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.

LANSING LINES: State Seeks To Dump Dental Contract Suit

The state is asking a judge to dismiss a lawsuit claiming the Department of Technology, Management and Budget showed “blatant favoritism” in awarding a $657 million contract for the Healthy Kids Dental Program.

The state says MCNA Insurance Company’s suit filed in Ingham County should be dismissed “because disappointed bidders lack standing to challenge a public bid process,” according to court documents.

The state further alleges the court doesn’t have jurisdiction over MCNA’s appeal because DTMB’s award recommendation was not a final decision by a judicial agency.

“The state’s attempt to dismiss the case, on a technicality, sends a clear message: It believes DTMB’s procurement decisions are immune from judicial review and it can act with impunity no matter how flawed the process or how blatant a violation of the law has occurred,” said MCNA attorney Scott Eldridge, of Miller Canfield Paddock and Stone.

“Transparency and fiscal responsibility require judicial review of this flawed decision,” he added. “These tactics contradict Michigan’s stated commitment to fiscal responsibility and competitive bidding.”

MCNA Insurance Company asked an Ingham County judge to reverse the DTMB’s decision to award the Healthy Kids contract to Blue Cross Blue Shield. It filed a related suit in the Court of Claims in January regarding DTMB’s response to its Freedom of Information Act request for documents related to the bid process.

According to the Ingham County court filing, DTMB admitted the process “involved multiple improprieties, secret negotiations and special exceptions granted in favor” of BCBS.

Lyon’s Notes Show Knowledge Of Legionella In July 2015
(FLINT)—Notes about Flint’s lead and Legionnaires’ disease outbreak were on the phone of Michigan Department of Health and Human Services Director Nick Lyon in July 2015—six months before the governor’s public announcement.
That testimony from Jeff Seipenko, a special agent for the state’s Attorney General’s Office, came during day 14 of Lyon’s preliminary exam in Flint and it arguably provides confirmation that the DHHS director was aware of suspicions that the city’s drinking water source was tainted with legionella bacteria.

Public health officials have said at least a dozen people died of Legionnaires’ disease in Genesee County in 2014 and 2015, and the prosecution has charged Lyon with involuntary manslaughter connected to the December 2015 death of Robert C. Skidmore, 85, of Mount Morris. The prosecution expects to seek a second charge in connection with the death of John Snyder, 83, in June 2015.

Skidmore’s son, Robert J. Skidmore, also testified, saying his father liked to laugh, sing, hunt and spend time at his cabin. But, after his legionella diagnosis in June 2015, his father was lethargic, only sitting.

“He never seemed like he got better,” said the son, who grieved the loss of his mother in June 2015 and his father the following December.

The younger Skidmore said neither he nor his father had warning of a Legionnaires’ disease outbreak in Flint. He said he learned about it when it was made public in January 2016.

The outbreak is generally believed to be tied to the city’s switch from the Lake Huron water to Flint River in April 2014.

Lyon also is charged with misconduct in office. The preliminary exam was continued to Feb. 7 before Judge David Goggins.

The July 22, 2015, note, which was displayed in court, noted “lead is probably a result of the pipes from street to house” and “increased anemia and other health issues (update on legionnaires.” It also references “DM,” “Wyant” and “Dan,” whom Seipenko believed was former Chief of Staff for the governor, Dennis Muchmore and Michigan Department of Environmental Quality Director Dan Wyant.

“Talk to Dan about potential increase lead testing . . . we care,” one part of the note reads. “Higher levels of chlorine. Gam won’t use. Pipes replaced for GM,” a reference to General Motors.

Seipenko said the date on the note also was of importance because it was the same day of a meeting between Muchmore, another aide to the governor, pastors and Flint residents about the city’s water problems.

The date also conflicts with Lyon’s previous comments about when he learned of legionella in Flint. He told media he learned of the outbreak in January 2015 and email shown in court labeled “FW: Legionella” is dated January 2015. However, according to video of his testimony before a joint committee meeting of the Michigan House and Senate in April 2016, he learned about it in July 2015.

Also testifying Friday was Jim Henry, the Genesee County Health Department’s environmental health director, who said his office was “significantly” understaffed in 2014 and 2015. He said he learned of legionella in Flint in October 2014 and started working with DHHS, whom he said was not present in Flint when needed.

“Why didn’t you publish something in the paper to tell people in Flint about the outbreak?” Special Prosecutor Todd Flood asked.

“I wish we had; I do,” Henry replied. “At the time, I can tell you, our office was overwhelmed…there was a lot of things going on that inundated our office; this (legionella) was, at the time, something else and we should have. I wish we would have.”

State To Provide Hepatitis C Medication Under Medicaid
The state of Michigan is expected to begin providing Hepatitis C direct-acting antiviral medications to more Medicaid patients, according to a federal lawsuit settlement.

Lansing attorney Aaron Burrell, who represents the plaintiffs in a class-action complaint filed in U.S. District Court in Detroit, confirmed that the settlement calls for the state to begin providing the antiviral medications to Medicaid patients with a metavir fibrosis score (MFS) of F1 and above beginning Oct. 1. That expands to patients with an F0 score beginning Oct. 1, 2019.

Currently, the state allows coverage to Medicaid patients with an F2 score or above.

“It’s a good settlement for everybody,” Burrell said about the settlement, which also calls for the plaintiff, identified only as J.V., to receive $5,000 plus attorney fees under her federal civil rights violation claim.

“I think the state of Michigan did a great job and the attorney general staff working on the case did a good job,” he added. “It’s good for all parties.”

Lynn Sutfin, public information officer for the Michigan Department of Health and Human Services (MDHHS), declined to comment, saying “technically the court order is not final, yet.” She also declined to say how many patients were affected.

Burrell said both sides are working on the final agreement, which will be submitted with in the next 90 days to Judge R. Steven Whalen for final approval.

Burrell said the state would send out notices to patients previously denied the Hepatitis C medication once the judge approves the final settlement. The notices will have instructions on how patients can re-apply for the medication.

The plaintiff was diagnosed as chronically infected by the Hepatitis C virus and her MFS was F0, which made her ineligible for the direct-acting antiviral medications that could cure her, according to the April complaint.

The MFS measures the severity of liver damage from mild fibrosis (F0-F1), which is no liver damage to very mild liver damage, to decompensated cirrhosis where the liver can no longer maintain its function.

The complaint alleged MDHHS’ denial of J.V.’s application to receive the medications violated her constitutional rights and failed to provide necessary medical assistance.

Couple Claims MDHHS Didn’t Destroy Newborn’s Blood As Requested
A Saginaw County couple is suing the Michigan Department of Health and Human Services for not returning or destroying blood samples taken from their son at birth without their permission.

According to the Jan. 19 Court of Claims filings, Hemlock attorney Philip Ellison and his wife, Katherine Ellison, allege individuals working as agents of DHHS extracted and seized six blood samples or blood spots from their son, who was born in September, without a warrant and without their permission.

The couple does “not wish the state government or any entity” to have their son’s blood, the court filing states.

According to MDHHS’ Michigan BioTrust for Health website, five to six blood spots are collected from almost every newborn shortly after birth for newborn screening and any unused blood spots are stored indefinitely unless a parent or grown child—age 18 and older—opts-out.

Philip Ellison claims he completed the department’s Directive to Destroy Residual Newborn Screening Blood Specimen’s form in October, but the state failed to confirm it destroyed the extra blood samples.

The court filing also alleges MDHHS did not properly respond to the couple’s Freedom of Information Act request.

The Ellison couple seeks an order compelling MDHHS to return their son’s blood samples and original medical records containing test results. The couple seeks reasonable attorney fees and punitive damages, which it did not define in the court filing.

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

Medical Community Town Hall in Flint

The Genesee County Medical Society presents a Dinner Business Meeting and Medical Community Town Hall

Mindfulness: its Importance to the Medical Community and Patients
February 1, 2018
Flint Golf Club
3100 Lakewood Drive
Flint, MI 48507

Physicians, Practice Managers, and Health Care Professionals Welcome!
$40.00 – GCMS Members, Spouses, Practice Managers, & Staff
$40.00 – Genesee County Osteopathic Association Physician Members & Spouses
$25.00 – Residents & Students
$75.00 – All Non-Member Guests

Evening Schedule:
6 pm, Registration & Social Hour
6:30 pm, Dinner
7 pm, Meeting
7:15 pm, Presentations

Space is limited!
Please register by January 25, 2018
Please mail your reservation payment to:
Genesee County Medical Society
4438 Oak Bridge Drive, Suite B
Flint, MI 48532
Email Sherry at ssmith@gcms.org to register your attendance or call 810-733-9923 for more information.

Legionnaires’ Researcher Says Wells Repeatedly Blamed Hospitals

(FLINT) – A Wayne State University professor testified that Michigan’s chief medical executive consistently tried to blame Genesee County hospitals for the 2014 and 2015 Legionnaires’ disease outbreaks in Flint.

Shawn McElmurry, who led a team of researchers trying to identify the source of the outbreak that is attributed to 12 deaths, also testified Dec. 20 at the preliminary exam for Dr. Eden Wells that he told Gov. Rick Snyder that the team’s study “wasn’t going well” and he could use his help to carry out much-needed testing.

“It was made clear to me I don’t (report) directly to the governor,” McElmurry testified. ” . . . It was made clear to me I was to work with (Michigan Department of Health and Human Services Director) Nick Lyon.”

When Lyon wasn’t available, McElmurry said, he was to reach out to Rich Baird, a Snyder senior advisor.

Wells is charged with obstruction of justice and with lying to a peace officer by knowingly giving false statements to a water investigator.

The prosecution is expected to seek an involuntary manslaughter and misconduct charges at the conclusion of the preliminary exam, which continues Jan. 28 before Judge William Crawford III in downtown Flint. The manslaughter charge is in connection with the death of John Snyder, 83, of Genesee County, in June 2015.

McElmurry first took the stand for the Wells’ prelim on Dec. 11, testifying that the research team, Flint Water Interagency Coordinating Committee (FWICC), wanted to test water samples from the filters the state distributed, but Wells claimed in an August 2016 meeting that doing so was a “red line.” He interpreted that to mean the team would not be allowed to move forward unless it left the water filters alone.

Wednesday’s testimony began with defense attorney Steve Tramontin cross examining the witness about problems within the research team.

Tramontin also questioned McElmurry about his distrust of the state during the FWICC research and about outside influences on his team’s conclusions due to McElmurry’s discussions with other groups or individual people about the crisis.

Special Prosecutor Paul Stablein asked point blank if the state tried to influence the group’s results.

“The state has strongly pushed us to recognize the Legionnaires’ outbreak as a hospital-associated outbreak,” McElmurry said, noting that while researchers “continue to analyze the data,” it is “fairly safe to say we cannot explain all the Legionnaires cases based on hospital association.”

That prompted Stablein to ask what, if anything, Wells did to try to influence FWICC’s study.

Wells consistently reiterated “it’s the largest hospital known . . . outbreak of Legionnaires,” McElmurry said, emphasizing the word “hospital.”

“She always tried to qualify the outbreak as hospital related,” he added. “It certainly made it difficult to approach McLaren (Hospital).”

On cross examination, McElmurry said McLaren officials “didn’t consent to participate” in the group’s study.

It was during the “red line” meeting, McElmurry said, that Snyder asked about the study’s progress.

“I told him it wasn’t going at all,” he said. “We needed a push.”

McElmurry said he didn’t attempt to follow up with the Governor nor did the Governor contact him after the meeting.

Wells and Lyon, who also faces charges of involuntary manslaughter and misconduct in office for his response to the Flint water crisis, are two of 15 current and former state and city officials charged in connection with the water crisis and Legionnaires’ disease outbreak.

Four other defendants have accepted plea deals and agreed to cooperate with the prosecution, which could lead to dismissed charges.

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

Treat Pain And Opioid Addiction At The Same Time

By JOHN DALEY
Colorado Public Radio

Seven years ago, Robert Kerley, who makes his living as a truck driver, was loading drywall when a gust of wind knocked him off the trailer. Kerley fell 14 feet and hurt his back.

For pain, a series of doctors prescribed him a variety of opioids: Vicodin, Percocet and OxyContin.

In less than a year, the 45-year-old from Federal Heights, Colo., said he was hooked. “I spent most of my time high, laying on the couch, not doing nothing, falling asleep everywhere,” he said.

Kerley lost weight. He lost his job. His relationships with his wife and kids suffered. He remembers when he hit rock bottom: One night hanging out in a friend’s basement, he drank three beers, and the alcohol reacted with an opioid.

“I was taking so much morphine that I [experienced] respiratory arrest,” Kerley said. “I stopped breathing.”

An ambulance arrived, and EMTs administered the overdose reversal drug naloxone. Kerley was later hospitalized. As the father of a 12-year-old boy, he knew he needed to turn things around. That’s when he signed up for Kaiser Permanente‘s integrated pain service. (Kaiser Health News is not affiliated with Kaiser Permanente.)

“After seven years of being on narcotics and in a spiral downhill, the only thing that pulled me out of it was going to this class,” he said. “The only thing that pulled me out of it was doing and working the program that they ask you to work.”

The program he refers to is an eight-week course, available to Kaiser Permanente members in Colorado for $100. It’s designed to educate high-risk opioid patients about pain management. A recent class met at Kaiser’s Rock Creek medical offices in Lafayette, Colo., a town east of Boulder. Will Gersch, a clinical pharmacy specialist, taught several patients learning to battle addiction the science behind prescription drugs.

“So, basically the overarching message here is the higher the dose of the opioids, the higher the risk,” he told the group, as he jotted numbers on a whiteboard. “If you’re over these two doses, that’s a risk factor.”

Upstairs, Gersch’s colleague Amanda Bye, a clinical psychologist, highlighted a key element of the program: It’s integrated. For patient care, there’s a doctor, a clinical pharmacist, two mental health therapists, a physical therapist and a nurse — all on one floor. Patients can meet with this team, either all at once or in groups, but they do not have to deal with a series of referrals and appointments in different facilities. A spokesperson for Kaiser Permanente said researchers tracked more than 80 patients over the course of a year and found the group’s emergency room visits decreased 25 percent. Inpatient admissions dropped 40 percent, and patients’ opioid use went way down.

“We brought in all these specialists. We all know the up-to-date research of what’s most effective in helping to manage pain,” Bye said. “And that’s how the program got started.”

Bye said the team helps patients use alternatives like exercise, meditation, acupuncture and mindfulness. Some patients, though, do need to go to the chemical dependency unit for medication-assisted treatment for their opioid addiction. Benjamin Miller is an expert on integrated care with the national foundation Well Being Trust. Kaiser is on the right track, he said.

“The future of health care is integrated and, unfortunately, our history is very fragmented, and we’re just now catching up to developing a system of care that meets the needs of people,” he said.
Similar projects in California showed a reduction in the number of prescriptions and pills per patient, said Dr. Kelly Pfeifer, director of high-value care at the California Health Care Foundation. Her group released case studies of three programs similar to Kaiser’s Colorado program. (Kaiser Health News produces California Healthline, an editorially independent publication of the California Health Care Foundation.)

“We’ve seen great success with these models that are integrating complementary therapy, physical therapy, behavioral health and medical care,” Pfeifer said. A key strategy is to gradually decrease the amount of opioids a patient takes, rather than cut them off before they’re ready. “It works so much better when the patients have access to these complementary therapies,” she said. “And it works even better when those complementary therapies are part of an integrated team.”

But it can be difficult to implement universally. One challenge is scale: Big systems like Kaiser Permanente have ample resources and enough patients to make the effort work. Another issue is payment. Some insurers won’t pay for some alternative treatments; others have separate payment streams for different kinds of care.

“Frequently, behavioral health and medical health are paid for by entirely different systems,” Pfeifer said.

The need for programs like Kaiser’s is urgent. In 2016, a record 912 people died from an overdose in Colorado, according to data recently released by the state health department. Of those, 300 people died from an opioid overdose. Opioid use often leads to an addiction to heroin, which claimed another 228 lives last year in the state. Those two causes together now rival the number of deaths from car accidents in the state.

Colorado faces a severe shortage of treatment options. Making matters worse, the state’s largest substance abuse treatment provider, Arapahoe House, decided to close as of Jan. 2.
Kaiser’s integrated pain service has given some patients a second chance.

Robert Kerley, now a veteran of the program, recently shared his story with other patients. “I got my life back. I can sleep. I can eat. I can enjoy things,” Kerley told them.

To cope with pain, Kerley starts his morning with stretching and a version of tai chi that he calls “my chi.” He practices deep breathing. His advice to others suffering from pain or addiction?

“Do whatever it takes to walk away from it, like no matter what,” Kerley said. “Trust me, it gets better. It gets 100 percent better than where you’re at right now.”

Better for Kerley means his relationships with his family have improved. And he’s back at work, once again able to make a living as a truck driver.

This story is part of a reporting partnership with NPR, Colorado Public Radio and Kaiser Health News.

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.

Are EDs Inadvertently Taking Money From Primary Care?

By EWA MATUSZEWSKI
CEO MedNetOne Health Solutions

For years, there’s been a concerted effort by insurance companies to halt the number of unnecessary visits to the Emergency Department. (Note – it is no longer a room.) This was a wise move designed to contain overall health care costs and excessive—and often unmerited—testing. While numbers are still too high, there’s been a decrease in the number of visits over the past several years.

That’s good news, the education on not using the ED like a physician’s office is working! Yet the shift from the ED to urgent care clinics or primary care physicians, where patients’ nonemergent needs are best met, resulted in reduced fees to hospitals and health systems. Darn those unintended consequences! Coupled with the trends of decreasing hospital admissions and shortened hospital stays, something needed to be done, right? In response, the Agency for Healthcare Research and Quality (AHRQ) released a five-level emergency department triage algorithm that stratifies patients into five groups, from least to most urgent, based on patient acuity and resource needs; but left out of the reimbursement bonanza are PCPS rightfully doing the same work in their own office – which they pay for.

PCPs can’t charge an exorbitant facility fee, while hospitals and emergency departments can. An ambulatory sensitive condition such as a strep throat isn’t generally a level 5 case, even though it can escalate into a very serious health risk if not treated, but do you want to bet that it’s been coded as such in the ED?

Interestingly, I stumbled across this article on how Emergency Departments are monopolies, with patients paying the cost, around the same time I was reviewing data for our own organization’s patient population ED use. It’s the 80/20 rule all over again, with a small number of patients incurring the majority of ED costs. And unlike the article’s thesis, I felt like we were paying the costs.

Staying on the ED theme, I recently participated in a Detroit area community health forum looking at reducing emergency department costs. I found myself wondering if Detroit-area hospitals (and likely those in other large metropolitan areas throughout the country) continue to increase unnecessary ED use by advertising ED wait times? If the doctor will see me in 20 minutes and I live close by, why should I see my PCP and risk having to wait in the office for an hour to be “worked-in” while pre-scheduled patients are seen? I also discovered that emergency department professional services have not gone through any auditing process to determine whether the level of acuity warrants the reimbursement received. Yet, office-based services are being reviewed by a national vendor and repriced. Repricing is occurring more frequently. Those pesky unintended consequences again! ED overuse is not a new issue – but it appears that options to curb abuse are causing the healthcare balloon to bulge elsewhere, with PCPs paying the price.

Segueing into an ED alternative leads me to a new favorite topic – house calls. Some physician members of our organization are now making house calls again, perhaps prompted by the CDC’s new push for an old practice. House calls peaked mid-century and were almost completely out of favor by the 1970s. Now, they may be slowly regaining steam, as PCPs hit the streets for true community based care. Will their visits help limit ED use? How could they not? Will PCPs be reimbursed accordingly for their efforts? Stay tuned.

The Importance Of Maintaining Accurate Mailing Information

By SARAH HILLEGONDS
Wachler & Associates, P.C.

In today’s mobile society, it is important that physicians are reminded of the requirement to maintain current, accurate mailing information with the appropriate state and federal agencies for licensing and Medicare and/or Medicaid billing purposes. There are significant potential consequences if a physician has an inaccurate address on file, fails to regularly check the mailbox connected to the address on file, or does not timely report a change in mailing address or practice location.

For state licensing, under the Michigan Public Health Code, Act 368 of 1978, physicians have a duty to notify the Michigan Department of Licensing and Regulatory Affairs (“LARA”) of a change in mailing address within 30 days after the change occurs(1). Failure to report a change of mailing address is, by itself, a sanctionable offense under the Public Health Code. The disciplinary subcommittee may impose a fine or reprimand a physician who fails to timely report a change of address(2).

In addition, if LARA files an administrative complaint against a physician alleging any sanctionable offense, it may notify the physician by sending a copy of the administrative complaint through regular mail and certified mail, return receipt requested, to the provider’s last known mailing address(3). A physician has 30 days from receipt of the complaint to respond to the allegations in writing or LARA will treat the allegations as admitted(4). If the time to respond to the administrative complaint expires and the physician has not submitted a written response, a copy of the complaint will be forwarded to the disciplinary subcommittee, which may then impose sanctions against the provider(5).

This means that a physician who does not receive notice of an administrative complaint and therefore fails to timely respond may be defaulted by the disciplinary subcommittee and subject to the penalties authorized under the Public Health Code. The penalties, which may be as severe as suspension or revocation of the physician’s medical license, will be imposed based on allegations that the physician does not have the opportunity to defend against on the merits.

Once a final order is entered by the disciplinary subcommittee, there is no administrative mechanism for overturning it. Under current law, the only avenue for relief that is available to a physician who has been defaulted is to challenge entry of the disciplinary subcommittee’s order in the Michigan Court of Appeals, which is a costly and time-consuming process.

It is therefore critical that physicians maintain a current, reliable address on file with LARA, and regularly check the mailbox for that address. Physicians should be cautious of maintaining a Post Office (P.O.) Box address on file with LARA, instead of a business or residential address, because there is a greater risk of delayed notice of an administrative complaint. With a P.O. Box, the recipient of certified mail is not present to accept delivery, thus, it may take longer to receive important documents such as an administrative complaint. Physicians that use a P.O. Box, or any other mailing address, should have a system in place to ensure that their mailbox is regularly checked in the event they are unavailable or unable to do so.

Similarly, physicians that bill Medicare or Medicaid are required to timely report a change in practice location. For Medicare, physicians are required to report a change in practice location within 30 days(6). CMS may take adverse action against a physician who fails to comply with this requirement, including deactivation of the physician’s Medicare billing privileges, an assessment of an overpayment back to the date of the change in practice location and, most significantly, revocation of the physician’s Medicare billing privileges(7).

For Medicaid, the Michigan Medicaid Provider Manual requires that physicians notify the Michigan Department of Health and Human Services (“DHHS”) via the online CHAMPS system of any changes to their enrollment information within 35 days, including “moving to a new office,” “adding another office or location,” and “changing the address to which [remittance advices] and/or correspondence are sent.(8)” DHHS may terminate a physician’s enrollment in the Michigan Medicaid Program, which means revocation of billing privileges, if he or she fails to submit timely and accurate information.

Accordingly, to comply with Medicare and Medicaid billing rules, physicians should promptly notify the appropriate state and federal agencies if there is any change in practice location. Failure to do so may result in severe penalties including, but not limited to, revocation of billing privileges. If you need additional information or assistance, contact a Wachler & Associates attorney at (248) 544-0888.

Sarah Hillegonds is an associate attorney at Wachler & Associates, P.C. Ms. Hillegonds practices in all areas of health care law and devotes a substantial portion of her practice to representing health care entities in the defense of RAC, Medicare, Medicaid, and third party payor audits. Ms. Hillegonds also represents health care providers in licensing matters.

(1)MCL 333.16192
(2)MCL 333.16221(g) and MCL 333.16626.
(3)MCL 333.16192(2).
(4)MCL 333.16231(8), (9)
(5)Id.
(6)42 CFR § 424.516
(7)42 CFR § 424.516; 42 CFR § 424.540; 42 CFR § 424.565
(8)DHHS Medicaid Provider Manual, General Information for Providers, Section 3, Maintenance of Provider Information

IN MY OPINION: The World Turned Upside Down

By PETER LEVINE, MPH

Recently, it was reported on CNN that a county in Great Britain has announced a controversial policy to “support patients whose health is at risk from smoking or being very overweight.” The plan for the local clinical commissioning group is to “delay access to routine or non-urgent surgery under the National Health Service until patients improve their health.” Criteria have been established for the time limits and percentage of weight loss required for those with a BMI of over 30 and over 40. For smokers to have elective surgeries would require a patient to go eight weeks or more without a cigarette. They would have to take a breath test to prove their claim of abstinence. The Royal College of Surgeons in the UK opposes this policy. These patients will eventually get surgery, even if they are unable to lose weight or stop smoking, but they will have to wait.

The CCG states that financial savings are not expected. These proposals were developed “with the best interest of the whole patient population of our area in mind!” Interestingly enough, surveys are reporting 85 percent public agreement with these policies. A 2016 report by the Royal College of Surgeons shows that one in three of the clinical commissioning groups that develop policies on a county by county basis are denying or delaying routine surgery to smokers and obese patients in some way. What makes the recent Hertfordshire County decision unusual is that it makes the delay indefinite.

The arguments on both sides of this issue are quite compelling. There is a need for communities to decide how they want their health care resources expended. In the United States, the length and breadth of services that insurance policies promise to cover are more than the system can provide without inflation. On the other hand, restricting access to, or delaying, non-emergency surgery can lead to all sorts of complications, ultimately costing more. The morality is an open question. Ultimately, these types of discussions are going to have to be held, not just in England and Canada, but here in the United States as well.

On a completely separate topic, while I was cleaning out a corner of my office, I found posters from the defunct bi-annual Post-Election Catharsis Party. These parties were held every other year when all levels of government held elections in Lansing. It was sponsored each time by political junkies. The idea was that, after national, state, and local elections, folks from both parties should get together and have a party so the relationships could be maintained, healed, or formed. Political parties that went out of power would have hundreds of government staffers, and sometimes legislators, looking for a job. These parties were held every two years in Lansing at Beggar’s Banquet. I was always thrilled to be one of the sponsors because the purpose of these get-togethers was so important. Sadly, these events are no longer held. In truth, politics have become so contentious in Lansing, that I’m not surprised. The folks from disparate parties do not wish to socialize together. There’s very little working across the aisle, and there certainly is almost no hiring across party lines. Decision-making takes place via rote party affiliation, without input from the other party. Sadly, term limits have made this worse than ever, but that is a whole other discussion. It is just a shame that collegiality has disappeared almost completely from politics. It means that very little is successfully accomplished on behalf of the state. Almost everything is done based on parochial interests. It makes it hard to work out of a mess like this state is experiencing.

As this year ends, we sincerely hope everyone has a peaceful wonderful family-based holiday season full of joy and good health!

Peter Levine is executive director of the Genesee County Medical Society. His column comes to us courtesy of GCMS.