Updated Opioid Laws Enact More Stringent Reporting And Usage Requirements

By JESSE A. MARKOS, ESQ.
Wachler & Associates, P.C.
The Michigan Opioid Laws include a 10-bill package of legislation passed in December, 2017, to help curb Michigan’s increasing substance abuse and drug diversion problem. The majority of these provisions came into effect on June 1, 2018 and healthcare providers must become familiar with and incorporate these provisions in to their practice to ensure they are compliant with the changes.

Healthcare providers use the Michigan Automated Prescription System (MAPS) to review a history of any Schedule 2-5 controlled substances that a patient has legally obtained. Not only does MAPS list the prescriber and type of controlled substance that has been prescribed, but it also lists the location of the pharmacy it has been dispensed at. MAPS data assists healthcare providers in identifying evidence of potential diversion such as: obtaining controlled substance prescriptions from more than one provider, filling prescriptions early, filling prescriptions at multiple different pharmacies, and filling prescriptions at distant pharmacies. In the past, providers were not required to register for or use MAPS, although it was highly encouraged and likely to be considered the standard of care when prescribing a controlled substance. Nevertheless, while it was largely considered the standard of care to run and review a MAPS report when prescribing a controlled substance, the issue of how frequent such reports should be run for a chronic patient was less certain. The new laws make it both an express requirement that a prescribing healthcare provider register with MAPS and that they run and review such data every single time a prescription is written that exceeds a three-day supply.

Another important provision in the Michigan Opioid Laws is the “Start Talking” consent form, which must be filled out whenever a prescriber issues a controlled substance containing an opioid to a minor or adult. This form not only has signatures from all involved parties, but it contains all of the relevant information about the risks of taking the opioid, such as: acknowledgement that the drug has potential for abuse, how to properly dispose of an expired or unused controlled substance, and that the delivery of a controlled substance is a felony, among other things. Again, although obtaining prior consent was certainly a standard of care requirement previously, the new laws make it an express requirement that the specific notice listed in the new laws must be adopted in any Consent Form being utilized by a health care provider moving forward.

The Michigan Opioid Laws contain ten (10) new provisions that were passed by the Michigan Legislature, and providers who prescribe or dispense controlled substances must familiarize themselves with these new laws in order to remain compliant and protect their licensees. For additional information or assistance, contact Jesse A. Markos, Esq., of Wachler & Associates, P.C., at (248) 544-0888.

IRS: The Good, Bad and Ugly for Health Care Providers

By RALPH LEVY
In early August, the Internal Revenue Service issued proposed regulations that provide guidance to owners of pass-through businesses as to eligibility for a federal tax deduction of 20 percent of the income generated by the businesses. This deduction was part of the Tax Cuts and Jobs Act (TCJA). Although the stated purpose of the proposed regulations is to provide clarity on eligibility for and the means to compute the deduction, this guidance is lengthy and complex. However, for healthcare providers, there are two important takeaways.

Takeaway No. 1: Guidance on whether a healthcare business is a “specified service trade or business.”

One of the important limitations to the pass-through deduction in the TCJA is that owners of pass-through businesses that conduct a specified service trade or business (SSTB) and whose income exceed the so-called income limitation ($207,500 for single taxpayers and $415,000 for married taxpayers who file jointly) are not entitled to claim the 20 percent deduction. The TCJA provides that a SSTB includes a trade or business that involves the performance of services in the health field.

The proposed regulations provide guidance as to what types of businesses involve the performance of health services:

The performance of services in the field of health means the provision of medical services by physicians, pharmacists, nurses, dentists, veterinarians, physical therapists, psychologists, and other similar healthcare professionals who provide medical services directly to a patient (emphasis supplied).
Prop Reg. 1.199A – 5(b)(2)(ii).

Providers of certain types of healthcare services might be able to avoid the SSTB limitation if their services are not provided directly to patients. For example, radiologists who are partners in a professional limited liability company and who merely read test results may be eligible for the deduction but the treating physician will not be entitled to the deduction since the treating physician provides services “directly to patients.”

Similarly, if an orthopedic group also owns a physical therapy clinic, because that clinic’s services are directly related to the medical field, it is likely that the clinic will be deemed to be engaged in a SSTB. However if the same physician group also operates a health clinic “that provide[s] physical service or conditioning to their customers (i.e., not medical related)”, the clinic will not be engaged in a SSTB.

Takeaway No. 2: The use of a “captive MSO” will not work.
Prior to issuance of the proposed regulations, one of the planning suggestions that many advisors had recommended for consideration by owners of healthcare businesses whose income exceeded the income limitation was segregation of the billing, collection, accounting and other “back office” activities of the practice into a separate legal entity under common ownership with the practice group. This new legal entity would in reality be a management service organization (MSO) that provides services only to the affiliated practice group. Such a new entity was referred to by some as a “captive MSO”.

Under the proposed regulations, if the captive MSO provides services only to the practice group under common control, the MSO would be deemed to conduct a SSTB. This of course eliminates the tax advantage of establishment for the MSO.

By contrast, if more than 20 percent of the income of the MSO is generated from providing management services to other payors such as unrelated medical practice groups, the MSO would not be found to engage in a SSTB.

Similarly, if a dentist is the sole member of a limited liability company that owns a two story office building and rents the first floor to the dentist’s dental practice but leases the second floor to an unrelated business, half of the income generated by the LLC from the building will be deemed to be generated from a SSTB.

Although the proposed regulations limit the ability of health care providers to use affiliated entities to maximize the 20 percent deduction, planning opportunities still exist if the ancillary business is owned by a trust or other entities not under “common control” or if the business provides services to unrelated service providers.

In summary, even though they are complex and cut-off some available planning opportunities, the newly issued proposed regulations do not eliminate all planning opportunities to maximize the 20 percent deduction for owners of pass-through businesses that provide health care services.

LANSING LINES

Lyon’s Attorneys Seek To Dismiss Criminal Case
As expected, attorneys for Michigan Department of Health and Human Services Director Nick Lyon are asking the Genesee County Circuit Court to quash the bind over from district court and dismiss all criminal charges.
In court filings Sept. 10, defense attorneys John J. Bursch, Larry Willey and Charles “Chip” Chamberlain Jr. say Genesee County District Judge David Goggins’ made his “decision by closing (his) eyes to numerous principles well-settled in Michigan law” and that his decision to send Lyon to trial on two counts of involuntary manslaughter and misconduct in office is the first in the state’s history to hold a director criminally liable for subordinates.

“The families of Mr. (Robert) Skidmore and Mr. (John) Snyder desire justice, as do the people of Flint,” Bursch wrote. “But that desire cannot be satisfied subjecting Director Lyon to a trial for criminal charges that fail as a matter of law. That would be the exact opposite of justice.”

A 9 a.m. Sept. 26 hearing was set, but it’s unclear if Circuit Judge Joseph J. Farah will hear the defense’s motions that day.

The state had not filed a response as of Sept. 10.

The state argued at a preliminary examination that Lyon’s failure to notify the public about Legionnaires’ disease in the Flint area in 2014 and 2015 led to the deaths of Skidmore, 85, of Genesee Township, and Snyder, 83, of Flint-area.

Lyon also faces one count of misconduct in office for allegedly misleading and withholding information about Flint’s Legionnaires’ disease outbreaks and directing a health official to discontinue analysis to find the source.

In a separate motion, the defense also seeks to dismiss a misdemeanor count of willful neglect of duty, which automatically moved to Circuit Court with the felonies when Goggins didn’t make a ruling on the defense’s motion to dismiss the charge.

The defense says Lyon had no ministerial duty and any alleged duty to “protect the public health” is too vague to be enforceable. To support their argument, the defense points to preliminary examination testimony in which witnesses testified whether, when and how to give notice of an outbreak is professional judgment and discretion.

“As far as the MDHHS director is concerned personally, the statute requires only that he ‘be qualified in the general field of health administration.’ . . . Indeed, the MDHHS director’s oversight of his epidemiologist and health officers in the event of a Legionnaires’ outbreak is the epitome of discretion,” Bursch wrote.

“Based on this legal defect in the charge, the lack of any evidence of willful neglect, and the additional reasons described below, the defense moves to dismiss (the charge),” he added.

Health Policy Considers Creation Of Statewide Mental Health Hotline
A state-wide mental health hotline—which would connect callers experiencing a mental health crisis to facilities that have psychiatric beds available and other service providers — would be created under legislation taken up Sept. 5 in the House Health Policy Committee.
Rep. Mary Whiteford (R-Casco Twp.) told the committee her HB 6202 was inspired by an experience she had with a friend who had become depressed after the death of her grandmother. Whiteford said she contacted local mental health services, one of which said if her friend was not suicidal there was nothing they could do. Another behavioral help group said it usually takes three to five months for new patients to see a provider.

Eventually, Whiteford took her friend to an emergency room where the friend was admitted. After a one-week stay, the bill was $10,000, Whiteford said, of which the friend owed $5,000.

How many would persevere after getting turned away twice, she asked.

“The answer is most people don’t know where to go. They don’t know who to ask for help. They do nothing. What happens to the struggling person? They hurt themselves. They commit suicide. They hurt others. What would have helped? What can help others in the same situation?” she said.

Such a hotline was called for in the House CARES (Community, Access, Resources, Education, and Safety) task force report members worked on last year and was unveiled in January. The task force reviewed the status of mental health services across the state, and found that availability of services is inconsistent from county to county.

Rep. Daniela Garcia (R-Holland) had several questions. For one, Community Mental Health services in counties are required now to have hotlines. Why is that not sufficient? she asked.

“Did you know that it is easier for somebody on Medicaid to access services than it is for someone who is uninsured, or someone who is insured. This allows access to everybody,” Whiteford answered.

Garcia also asked who would be assigned to answer that hotline, how they would be trained and evaluated.

“At this point, I don’t want to be so prescriptive that we lose innovation that we lose the ability for a company to make those judgment calls. So, the way I see it, is that the department will put out a request for proposals,” Whiteford responded.

Under the bill, the Department of Health and Human Services would contract for the design, operation, and maintenance of the hotline. DHHS would work with the contractor as well as the Department of Licensing and Regulatory Affairs to tap into existing databases and lists of service providers. Any operator company would be expected to run the hotline using various methods of communication including phone calls, texts, e-mails and internet chats.

Garcia put the estimated cost of creating the hotline at around $6 million. The bill analysis states the annual cost of operation would likely be similar to other hotlines the state operates, which range between $1 million and $2.5 million.

The committee ran out of time for further testimony. No vote on the bill was taken.

Proposal 1 On November Ballot: Marijuana Legalization
Michigan Director of Elections Sally Williams released Aug. 31 draft ballot language for the Coalition to Regulate Marijuana Like Alcohol’s initiative to legalize marijuana.
The proposal, 18-1, would initiate a law to “authorize possession, use and cultivation of marijuana products by individuals who are at least 21 years of age and older, and commercial sales of marijuana through state-licensed retailers.”

The Board of State Canvassers was expected to consider the recommended language at its 10 a.m. Sept. 6 meeting at Delta Charter Township Hall, 7710 W. Saginaw Highway, Lansing.

In addition, the proposal would:

– Allow individuals age 21 and older to grow up to 12 marijuana plants for personal consumption;

– Impose a 10-ounce limit for marijuana kept at residences and require that amounts over 2.5 ounces be secured in locked containers;

– Create a state licensing system for marijuana businesses including growers, processors, transporters and retailers;

– Allow municipalities to ban or restrict marijuana businesses.

– Permit commercial sales of marijuana and marijuana-infused edibles through state-licensed retailers, subject to a new 10 percent tax earmarked for schools, roads and municipalities where marijuana businesses are located.

CRMLA was formed this year to support the ballot initiative to end marijuana prohibition in Michigan and establish a system in which it is regulated and taxed, similar to alcohol.

In April, the Board of State Canvassers approved the coalition’s petition.

In June, the Michigan Legislature didn’t have the votes to pass the legalization ballot initiative, which means the issue appears on the Nov. 6 ballot.

If approved, Michigan would become the 10th state to legalize, regulate and tax marijuana, according to CRMLA’s website.

Agencies, businesses and organizations opposing recreational marijuana legalization have mobilized in recent months.

Witness: Finding Cause of Flint Water Crisis ‘A Luxury’
A former state epidemiologist testified Aug. 30 that finding the cause of elevated blood-lead levels in Flint’s children during the water crisis would have been “a luxury.”
Cristin Larder returned to the stand for the fourth time in the preliminary examination for Nancy Peeler, director of Michigan Department of Health and Human Services Program for Maternal, Infant, and Early Childhood Home Visiting, and Robert Scott, data manager for the department’s Healthy Homes and Lead Prevention program. The hearing, which will determine if there is probable cause to send criminal charges to Circuit Court for trial, resumes Sept. 20.

The state alleges Peeler hid Larder’s report and joined Scott to create a second report that falsely indicated no statistically significant rise in blood-lead levels of children in July, August or September 2014.

Larder’s testimony remains consistent that Peeler asked her in February 2015 to analyze data to determine if there was an uptick in blood-lead levels in Flint children during the water crisis, which began in April 2014 when the city switched its drinking water source to the Flint River, and that she learned during a Freedom of Information Act file dump that her report wasn’t in the state files.

Larder also maintained that she didn’t have enough raw data to explore more thoroughly or to reach a conclusion about the cause.

“I cannot say and I couldn’t say at the time,” she said.

Larder was the only witness today and at times the proceedings felt slow as Special Prosecutor Todd Flood sparred with Scott’s attorney, Mary Chartier, who carefully questioned Larder about emails she wrote in 2015 about her analysis and whether Peeler and Scott were recipients of those emails.

Chartier argued that information Larder penned in a February 2016 email wasn’t sent to Peeler or Scott and therefore, isn’t relevant, but Flood countered that the email shows Larder’s report “was basically suppressed,” which is the basis for the charges against Peeler and Scott.

“Bob Scott is not misleading anyone,” Chartier told the court as she questioned Larder.

“Bob Scott is not in charge of anyone. He’s there to provide data and what I’m trying to get from Miss Larder is smart people are looking at a challenging issue and trying to come up with ideas,” the attorney added. “He’s not directing what they do or don’t do and that goes to the heart of what Mr. Flood is trying to put on the shoulders of my client, who is not even involved in these matters.”

Peeler and Scott are each charged with misconduct in office and conspiracy, both of which are felonies. They are also charged with misdemeanor count of willful neglect of duty in connection with the Flint water crisis.

Lansing Lines is presented in cooperation with MIRS, a Lansing-based news and information service.

LETTER

Editor:

Just A Few Questions
How can it be expected that all physicians and all citizens will succumb to the idea of socialized medicine without inquiring as to why they should? Is it somehow mandatory that we U.S. citizens duplicate the socialist-lite bloated welfare states that are the examples of how the rest of the “advanced” world’s approaches healthcare? How is it always correct to increasingly subvert the medical profession by employing ever more restrictive regulatory shackles? Isn’t it interesting to witness how the left-leaning elites write a check with money they do not have that comes from our bank accounts so that they can snoot and virtue signal? Isn’t social justice great when some elites can redistribute wealth to achieve equal outcomes in a world of humanity with individual cultures and aspirations? It seems I read somewhere that God created each person as unique and in His own likeness.

As the cadre of newly enlightened devotees to the alleged equality of their social justice platform prescribe socialized medicine for all of us, will this not steal coveted freedoms from physicians and citizens? Critical thinking versus emotional feel-good stuff?

You know, let these great new falsely pious warriors have at it. But leave the rest of the doctors and patients out of their unfunded, freedom-sapping never in history workable plans for us all.

Is not the pitifully decreasing physician morale in this country sufficient? Does it need to be at the pathetic levels of physicians functioning in those socialized medicine havens of provider underpayment for rationing care their governments can increasingly not afford? We already have two physician suicides a day in the United States.

Duplicating failure seems a strange goal, does it not?

The ‘Right’ To Healthcare?
When healthcare is presumed a right, the provider, doctor, has no rights. That someone would expect a service from another without payment seems much like the scourge of slavery that was belatedly banished from this country in the mid-19th century. There seems a hypocrisy here as the loud screams of the virtue signalers for social justice are joined by equally loud screams for physician services on demand for “free.” Is it not abusive to expect care without any expectation of payment or even a hint of appreciation? Explain the moral basis of those who want healthcare for “free” and those who benefit from this politically. There seems a loud and clear message here regarding the progressive movement and the duplicity of virtue signaling and social justice.

Then there is a mandatory obligation to preach false magnanimity devoid of any relationship to economic realities. With government-run healthcare, would there be any incentive for capital investment? Let me give a unambiguous answer, ‘no.’ Without capital investment, innovation disappears. Entrepreneurs are eradicated. And remember, financial capital effects human capital in direct correlation, and this includes the number, type and quality of future physicians. You cannot stave off voluntary and intelligent capital flow to the innovators in exchange for political favoritism, mercantilism, and expect anything other than the status quo at best. The emotional “feel good high” of the Medicare for all crowd can’t have it both ways, progress versus increasing government control.

Yes, for a person to share the most private aspects of their life often with nothing covering them other then a drape, this truly is a special bond, “a sacred relationship.” It cannot be legislated. In fact legislation has consistently eroded it. God help us if the bureaucrat elites are able to destroy it. The profession of medicine will be lost. This is a tragedy for all of us who will at some point need healthcare. You can meet your favorite bureaucrat or hospital administrator in the ER. The real doctors are likely a rapidly diminishing group in an environment of mandatory capitulation. There must be consequences, and these will most assuredly be negative.

—Allan Dobzyniak, MD

The opinions expressed above are those of the author and not necessarily those of Healthcare Michigan or its advisors.

PFAS Firefighting Foam Still Used Because It Works Better

The firefighting foam linked to the group of chemicals known as PFAS—which is believed to be harmful to infants, toddlers and pregnant women—is still being used because firefighters say the alternative extinguishing products don’t work as well.

Detection of PFAS has led to the creation of the Michigan PFAS Action Response Team, a multi-agency organization dedicated to understanding the far-reaching effects of the chemical and educating the public on the threat it poses.

The discovery of high concentrations of PFAS in the drinking water near Camp Grayling, Kent County and Parchment has spurred public and political concern. Most recently, U.S. Reps. Debbie Dingell (D-Dearborn), Fred Upton (R-St. Joseph) and Tim Walberg (R-Tipton) are pulling together a public meeting on the subject.

House Democrats are working with the League of Conservation Voters in demanding Republican legislative leaders hold hearings on the issue.

“It’s reason for concern because it’s an issue of public health,” said Katie Parrish, communications director for the Michigan League of Conservation Voters.

The Michigan PFAS Action Response Team has asked State Fire Marshal Kevin Sehlmeyer to survey over 1,000 fire departments to identify the amount of PFAS in firefighting foam, according to the Michigan Department of Licensing and Regulatory Affairs.

Although the survey has not been completed, the response team and other agencies have evidence that the foam has been used to contain fuel and electrical fires and in training drills.

Firefighters and certain military personnel are required to use the foam. The response team believes the military’s heavy use of it contributed to elevated levels of the chemicals in Lake Margrethe, a lake adjacent to Camp Grayling. About a dozen similar sites are also affected.

Because of the danger, many newer firefighting foams don’t contain PFAS, said David Glotzbach, president of the Michigan Association of Fire Chiefs and a 33-year veteran firefighter.

“However,” Glotzbach said in an email, “these products are not effective in extinguishing flammable liquid fires.”

The Department of Environmental Quality has 35 active investigations for potential PFAS contamination across the state. It has begun testing public drinking water for the contaminant throughout the state, said Scott Dean, the agency’s communications director.

The testing will be finished by the end of the year and the agency has only found one public drinking supply—in Parchment—with dangerous levels of the chemical, he said.

Some commercial businesses have fought the testing. In May, the managers of Gerald R. Ford International Airport attempted to deny DEQ testing, claiming government overreach. The DEQ eventually tested the airport and found elevated levels of the chemical.

PFAS is dangerous in part because it does not break down in the environment or the human body, leading to its designation as a “forever chemical” by the LCV.

The chemical is produced across the country and used not just for firefighting but for products such as stain-resistant shoes and no-stick pans. Waste from these production sites cannot always be treated by generic wastewater treatment plants, according to the Michigan Environmental Council. Specifically, when several industrial buildings discharge waste directly into a treatment plant, the chemicals will still survive.

Meghan Swain, executive director of the Michigan Association for Local Public Health, says the federal government should be more proactive in regulating PFAS.

“Michigan is the only state talking about PFAS chemicals,” Swain said referring to the formation of the state’s PFAS Action Response Team. “The EPA should have sounded the alarm years ago.”

The EPA says 70 parts per trillion is the limit on PFAS for safe drinking water. But some groups, such as the LCV, say that it is too lenient and want limits set at 5 ppt.

“The state is using the EPA’s standard but it’s critical to understand that this EPA standard is an unenforceable, advisory-only recommendation and only covers two of the many PFAS chemicals,” Parrish said.

(Contributed by Capital News Service correspondent Jeremy WAHR.)

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

In Trump’s First Year, Nation’s Uninsured Rate Unchanged

By PHIL GALEWITZ
Despite Republican resistance to the federal health law, the percentage of Americans without health insurance in 2017 remained the same as during the last year of the Obama administration, according to a closely watched report from the Census Bureau.

However, the uninsured rate did rise in 14 states. It was not immediately clear why, because the states varied dramatically by location, politics and whether they had expanded Medicaid under the federal health law. Those states included Texas, Florida, Vermont, Minnesota and Oregon.

The uninsured rate fell in three states: California, New York and Louisiana.

An estimated 8.8 percent of the population, or about 28.5 million people, did not have health insurance coverage at any point in 2017. That was slightly higher than the 28.1 million in 2016, but did not affect the uninsured rate. The difference was not statistically significant, according to the Census report.
About 17 percent of Americans were uninsured in 2010, the year the Affordable Care Act was enacted. The Census numbers are considered the gold standard for tracking who has insurance because the survey samples are so large.

Analysts credit the health law with helping drive down the number of uninsured. But also a factor: The proportion of people without insurance typically falls as unemployment rates decline. That’s because more people can get health coverage at work or can better afford buying insurance on their own.

The nation’s unemployment rate has generally been falling since before 2011 and was 4.1 percent for the last quarter of 2017, the lowest level since before the Great Recession began in December 2007.

Critics of the health law said the report emphasized its deficiencies. “Today’s report is another reminder that Obamacare has priced insurance out of the reach of millions of working families,” Marie Fishpaw and Doug Badger of the Heritage Foundation said in a statement. “Despite a growing economy and very low unemployment rate, the uninsured rate remains virtually unchanged.”

But the law’s supporters instead saw the glass as half full.

“These numbers show the resilience of the Affordable Care Act,” said Judith Solomon, senior fellow at the Center on Budget and Policy Priorities. She said people still value the coverage they receive from the health law even as it’s been under attack by President Donald Trump and Republicans who want to repeal it. “It’s good news because the numbers show the strength of the ACA but bad news in that we have not seen further progress.”

Solomon expressed concern, though, about the large number of states seeing uninsured rates increase.
Uninsured rates last year ranged from a high of more than 17 percent in Texas to low of just under 3 percent in Massachusetts.

West Virginia had one of the sharpest increases in uninsured.

About 14 percent of the state’s residents were uninsured in 2013 before the ACA’s premium subsidies and Medicaid expansion began. That rate fell by nearly two-thirds by 2016. Last year, however, West Virginia’s uninsured rate crept up 0.8 percentage points to 6.1 percent, according to the Census report.
Carol Bush, who has worked as a health insurance navigator the past three years in West Virginia, expects to be uninsured by month’s end. She is losing her job amid Trump administration cuts to the Affordable Care Act navigator program.

Carol Bush, 58, of Elkins, W.Va., expects to lose coverage Oct. 1 because her job is ending.
It’s an unfortunate irony: Elkins has served for the past three years as a navigator helping people in her community find coverage in the health law marketplaces. Federal officials have largely scrapped that program.

The Trump administration cut funding by more than 80 percent during the past two years, saying it had no proof that navigators were helping people find coverage. Only if consumers signed up in the presence of the navigator was a session considered a success.

Bush had coverage through the University of West Virginia, which has a navigator contract that ends at the end of this month. Without employer coverage, Bush said, the cheapest insurance she could find would be about $1,100 a month. She won’t qualify for a federal subsidy to lower her premium because of her family’s income. Her husband is insured through Medicare.

Although she said she has strongly considered going without insurance because of the cost, she knows she needs it.

“In all honesty, I’ve always had some kind of health insurance, and the thought of being without it worries me,” she said. “I can’t risk getting seriously ill and incurring enormous debt at this point in my life. Peace of mind has a value too.”

Shenandoah Community Health Center, a federally funded health clinic in Martinsburg, W.Va., has started to see an increase in uninsured patients the past year, although it’s still below levels it saw before the health law’s coverage expansion began in 2014, said CEO Michael Hassing. Hassing said he believes many patients have dropped coverage, thinking the ACA’s individual mandate was repealed.

“Folks say, ‘I don’t need to have it anymore,’ and they let it go,” he said.

While the GOP failed last year to repeal the law, Congress was able to strip out one of its key features — the individual penalty for not having coverage. The vote last December eliminated that penalty starting in 2019 — meaning Americans are still required this year to have health coverage or face the consequences on their 2018 taxes.

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. http://www.kaiserhealthnews.com

McCain’s Complicated Health Care Legacy: He Hated the ACA. He Also Saved It.

By EMMARIE HUETTEMAN
There are many lawmakers who made their names in health care, seeking to usher through historic changes to a broken system.

John McCain was not one of them.

And yet, the six-term senator from Arizona and decorated military veteran leaves behind his own health care legacy, seemingly driven less by his interest in health care policy than his disdain for bullies trampling the “little guy.”

He was not always successful. While McCain was instrumental in the passage of the Americans with Disabilities Act in 1990, most of the health initiatives he undertook failed after running afoul of traditional Republican priorities. His prescriptions often involved more government regulation and increased taxes.

In 2008, as the Republican nominee for president, he ran on a health care platform that dumbfounded many in his party who worried it would raise taxes on top of overhauling the U.S. tradition of workplace insurance.

Many will remember McCain as the incidental savior of the Affordable Care Act, whose late-night thumbs-down vote halted his party’s most promising effort to overturn a major Democratic achievement — the signature achievement, in fact, of the Democrat who beat him to become president. It was a vote that earned him regular — and biting — admonishments from President Donald Trump.
McCain died Saturday, following a battle with brain cancer. He was 81. Coincidentally, his Senate colleague and good friend Ted Kennedy died on the same date, Aug. 25, nine years ago, succumbing to the same type of rare brain tumor.

Whether indulging in conspiracy theories or wishful thinking, some have attributed McCain’s vote on the ACA in July 2017 to a change of heart shortly after his terminal cancer diagnosis.

But McCain spent much of his 35 years in Congress fighting a never-ending supply of goliaths, among them health insurance companies, the tobacco industry and, in his estimation, the Affordable Care Act, a law that extended insurance coverage to millions of Americans but did not solve the system’s ballooning costs.

His prey were the sort of boogeymen that made for compelling campaign ads in a career stacked with campaigns. But McCain was “always for the little guy,” said Douglas Holtz-Eakin, the chief domestic policy adviser on McCain’s 2008 presidential campaign.

“John’s idea of empathy is saying to you, ‘I’ll punch the bully for you,’” he said in an interview before McCain’s death.

McCain’s distaste for President Barack Obama’s health care law was no secret. While he agreed that the health care system was broken, he did not think more government involvement would fix it. Like most Republicans, he campaigned in his last Senate race on a promise to repeal and replace the law with something better.

After Republicans spent months bickering amongst themselves about what was better, McCain was disappointed in the option presented to senators hours before their vote: hobble the ACA and trust that a handful of lawmakers would be able to craft an alternative behind closed doors, despite failing to accomplish that very thing after years of trying.

What bothered McCain more, though, was his party’s strategy to pass their so-called skinny repeal measure, skipping committee consideration and delivering it straight to the floor. They also rejected any input from the opposing party, a tactic for which he had slammed Democrats when the ACA passed in 2010 without a single GOP vote. He lamented that Republican leaders had cast aside compromise-nurturing Senate procedures in pursuit of political victory.

In his 2018 memoirs, “The Restless Wave,” McCain said even Obama called to express gratitude for McCain’s vote against the Republican repeal bill.

“I was thanked for my vote by Democratic friends more profusely than I should have been for helping save Obamacare,” McCain wrote. “That had not been my goal.”

Better known for his work on campaign finance reform and the military, McCain did have a hand in one landmark health bill — the Americans with Disabilities Act of 1990, the country’s first comprehensive civil rights law that addressed the needs of those with disabilities. An early co-sponsor of the legislation, he championed the rights of the disabled, speaking of the service members and civilians he met in his travels who had become disabled during military conflict.

McCain himself had limited use of his arms due to injuries inflicted while he was a prisoner of war in Vietnam, though he was quicker to talk about the troubles of others than his own when advocating policy.
Yet two of his biggest bills on health care ended in defeat.

In 1998, McCain introduced a sweeping bill that would regulate the tobacco industry and increase taxes on cigarettes, hoping to discourage teenagers from smoking and raise money for research and related health care costs. It faltered under opposition from his fellow Republicans.

McCain also joined an effort with two Democratic senators, Kennedy of Massachusetts and John Edwards of North Carolina, to pass a patients’ bill of rights in 2001. He resisted at first, concerned in particular about the right it gave patients to sue health care companies, said Sonya Elling, who served as a health care aide in McCain’s office for about a decade. But he came around.

“It was the human, the personal aspect of it, basically,” said Elling, now senior director of federal affairs at Eli Lilly. “It was providing him some of the real stories about how people were being hurt and some of the barriers that existed for people in the current system.”

The legislation would have granted patients with private insurance the right to emergency and specialist care in addition to the right to seek redress for being wrongly denied care. But President George W. Bush threatened to veto the measure, claiming it would fuel frivolous lawsuits. The bill failed.

McCain’s health care efforts bolstered his reputation as a lawmaker willing to work across the aisle. Sen. Chuck Schumer of New York, now the Senate’s Democratic leader, sought his help on legislation in 2001 to expand access to generic drugs. In 2015, McCain led a bipartisan coalition to pass a law that would strengthen mental health and suicide prevention programs for veterans, among other veterans’ care measures he undertook.

It was McCain’s relationship with Kennedy that stood out, inspiring eerie comparisons when McCain was diagnosed last year with glioblastoma — a form of brain cancer — shortly before his vote saved the Affordable Care Act.

That same aggressive brain cancer killed Kennedy in 2009, months before the passage of the law that helped realize his work to secure better access for Americans to health care.

“I had strenuously opposed it, but I was very sorry that Ted had not lived to see his long crusade come to a successful end,” McCain wrote in his 2018 book.

While some of his biggest health care measures failed, the experiences helped burnish McCain’s résumé for his 2000 and 2008 presidential campaigns.

In 2007, trailing other favored Republicans, such as former New York City mayor Rudy Giuliani in early polling and fundraising, McCain asked his advisers to craft a health care proposal, said Holtz-Eakin. It was an unusual move for a Republican presidential primary.

The result was a remarkable plan that would eliminate the tax break employers get for providing health benefits to workers, known as the employer exclusion, and replace it with refundable tax credits to help people — not just those working in firms that supplied coverage — buy insurance individually. He argued employer-provided plans were driving up costs, as well as keeping salaries lower.

The plan was controversial, triggering “a total freakout” when McCain gained more prominence and scrutiny, Holtz-Eakin said. But McCain stood by it.

“He might not have been a health guy, but he knew how important that was,” he said. “And he was relentless about getting it done.”

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. http://www.kaiserhealthnews.com

How Rival Opioid Makers Sought To Cash In On Alarm Over OxyContin’s Dangers

By FRED SCHULTE
As Purdue Pharma faced mounting criticism over deaths linked to OxyContin, rival drugmakers saw a chance to boost sales by stepping up marketing of similarly dangerous painkillers, such as fentanyl, morphine and methadone, Purdue internal documents reveal.

Purdue’s 1996-2002 marketing plans for OxyContin, which Kaiser Health News made public this year for the first time, offer an unprecedented look at how that company spent millions of dollars to push opioids for growing legions of pain sufferers. A wave of lawsuits demanding reimbursement and accountability for the opioid crisis now ravaging communities has heightened awareness about how and when drug makers realized the potential dangers of their products.

The Purdue documents lay out how the company and its biggest competitors were jockeying for market share. Some of those drugmakers’ sales promotions downplayed or ignored the risks of taking opioids, or made false claims about their safety, federal regulators have asserted in warning letters to the companies.

Purdue first offered OxyContin as a remedy for moderate to severe cancer pain in 1996. Within three years, the company viewed the cancer market as too limited, with $261 million in potential annual sales versus $1.3 billion for a broader range of chronic pain care, the company’s marketing reports said.

“That was a pretty good recipe for a blockbuster,” said Andrew Kolodny, who directs Physicians for Responsible Opioid Prescribing, an advocacy group critical of drug industry marketing.

Purdue has become the most high-profile drugmaker linked to the surging opioid crisis. But other opioid manufacturers didn’t sit by idly as sales of OxyContin skyrocketed, topping $1 billion in 2000, despite reports of overdose deaths and addiction.

Purdue’s marketing reports indicate the company was worried about losing business to fentanyl-laced patches called Duragesic, as well as morphine pills and, to a lesser degree, methadone — which some managed-care groups and Medicaid health plans preferred because it cost much less than OxyContin. Methadone and morphine are made by a variety of drug companies.

In its 1999 marketing report, Purdue noted that Janssen Pharmaceuticals, an arm of drug giant Johnson & Johnson, was making “slow but steady” progress in promoting its Duragesic patches. The patches, which users attach to their skin, deliver a dose of fentanyl, an opioid drug about 50 to 100 times more powerful than morphine, according to the Drug Enforcement Administration.

Purdue estimated that Janssen would spend about $4 million in 1999 on medical journal advertising to persuade doctors to prescribe the patches for “early treatment of non-cancer pain and pain in the more frail elderly.” That is more than triple what Janssen spent the year before, according to the 2000 Purdue marketing report. In a statement to KHN, a Janssen spokesman said the company quit “actively marketing” Duragesic in 2008.

Purdue also spent millions on medical journal ads — and like Janssen, it drew criticism from the Food and Drug Administration for minimizing the dangers of opioids, government records show.

In 2000, the Food and Drug Administration criticized Purdue for exaggerating the benefits of using OxyContin to treat arthritis, while in 2003 the agency found that some other ads had “grossly overstated” OxyContin’s safety.

Janssen also drew the ire of the FDA. In March 2000, the agency called some claims made for Duragesic “false or misleading,” including the suggestion that the drug “has less potential for abuse than other currently available opioids.”

In September 2004, the FDA told Janssen to “immediately cease” making “false or misleading” claims, including saying that Duragesic was “less abused than other opioid drugs.” In its statement to KHN, Janssen said its marketing actions were “appropriate and responsible,” adding that it “acted quickly to investigate and successfully resolve FDA’s inquiries.”

The Purdue marketing reports are part of a cache of documents the company provided to the Florida attorney general’s office in 2002. The Florida attorney general released them to two Florida newspapers in 2003 after Purdue lost a court battle to keep them under wraps.

More than 1,500 groups, mostly cities, counties and states, are suing Purdue Pharma, Janssen and several competitors and drug distributers in federal court in Cleveland demanding reimbursement for treatment costs and other compensation. In a statement to KHN, Purdue said: “We vigorously deny these allegations and look forward to the opportunity to present our defense.”

The growing cluster of lawsuits argue that drugmakers set out to deceive doctors and the public by claiming their products presented little risk.

For its part, Purdue accused Janssen of trying to exploit public alarm over OxyContin-linked deaths to spark new sales of Duragesic.

“It has been reported that Janssen sales representatives are using improper techniques to capitalize on the negative press surrounding OxyContin Tablets and the issue of abuse and diversion,” reads the 2002 Purdue marketing plan.

In fact, opioids made by Purdue’s rivals also contributed to overdose deaths in those years and have continued to do so. In 2016, more than 42,000 people died nationwide from opioid-related causes, according to the Department of Health and Human Services.

Florida was one of the early states to see a rise in overdose deaths tied to prescription drugs. Florida medical examiner’s toxicology reports in 2002 detected oxycodone, the active ingredient in OxyContin, in hundreds of overdose fatalities. Abusers realized they could crush the pills and inject or snort the powder to get high. Many others died after mixing the pills with sedatives also prescribed by their doctors.

Florida medical examiner files also showed that abuse of fentanyl pain patches, methadone and morphine took many lives. Some abusers had figured out how to drain the Duragesic patch of its liquid fentanyl and inject it like heroin, or otherwise ingest it.

In July 2005, the FDA warned health care professionals about abuse of fentanyl patches. In December 2007, FDA cited reports of deaths and “life-threatening adverse events” when the fentanyl patch “was used to treat pain in opioid-naïve patients and when opioid-tolerant patients have applied more patches than prescribed, changed the patch too frequently and exposed the patch to a heat source.”

Purdue also kept an eye on methadone, noting in a 1999 marketing plan that “market research as well as reports from the sales force indicates that methadone use is increasing in both the management of cancer pain and non-malignant pain due to its low cost.” But as methadone won acceptance for treating pain, it also began to kill with alarming frequency.

The FDA in November 2006 warned of deaths and dangerous side effects among patients “newly starting methadone for pain control and in patients who have switched to methadone after being treated for pain with other strong narcotic pain relievers.”

KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation.

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. http://www.kaiserhealthnews.com

No One Knows How Many Lose Coverage From Healthy MI Work Reqs

The state still doesn’t have an exact figure on the number of Healthy Michigan recipients who could lose health coverage because of the work requirements recently enacted by the Legislature.

However, the Michigan Department of Health and Human Services said it doesn’t expect more than 400,000 of the roughly 680,000 Healthy Michigan recipients to be affected by the 80 hours-per-month requirement that came with Sen. Mike Shirkey’s (R-Clarklake) SB 0897, signed into law by Gov. Rick Snyder in June.

That 400,000 number is based on subtracting from the total program population the number of people who are already meeting those hours, or are exempt from other work requirements posed by food assistance and cash assistance programs, DHHS spokesperson Bob Wheaton said.

Yet, Wheaton said the number impacted by the requirements could still be less than 400,000, because some may be exempt from the work requirements and some may already be working.

But the DHHS hasn’t been able to calculate how many people might be kicked off their health coverage for not complying with work requirements, a question posed to the state by House Minority Leader Sam Singh (D-East Lansing) July 31 during a public hearing on the DHHS’ proposed Healthy Michigan waiver.

Singh argued that because the state doesn’t have that data—or on how the work requirements would affect uncompensated care levels or how much it will cost the state to implement the changes, two other questions Singh posed to the state—the program changes don’t live up to their stated goals.

“The goals of this amendment really is supposedly, to improve access to healthcare for uninsured or underinsured low-income Michigan residents, also that we’re going to reduce uncompensated care,” Singh said to DHHS official Jackie Prokop, who gave a presentation on the waiver.

Prokop said DHHS staff is working on that and trying to get to a number. But Singh said that Prokop’s presentation and answers to his questions show that “Both of those things are not actually going to improve, they’re actually going to go in the opposite direction.”

Rep. Tom Cochran (D-Mason) also was at the hearing and spoke against the work requirements, which he called “social engineering.” And Rep. Christine Greig’s (D-Farmington Hills) name made it onto a letter sent to the state about House Democrats’ concerns over the waiver, according to a press release.

The DHHS is required by SB 0897 to submit a waiver to the feds outlining changes to Healthy Michigan that implement the work requirements and other requirements for some beneficiaries who have been on the program for 48 months.

If the feds reject the waiver, or the waiver is determined to be noncompliant with the state law, then the entire Healthy Michigan program will die, per state law, which was referred to as the program’s “kill switch” by some of the groups.

Other groups that spoke out included the Center for Civil Justice, the Michigan affiliate of the American Lung Association, the Michigan League for Public Policy and the Michigan Protection and Advocacy Service, all of which raised concerns of one degree or another with the changes to Healthy Michigan in the proposed waiver.

Under the proposed DHHS waiver, the work requirements wouldn’t be implemented until Jan. 1, 2020, and would require all Healthy Michigan beneficiaries aged 19 to 62 who aren’t already exempt to log an average of 80 hours a month of qualified work activities.

Among those qualified activities include education related to employment, job training, vocation training, internships, participation in a substance abuse disorder treatment program, and community service with a nonprofit, although the community service can only count for three months of work activity in a 12-month period.

There are a number of exemptions to the work requirements, including caretakers of a family member under age 6, pregnant women, beneficiaries of temporary or long-term disability benefits, the medically frail and people who had been incarcerated in the past six months, among other categories.

Beneficiaries will be expected to self-report these hours, and are allowed three months of noncompliance in a 12-month period. After that, the beneficiary’s eligibility would be suspended, and if anyone misrepresents his or her compliance with work requirements, they’d be barred from Healthy Michigan for a one-year period.

Yet Singh said he is “deeply concerned” about the waiver process, and that fears that this is “a backdoor way of kicking people off healthcare because they couldn’t do it in Washington, D.C.” a reference to congressional Republicans and President Donald Trump’s failed attempt to repeal the Affordable Care Act.

Singh and others at the hearing also mentioned a lawsuit that involved a judge throwing out a program waiver Kentucky submitted to the feds that had implemented work requirements on Medicaid.

While the Centers for Medicare and Medicaid Services approved the waiver, a federal judge said the administration acted in an “arbitrary and capricious” manner.

The argument from some is that Michigan’s waiver could face a similar legal fate if it follows through with the work requirements.

“Now that we have this information which could now jeopardize the entire program for all 655,000 people that are enrolled today, to me that’s something that this group needs to come back and let the Legislature know,” Singh said.

The new law and the waiver also put in requirements for Healthy Michigan beneficiaries above the federal poverty line who have been on the program for a cumulative 48 months.

They’d have to meet requirements for healthy behaviors and must meet cost-sharing requirements—which amounts to 5 percent of their income—or get kicked off coverage, effective July 1, 2019.

Also, the new law takes away the option of sending Healthy Michigan beneficiaries above the poverty line who had not completed a healthy behavior to the marketplace for insurance.

The state had notified thousands of people this may happen earlier this year, but didn’t end up sending anyone to the marketplace, Prokop said.

Because of how the law had been structured, that would’ve cost the state even more money than keeping them on Healthy Michigan.

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

Physician Practices Should Incubate Future Physicians

By EWA MATUSZEWSKI
In the waning days of summer, I allow myself to meander at bit, including in my columns.

First off is an issue that has a bit of a back to school connection, and that is that primary care physician practices and their teams should be incubators for future physicians. While training in an ambulatory setting is preferable to a hospital setting, such an environment generally doesn’t reflect the value of the ongoing relationship that is developed between the PCP and patient—a relationship that can reinforce healthy behaviors and provide health strategies that help prevent or manage chronic conditions and co-morbidities.

When residents are trained day in and day out in this setting, they are also afforded a unique mentoring experience, with “teacher” and “student” not only jointly providing care, but with the resident learning communication (listening) skills with the patient and the patient’s family from the physician mentor. Such practice-based training is also imperative for population health, with residents seeing patients in their medical home, rather than in acute situations in a hospital setting.

Now I want to revisit a training approach that does not take place in a physician’s office, or even a traditional health setting, but is primary care training, nonetheless. I think it merits attention here because it is such an impactful and humane program.

Wayne State University has a Street Medicine Detroit program started in 2012 that does outreach to the homeless population in the community. Open to MD and DO medical students regardless of their future specializations, it is a primary care initiative meeting the underserved physical and psychosocial needs of the homeless on the streets and in shelters and soup kitchens. While providing care and learning about healthcare in the real world, the program also reinforces to medical students the humanity of all patient populations, not to mention the need for solutions to the country’s growing number of homeless adults and children.

Were programs such as this to be implemented more widely, with care offered at permanent sites, this approach would have even greater impact on even more patients—and more primary care learning opportunities for residents. I know, there’s a not-so-small matter of funding that limits such city-based care…in the meantime, hats off to WSU for their Street Medicine Detroit program, its medical director Richard Bryce, DO—and congrats to the university on its 150th anniversary.

It’s not just the cities, though, where PCPs should be trained. Suburbanites are aging alongside city dwellers and are also in need of more primary care access for prevention and treatment of chronic conditions as well as the physical realities of aging. Some progressive developers and builders, notably in Oakland County, are establishing partnerships with health systems to serve independent and assisted living communities for seniors that have lots of green space.

The model of one or two physicians seeing an entire senior residence will not work for the larger senior communities. Why not bring in residents in family practice, internal medicine and geriatrics to see first-hand the needs of this burgeoning population? (I just read in a Wall Street Journal article—“U.S. is Running out of Caregivers” that 10,000 people turn 65 every day in the U.S., and in 2020, there will be 56 million people 65 and older, up from 40 million in 2010. So we lack caregivers in addition to PCPs in the geriatric space. So many challenges for the healthcare community to resolve!)

Now, on to the topic of family medicine residency programs, which require three years of training in ambulatory, community and inpatient settings. In recent years, the community emphasis has increased, which is good, but we need to turn to our experienced, senior physicians as well, many of whom welcome the opportunity to train primary care residents in their private practices. Progressive OB/GYNs and pediatricians, for example, are checking for post-partum depression during the newborn visit and in the weeks following the baby’s birth. This is the type of behavioral health approach so critical to whole person primary care—and when possible it’s best offered in the mother’s medical home, where she has a trusted confidant in her physician. Think of the opportunity for a resident to learn the intricacies of treating the physical and emotional health of potentially vulnerable patients! Think of the end result!