ON MEDICINE: The Girl And The Doctor

By SUSAN ADELMAN, MD
In the age of Larry Nassar, in the era of #metoo, what is a girl to think? What is a doctor to think? What are the rules these days? From the standpoint of doctor-patient relations, the fallout from the Larry Nassar case could be toxic for medical care.

First, how are doctors trained? When young people graduate from medical school and enter practice, traditionally they take the Hippocratic Oath, either as originally written, or as updated. The Oath has two salient sentences. The first is: “I will use treatment to help the sick according to my ability and judgment, but never with a view to injury and wrong-doing.”

The other pertinent sentence is “Into whatsoever houses I enter, I will enter to help the sick, and I will abstain from all intentional wrong-doing and harm, especially from abusing the bodies of man or woman, bond or free.” Both of these promises are intended to prevent the doctor from engaging in self-serving behavior that is not in the best interests of the patient.

One more principle is taught to all medical students: “First do no harm,” often quoted in the original Latin: Primum non nocere.

It is assumed that the young doctor understands these admonitions. If not, he or she has no business practicing medicine. Then, after entering practice, if he or she is found to be in violation of these precepts it is up to the profession first to take appropriate action. All or almost all medical institutions have – or should have – mechanisms for reporting and acting on possible abuses. It goes without saying that any that do not have such protocols need to develop them, stat. Further, in every state our profession maintains very successful Physician Health Plans for dealing with treatable physicians who have psychiatric issues. For those who are not amenable to treatment, the Board of Medicine in every state is empowered to remove the license of any physician whose behavior is criminally harmful to patients. Beyond that, the legal system is the obvious place for addressing egregious and dangerous behavior.

What can we tell patients so they will feel secure the next time they visit a doctor? This is more complicated. Without medical backgrounds, they may not know exactly what constitutes appropriate practice and what does not. Some already fear doctors and misinterpret the reason for a legitimate pelvic exam. As a result, the doctor, intimidated by fear of the patient’s reaction, fears touching the pelvic area, even when it is entirely appropriate. Doctors today are required to have a third person present, but patients will remember that this did not protect young girls in the examining room of the crafty Larry Nassar. According to newspaper reports, he was able to conceal what he was doing even from a concerned parent.

So what are the rules that will make patients and doctors comfortable? The internal examination of any woman who ever has been sexually active is perfectly appropriate when performed in order to rule out or treat pathology in the gynecologic area. This exam also is performed in order to identify and document sexual abuse in a young girl of any age. To reiterate, in this case an invasive exam is done, with gloved hands and in the presence of a female observer, when a medical condition of the female genitalia is suspected or treated. There are very few indications for performing such an exam on girls who have never been sexually active. There is no indication at all for an internal exam to be performed without gloves. Note: The physician must be aware that in some cultures an internal exam is considered a violation of a girl’s virginity, thus possibly impairing her chance of marriage in the future.

Beyond the routine adult gynecologic exam, babies and young children may come to the doctor because of a diaper rash, an accident or other problems that warrant careful examination of the perineum, and sometimes it is necessary to perform visual inspection of the vagina using a small scope or speculum. Normally such examinations are performed by a pediatrician, pediatric surgeon, pediatric urologist or other qualified specialist. Whether or not to perform routine examinations on sexually active minors is another question, one that requires physicians to make a judgment call.

It is almost impossible to think of any indication for a sports doctor, orthopedic surgeon or any similar specialist to perform any internal examination on a girl of any age, unless possibly in the context of major surgery to treat serious trauma, cancer, other dramatic illness, or birth defects.
Doctors need to inform their patients in advance of their intention to perform examinations of the perineum, and they need to explain the rationale. Patients need to be reassured that when they go to a doctor they will be treated with respect. And, as the Larry Nassar case has shown us, when they suspect they are being mistreated, they should voice their concerns immediately.

If the doctor is able to explain the questioned procedure in a way that makes sense, that should be the end of it. If not, the patient or family should take the concern to the referring doctor or, if that is not feasible, to the institution that employs the doctor. The popular #metoo meme may help empower patients to do just that today.

What we must avoid is for patients to fear doctors and doctors to fear patients. If we need to put up the Hippocratic Oath in our offices, so be it. If we need to create and post our own office rules for examinations so patients can read them, so be it. If we need to take an extra moment to explain what we are doing, so be it. Patients need to be reassured that they will be safe when they visit the doctor and that their next doctor will not turn out to be another Larry Nassar.

LEGAL LEANINGS: As Telemedicine Soars, Reimbursement For Telemedicine Services Slowly Evolve

By MARKI STEWART
The use of telemedicine has soared in recent years, as new technologies develop and consumer demand for instant access to healthcare increases. Indeed, the telemedicine market is expected to grow to $113.1 billion by 2025, at an estimated compound annual growth rate of 18.8%. It is expected that at least 7 million patients in the United States will access telemedicine services in 2018, a sharp increase from 2013, when the estimated number of telehealth patients was fewer than 350,000. Despite this momentous growth, reimbursement continues to be a key obstacle for telemedicine providers. However, reimbursement rules by various payors are slowly expanding to cover more telemedicine services.

Medicare remains one of the most restrictive payors for telemedicine services, with exceptionally limiting reimbursement rules. With some exceptions, Medicare will pay for a telemedicine encounter only when the patient is located in a rural area and present at an eligible originating site, the service must be delivered by one of eight eligible professionals and the modality must be real-time, interactive, and face-to-face (thus prohibiting “store and forward” telemedicine technologies), with a limited number of available codes. Notably, Medicare recently changed its coding for telemedicine services, eliminating use of the “GT” modifier traditionally used to indicate that the service was provided via telemedicine; in its place, Medicare has created Place of Service Code 2, which should be used in the place of the former GT modifier. A list of Medicare’s rules, restrictions, and codes for telemedicine encounters can be found at: https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/downloads/TelehealthSrvcsfctsht.pdf. Despite Medicare’s reluctance to shed its restrictive reimbursement rules, several drafts of legislation have been proposed to expand Medicare payment for telemedicine services, typically targeted to particular conditions and disease states. Accordingly, Medicare payment restrictions may soon be eased, albeit gradually.

Contrary to Medicare, Medicaid plans are generally more liberal in reimbursing a variety of telemedicine services. According to www.medicaid.gov, Medicaid views telemedicine as a “cost-effective alternative to the more traditional face-to-face way of providing medical care . . . . As such, states have the option/flexibility to determine whether (or not) to cover telemedicine; what types of telemedicine to cover; where in the state it can be covered; how it is provided/covered; what types of telemedicine practitioners/providers may be covered/reimbursed, as long as such practitioners/providers are ‘recognized’ and qualified according to Medicaid state/regulation; and how much to reimburse for telemedicine services, as long as such payments do not exceed Federal Upper Limits.”

Currently, 48 state Medicaid programs offer some type of coverage for telehealth services. The Center for Connected Health Policy has compiled a survey of each state’s Medicaid reimbursement rules for telemedicine, with hyperlinks to each Medicaid program’s rules, available at http://www.cchpca.org/state-laws-and-reimbursement-policies. Michigan’s Medicaid program currently reimburses for a variety of live video encounters, including inpatient consults, outpatient consults, psychiatric diagnostic procedures, training services, end stage renal disease-related services, behavioral health and substance use disorder treatment and education services. Although Michigan’s Medicaid program typically requires the patient to be located at an eligible original site, which includes physician or other provider offices, a patient may be treated from home for behavioral health therapies. Further details can be found in Michigan’s Medicaid Provider Manual, available at http://www.mdch.state.mi.us/dch-medicaid/manuals/MedicaidProviderManual.pdf.

Commercial payors vary with respect to payment for telemedicine services. State “parity” laws may require a health plan to pay for telehealth services, and a minority of states require health plans to pay the same amount for telehealth services as if the treatment had been provided in-person. However, many payor contracts omit specific terms relating to telemedicine payment, perhaps unintentionally. Physicians need not be passive in hoping that a private health plan will pay for telemedicine services. Providers can get ahead of a telehealth payment dispute by requesting key terms for telemedicine reimbursement when payor contracts are first negotiated and signed. Providers should make their contracting team aware of what telemedicine services are available to their patients, so that they can request specific terms for the telemedicine modalities used by that provider in their negotiations. Knowledge of your state’s parity law can and should be used in negotiations with payors as well (although a parity statute is not required to negotiate reimbursement). Additionally, Medicare Advantage coverage for telehealth is a potential area for growth, as Medicare Advantage plans recognize the positive outcomes and lower costs for telemedicine services, and can benefit greatly from those cost savings.

Finally, telemedicine providers need not be restricted to the intricacies of Medicare, Medicaid and private health plan reimbursement rules, which frequently conflict. Telehealth providers can find other ways of generating revenue for its services, including providing services for a flat rate or an hourly rate charged directly to patients. Many patients are willing to pay a reasonable out of pocket amount for the convenience of telehealth services, provided the rate is fair market value and meets other state-specific rules.

With some advance planning and knowledge of the reimbursement rules for the specific telemedicine modalities used in their practice, providers can develop a workable plan for generating telemedicine revenue. For more information on telemedicine reimbursement issues, contact Marki Stewart at Dickinson Wright.

Marki Stewart is an attorney in Dickinson Wright’s Healthcare Practice group. Her practice focuses on healthcare regulatory and transactional law, with extensive experience regarding federal and state fraud and abuse laws, including Stark and the Anti-Kickback Statute, HIPAA, electronic health records, business transactions, joint ventures, physician recruitment, and Accountable Care Organizations. Marki has specialized knowledge of the unique legal issues surrounding telemedicine, including licensing issues, credentialing, privacy, and security.

IN MY OPINION: A Look Back

By ALLAN DOBZYNIAK, MD
The collective “wisdom” promoted by the MBAs, nouveau healthcare experts, politicians and bureaucrats can be condensed into a singular thought: Doctors were part of an anachronistic model which was condescendingly labeled a “cottage Industry.” According to this expanding array of mutually anointed experts, this was a stupid residual from a previous era. The truly operative word here is industry. Then, as an industry, it needed to be aggressively nudged into modernity as these wizards envisioned it. Included in this group-think vision was the caveat that turning the physicians’ practice of medicine, a profession, into an industrial model laden with regulations, mandates, rules, care models and protocols was mandatory. But could it have been the dollar signs in the eyes of the industrialists when gazing at 16 percent of the U.S. economy attributed to healthcare that was originally and continues at present to be the salient motivator? Add to this the enormous transfer of power to the federal government.

Those fortunate enough to get in on this potential bonanza certainly have prospered. The exponential increase in government healthcare bureaucrats with their lavish salaries and benefits, the hospital management aristocracy, the health insurance companies, the IT companies selling their ludicrous fantasies, the pharmaceutical enterprise with its layers of profiteering and of course the trial lawyers always vigilant to new financial opportunities have all prospered as each has taken a bite out of the blossoming financial and power laden cornucopia. Now we have hospital systems consolidating in their battle with insurance companies, which themselves are merging with pharma, to directly compete with hospitals by extracting previous inpatient dollars to outpatient initiatives.

This has produced the increasing movement of physicians, buried in valueless, unproven nonsensical schemes that magnified their overhead and sapped their productivity, to hospital employment or incorporated into conglomerates funded by venture capitalists as these businesses bought their practices. Physicians’ professional organizations have been complicit in inflicting MACRA on the medical profession. MACRA is a barely understandable moving target virtually guaranteed to reduce physicians’ incomes as the law satisfies its budget-neutral requirement. [Editor’s Note: The Medicare Access & CHIP Reauthorization Act is a law regulating how the Center for Medicare and Medicaid Services pays physicians. The act pays increased or decreased rates based on a variety of criteria. MACRA has drawn considerable criticism from the healthcare community based both on its structure and program details.]

Hospitals utilize what may be one of the single most corrosive forces ever devised, the relative value unit (RVU). What employed physician does not eagerly await these “dashboards” of “value” showing his or her productivity including how well they stack up with other doctors locally and even across the country? This wondrous array of colorful graphs ostensibly tells a physician’s employer if he or she is a hard worker. Where is listening to patients, examining patients, counselling patients, teaching colleagues or even hugging a patient reflected in the RVU? Hint, it isn’t. Physicians must make few waves, select the best templates on their EHRs so that billing documentation is maximized and produces many lucrative procedures to optimally fulfill the RVU productivity demands. But if a physician works slowly, deliberately and conservatively, creates clinically valuable narrative notes or, “God forbid,” is thoughtful and frank about silly policies, he or she is an outlier. Now really, does productivity as measured by the RVU really have a place in rendering medical care?

Then there is the matter of masters. The doctor now answers to an employer, to an insurance company, to a government bureaucrat and finally to a patient. Somehow, one must question the appropriateness or even the morality of such a bastardized system.

While all of this money from 16-plus percent of an $18 trillion economy is being distributed among the industrialists, physicians are being taught altruism. What a wonderful tool has altruism been to regulate physicians’ singular and crucial role relative to the entire industry to irrelevance both as practitioners and as entrepreneurs.

In retrospect, maybe the good old “cottage industry” with the simplicity of a valued interaction grounded in the relationship of a doctor with a patient may have actually been superior to what exists now and where the profession seems to be heading in its future. Don’t buy into the predictable gotcha response by the elitists, “American medicine was never great.” Of course things in medicine’s past could have been better. But medicine will never be perfect. The mistake though is to abandon certain ideas from the past and eventually forget them when racing toward a questionable future. In no way is this meant to imply time travel back to the “good old days.” It sometimes seems that the more healthcare is forced to change, the more screwed up it becomes. The more screwed up it becomes, the less chance remains for reasoned inclusion of still-valued traditions of the past. It is incredible the changes in healthcare that have resulted from unproven assumptions and continue to be used as a basis for abandoning what has worked before. Physicians still have choices; options still exist. But the window is closing and will do so more rapidly with the passage of time. Inertia, apathy and finally surrender are traits of those “burned out.”

Remember, ink and paper still exist and printed notes cannot be hacked, not to be taken in its literal sense but for what is implied.

80% Of Flint Legionnaire’s Cases From Water Switch

(FLINT)—an 80 percent majority of the 87 Legionnaires’ diseases cases that came out of the city of Flint from 2014 to 2017 can be connected to the city’s water supply, according to a hotly disputed study released in early February.

A research team made up of experts from the University of Michigan, Wayne State University and Colorado State University also found the less chlorine used to treat Flint River water, the more likely those who drank the water contracted Legionnaires’ disease.

Temperature of the water was not tested, a key point because the warmer the water, the easier it is for Legionella to grow. However, the researches from the “Flint Area Community Health and Environment Partnership (FACHEP) research team” did suggest using polyvinyl chloride pipes, which don’t release iron when exposed to corrosive water.

The Department of Health and Human Services (DHHS) quickly disputed the report’s findings, writing that it reviewed the final draft articles, as did an independent third party, KWR Watercycle Research Institute and found numerous flaws that were brought to the research team’s attention, but to no avail.

“By publishing these inaccurate, incomplete studies at this point, FAHCEP has done nothing to help the citizens of Flint and has only added to public confusion on this issue,” wrote the department.

“The researchers not only failed to accurately describe conversations with MDHHS, but utilized variables in their dataset that inaccurately reflect the timing associated with cases of Legionnaires in Flint. Researchers also overestimate the risk to public health by focusing on a string of the bacteria, serogroup 6, that is not typically associated with Legionnaires’ disease.’

The release is unique in that it questions the articles at a time when the agency’s director and chief medical executive are facing charges arising over Flint water and Legionnaire’s Disease.

The findings, published in the academic journals Proceedings of the National Academy of Science and mBio, were announced the same day as more criminal court action took place from those public officials neck deep in the Flint water crisis.

A Genesee County Drain Commissioner’s office officials testified at a preliminary exam for four current and former Michigan Department of Environmental Quality employees that he warned then-appointed emergency manager Darnell Earley, former finance director Gerald Ambrose, Flint’s former director of public works Howard Croft, former utilities director Daugherty Johnson, former Mayor Dayne Walling and district supervisor Stephen Busch that they didn’t have to switch to the Flint River. However, Croft said they were ready and Ambrose called it a “good deal for the city of Flint.”

Busch is one of the four MDEQ employees charged. Early, Ambrose, Croft and Johnson were also charged with crimes related to the water crisis.

John O’Brien, division director in the Genesee County Drain Commissioner’s office, testified that he toured the city’s water treatment plant at least twice pre-April 2014—when the city switched from Detroit water to Flint River—and that the plant wasn’t capable of providing safe drinking water because, in part, it was still under construction, including the chlorine room. Chlorine is essential to treating the water.

“We believed the plant was not ready to go based on conversations we had with the state and city from June 2013 to February 2014,” he testified.

O’Brien estimated it would take at least 90 days to complete construction on the water plant, which had been dormant decades, and test the facility to produce water before introducing it to the drinking water supply. He said staff also needed training because several employees were clearly there simply because they were “happy to have a job because they just came over from solid waste management” department.

“They came from garbage haulers,” he said. “Two weeks before that they were all riding shotgun on a garbage truck.”

O’Brien questioned Busch about why he authorized the city to activate the water treatment plant when it wasn’t ready and Busch replied that he “was directed to,” which O’Brien interpreted meant someone “higher up at MDEQ or (Department of) Treasury gave the go-ahead to move the treatment plant forward.”

Special Prosecutor Todd Flood questioned whether O’Brien would allow his family to drink the water with that knowledge, and O’Brien replied he did because in 2014 both city leaders and DEQ gave no indications there were problems so “we had no reason not to drink it.”

But, O’Brien changed his mind when he learned in late 2015 that there were issues with the water.

O’Brien was the only witness Monday in the preliminary exam for Busch; Liane Shekter Smith, 57, former chief of the DEQ’s Office of Drinking Water and Municipal Assistance; district engineer Michael Prysby, 54; and Patrick Cook, 54, a specialist for the DEQ’s Community Drinking Water Unit.

At the conclusion of the exam, Judge Jennifer Manley will decide if the four defendants will head to Genesee County Circuit Court for trial in connection with the 2014 Flint water crisis.

Busch and Prysby both face two counts each of misconduct in office, tampering with evidence and violation of Michigan’s Safe Drinking Water Act. They are alleged to have mislead the U.S. Environmental Protection Agency and Genesee County Health Department about the lack of safety in drinking in Flint’s water from the Flint River.

Shekter Smith and Cook both face one count each of misconduct in office and willful neglect of duty. Cook also is charged with conspiracy to commit misconduct in office for allegedly manipulating reporting of the lead and copper levels in the drinking water.

The prosecution previously announced they also will seek an involuntary manslaughter charge against Busch and Shekter Smith at the conclusion of the preliminary exam. The charge is in connection with the deaths of two people whom prosecutors say legionella contributed to their deaths.
This story presented in cooperation with MIRS, a Lansing-based news and information service.

Amazon And Healthcare

Three huge and influential employers, Amazon, Berkshire Hathaway and JP Morgan Chase, announced Jan. 30 they were partnering to create an independent company aimed at reining in health-care costs for their U.S. employees.

There were almost no details available about what the company would do or how it would use technology to disrupt and simplify the complicated fabric of American health care. But there’s no doubt that the companies, which collectively employ more than 1 million workers worldwide, have a real interest in ratcheting down their spending on health care. Health-care premiums are split between employers and employees and have been growing much faster than wages.

Major health company stock prices tumbled on the news, and the announcement stirred excitement — and questions — about how the three companies could bring their clout to containing costs in the massive employer-sponsored health insurance market, which provides coverage to approximately 160 million Americans.

According to a survey of employer health benefits, health insurance premiums have been rising faster than wages. Between 2012 and 2017, workers’ earnings grew by 12 percent, while premiums went up by 19 percent. Between 2007 and 2012, premiums increased twice as fast as workers’ earnings.

The announcement comes amid rampant rumors and anticipation that Amazon could disrupt health care as it has in other industries, particularly in the business of selling prescription drugs.

A person at one of the companies who is familiar with the matter said that this is day one of the joint venture and that specific plans will take shape over time. The person said that the joint venture is not currently expected to be a new health insurance company or a hospital or a pharmaceutical company, but a company that can bring technology tools to bear on making health care more transparent, affordable and simple. The person warned that could change.

“The ballooning costs of healthcare act as a hungry tapeworm on the American economy. Our group does not come to this problem with answers. But we also do not accept it as inevitable,” Warren Buffett, Berkshire Hathaway chairman, said in a statement.

This isn’t the first time big employers have tried to tackle health-care costs. Two years ago, 20 major companies including Verizon, American Express, IBM and Shell Oil joined in a Health Transformation Alliance to improve the way health care is purchased for employees. Mercer, a human resources consulting firm, runs several collectives of employers that join forces to purchase prescription drugs, using the extra leverage from having a larger group to wring better prices.

Amazon, with 541,900 employees globally as of October, is known for transforming industries. For months, rumors that it could enter health care have sent shudders through the stock prices of companies whose business models might be threatened. Some see the biggest health-care deal in years—a merger between CVS and Aetna announced last year — as partially fueled by the threat that Amazon could start selling drugs.
Amazon, already one of the country’s largest employers, has been expanding. Last year, the company announced plans to hire 50,000 warehouse workers, staging a one-day blitz dubbed “Amazon jobs day.” The company is also scouting sites for a second North American headquarters, where it plans to employ as many as 50,000 full-time workers, many of them in high-paying office jobs.

Berkshire Hathaway is an Omaha-based conglomerate employing approximately 367,700 employees across a variety of industries including insurance, candy manufacturing, electric utilities, newspapers, fractional jet ownership, ice cream, bricks and furniture. Its longtime chairman, Buffett, said last year at his shareholder meeting that health-care costs were a bigger impediment to American competitiveness than taxes.
“Medical costs — which are borne to a great extent by business — have gone from 5 percent to 17 percent” of the economy since 1960, Buffett said. “Our health costs have gone up incredibly and will go up a lot more.”
The holding company is one of the most valuable in the world, as measured by market capitalization. Berkshire Hathaway earned $24 billion in net profit in 2016 and has more than $100 billion in cash on hand.

JPMorgan Chase is the largest bank in the country with more than $2 trillion in assets and what its chief executive, Jamie Dimon, calls a “fortress” balance sheet. It is unclear what specific expertise the bank will bring to the effort, but the company has a lot at stake in reining in health-care spending. The company last year spent $1.25 billion on medical benefits for 300,000 U.S. employees and family members.

As the head of the powerful Business Roundtable, Dimon emerged as one of the most vocal and visible chief executives pushing for changes to the corporate tax code last year. But he has not spoken as often or as forcefully about the problems in the health-care system, mentioning it only briefly in his annual letter to shareholders last April.

“Our nation’s healthcare costs are essentially twice as much per person vs. most other developed nations,” Dimon said.

The independent company would be jointly led by executives from all three companies, although a chief executive has not yet been announced. It will be free from the need to deliver a profit. Todd Combs, an investment officer of Berkshire Hathaway, Marvelle Sullivan Berchtold, a managing director of JPMorgan Chase and Beth Galetti, a senior vice president at Amazon will manage the company in its early stages.

ON POINT WITH POs: Diabetes Prevention

By EWA MATUSZEWSKI
According to the CDC website, many health plans and employer groups offer diabetes prevention programs (DPP) because scientific research shows that they work. The federal government must read its own webpages (eventually) because effective April 1, 2018, Medicare and Medicare Advantage programs will begin reimbursing for DPP services as well. It’s long overdue, but now that it’s on the horizon, we need to take action as a healthcare community and encourage the full use of these programs to raise awareness of the high incidence of Type 2 diabetes and halt its devastating impact on overall health and quality of life. Some quick facts:

Eighty-six million adults in the United States have prediabetes, with nine out of ten people not knowing they have it. The risk for prediabetes and diabetes is higher if the person is:

• Overweight or obese
• Has a family history of the disease
• Aged 45 or older
• Not physically active
• Had diabetes while pregnant
• Is African American, American Indian, Hispanic, Asian American or Pacific Islander

Full disclosure – my organization was the first independent physician organization in Michigan to be fully accredited by the CDC for our DPP. The Medicare reimbursement won’t incentivize us though; we were incentivized years ago when we saw a patient population suffering the avoidable co-morbidities of Type 2 diabetes, from diabetic retinopathy and renal failure to loss of toes and limbs. That being said, I think the reimbursement will influence physician practices (and employer and community groups) to take a more aggressive approach to discussing Type 2 diabetes and the services available to patients (often at no charge) to learn about prevention. That’s where formal DPP programs come into play.

With prescription pad in hand, physicians can encourage incremental changes in diet and activity level and direct patients at risk of developing Type 2 diabetes to lifestyle coaches, exercise specialists and registered dietitians accessible through accredited DPPs. Even better? In a PCMH environment, physicians can offer DPP services in their office through a traveling DPP; that’s because the nature of the training makes these programs portable and community-driven.

Primary care physicians or members of their care team should now feel emboldened to urge (or should I say “prescribe”?) patients to participate in this potentially lifesaving program, just as they would do for cardiac rehab after heart surgery or physical therapy after a hip replacement. The conversation shouldn’t be limited to the Medicare population, of course. The Medicare covered benefit is just another reason to bring up the topic of diabetes prevention to the entire practice population. Physician organizations (POs) can help by providing signage, offering or facilitating DPP programs at convenient times and locations – including at the physician’s office or in community centers or places of worship – and ensuring that DPP activities are being billed correctly.

We can’t lose hope on quelling the Type 2 diabetes epidemic. Just as the vaccination rate has increased impressively in Michigan following legislation, public awareness campaigns and vaccination advocacy group action, so to can we put forth a collective effort to halt this disease. As we might say to patients on the subject, let’s get moving!

COMPLIANCE CORNER: Physicians And Laboratories

By DUSTIN WACHLER-WACHLER & ASSOCIATES, P.C.
Physicians increasingly seek to provide comprehensive care and increase revenue by offering clinical laboratory services to their existing patients. While many laboratory arrangements are permissible, Michigan healthcare providers must be aware of federal and state authorities governing their ability to derive revenue from orders for clinical laboratory services.

Physician practices may provide testing for their own patients through a physician-office laboratory, or refer laboratory tests to an independent clinical laboratory. The federal Stark law prohibits a physician from referring Medicare or Medicaid patients for clinical laboratory services to an entity with which the physician or an immediate family member has a financial relationship. Michigan licensure laws applicable to physicians and other healthcare professionals incorporate the Stark law, and thus the Stark law’s prohibitions and exceptions apply to referrals of laboratory tests for all patients in Michigan.

Michigan healthcare providers structure physician-office laboratories to comply with the Stark law’s exception for in-office ancillary services. This exception permits a physician group practice to provide clinical laboratory services to the practice’s patients if the arrangement satisfies certain requirements related to the performance and supervision, location, and billing of the laboratory services. However, due to these requirements, physician groups generally cannot own and refer to a clinical laboratory in Michigan if the laboratory is co-owned by any other individual or entity. With regard to independent clinical laboratories owned by third parties, state and federal self-referral laws will only apply if the referring physician has some type of financial relationship with the laboratory.

Under the federal anti-kickback statute, it is illegal to knowingly and willfully offer, pay, solicit, or receive any remuneration to induce, or in return for, referrals of clinical laboratory services reimbursable by Medicare or Medicaid. The Department of Health and Human Services’ Office of Inspector General (OIG) has published Special Fraud Alerts, advisory opinions, and other guidance related to financial relationships between referring physicians and clinical laboratories. Specifically, the OIG provides that when a laboratory pays a physician more than fair market value for the physician’s services or for services the laboratory does not actually need or for which the physician is otherwise compensated, the anti-kickback statute is implicated. Additionally, the OIG maintains the position that when a laboratory offers or gives an item or service for free or less than fair market value to a referral source, an inference arises that the item or service is offered to induce referrals.
Michigan law also includes anti-kickback provisions within the Public Health Code, Medicaid False Claim Act, Health Care False Claim Act, Penal Code. Specific to clinical laboratory arrangements, Michigan law provides that a person licensed to practice medicine in Michigan shall not receive a fee or other remuneration from a clinical laboratory or an intermediary for a clinical laboratory for submitting specimens from patients to a clinical laboratory.

Accordingly, arrangements between referring physicians and clinical laboratories may implicate state and federal anti-kickback laws. For example, specimen collection or packaging arrangements that involve per-test payments to referring physicians may be viewed by the OIG or state as intended to influence the physicians’ referrals to a laboratory. Similarly, a laboratory’s provision of free or below-market items or services (e.g., free point of care test cups) to a physician may also implicate anti-kickback laws. In sum, federal and state anti-kickback laws must be considered whenever a clinical laboratory provides compensation, items, or services to a referring physician.

An increasingly common arrangement involves laboratory companies that manage low-to-moderate complexity physician-office laboratories on behalf of group practices, but separately own a high-complexity independent clinical laboratory. For high-complexity tests that cannot be processed by the physician-office laboratory, the physician group refers the tests to the management company’s independent clinical laboratory. These arrangement raise significant legal concerns and must be structured to comply with state and federal self-referral and anti-kickback laws.

In 2017, Michigan experienced an uptick in enforcement activity related to violations of federal and state self-referral and anti-kickback laws by clinical laboratories. Accordingly, while laboratory arrangements offer healthcare providers the opportunity to increase revenue through their existing patient base, Michigan providers must carefully consider state and federal law prior to entering into any type of laboratory arrangement.

(1) 42 C.F.R. § 411.353.
(2) MCL 333.16221(e)(iv)(B).
(3) 42 C.F.R. § 411.351.
(4) Id.
(5) 42 USC § 1128B(b).
(6) Department of Health and Human Services’ Office of Inspector General, Special Fraud Alert, “Laboratory Payments to Referring Physicians” (June 25, 2014).
(7) See, e.g., Department of Health and Human Services’ Office of Inspector General, Special Fraud Alert, “Arrangements for the Provision of Clinical Lab Services,” 59 Fed. Reg. 65,372, 65,377 (Dec. 19, 1994).
(8) MCL § 333.16221(d)(ii); MCL § 400.604, MCL § 752.1004; MCL § 750.428.
(9) MCL § 445.162.

LEGAL LEANINGS: Healthcare Compliance Programs

By ROSE WILLIS-DICKINSON WRIGHT
The phrase “healthcare compliance program” is commonly used to describe those processes and procedures implemented by a healthcare provider to prevent submission of erroneous claims and combat fraudulent conduct. The expectation is that providers using internal controls will more efficiently monitor adherence to legal and regulatory requirements than providers without such controls in place. However, confusion remains over whether a healthcare compliance program is legally required for many healthcare providers, particularly those in clinical practice.

Some healthcare providers may believe a formal compliance program is not necessary until a clear, legal requirement is established involving detailed parameters and penalties. This perspective primarily comes from those who don’t have the time, energy or resources to implement a program unless they understand it as an enforced legal mandate tied to penalties. Understandably, the same perspective surrounded compliance with HIPAA until the 2009 HITECH Act issued a clear enforcement rule with sizeable penalties for noncompliance.

Unlike HIPAA, currently there exists no clear enforcement rule setting forth explicit penalties against all types of providers for failure to implement a formal healthcare compliance program. While Section 6401 of the Patient Protection and Affordable Care Act requires as a condition of participation, all healthcare providers participating in a federal healthcare program establish a compliance program, such mandate is subject to when the Secretary of the Department of Health and Human Services (“HHS”) determines the timeline and core elements for such mandate. To date, the Secretary of HHS has not formally issued a timeline.

However, HHS through its Office of Inspector General (OIG) has issued significant guidance surrounding core elements of compliance programs for many types of participating providers. Beginning in the late ‘90s and through early 2000, HHS issued compliance program guidance for multiple healthcare providers, from physician practices to nursing facilities. The OIG’s website currently contains 13 compliance resource publications and an abundance of other compliance education materials (including PowerPoints and videos for ease of understanding). Just last year, OIG issued a resource guide on measuring compliance program effectiveness “to ensure that all elements of a compliance program [are] covered.” This guidance and commentary make it clear compliance programs are, at a minimum, an expectation from key enforcement agencies.

Additionally, compliance program obligations were recently addressed by HHS’s Centers for Medicare and Medicaid Services (CMS) in the 2016 “Overpayments” Final Rule (the “Overpayments Rule”) . Under the Overpayments Rule, a provider is required to exercise “reasonable diligence” in identifying “overpayments.” In its commentary to the Overpayments Rule, CMS emphasized that “effective compliance programs [are] a way to avoid receiving or retaining overpayments” and, further, “undertaking no or minimal compliance activities” could result in the government finding “a failure to exercise reasonable diligence” and resulting violation of the False Claims Act. Thus, providers who fail to implement compliance programs would have a challenging defense to the “reasonable diligence” requirements when an overpayments issue arises.

The question a provider must ask is not whether compliance programs are legally required, but whether the provider’s risk tolerance for business and individual liability is sufficient to ignore these obligations and expectations. Assuming this risk is not tolerable for most providers, the provider should focus its energy on developing a plan for an effective compliance program that is reasonable in size and scope to its practice.

(1) See Compliance Program Guidance for Individual and Small Group Physician Practices, at 65 Fed. Reg. 59434 (October 5, 2000).
(2) See the Health Information Technology for Economic and Clinical Health (HITECH) Act, signed into law on February 17, 2009 as part of the Title XIII of the American Recovery and Reinvestment Act of 2009.
(3) It is worth noting in contrast, Section 6102 of Patient Protection and Affordable Care Act established a clear and detailed compliance program mandate for nursing facilities.
(4) See, for example, Compliance Program Guidance for Individual and Small Group Physician Practices, et. seq.
(5) See Compliance Education Materials, at https://oig.hhs.gov/compliance/101/index.asp, and Compliance Guidance, at https://oig.hhs.gov/compliance/compliance-guidance/index.asp (last accessed February 2, 2018).

(6) See Measuring Compliance Program Effectiveness: A Resource Guide; HCCA-OIG Compliance Effectiveness Roundtable (Issue Date: March 27, 2017), located at https://oig.hhs.gov/compliance/101/files/HCCA-OIG-Resource-Guide.pdf (last accessed February 2, 2018).
(7) See 81 Fed. Reg. 7653 (February 12, 2016).
(8) See, i.d.

ON MEDICINE: Treating Chronic Lead Toxicity?

By GERALD NATZKE, JR. DO
President
Genesee County Medical Society

As we enter the holiday season and ponder how 2017 has quickly flown past, many of us wonder if there is anything more we could medically do to assist the Flint residents who drank leaded water. We could easily argue that more should have been done to prevent this disaster by those responsible for monitoring the quality of the city’s water. Fortunately, a lot of good, caring people in this world have stepped up to provide aid. Several foundations, as well as the state and the federal government have granted monies for services to improve education, research, epidemiological needs and water line repair. On the periphery, it would seem everything is being taken care of as much as it can be. The true situation is…not really. There is still more, possibly a lot more. The GCMS Community and Environmental Health Committee have been researching this subject since the end of 2015. As a result, it has thoroughly evaluated several potential treatments and may have some answers. It seems there is very little information in the literature on the effects of low-level chronic lead ingestion and accumulation within a population. The FDA had long approved both oral DMSA and intravenous Calcium EDTA for lead toxicity, but it was only used for only acute lead toxicity with blood lead levels that reached 45 ppm and above. Despite that recommendation researchers along with the Centers for Disease Control felt that neurologic damage would occur with levels even as low as 5 ppm. With hypertension, cardiovascular, kidney, renal, neurological and other end-organ damage through long-term exposure being reported in the literature, it became necessary for the committee to determine if treatment seemed feasible. Extensive harm follows long-term lead storage in organs such as the nervous, cardiovascular, and urologic systems. Because of this, it was decided to press for an adult study that treated lead with both DMSA and EDTA.

Dr. Gervasio Lamas, Cardiologist, and Professor of Medicine at Mt Sinai and Chairman of Cardiology at Columbia University caught wind of the Committee’s work and has taken a keen interest in the idea. He has aligned himself and his support team with this effort. He too believes, as a result of his own past research (including TACT 1), that a study has real merit. It potentially could show improvement in long-term health parameters such as reducing cardiovascular events, decreasing blood pressure, improving creatinine and GFR, normalizing uric acid levels, and improving neurologic function ( such as emotional lability, memory loss, attention deficit, and peripheral nerve disorders).

From this was created the Flint Adult Chelation Trial (FACT) descriptor that will be presented to potential donors and others who require better understanding of its purpose:

Flint Adult Chelation Trial (FACT) Descriptor
In response to the exposure of all Flint water consumers to lead, the Genesee County Medical Society is planning to initiate a 5-year study with Dr. Gervasio Lamas and his NIH funded team to determine the effectiveness of oral and intravenous chelating medicines in reducing the body burden of stored/sequestered lead in bones.

The goal of this study is to reduce the incidence of heart attacks, brain damage, strokes, gout, hypertension, and kidney disease due to the release of trapped lead over the years from bones. Lead is a known toxic metal that replaces calcium in living cells and disrupts normal function, contributing to the cause of these chronic conditions. The problems may not be evident until years after the exposure to lead in water, dust, soil, paint or other sources.

Chelating (toxic metal binding) agents have been used safely for decades to treat high-level lead exposure in children and adults. These chelators bind the lead- and other harmful metals—in the blood so more lead can be drawn out from bone storage to be bound and eliminated by the kidneys and gut. These medicines have been given intravenously by trained physicians and can also be taken by mouth.
Biweekly doses of oral chelating medicines or weekly intravenous treatments will be administered to clear lead from the body. Participants will be followed to see if there are fewer health and brain function problems.

Participants should be over 18 years of age at the time of recruitment and have consumed Flint water at any time from April 2014 until present. Follow-up will be performed by Genesee County Medical Society members or at the Emergency Medical Center of Flint. NIH, state and other funding is essential to carrying out this work. There have been recent studies published in the Journal of the American Medical Association (JAMA) and other peer-reviewed journals which demonstrate a reduction in cardiovascular morbidity and mortality in patients who have undergone chelation therapy. Considering the number of people who have been exposed to lead via water and a lifetime of exposure, action must be taken. The information gained from this study may also benefit children of women who may have been exposed while pregnant and other exposed populations. There are many other communities which will benefit from the results of this study.

Dr. Gervasio Lamas and his team were sought out by the Medical Society because of their ongoing work that demonstrated a significant reduction in repeat heart attacks for adult patients. We also have a small group of trained environmental health physicians who have helped patients with chelating medicines for other conditions.

The study will require a baseline check of mental and physical function, and various organ tests to estimate how much lead can be eliminated. The homes of participants and their work/exposure history will also be studied to eliminate continued exposure to lead from various sources.

Should the study be performed as expected it will provide information that will prove vital to many communities not only in Michigan but elsewhere within this country and world where chronic elevations of lead are feared to cause future disease. This is only part of what the Genesee County Medical Society does to support its mission, helping its members and improving the health of the citizens of this county.

The Opioid Crisis: It Is Not Physicians

By ALLAN DOBZYNIAK, MD
Blaming physicians for the “opioid crisis” is so far off the mark as to be potentially harmful. Then throw in pharmaceutical companies, and politics has definitely been substituted for truth. On “Face the Nation” former New Jersey Gov. Chris Christi, chair of the president’s opioid commission, blamed overprescribing doctors. He said, “This crisis started not on a street corner somewhere. This crisis started in the doctors’ offices and hospitals of America.” In the following discussion I will not even mention the significant contribution to the crisis related to the obsession with pain management by JCAHO, Medicare, Medicaid and finally by private insurance companies. But remember it was these bodies that forced the definition of pain as the fourth vital sign.

Correlation does not mean causation, but there are some correlations that seem not only interesting, but important relative to opioid abuse. If you have a job, are married, older than age 50, female and black the scourge of opioid abuse is less, much less. Recent studies though have shown cocaine related deaths to be greater in the African-American community. Being unmarried, divorced, unemployed or a young adult correlates with greater risk. One can wonder if the increased geographic risk in West Virginia, New Hampshire, Kentucky and Ohio might be related to these. None of this has any basis in physicians’ offices.

Young adults, especially adolescents, account for the majority of first-time abusers. According to a Columbia University CASA (Center for Addiction and Substance Abuse) study in 2011, adolescent physiology and other issues typical of this age group such as peer pressure, adverse childhood events, genetics and engagement in other risky behaviors contribute to addiction risk. Additionally, there is interesting data related to the deterioration of the family. Almost half, 45.4 percent, of teenagers live with a parent who is a risky substance user. Some 17.8 percent live with an adult who has a substance abuse issue. Less than half, 42.6 percent, of parents list refraining from tobacco, alcohol, marijuana, or abusing prescription or illicit drugs as one of their top three concerns for their teenage children. Other than lack of education on the subject, one can only ponder the reasons for this tragedy. Again, none of these have their basis in physicians’ offices.

According to the National Survey on Drug Use and Health, 75 percent of opioid pill abusers and almost all heroin addicts got hooked without ever having been prescribed pain medication. As published in JAMA only 13 percent of opioid overdose patients presenting to emergency rooms started taking drugs because of pain.

One does not choose to become ill, and chronic diseases do not go away by choice. In contrast, experimenting with opioids is nearly always a choice. Also, half of addicts who quit do so without treatment. One cannot quit rheumatoid arthritis or heart failure. With this in mind, maybe just maybe, labelling drug addiction as a disease might be an error. This could be another example of misguided political correctness aimed at not stigmatizing addicts or injuring frail psyches, just something else to consider.

That drug companies are at fault is an interesting supposition. There has never been a drug-free society. The problem of abuse was present long before these companies existed. During my 35 years of medical practice never have I personally promoted, nor have I ever heard of any pharmaceutical company promoting, opioid use or suggesting that opioids are not addicting. This seems almost ludicrous. Now that these companies are being sued by states’ attorneys general it is fair to speculate this as simply another attempt at government extortion. This of course will raise the price of pharmaceuticals, confiscate dollars that could be used for research and development and ultimately lead to shortages of this important therapeutic class of drugs. Acute and chronic pain does exist with opioids often an appropriate adjunctive treatment choice. Dollars extorted from drug companies at the same time as development of opiate alternatives is encouraged presents an interesting quandary.

There then exist cultural components, intellectual or educational components, biological components and the most unfortunate component, that which is political. If the analysis selectively adopts the political consensus of certain individuals within the scientific community, then it is political consensus. This then concludes with science reflecting opinion rather than, as it should, the opposite. Scoring political points by simplistically blaming physicians caricatured as a group at fault for the multifactorial nature of the opioid epidemic avoids the truth. Quid ist Veritas? This gets us nowhere.

Physicians have a role, but not as depicted. They can help but cannot resolve the societal and cultural problems that if unrecognized and unaddressed will continue to provide the pollution underlying the opioid epidemic.