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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!

COMPLIANCE CORNER: Private Equity In MI Healthcare Entities

By REESA N. BENKOFF & DUSTIN WACHLER
Michigan healthcare providers contemplating a relationship with private equity investors must be aware of various legal considerations relative to such arrangements. Increasingly, private equity investors are becoming more interested in investing in healthcare entities. Such investments often present lucrative opportunities for healthcare providers, yet these arrangements implicate a myriad of legal issues. This article will focus on health law issues, however other legal issues including, without limitation, corporate, tax and real estate matters, must be considered when evaluating private equity investment in healthcare entities.

Michigan laws include a legal doctrine commonly referred to as the corporate practice of medicine (CPOM) doctrine. CPOM laws restrict who can own and control certain healthcare entities and employ certain healthcare providers. Specifically, Michigan law requires entities that provide professional medical services to be organized as professional corporations (PCs) or professional limited liability companies (PLLCs). Michigan PCs and PLLCs engaged in the practice of medicine may only be owned by individuals licensed to provide the professional medical services rendered by the entity, or by entities directly or indirectly solely owned by such licensed individuals (1). Further, all officers of PCs and managers of PLLCs must be licensed to provide the professional medical services rendered by the entity. Accordingly, a medical practice through which physicians perform professional medical services cannot be owned or controlled by non-physicians (with the exception of ownership by a non-profit hospital). Thus, Michigan’s CPOM laws do not generally permit a physician practice to be owned or controlled by non-physician private equity investors. Accordingly, relationships with private equity investors must be structured so that the providers retain ownership of the professional entity (2) when required by the Michigan CPOM laws. The result is usually a complex organizational structure that involves holding companies and management companies, some of which may include joint-ownership opportunities for the providers. Such structural considerations must also address any entities that are related to the professional practice but that are not governed or restricted by Michigan’s CPOM laws, as ownership of these entities may be transferred to private equity investors in certain cases, subject to federal and state fraud and abuse laws.

Federal fraud and abuse laws include, without limitation, the Anti-Kickback Statute (“AKS”) and the physician self-referral prohibition commonly referred to as the “Stark law.” (3) The AKS prohibits a person or entity from knowingly and willfully offering, paying, soliciting or receiving remuneration, directly or indirectly, overtly or covertly, in cash or in kind, to induce or reward the: (a) referral of an individual for the furnishing of any item or service that may be reimbursed under a federal health care program, or (b) purchase, lease, ordering or arranging for or recommending the purchasing, leasing or ordering of any item, facility or service that may be reimbursed under a Federal Healthcare Program (4). Protection of an arrangement under an AKS exception or safe harbor avoids treatment as a criminal offense under the AKS. Stark contains a ban on physician self-referral which generally makes it unlawful for a physician to refer Medicare or Medicaid patients (or present claims for payment to Medicare or Medicaid) for designated health services (DHS) to an entity with which the physician (or an immediate family member) has a financial relationship (5). If Stark is implicated, the arrangement must satisfy all elements of a Stark exception in order to comply with Stark. These laws must be evaluated by the parties to ensure previous and future compliance, particularly since the relationship between the healthcare entity and private equity investors often results in organizational restructuring involving multiple entities. For example, if the resulting organizational structure involves a management company and private equity ownership of related entities, the relationship between these entities and the professional healthcare entity must be evaluated for compliance under the AKS and Stark.

Similarly, Michigan fraud and abuse laws must be considered and include, without limitation, state self-referral laws, anti-kickback laws, and fee-splitting laws (6). Michigan’s fraud and abuse laws differ from Stark and the AKS in various ways and as applied to various healthcare providers. Whereas Stark and the AKS only apply to governmental healthcare programs, Michigan fraud and abuse laws also apply to services reimbursed by commercial payors such as Blue Cross Blue Shield of Michigan (BCBSM). Michigan fraud and abuse laws, in conjunction with the CPOM doctrine, may also be implicated in arrangements whereby physicians retain ownership of the professional entity but the private equity firm earns fees generated by professional medical services. In addition to state fraud and abuse laws, Michigan healthcare providers must comply with additional licensure-based laws. Healthcare transactions must also account for rules regarding changes in ownership of licensed healthcare entities, which often require prior or contemporaneous notice to, and approval from, relevant state agencies.

A crucial part of any private equity investment in a healthcare entity is the due diligence process. This process generally involves evaluating all aspects of the healthcare entity’s operations and structure. During the due diligence process, the healthcare entity’s current organizational structure, legal and billing compliance, licensure, operational and legal risks, contractual arrangements, tangible and intellectual property, prior and current litigation, financial information, and other relevant information and documentation is provided to and analyzed by the private equity investors. The due diligence process may reveal a variety of issues that the parties may decide to address prior to, contemporaneous with, or following closing, as appropriate. For example, in the event a non-professional entity owned by the private equity investor will assume the non-clinical assets of the physician practice, the parties may evaluate contractual restrictions (e.g., assignability of a lease) and other concerns related to such assets prior to closing. Typically, either during or after the due diligence process, the parties will begin to draft and negotiate the agreements and supporting documents necessary to effectuate the transaction. Legal review of these documents is imperative in order to protect the rights of the healthcare provider.

While private equity investments offer exciting opportunities for Michigan healthcare providers, these arrangements must be structured properly under federal and state laws. Private equity firms often invest in multiple healthcare providers nationwide and Michigan’s restrictive CPOM doctrine requires private equity investments in Michigan to be structured differently than in many other states. When considering a private equity investment, Michigan healthcare providers may first want to evaluate their current compliance with federal and state law, examine utilization patterns, and otherwise assess their practice in anticipation of the due diligence process and to mitigate compliance concerns that may impact the private equity investment. Once the private equity investor and healthcare provider agree to an investment, the parties must structure the arrangement to comply with complex federal and state laws including, but not limited to, Michigan’s CPOM doctrine, the federal AKS and Stark law, and Michigan fraud and abuse laws governing self-referrals, kickbacks, and fee-splitting. While non-compliance may result in business risk to both parties, healthcare providers face additional risks such as false claims liability, licensure sanctions, and termination from participation in Medicare, Medicaid, and commercial payor networks. Accordingly, a comprehensive legal review of private equity investments is necessary to evaluate compliance with federal and state law in light of the lucrative financial opportunities offered to healthcare providers.

1.MCL § 450.1283(2); MCL § 450.4904(1).
2.MCL § 450.1286; MCL § 450.4905(1).
3.42 USC § 1320a-7b(b); 42 USC § 1395nn.
4.42 USC § 1320a-7b(b).
5.42 USC § 1395nn.
6.See MCL § 333.16221; MCL § 400.604; MCL § 752.1004; MCL § 750.428.

LEGAL LEANINGS: HIPAA And The Opioid Crisis

By KIMBERLY J. RUPPEL
With the ever-growing opioid crisis and the president’s call to action to address that crisis, primary care, pain management and behavioral health providers in particular may be faced with privacy issues dealing with a patient’s family, friends or others in relation to treatment for opioid abuse. What can a provider disclose to others in the aftermath of an overdose in order to assist a patient’s recovery efforts and prevent future incidents? What information can a provider share about a patient’s condition and treatment in such a situation?

The Health Insurance Portability and Accountability Act (HIPAA) prohibits disclosure of a person’s protected health information (PHI) to family members, friends or others involved in the patient’s care (or payment for care) without patient consent except for certain defined situations.

In the event an individual is disoriented, unconscious or otherwise incapacitated, a medical provider may provide information to others without the patient’s permission so long as sharing that information is: (1) in the best interest of the patient; and (2) the information shared is directly related to the patient’s care. Thus, a provider may exercise his or her judgment to advise family or others that an opioid overdose occurred, describe the patient’s condition and how the patient is being treated as a result.

However, when a patient possesses decision making capacity, a provider may only share information without the patient’s consent if sharing that information is for the purpose of avoiding or lessening an imminent threat to the patient’s health or safety. Put another way, a provider may disclose information about the patient’s opioid use or abuse to someone who the provider has a good faith basis to believe could reasonably lessen or prevent further harm from continued opioid use or abuse following the patient’s discharge. For example, a provider may share information with others in order to help prevent a future overdose, decrease ongoing dependence, or to assist in seeking treatment. Other appropriate discussions potentially include alternate treatment for pain management, efforts to break an addictive cycle, explanation and treatment of withdrawal symptoms and relapse prevention strategies. In contrast, a provider should avoid disclosing information about a patient’s history of substance abuse to a family member who the patient may live with but has no involvement in the patient’s care or treatment.

A patient’s decision making capacity is not static and may change during the course of care. For example, a patient may present to an emergency room in an unconscious or altered state such that at the time of admission, the patient lacks sufficient capacity to consent to sharing PHI. Nonetheless, sometime later, the patient may recover sufficiently to be alert enough to make informed decisions. During the initial period of incapacity, a provider may share information with family or others related to the patient’s condition or care without the patient’s consent following the guidance discussed above. Later, after a patient recovers, a provider may share information in order to prevent a future overdose even if the patient does not consent so long as the provider believes disclosure is in the patient’s best interest and the information shared is related to that person’s involvement in the patient’s health care.

Easier to address are situations involving powers of attorney or patient advocate designations involving express authorization to disclose PHI to a particular individual. Such documentation allows a provider to disclose information without fear of violating HIPAA. In addition, parents of minor children are generally considered authorized personal representatives who are entitled to obtain information about a child’s health care.

Also important to consider are state and federal guidelines on confidentiality or rules of medical ethics that would preclude disclosure of a patient’s PHI.

In conclusion, before a nurse, physician or even billing administrator discloses PHI regarding a patient’s opioid use or dependence, care must be taken to comply with HIPAA in the manner discussed above.

For guidance or training on this topic, feel free to contact the author at 248-433-7291 or kruppel@dickinsonwright.com.

LANSING LINES

Health Org: Prosecuting Lyon Could Cause ‘Threat’ Nationwide
A non-profit organization representing health agencies and public health professionals says holding state Department of Health and Human Services Director Nick Lyon criminally responsible for actions done in his professional responsibility could “cause a threat to public health nationwide.”

A second nonprofit organization disagreed with criticism of criminal accountability for the Flint water crisis.

The two statements came in amicus curiae briefs filed by the Association of State and Territorial Health Officials (ASTHO) and Community Based Organizing Partners (CBOP), respectively, just two days before Lyon learns if he will head to trial on felony criminal charges for decisions he made during Flint’s Legionnaires’ disease outbreaks in 2014 and 2015.

“This prosecution greatly concerns ASTHO and its members, who fear that the criminalization of professional, discretionary decision making will harm, not help, public health,” ASTHO’s attorney Jeffrey Muth, of Grand Rapids, says in a court filing. “. . . In seeking to punish public health officials for their administration of their professional responsibilities, this case could cause a threat to public health nationwide.”

Flint-based CBOP’s brief from East Lansing Attorney Mark A. Totten stated: “Several voices—the well-connected, who neither live in Flint nor experienced this horror—have publicly criticized the idea of criminal accountability for the Flint water crisis. CBOP . . . believes a thorough examination by the criminal justice system is fitting and necessary.”

The prosecution alleges the totality of its evidence shows Lyon had a “willful disregard” someone would get sick or die from Legionnaires’ disease and he failed to promptly notify the public when he first learned about the crisis in late January 2015.

The defense argued Lyon has no “personal, individualized legal duty by statute or otherwise” to notify the public about the outbreaks.

Lyon is charged with two counts of involuntary manslaughter in connection with the deaths of two men and misconduct in office for allegedly misleading and withholding information from Gov. Rick Snyder about the outbreak. He also is charged with a misdemeanor count of neglect of duty.

Flint District Judge David Goggins is expected to announce Wednesday whether Lyon will head to trial.

ASTHO, a national nonprofit organization representing health agencies and public health professionals, argues a cautious approach that considers the circumstances of the outbreak and the type of disease is needed.

CBOP, a nonprofit organization in Flint that includes members from more than 50 local organizations focusing on diverse issues including public health, education and civil rights, filed a brief to “assist the court in understanding the crime of misconduct in office,” and specifically notes the court filing isn’t assessing the prosecution’s evidence nor addressing the other crimes alleged.

CBOP said the crime of misconduct in office hasn’t receives extensive attention by the courts, yet it is a “critical means of government accountability.”

To prove that count, the prosecution must establish that the defendant is a public officer who committed misconduct in the exercise of official duties while acting with corrupt intent. Misconduct can take the form of malfeasance, misfeasance or nonfeasance.

“The offense is broad, covering a wide range of government actors who purposefully commit misconduct, including a failure to carry-out a non-ministerial duty,” Totten said. “As a first-hand witness to the havoc caused by the Flint water crisis, the amicus curiae believe this robust crime must be applied with thoroughness and rigor to determine criminal liability for this crisis.”

Pfizer Scores First ‘Good Jobs For Michigan’ Incentive
The state July 24 pulled the “Good Jobs For Michigan” (GJFM) tool out of its economic development toolbox for the first time since Gov. Rick Snyder signed the legislation in 2017 in an attempt to lure big corporate fish to Michigan.

The Michigan Strategic Fund (MSF) Board today approved a GJFM incentive worth $10.5 million for Pfizer to build a new facility in Portage to manufacture injectable drugs.

Last year, Snyder and a coalition of supporters convinced the Legislature to adopt what was dubbed the GJFM package, which would allow companies awarded the incentive to capture income tax withholdings off the created jobs if they pay above the average regional wage.

It was believed a driving factor behind the legislation was to lure the Taiwan electronics manufacturer Foxconn to Michigan. The company best known for being an Apple product supplier was dangling a facility to U.S. states that would employ thousands of people.

But on the same day Snyder signed the GJFM package, Foxconn announced Wisconsin as its site for its plant.

Under GJFM legislation, if a project creates 250 to 500 jobs, those jobs must pay wages that are 125 percent more than the average regional wage. For projects creating 500-plus jobs, those have to pay 100 percent or more of the average regional wage.

In Pfizer’s case, the company was granted 100 percent withholding capture for 354 new jobs, with the average wage of those jobs landing around $80,000. If the company didn’t end up paying high enough wages, it would affect the incentive it would receive.

The Pfizer project is expected to deliver 450 jobs within the next eight years and generate $465 million in private investment.

“Pfizer’s investment is a major boost to the state’s pharmaceutical industry and further diversifies Michigan’s business environment,” said Snyder in a press release. “I appreciate Pfizer’s long-term commitment and the economic benefits this will bring to the region and the people who live there.”

The GJFM coalition, which includes business and economic development, community and labor groups, released a statement today noting that the Pfizer project is “exactly the type of transformational project this latest tool was designed to attract—with hundreds of good-paying jobs and opportunities for Michiganders that will also help bolster communities, advance quality of life and build a strong, resilient economy for current and future generations.”

The $10.5 million awarded via the GJFM incentive comes on top of a $1 million performance-based grant awarded to Pfizer for the same project, also approved by the MSF Board.

Jeff Mason, CEO of the Michigan Economic Development Corp. (MEDC), said Pfizer has 13 facilities around the globe, so this project was competing with its other company sites, which necessitated the use of the GJFM package.

According to the MEDC briefing memo on the Pfizer incentive, for the project to be “cost competitive it must remain financially viable compared to other Pfizer sites, contracted manufacturing sites” and the company’s competitors.

U.S. Rep. Fred Upton (R-St. Joseph) also released a statement celebrating the Pfizer project.

Under the GJFM package, the MSF Board is allowed to execute up to 15 written agreements per calendar year, and the program has a $200 million cap and ends at the end of December 2019.

Lansing Lines is a cooperative feature presented by MIRS, a Lansing-based news and information service and Healthcare Michigan.

ON MEDICINE: The Death Of Private Practice, Maybe Not

By ALLAN DOBZYNIAK, MD
Is there any life remaining in the longstanding and cherished method of healthcare delivery by staunchly independent, patient-centric physician entrepreneurs? Do those physicians relishing the autonomy of small businesses aligned around patient care still exist? Are the market and political forces evolving in ways not permitting independence for such physicians, and is their demise inevitable?

When examining the history of healthcare in the United States, at some point predicting that the private practice of medicine would be in peril now seems inevitable. Tax-exempt policy toward employer-based health insurance, the expensive cost-plus Medicare and Medicaid payment policy at the outset of those programs in the 1960s and first-dollar (no deductible) health insurance policies could not help but result in healthcare cost inflation. These are symptoms of what Justice Louis Brandeis dubbed the problem of “Other People’s Money.” With advances in technology and an aging demographic added to the mix, the seeds of healthcare inflation have long been sown.

Of course as these myriad poor decisions stoked inflation, action by the same decision makers who created the problems was deemed necessary. The result was pricing controls disguised within various schemes, a regulatory onslaught, burgeoning numbers of mandates and the two programs delivering the coup de gras, MACRA (Medicare Access and CHIP Reauthorization Act) and the ACA (Patient Protection and Affordable Care Act). Consider the forced incorporation of the EMR (Electronic Medical Record) with its promises of improved care and lower cost. There is little data to show improvements in care, costs have increased, physician productivity has suffered, physician morale has deteriorated and burnout has accelerated. But alas, some have suggested that several decades may need to pass before benefits result. These gifts to physicians have increased practice overhead and complexity without any appropriately commensurate increase in reimbursement.

Organized medicine has failed through its populist, politically correct persona. This has produced controversy avoidance and rendered physician advocacy impotent. The physician “elites” who were in charge of organized medicine when the flames of change first appeared and now their heirs, who have failed to respond or even recognize it, are now unlikely to be called upon to lead this profession.

Healthcare systems have consolidated to dominate markets, increase revenue and monopolize the ownership of ancillaries.

Physician failure to optimize Independent Practice Associations or Physician Organizations has been a huge missed opportunity, which has allowed the Independent Organized Medical Staff—with its critical physician-led oversight for hospital patient care—to languish and become subservient to hospital management.

Physician demographics are also problematic. Older doctors are simply saying “to hell with it” and becoming employees as they transition to retirement. Younger physicians have abysmal economic and business savvy, as there is virtually no educational exposure to business matters, a vital topic in today’s practice environment. Those physicians who previously were entrepreneurial mentors to new graduates are increasingly avoided and thus absent from the medical educational process.

Wow! With all of this appearing as an insurmountable headwind, it is reasonable to conclude that private practice is in its terminal stages and that all physicians will end up employees. But hospitals are tailing off on binge-hiring physicians, and some healthcare systems are even terminating physician employees. It seems the return on investment of generally less productive employed physicians was not as anticipated. If profitability is not there, the strength of employment models for doctors working in hospitals becomes suspect.

Autonomy over business and patient care along with being facile in a rapidly changing healthcare environment are proving to be desirable physician traits, especially when compared to bureaucratic hospital system megaliths with their layers upon layers of management (a 3,000 percent increase since the year 2000). And this is dawning on physicians. They can maintain their focus on outcomes, as they should, rather than be captive to the process obsession indelibly incorporated into the hospital business.

It seems the plausible is morphing into the obvious. The more responsibility physicians take for their futures, the better off they will be. Never will another party have the same concern for physicians than they have for themselves. There are no “white knights” out there dying to solve physicians’ problems and assume all business risk. Organizations, especially those under stress like hospitals, will always put their own interests first.

Private practitioners still exist with that traditional old American entrepreneurial spirit. Consultants are available, business education can be had, differential value can be marketed and innovation can occur. Forward thinking hospitals—unencumbered by the need for power—and other partners experienced in ancillaries are entering the market anxious to partner with physicians. They seek those physicians motivated to engage 100 percent to make their own businesses successful in these newly formed enterprises and reap the rewards for their effort.

Without question, venturing into the healthcare marketplace has risk, but it also has rewards. Albeit, the future challenges to the private practice of medicine are not entirely predictable since politics has increasingly infiltrated and finally infected healthcare. But given the public’s growing concern with the cost of healthcare, it is reasonable to see those major drivers of cost becoming the right targets for reform, first hospitals, then pharma, and then insurance companies. Physicians are not the drivers of cost. It is not the inputs into the system, but the price that is making the cost of healthcare escalate.

Can a profession exist at all without having major control over its own fate? In this new era of healthcare, one would assume there exists a desperate and spreading desire among physicians to preserve who and what they are. I, for one, cheer on the traditional physician entrepreneurial spirit.