insulin pens manufactured by Novo Nordisk—time-released Tresiba for long-term management and short-acting Fiasp for faster adjustments.

However, Kimball carries no insulin onboard his IndyCar, cockpit conditions and his fireproof suite are too warm for the drug to remain viable. But elevated blood glucose is not Kimball’s worry. The physical toll of racing without power steering or brakes at more than 200 mph tends to burn glucose, so Kimball is more likely to suffer from low blood sugar. He tries to start each race with slightly elevated blood sugar. So far, he has not had to use the toggle switch in his water bottle to deliver a glucose-fortified orange juice option.

This year’s Indy 500 tied the record for the hottest Indy 500 on record, said Kimball. He said he lost between eight and 10 pounds during the race. While that sort of speeding sauna might not be typical, extreme physical exertion is part of every race.

It is difficult for ordinary people to understand the physical demands of race car driving because they can’t go out and do it to get a feel for it, said Kimball. The closest they come is driving their road car to work or to the grocery store.

When Kimball details the grueling physical effects of driving his IndyCar he sounds like the techie kid he was more than a decade ago who had been accepted to Stanford University and pondered studying mechanical engineering. Kimball said his Indy car reaches speeds in excess of 225 mph, travels the length of football field every second and has enough downforce to hold two Indy cars on the ceiling. The car, with him in it, weighs 1,600 pounds, produces about 3,500 pounds of downforce, has no power steering, no power breaks and puts 700 horsepower under his right foot.

The numbers gleaned from Ferguson’s work with Kimball at MSU compare his physical conditioning favorably to that of a National Hockey League player—but there are some things hockey players and other elite athletes don’t face. “One of the unique things we see in the IndyCar series is the G-forces. My G-tolerance would have easily qualified me for the Apollo XI space program back in the day,” said Kimball.

A lot people in racing talk about their sponsors, said Kimball. But, for him, it’s been more of a partnership with drug maker Novo Nordisk. “Long before they knew who I was, I was on their insulin and their insulin delivery devices. I have been using Novo Nordisk insulin since the day I was diagnosed, back in 2007.

“When I talked to them about being involved in my race program, they saw some value and were excited. It started out really small and grew and grew and grew. This year is the 10th season of the Race with Insulin program with Novo Nordisk and myself sharing the message that diabetes shouldn’t stop you from living your dream; in my case racing at over 200 mph in the IndyCar series.”

Kimball said he and Novo Nordisk do a lot of community work, including talking to healthcare professionals to give them an anecdote they can share with newly diagnosed diabetic patients.

Kimball was born in England (his father, Gordon, who designs Formula 1 race cars, was on a job there), raised in Southern California and now makes his home in Indianapolis with his wife, Kathleen. They “love this city and how it comes alive for all four seasons,” but Kimball eyes an eventual return to California.
Gordon Kimball is an avocado farmer and Charlie envisions the more relaxed lifestyle “working on the ranch” might hold for him after his racing career is over.

“It’s a little different pace when in racing you are talking about tenths and hundredths and one-thousandths of a second and in avocado farming, you are talking about a fruit that takes 18 months to develop,” said Kimball.
But Kimball has no plans of driving a tractor soon. He has miles to go before he reaps.

His ultimate goals in racing include “being the first driver with diabetes to win the Indy 500 and being the first driver with diabetes to win the IndyCar championship; because the 500 is a body of work that is three weeks long and one of the most challenging races, if not the most challenging—and the largest one-day attended sporting event in the world—and the IndyCar championship is six months of work over 18 races. So those two are definitely on my list.”

Kimball, who raced in Europe at the beginning of his career, said he would consider other racing formats. “I’ve always said, ‘have helmet, will travel.’ I would love to drive anything, anywhere, anytime, but I still have a lot to accomplish in IndyCar. Here in the U.S., I think I can make a bigger impact within the diabetes community. That is something I take very seriously. The chance to give back to the diabetes community that gave me so much support after I was diagnosed is very important to me.”

So for now, Kimball will enjoy the rush of racing, Indianapolis’ four seasons and the remote starter in his Chevy Tahoe on those cold Midwestern nights.

OUR VIEW: An Attack On ACA Protections

Setting a building on fire and then “rescuing” its inhabitants does not make one a hero—quite the opposite.

Thwarting the intent of a law by refusing to enforce it and then using that action to further undermine the law does not make one a skilled policymaker representing the will of the people—quite the opposite.

But that is what the president and his attorney general have done in supporting a lawsuit that would eliminate the Affordable Care Act’s requirement to cover pre-existing medical conditions, leaving those who are sick and uninsured without coverage options. The suit was filed by several conservative states and the ACA is being defended against by a group of heavily Democratic states.

Actually, the administration is going much further, endorsing the declaration of the entire ACA as unconstitutional because the health insurance mandate (upheld famously by the Supreme Court in 2012) is so central to the law.

The conservative states’ lawsuit argues that if the there are no penalties connected to the mandate (a provision Republicans included in the recently passed tax bill), then there is no incentive for people to seek insurance until they are already sick—an unfair and expensive situation for insurers.

The lawsuit and the attorney general’s brief in support of it is the latest salvo from the Trump Administration and congressional leaders. It is also illustrative of the approach both of those entities have taken toward alleged healthcare reform.

To wit:
-After the passage of the ACA, Republican congressional leaders and most of the party’s rank-and-file passed straight-up repeal bills for seven years running, knowing they could make political hay amid repeated presidential vetoes.

-Donald Trump and most Republican candidates in 2016 campaigned on a “repeal and replace” position on the ACA and healthcare reform and—by-and-large—won.

-After gaining control of the presidency, majorities in both chambers of Congress, the Supreme Court, most state governorships and state legislative majorities, Republicans faced their most dreaded enemy—one another. With seven years to come up with a replacement plan, congressional leaders spent months tearing one another apart without coming up with a replacement for Obamacare.

-After failing at healthcare reform, congressional Republicans used a budget bill as a vehicle to strip enforcement of the financial penalties attached to the ACA’s mandate that all individuals buy health insurance.

That leads us to the most recent development, the lawsuit challenging the constitutionality of requiring insurers to cover pre-existing medical conditions. This move, as have past initiatives features no “replace,” only “repeal,” which leaves the United States with the most embarrassingly ineffective healthcare coverage environment in the free world and hurts the nation’s most vulnerable populations most.

This chain of events is most confounding because it occurs as public support for the ACA is rising and on the heels of Republican replacement plans that garnered widely reported support numbers of 17 percent.

Amid all of the smoke and debris, Republican leaders have consistently claimed that the main problem with the ACA and the current insurance environment is steadily rising premiums that put health insurance out of reach for middle-class people. Conservative policy wonk Sen. Ted Cruz in town hall meetings cited examples of small business people who could not afford to offer health insurance to their workers because of rising premiums that many who, while not wealthy, exceeded the income limits for federal premium subsidies.

Ironically, the lawsuit to end pre-existing condition coverage renders the affordability issue moot. Insurers can simply refuse to offer insurance to an individual—at any price. History suggests that is exactly what many will do.

It will be interesting to see how those who filed and those who support this lawsuit explain how creating more uninsured people and excluding the sickest among us from coverage is a good thing.

By the way, we’re still waiting for that replacement plan.

ON POINT…WITH POs: Alternatives To Board Exams

By EWA MATUSZEWSKI
Several DO and MD primary care physicians recently noted to me the grueling commitment of preparing for their respective medical boards. These exemplary practice leaders have been physicians for several decades—and plan to continue working for the foreseeable future. Each of the physicians I spoke with is a PCMH champion with an outstanding reputation for serving their patients and the surrounding Macomb, Oakland and Wayne County communities.

Why do physicians with a career history of providing high quality care have to continue to take board re-examinations every six years? I’m looking for a reasonable answer, but the response currently seems to be, “so they don’t get kicked out of a health plan.” At the same time, I can’t help but ponder the big business behind board certifications. Consider the cost of the board examinations and the prep programs including pre-tests, times the number of physicians taking them and it’s hard to deny the financial implications/advantages of keeping the status quo.

At a time when we aggressively aim to attract and retain primary care physicians, we need to remove barriers that prevent senior physicians in the field from staying. This problem is of notable concern in underserved areas where primary care physicians may be opting out of full-time physician status but want to stay engaged as a community physician resource. The financial and mental costs associated with the actual exam, pre-tests and preparation serve as further inducement for rural physicians to retire too soon, often to the detriment of the community.

Adding to the frustration (forgive the digression), is that Board exams for family practice physicians are peppered with questions a community-based physician striving to provide population-based care likely will never encounter. The fact is that board examinations as they currently stand are archaic in their continued focus on acute care. Where is the recognition of population health? That’s the future of primary care. How about the five social determinants of health? Today’s PCPs are trying very hard to be good stewards of care, especially in the era of Choosing Wisely and the Triple Aim. Board exams need to incorporate this mindset.

As a member of the Patient Centered Primary Care Collaborative (PCPCC), I see the number of PCPs leaving practice before their time—it’s not just a rural-area phenomenon. Easing rules on board-certified senior physicians could help reverse the trend. For example, a milestone combination of age 60 with 30-plus years of practice and currently practicing in a BCBSM-designated or NCQA-recognized patient centered medical home could qualify as an exemption from taking boards. Another option is to create a point system for PCPs in private practice using key criteria such as PCMH certification, CME hours and quality scores—or quality improvement programs that address population health.

Let’s be creative in addressing a new designation, such as board certified emeritus. Senior PCPs can retain the benefits and prestige that come with the designation and communities retain much needed primary care physicians.

‘Exposure’ & ‘Poisoning’ Toxic When It Comes To Lead

(Editor’s Note: The following is a statement issued by the Genesee County Medical Society, June 4)
The Genesee County Medical Society has reviewed the position taken by the Medical Staff of the Hurley Medical Center regarding the term “lead poisoned.” It’s very important to recognize there are no strict guidelines that would allow us to state that using the term “exposed” is different than using the term “poisoned” in regard to physiologic disruption caused by the toxic metal lead. It is vital to emphasize that there is no safe amount of lead when ingested by children, pregnant women, or any person daily for 15 months without any risk to health and/or development.

While there are still some who must see organ failure, seizures or altered consciousness to use the word poisoned, many medical and scientific experts along with the federal Centers for Disease Control have recognized the more subtle effects of lead poisoning and have repeatedly lowered the level of concern from 40 to 5 ug/ml starting in the 1970s. This has happened in part because the methods to measure blood levels have improved as well as the tools to evaluate brain function. Additionally, screening with blood lead levels does not measure the lead storage in other organs such as the brain, heart, kidneys, teeth, and bones. Perhaps more importantly, we have come to recognize that something being common does not make it acceptable.

Because the literature repeatedly states that there is no safe level of lead, we do not feel comfortable declaring a population safe unless all of its members are free of preventable exposure to this known neurotoxin. It is even more egregious that this neurotoxin is present in their tap water.

Our patients should not be exposed to any toxins when that exposure is preventable. As a clarifying analogy, we note that if a manufacturer knowingly produced a product containing lead for human consumption, they would be stopped from doing so. So too, for our government.

The use of averages, as has been cited in the Medical Staff position, does not take into consideration variations in exposure and susceptibility. It also does not consider the cumulative impact from other environmental insults and other longstanding health disparities. Finally, as an environmental justice issue, there is no acceptable reason why any one group of Michigan residents should tolerate a higher level of lead exposure and ingestion than others just because they live in a certain city or service area.

The statement issued from the most recent HMC Medical Staff meeting does not represent the opinion of the Genesee County Medical Society.

We stand by our position regarding water consumption in the City of Flint, a position also held by the Genesee County Health Department and the City of Flint.

Our communications have never used the term “lead poisoned.” We believe that physicians, and other health professionals who require the elimination of the term “lead poisoned” when referring to lead exposure resulting from the water crisis may in fact be doing harm. Despite the well-meaning intention of removing the possible stigma due to exposure and ingestion of tainted water, their statement may in fact increase stress levels, anger and distrust among the exposed populations. They may be perceived as denying or dismissing traumatic lived experience. We fear this may seriously damage the doctor-patient relationship, and the community’s trust in the medical community in general.

We are encouraged by some of the measures which have been taken to counteract the impact of lead such as avoidance, early childhood programs and the provision of nutritious foods. We believe that the resilience and strength of the people of Flint, in addition to a significant upgrade of the water infrastructure and other future needed measures will serve to help to reverse the effects of this toxic ingestion of lead and other contaminants in our water. Further, we hope that the problems and potential solutions will help to inform other communities that face similar contamination of a basic human need: Clean Drinking Water.

We look forward to future efforts to work with the people of Flint and physicians of Hurley Medical Center to improve communication to the public that best clarifies their risk in the wake of this environmental health crisis.

For questions or comments, you may contact Peter Levine at plevine@gcms.org.

COMPLIANCE CORNER: CMS Changes Home Health Policy

By KEVIN R. MISEREZ, ESQ.
Wachler & Associates, P.C.
On May 29, the Centers for Medicare & Medicaid Services published its 60-day notice to allow interested stakeholders the opportunity to comment on CMS’s proposed Review Choice Demonstration for Home Health Services (revised demonstration). The Review Choice Demonstration is a revised version of the CMS’s previous Pre-Claim Review Demonstration for Home Health Services, which was paused by CMS on April 1, 2017. According to CMS, the revised demonstration will “offer more flexibility and choice for providers.”

Under the revised demonstration, home health agency providers subject to the demonstration have the choice of participating in either a 100 percent pre-claim review or 100 percent post-payment review. These HHAs will remain under the chosen review method until the HHA reaches the target affirmation (for pre-claim reviews) or claim approval rate (for post-payment reviews). At this time, CMS has not provided any specific benchmarks with respect to the requisite “target affirmation” or “claim approval rate” HHAs will need to satisfy. However, once the target affirmation or claim approval rate has been met, HHAs may choose to be relieved from claim reviews with the exception of a “spot check” of their claims to ensure continued compliance.

Under the pre-claim-review option, CMS will review the medical documentation prior to payment to determine if the home health services meet all of the coverage requirements. The review request may be submitted at any time before the final claim is submitted and can occur after home health services have begun. According to CMS, the pre-claim review does not create new documentation requirements; rather, HHAs will submit the same information they are currently required to maintain for payment. Under the post-payment review option, the review by CMS will occur after the beneficiary has received the home health services and the HHA has received an Additional Documentation Request (ADR) for the particular claims under review.

In addition to the forgoing pre-claim and post-payment review options, CMS has also proposed a third option for those HHAs that do not wish to participate in either 100 percent claim review. Under this third option, HHAs may continue to furnish home health services and submit the associated claim for payment without such claims being reviewed, but those HHAs opting to do so will receive a 25 percent reduction in payment on all claims submitted. Moreover, CMS indicated in its notice that HHAs under the third option may still be eligible for review by Recovery Audit Contractors.

The precise start date for the revised demonstration has not currently been announced but will begin no earlier than Oct. 1, 2018 and will last for five years. Furthermore, the revised demonstration will initially only be in effect for HHAs located in five states, which will be implemented on a staggered basis beginning with the state of Illinois, followed by expanding to Ohio, North Carolina, Texas, and Florida, respectively. According to CMS, “These states include known areas of fraudulent behavior and had either a high home health improper payment rate or a high denial rate during the Home Health Probe and Educate reviews.”

While the revised demonstration is currently only proposed to be implemented in the five states above, CMS indicated in its public notice that it has the option to expand to other states if there is increased evidence of fraud, waste or abuse in these states during the demonstration period. Accordingly, it is unknown at this time whether any additional states and/or which additional states could eventually become subject to the revised demonstration program or similar type of claim review process down the road. For example, states that could be potential targets to such types of reviews in the future may be those with areas currently subject to CMS’s temporary HHA enrollment moratoria as these states, including Michigan, have previously been determined by CMS as having significant potential for fraud, waste, or abuse with respect to HHA services. Therefore, HHAs outside of the fives states currently being targeted should nevertheless ensure their claims and supporting medical documentation meet all of the Medicare coverage requirements for home health services.

CMS is seeking comments from the public regarding this proposed revised demonstration. Any home health stakeholders should ensure their comments are submitted by the July 30, 2018 deadline.

ON MEDICINE: Leaders Or Followers

By ALLAN DOBZYNIAK, MD
The solution to healthcare’s costs and access problems is quite obvious. It has been repeatedly suggested that what is needed is a plethora of doctors. Of course this would lower cost and increase access. “Overpayment” of U.S. doctors would disappear as the market becomes oversaturated. Access to care would no longer be an issue as doctors compete for patients.

Only a few minor adjustments would be needed. Time and cost as barriers to manufacturing legions of new doctors could be rectified by eliminating the non-essential four years of college and the extraneous liberal arts courses. A year or so of several science courses in the local community college should suffice. Once in medical school, students could be indoctrinated to give up their rights and self-determination for the general good. Compromise as an approach to regulatory serfdom could be declared one of the most laudable qualities. The chorus of righteousness and the PR mumbo-jumbo of “openness,” “caring,” “sharing,” “community,” and “compassion” could be further integrated into the curriculum. Being taught to think like thinking machines would be pursued. Following the protocols and checking boxes in the myriad screens in the EMR to satisfy the masters of the very “moral” RVU invention would relegate thinking to mere coincidence.

These liberal arts degrees that teach future doctors to think critically, ask the right questions and effectively advocate for patients would be rendered antiques of the past. Can it really be justified to study philosophy, ethics, logic, humanities, ancient and modern literature, and history in a liberal arts curriculum? After all, the result might be the production of doctors who can think and who might also recognize what is good, true and even beautiful.

If a bounty of doctors would lower costs, one wonders why the greater density of physicians on the West and East coasts is far greater than in the interior of the United States, yet the costs of healthcare are much higher in these locations. Such facts should be ignored, even when knowing it is the price rather than the number of inputs into the system that creates the expense. Could it be that hospital administrators with, at most, a master’s degree having a median annual income of greater than $750,000 that contributes to hospital costs and the nasty economic price reality?

But maybe the compromise philosophy is not all that great either. If the goal is more control over physicians, no amount of compromise will ever be enough. Little by little, inch by inch, each small move seems like an insignificant compromise, only to wake up some day to the realization that you have compromised your rights away.

Once critical thinking has been discarded, the mushy consensus-driven group too scared of disagreement or power to speak truth to gibberish can feel secure and fulfilled as they follow the herd. The majority opinion coupled with peer pressure, even if such opinion is inaccurate or nefarious, can result in compliance with the group-think allure. Cognitive thought quite often produces one or few dissenters. If this caught on as the prevailing culture of physicians, members of the profession continuing to compromise, actually giving up and losing, might perhaps change. But of course physicians are never allowed to offend anyone, and they must give in. Why, because physicians’ morality as encompassed in ethics and professionalism has been weaponized against them. Never should passivity be confused with morality.

Just speculate on the state of the medical profession when the “dissenters” are finally silenced. Any remaining struggle between the profession and those who want to control it will be no more. This is an existential struggle whose outcome is still somewhat dependent on the choices physicians make, if they are still able.
Maybe then producing large quantities of the proposed “newly minted physician type” may not be the best answer.

LEGAL LEANINGS: Opioid Litigation Comes To Michigan

By: KERRY B. HARVEY & ANDREW L. SPARKS
Michigan, like the rest of the country, suffers from an opioid epidemic. Every day, more than 100 Americans die from an opioid overdose. Some economists estimate that the opioid crisis has cost the U.S. economy more than $1 trillion since 2001 and is on pace to cost an additional $500 billion through 2020.

The profligate use of opioid pain relievers has contributed mightily to the epidemic. A few data points tell the story:

• About a quarter of patients prescribed opioids for chronic pain do not use them as directed.

• Roughly 4 out of 5 heroin users first abused prescription opioids.

• United States citizens consume about 80 percent of the world supply of oxycodone and almost all of the supply of hydrocodone

Predictably, lawyers and their clients have engaged the legal system to assign responsibility for the opioid epidemic. The wave of opioid litigation has reached Michigan. Opioid litigation, modeled largely on the tobacco lawsuits of the 1990s, has grown exponentially over the last few years. State and local governments initially targeted pharmaceutical manufacturers. Now, distributors such as McKesson and Cardinal have been sued. In 2017, more than 250 state and local governments sued organizations throughout the opioid supply chain, including manufacturers, wholesalers and distributors. Michigan has joined the cause. The number of Michigan cities and counties that have sued opioid manufacturers and distributers is growing. The list includes Detroit, Oakland County and Wayne County. Healthcare providers have reason to fear the opioid litigation wave. Plaintiffs’ attorneys will continue to look down the opioid distribution chain for new targets.

Michigan physicians and hospitals may well be next. Indeed, the next wave of opioid litigation is already building. A growing number of lawsuits against hospitals and physicians allege negligent opioid prescribing practices. The suits typically allege that a physician was negligent by overprescribing opioids or that hospitals failed to effectively monitor their physicians’ prescribing practices, thereby contributing to addiction and all of its dire consequences.

This trend will continue. The United States Department of Justice targets physicians believed to overprescribe opioids. DOJ has hired new federal prosecutors who focus exclusively on investigating and prosecuting healthcare providers who improperly prescribe opioids.

Physicians and hospitals should, of course, strive to improve prescribing practices because it is the right thing to do for patients. Moreover, providers should take concrete steps to protect themselves from the building wave of opioid litigation. Physician groups and hospitals should:

• Require specialized training for all opioid prescribers on the medical staff. Hospitals should assure adherence to Michigan’s new standards for prescribers.

• Ensure that monitoring and testing for appropriate opioid prescribing practices is an integral component of every compliance program.

• Develop a comprehensive screening tool to identify patients who may have a genetic or social predisposition for opioid addiction, or who have struggled with such issues in the past.

• Develop quality metrics related to opioid prescribing practices. Mine the data to identify and counsel outliers. Assume that the government is mining your data to find outliers among opioid prescribers.

• Adopt an effective patient education program related to opioids and the potential for addiction.

• Implement a protocol for patient intervention for those suspected of developing dependency or addiction.

Hospitals and physician groups should adopt evidence-based best practices for the prescription and management of opioids. While a number of tools are available, the Center for Disease Control and Prevention Guidelines for Prescribing Opioids for Chronic Pain is an excellent resource. The guidelines are summarized as follows:

1. OPIOIDS ARE NOT FIRST-LINE THERAPY. Non-pharmacologic therapy and non-opioid pharmacologic therapy are preferred for chronic pain.

2. ESTABLISH GOALS FOR PAIN AND FUNCTION. Clinicians should continue opioid therapy only if there is clinically meaningful improvement in pain and function that outweighs risks to patient safety.

3. DISCUSS RISKS AND BENEFITS.

4. USE IMMEDIATE-RELEASE OPIOIDS WHEN STARTING.

5. USE THE LOWEST EFFECTIVE DOSE. Clinicians should use caution when prescribing opioids at any dosage, should carefully reassess evidence of individual benefits and risks when considering increasing dosage to more than 50 morphine milligram equivalents per day, and should avoid increasing dosage to 90 morphine milligram equivalents per day, or carefully justify a decision to titrate dosage to more than 90 morphine milligram equivalents per day.

6. PRESCRIBE SHORT DURATIONS FOR ACUTE PAIN.

7. EVALUATE BENEFITS AND HARMS FREQUENTLY.

8. USE STRATEGIES TO MITIGATE RISK. Before starting and periodically during continuation of opioid therapy, clinicians should evaluate risk factors for opioid-related harms.

9. REVIEW PDMP DATA. Clinicians should review the patient’s history of controlled substance prescriptions using state Prescription Drug Monitoring Programs (PDMP) data to determine whether the patient is receiving opioid dosages or dangerous combinations that put him/her at high risk for overdose.

10. USE URINE DRUG TESTING.

11. AVOID CONCURRENT OPIOID AND BENZODIAZEPINE PRESCRIBING.

12. OFFER TREATMENT FOR OPIOID USE DISORDER.

There is no assurance that opioid prescribing physicians and hospitals won’t be sued in today’s rapidly developing litigation environment. They can, however, through the rigorous implementation of common sense policies, ensure that they have a defense.

LANSING LINES

Legalized Pot Goes To Ballot, House Opts Not To Vote
Not only did the House Republican caucus not have the votes to legislatively adopt and amend a citizen initiative to legalize recreational use of marijuana, House Speaker Tom Leonard (R-DeWitt) said June 5 he’s not convinced the state Senate really did either.

Senate Majority Leader Arlan Meekhof (R-West Olive), presented with polling showing recreational marijuana passing this fall, said he had 20 votes in the Senate to pass the marijuana legalization citizens initiative.

Had the House passed it June 5, the last day of the 40-day constitutional deadline, Meekhof pledged he would have, too, giving Republican lawmakers an easier shot at amending the proposal to better regulate “home-brew” marijuana businesses, potency restriction and possession amounts.

But the House didn’t have the votes. Inside sources project the chamber had about 40 and likely weren’t going to get any more. Democrats had presented a united front against the proposal and hardline conservatives philosophically opposed legalizing pot.

And Leonard questioned whether the Senate had the 20 votes to pass it anyway, despite Meekhof’s claims.

“I have to believe that if they had the votes to pass this, if they were serious, that they would have taken the vote. And they have yet to take a vote,” Leonard said. “. . . It is hard for me to believe that any leader who was serious about getting this passed, excuse me, adopting and amending this, when they never presented members with an amended version or showed us what that would look like.”

Meekhof spokesperson Amber McCann responded to the comment with, “If Speaker Leonard wasn’t such a fan of putting something on the board to fail, the Majority Leader would have felt more comfortable putting up a vote on marijuana that depended on passage in the House.”

McCann is referencing Leonard’s decision earlier this term to take a vote on an income tax rollback and auto insurance reforms without the needed votes to pass.

At least one House Democrat suggested June 4 that if Republicans had agreed to not to vote to approve the prevailing wage repeal initiative, he would be open to talking about legalizing marijuana.

But House Minority Leader Sam Singh (D-East Lansing) said nobody approached him about dealing. Even if they did, he said he suspects his asking price would have been deemed “untenable” by his Republican colleagues. Senate Minority Leader Jim Ananich (D-Flint), likewise, said nobody talked with him, but he wasn’t under the impression Republicans were interested in dealing away prevailing wage.

“I did not have any direct conversations,” Singh said. “Did some of my members have any conversations? That’s possible, but I think if there were serious, conversations somebody would come to me at a point in time. But they never did.

“I think it was always a conversation about trying to shape this in a way to help a small number of Republican donors run this industry,” Singh added. “I think that’s unethical and they knew they weren’t going to get Democrats.”

With no vote June 5 in the House or Senate to legislatively adopt the initiative put forward in a petition drive by Coalition to Regulate Marijuana Like Alcohol (CRMLA), the question now heads to the ballot. That means voters will get to decide in November whether to make pot legal here in Michigan.

That’s good news to some.

“We represent nine million people in this state and it shouldn’t be left to 110 legislators in the House of Reps and Senators,” said Rep. Robert Kosowski (D-Westland). “It should go to a vote of the people. That’s who we work for . . . It’s their voice. It’s their decision. Some people are telling me they want it. Other people are telling me they don’t. How can I represent my district if it is on both sides of this issue?”

Leonard is not pleased with the prospects of legalization going on the ballot and he said he will be encouraging people to vote against it.

“I’ve seen the problems that marijuana can cause,” Leonard said. “We have spoken to insurance companies who have been pretty clear that auto insurance rates as well as home rates are going to go up in the event that this passes. When I look at the fact that we are likely going to have more operating under the influence arrests, situations where people are being killed by those that are under the influence of marijuana, this is not a good thing for our state.”

He said that once voters are educated about the issue, it could be defeated at the ballot box in November.

CRMLA said that while it would have been happy to see its proposal adopted legislatively, it is confident voters “understand that marijuana prohibition has been an absolute disaster and that they will agree that taxing and regulating marijuana is a far better solution,” said CRMLA spokesperson Josh Hovey.

He said in a statement that the organization’s goal now will be informing voters about what is in the proposal.

“Multiple polls show that roughly 60 percent of Michigan voters want to see marijuana legalized and regulated but, as we saw with the legislative debates these past few weeks, there is still a lot of misinformation out there,” he said. “The fact is that our proposal is carefully written to be a model for responsible cannabis regulation and closely follows the medical marijuana licensing law passed by the state legislature in 2016.”

Since the deadline was June 5 for lawmakers to act, the deal was sealed when the House adjourned without acting. Republicans met for a short caucus before Leonard came out to announce to reporters there would be no vote.

The House was always the challenge for legislative adoption, with Leonard consistently being against the measure and publicly questioning whether there were not enough votes in the Republican caucus to adopt the initiative. Also, House Democrats were leery of taking action, consistently wanting the citizens to vote on the measure.

The Senate had stayed in recess through the afternoon in case House Speaker Pro Tem Lee Chatfield (R-Levering), the point person in the House, was able to put the votes together.

Much of the argument in favor of adopting the initiative legislatively was that it could be amended with a simple majority vote with regulations that exactly mirror those of medical marijuana. If the people adopt it, the Legislature could only adopt it with a three-quarters majority.

Judge Grants Preliminary Approval In Hep C Case
A federal judge gave class-action status to a lawsuit and preliminary approval to a settlement that calls for Michigan to begin providing Hepatitis C direct-acting antiviral medications to more Medicaid patients.

U.S. District Court Judge Denise Page Hood’s decision May 29 in the lawsuit, M.R. v. Nick Lyon, came after both sides submitted a joint motion requesting class-action status and the proposed settlement.

The court’s order identifies the class as any Medicaid recipient 18 and older diagnosed with Hepatitis C virus that can receive the anti-viral treatment. Dickinson Wright was the appointed class counsel.

Notices will be sent to class members, who have until July 17 to file a written response or request to testify at an Aug. 8 fairness hearing, which is a procedure to consider final approval of a settlement.

If no objections are received from a class member, the settlement agreement would go into full effect Oct. 1.

The lawsuit, filed April 14, 2017, alleges the Department of Health and Human Services’ current prior-authorization criteria for Hepatitis C treatment violates three provisions of the Medical Assistant Program, Title XIX of the Social Security Act, excluding qualified Medicaid recipients from medically necessary treatment.

According to court records, DHHS continues to deny the claims alleged, maintaining it has strong defenses. However, the state concluded it would be “desirable and beneficial” to settle the case, court documents noted.

Health Insurance Tax Cut Shoots Through Panel, Senate 
PPOs and their roughly 1.2 million customers would see an accumulative $18 million state tax cut under legislation that’s connected with the Health Insurance Claims Assessment (HICA) repeal bills that moved May 17. The bill creating the cut shot through a Senate committee after a seven-minute hearing and the full Senate May 23 hours later.

Sen. Jim Stamas’s (R-Midland) SB 1016 encompasses a deal made with industry, particularly Blue Cross Blue Shield of Michigan, and state officials, which more than offsets a rate increase non-Medicaid PPO customers were facing under the Insurance Provider Assessment (IPA) tax scheme create.

“We believe the combined claims tax elimination and premium tax reduction is an effective way to ensure that small businesses who offer PPO coverage see relief on the cost of health care, as approximately 70 percent of our small business customers choose PPO coverage,” said BCBSM Corporate Affairs Director Helen Stojic.

Budget Director John Walsh appeared with Stamas in front of the Senate Michigan Competitiveness Committee May 23 to show his support of the work the Legislature is doing on the subject, said spokesman Kurt Weiss.

“We still have some work to do when it comes to finding a long-term revenue solution for health care,” Weiss said. The administration’s support is critical since Gov. Rick Snyder historically has been resistant to poking holes in the state revenue stream without finding a way to pay for it.

The bill does not impact HMOs, something Dominick Pallone of the Michigan Association of Health Plans said he’d like to see addressed. The double taxation issue solved by SB 1016 is $400,000, meaning much of the $18 million benefit is welcomed tax relief.

“This creates a competitive change in the tax structure that impacts one side of our commercial insurers, which is something we’d like to see addressed,” Pallone said.

The bill lowers the current 1.25 percent premiums tax on commercial licenses to .95 percent in 2019. HMOs pay taxes based on the Corporate Income Tax (CIT) and not the premiums tax, so any relief involving those plans would need to be addressed in another section of state law.

Stamas said it is the intent of the legislature for PPOs to pass these savings on to businesses and individuals, although he conceded the legislation doesn’t specifically mandate it. Stojic said as nonprofit mutual insurers, any cost savings for Blue Cross PPO product is passed on to customers.

According to 2015 data, 57 percent of Michigan commercial insurance market is made up of self-insured plans that insure 3.2 million Michiganders. Another 27 percent is made up of large groups, 8 percent small groups and 7 percent individual plans. It is the three latter categories that take advantage of Preferred Provider Organizations or PPOs or HMOs, both of which have roughly 1.2 million covered customers apiece, according to Delany McKinely of the Michigan Manufacturers Association.

SB 1016 moved unanimously out of committee and 36-0 on the Senate floor after Republican leadership agreed to amend the rules for the bill’s hasty passage to the House. In related news, the House Michigan Competitiveness Committee May 23 reported out the IRA package—SB 0992, SB 0993 and SB 0994—unamended.

Folks Can’t Skirt Medicaid Costs With Spouse’s Money
A court can’t allow someone to receive all of their spouse’s income if Medicaid is paying the costs to institutionalize the spouse and there are some patient-pay obligations, the Court of Appeals ruled May 23.

In a published opinion May 22, the court said probate judges in St. Clair and Eaton counties could grant a monthly income to the non-institutionalized or “community” spouses of Joseph Vansach Jr. and Jerome R. Bockes, respectively.

However, the local courts don’t have “unfettered discretion” to gives an allowance that lets the spouse maintain his or her current lifestyle without regard to what it costs to keep the other spouse institutionalized, the three-judge panel ruled unanimously.

To do otherwise, the court’s panel found, is an abuse of discretion. In the Vansach and Bockes cases, the trial courts granted the community spouses 100 percent of their husband’s income.

Vansach and Bockes receive Medicaid benefits to cover a portion of their health care. Their spouses successfully sought a protective order under the law, claiming they lacked sufficient income to meet their needs.

DHHS opposed the petitions, asserting the wives sought a larger community spouse income allowance than allowed, which “would have the effect of decreasing the patient-pay amount” that their spouses contribute to their care.

According to Medicaid.gov, nursing home care, which ranges from $5,000 per month to $8,000 or more per month, can rapidly deplete savings accounts. In 1988, Congress enacted what is called “spousal impoverishment” provisions to prevent the spouse who still lives in the community from having little or no income or resources.

The appeals panel included Judges Peter D. O’Connell, Joel P. Hoekstra and Kirsten Frank Kelly.

State Leaders Press Feds On PFAS Risk
PFAS contamination of water supplies is on the minds of a growing number of Michigan elected officials and they are pushing the federal government to take more action on addressing the emerging contaminants.

Specifically, there’s a push for President Donald Trump’s administration to release a report that reportedly shows PFAS can affect human health at a lower level than previously thought, according to coverage provided by Politico, The Washington Post and others.

An agency within the U.S. Department of Health and Human Services was preparing to release this report, but emails revealed the U.S. Environmental Protection Agency and the White House were concerned about the public reaction to such a report.

That got some stern reactions from U.S. Sen. Debbie Stabenow (D-Delta Twp.) and U.S. Rep. Dan Kildee (D-Flint Twp.).

“Under Scott Pruitt’s EPA, there’s lots of talk, but little action,” Kildee said in a release. “Time and time again, Administrator Pruitt has claimed he is working to address harmful contaminants in drinking water like PFAS or lead, but his EPA continues to kick the can down the road on taking any real action to protect American families. It’s long past time for the Trump Administration to get serious about updating outdated drinking water and cleanup standards to protect public health.”

Kildee started circulating an email petition to urge disclosure of the study, while Stabenow unleashed a fundraising email on the topic, which said in part, “Scott Pruitt’s EPA and Trump Administration officials purposefully hid a report on the dangers of PFAS chemicals from the public.” She called for Pruitt’s resignation.

The unreleased report also caught the attention of Rep. Winnie Brinks (D-Grand Rapids), considering the PFAS concerns tied to Wolverine’s operations in west Michigan are close by.

She offered a resolution May 22 calling on the federal government to release it.

“Science should never be held hostage by special interest groups or by the politicians who are catering to them,” Brinks said in a statement. “Everyone in Michigan deserves to live free from the fear that our air and water is making them sick, but that won’t happen if scientific research is prevented from reaching the public.”

While those agitating haven’t gotten a report, they did get Pruitt and the EPA, hosting a “national leadership summit” in Washington, D.C., on the topic late in May.

It was there that the state’s PFAS Action Response Team set up by Gov. Rick Snyder called on federal officials to move forward with additional research and rulemaking on the contaminants, according to a press release issued by the Michigan Department of Environmental Quality.

“Today, we’re calling on EPA to move forward with additional research and rulemaking on PFAS, so we have sound science and clear regulations from which to continue our mission of protecting people and the environment from this emerging contaminant,” said DEQ Director Heidi Grether.

And the Michigan League of Conservation Voters, citing “continued inaction” at the federal level, implored state and local officials to “protect the 14 communities across Michigan grappling with PFAS contamination.”

 

Pediatrician Says Wells’ Action Helped State ‘Change Course’ In Water Crisis

A Flint doctor whose research helped expose the lead contamination crisis in Flint’s drinking water said it was the chief medical executive’s work that moved state officials “to change course” in the water crisis.

Dr. Mona Hanna-Attisha, a pediatrician with Hurley Medical Center and Michigan State University, said Dr. Eden Wells’ phone call to her in October 2015 got the state to relook at its results—which contradicted the doctor’s research—of lead blood levels in Flint’s children.

“It was her phone call and I think what she did at the state level to re-look at the data . . . that really got them to change course,” the doctor testified April 24 at day 15 of Wells’ preliminary examination. “I’m grateful she was able to look at the data and to realize we did have a problem. If not for her action, I think it, the attacks and denials, would have gone on much longer.”

Hanna-Attisha summed up Flint’s situation rather succinctly: “Flint had no democracy; money was the bottom line.”

Wells is charged with involuntary manslaughter, lying to a special police agent and obstruction of justice in connection with the legionnaires’ disease outbreaks that killed 12 people and sickened nearly 80 more.

Special Prosecutor Todd Flood called the state’s last witness when Wayne State University associate professor Dr. Paul Kilgore was released from the stand April 24. He said the state would rest its case against Wells if the defense agreed to documents he wants to enter as evidence.

After a break, Flood and defense attorney Steve Tramontin announced they reached an agreement on some of the documents, but not two, including an executive order about Wells.

Flood was expected to report how he would proceed on April 25 when the hearing continues with testimony from defense witnesses, including Dr. Jeffrey Band, former chief of infectious disease at Beaumont Hospital in Royal Oak.

The defense called Hanna-Attisha to the stand Tuesday and Tramontin wasted little time in getting to the point as he asked her what inspired her to look into the Flint lead issue.

Hanna-Attisha said her family was hanging out with a friend’s family when the friend, who worked for the U.S. Environmental Protection Agency, explained that corrosion control wasn’t being used in the Flint River and that could mean lead was in the water.

“That was the very first time, at my house, glass of wine in my hand that I heard lead in the water,” she said. “It’s already a form of environmental injustice; our kids in Flint already had higher lead levels and when I heard there was lead, I was kind of freaking out.”

Until that moment, the doctor said, she had heard the state’s reassurance that “everything was OK” and she believed it—until she heard there was lead in the water.

Concern propelled Hanna-Attisha to act and she contacted county health officials who told her water wasn’t their jurisdiction. She tried state officials, but she said she was “meeting road blocks at every level of government.”

The doctor then examined a small sample of Hurley patient records and saw an increase in the number of children with elevated lead levels. However, her sample was too small for scientific certainty so she expanded her sample size, which validated her prior results.

On Sept. 24, 2015, Hanna-Attisha held a press conference at Hurley hospital where she announced her results and urged people to take caution, especially those vulnerable to bacteria, such as the elderly with other health issues and children.

Hanna-Attisha said she was “happy” following the press conference, which she called “awesome,” because finally information was getting to the public, but it was a short-lived feeling.

“Quite quickly, I was attacked by the state,” she testified, specifically calling out former Michigan Department of Environmental Quality spokesman Brad Wurfel, who called the doctor’s work “unfortunate.”

Wurfel, who resigned in December 2015, later apologized for the remark.

Hanna-Attisha also said she was “attacked by several” departments, including the governor’s office, DHHS and MDEQ, but she and the hospital “fought back because we knew our science was right.”

And, it was Wells, the doctor said, who helped, in part by providing the data Hanna-Attisha had requested, but hadn’t received.

“I always found her to be responsive and if she didn’t know something she’d try to connect me to people who did,” Hanna-Attisha said. “I felt she was professional and responsive . . . She takes her work seriously. We’ve been able to do great things for kids throughout the state because of post Flint work.”

On cross examination, Flood, thanked Hanna-Attisha for “standing to make a wrong a right,” said even if Wells was helpful, at the end of the day she did nothing to stop what was happening with Flint’s water.

“Do you hear sirens, boots and the Department of Health coming here to solve the issue immediately?” Flood asked.

Hanna-Attisha replied: “It should have never gotten to that point. It should have stopped when that first mom raised the water bottle.”

As Flood attempted to get Hanna-Attisha to point the finger at Wells, she instead pointed it at herself, saying she should have seen it earlier and that the medical community was “by and large late to get involved” and she wished she had done so earlier.

This story presented in cooperation with MIRS, a Lansing-based news and information service.

As Proton Centers Struggle, A Sign Of A Health Care Bubble?

By JAY HANCOCK 
The Maryland Proton Treatment Center chose “Survivor” as the theme for its grand opening in 2016, invoking the reality-TV show’s tropical sets with its own Tiki torches, palm trees and thatched booths piled with pineapples and bananas.

It was the perfect motif for a facility dedicated to fighting cancer. Jeff Probst, host of CBS’ “Survivor,” greeted guests via video from a Fiji beach.

But behind the scenes, the $200 million center’s own survival was less than certain. Insurers were hesitating to cover procedures at the Baltimore facility, affiliated with the University of Maryland Medical Center. The private investors who developed the machine had badly overestimated the number of patients it could attract. Bankers would soon be owed repayment of a $170 million loan.

Only two years after it opened, the center is enduring a painful restructuring with investors poised for huge losses. It has never made money, although it has ample cash to finance operations, said Jason Pappas, its acting CEO since November. Last year it lost more than $1 million, he said.

Volume projections were “north” of the current rate of about 85 patients per day, Pappas said. How far north? “Upper Canada,” he said.

For years, health systems rushed enthusiastically into expensive medical technologies such as proton beam centers, robotic surgery devices and laser scalpels — potential cash cows in the one economic sector that was reliably growing. Developers got easy financing to purchase the latest multimillion-dollar machine, confident of generous reimbursement.

There are now 27 proton beam units in the United States, up from about half a dozen a decade ago. More than 20 more are either under construction or in development.

But now that employers, insurers and government seem determined to curb growth in health care spending and to combat overcharges and wasteful procedures, such bets are less of a sure thing.

The problem is that the rollicking business of new medical machines often ignored or outpaced the science: Little research has shown that proton beam therapy reduces side effects or improves survival for common cancers compared with much cheaper, traditional treatment.

If the dot-com bubble and the housing bubble marked previous decades, something of a medical-equipment bubble may be showing itself now. And proton beam machines could become the first casualty.

“The biggest problem these guys have is extra capacity. They don’t have enough patients to fill the rooms” at many proton centers, said Dr. Peter Johnstone, who was CEO of a proton facility at Indiana University before it closed in 2014 and has published research on the industry. At that operation, he said, “we began to see that simply having a proton center didn’t mean people would come.”

Sometimes occupying as much space as a Walmart store and costing enough money to build a dozen elementary schools, the facilities zap cancer with beams of subatomic proton particles instead of conventional radiation. The treatment, which can cost $48,000 or more, affects surrounding tissue less than traditional radiation does because its beams stop at a tumor rather than passing through. But evidence is sparse that this matters.

And so, except in cases of childhood cancer or tumors near sensitive organs such as eyes, commercial insurers have largely balked at paying for proton therapy.

“Something that gets you the same clinical outcomes at a higher price is called inefficient,” said Dr. Ezekiel Emanuel, a health policy professor at the University of Pennsylvania and a longtime critic of the proton-center boom. “If investors have tried to make money off the inefficiency, I don’t think we should be upset that they’re losing money on it.”

Investors backing a surge of new facilities starting in 2009 counted on insurers approving proton therapy not just for children, but also for common adult tumors, especially prostate cancer. In many cases, nonprofit health systems such as Maryland’s partnered with for-profit investors seeking high returns.

Companies marketed proton machines under the assumption that advertising, doctors and insurers would ensure steady business involving patients with a wide variety of cancers. But the dollars haven’t flowed in as expected.

Indiana University’s center became the first proton-therapy facility to close following the investment boom, in 2014. An abandoned proton project in Dallas is in bankruptcy court.

California Protons, formerly associated with Scripps Health in San Diego, landed in bankruptcy last year.

A number of others, including Maryland’s, have missed financial targets or are hemorrhaging money, according to industry analysts, financial documents and interviews with executives.

“In any industry that’s really an emerging industry, you often have people who enter the business with over-exuberant expectations,” said Scott Warwick, executive director of the National Association for Proton Therapy. “I think maybe that’s what went on with some of the centers. They thought the technology would grow faster than it has.”

In the absence of evidence showing protons produce better outcomes for prostate, lung or breast cancer, “commercial insurers are just not reimbursing” for these more common tumors, said Brandon Henry, a medical device analyst for RBC Capital Markets.

The rebellion by private insurers “is very, very good” and may signal the health system “is finally figuring out how to say no to low-value procedures,” said Amitabh Chandra, a Harvard health policy professor who has called proton facilities unaffordable “Death Stars.”

Proton centers are fighting back, enlisting patients, legislators and nonprofits to push for reimbursement. Oklahoma has passed and Virginia has considered legislation to effectively require insurers to cover proton therapy in more cases.

To make the finances work, hospitals are combining forces. The first proton beam center in New York City is under construction, a joint project of Memorial Sloan Kettering, Mount Sinai and Montefiore Health System.

Smaller facilities, which can cost less than $50 million, should be able to keep their rooms full in many major metro areas, said Prakash Ramani, a senior vice president at Loop Capital, which is helping develop such projects in Alabama, Florida and elsewhere.

Kaiser Health News is an editorially independent program of the Henry J. Kaiser Family Foundation, a nonprofit, nonpartisan health policy research and communication organization not affiliated with Kaiser Permanente. https://khn.org/