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Hospice Workers Who Care For The Dying Don’t Plan Ahead Themselves

Kaiser Health News:Marketplace - November 07, 2017

Hospice workers may witness terminal illness and death almost daily, but that doesn’t mean they’ve documented their own end-of-life wishes, a new report finds.

A survey of nearly 900 health care workers at a nonprofit Florida hospice found that fewer than half — just 44 percent — had completed advance directives. Of the rest, 52 percent said they had not filled out the forms that specify choices about medical care. Nearly 4 percent said they weren’t sure if they had or not.

That surprised Dr. George Luck, a palliative medicine expert at the Charles E. Schmidt College of Medicine at Florida Atlantic University, who led the research.

Although the proportion is higher than the roughly one-third of Americans overall who have advance directives in place, Luck expected more from those who work with the dying.

“I expected people who work in a hospice setting, who see what happens when someone doesn’t have an advance directive, how that can be a struggle for the family, a bigger burden,” to be better prepared, said Luck. The report was published last month in the American Journal of Medicine.

Use Our ContentThis KHN story can be republished for free (details).

Equally surprising was that about 10 percent of hospice workers without directives said they didn’t know where to obtain the forms — which are widely available online. Another nearly 6 percent said cost was a barrier, even though the documents can be completed for free, without an attorney’s help.

“I don’t expect everybody to have an advance directive, but at least know the basics,” Luck said. “Basically, you could write it on a napkin if you wanted to.”

About 7 percent of workers said fear of the subject kept them from completing directives, he said.

Luck and his colleagues sent surveys last year to nearly 2,100 workers at Trustbridge, a hospice in Boca Raton, Fla., that serves about 2,000 patients. The 890 people who responded included doctors, nurses, clergy, office staff, volunteers and others.

Whether they had completed advance directives varied by ethnicity and age. Nearly 60 percent of white employees had filled out the documents, compared with about 30 percent of Hispanics, 22 percent of African-Americans and 14 percent of Asians, the study showed.

Doctors and volunteers were most likely to have advance directives, with almost 60 percent saying they had documents in place, compared with about 20 percent of certified nursing assistants.

That was probably related to age, Luck said. Doctors and volunteers tended to be older than the CNAs. Nearly 80 percent of workers older than 65 had filled out the forms, compared with about 25 percent of those 40 and younger.

It didn’t appear to matter whether workers cared directly for dying patients. About 46 percent of those who spent more than 75 percent of their time in hands-on care had directives, about the same as those with no patient interaction.

Although the proportion of Americans overall who put their wishes in writing is low, it’s getting better. In 1990, just 16 percent of those who responded to a Pew Research Center study had completed directives. By 2013, that figure rose to 35 percent.

Still, the new report underscores the reluctance of many people to address their own mortality, said Jon Radulovic, a spokesman for the National Hospice and Palliative Care Organization (NHPCO).

“It’s a reminder that hospice professionals, despite the fact that they deal with death and dying among the patients and families they care for, are still people who don’t really think their deaths might be imminent,” Radulovic said in an email.

Anyone can fill out an advance directive, said Luck. Once completed, the forms can be shared with caregivers and kept with important documents. An NHPCO program called CaringInfo.org, offers free, state-specific advance directive forms, plus a guide for having end-of-life conversations.

Better education is the key, Luck said. And it’s possible that hospice workers may just need a nudge. After the Florida staff members took his survey, 43 percent of those without documents said they intended to fill out the forms.

KHN’s coverage of end-of-life and serious illness issues is supported by The Gordon and Betty Moore Foundation and its coverage related to aging; improving care of older adults is supported by The John A. Hartford Foundation.

Ohio’s Drug-Pricing Ballot Question Triggers Voter Confusion

Kaiser Health News:States - November 07, 2017

COLUMBUS, Ohio — Lawmakers in the nation’s capital have yet to grapple with rising drug costs, but Ohio voters are being asked — in a single ballot-box question next week — to figure out how best to lower the tab the state pays for prescriptions.

The Drug Price Relief Act, better known as Ohio Issue 2, has been promoted and pilloried in a dizzying crush of robocalls, TV and radio ads, and direct mailings.

Opponents say it is impossible to implement, could limit patients’ access to medicines and would not necessarily save money. Proponents are selling the initiative as a rebellion that could save millions of dollars in an era of health care anxiety.

And, as Election Day approaches, voters say it’s difficult to make sense of it all.

Sean Hundley, a 30-year-old Medicaid beneficiary who works at a coffee shop in Columbus’ trendy Short North neighborhood, said he has seen plenty of advertising from both sides, but he can’t figure out who is telling the truth.

This KHN story also ran on NPR. It can be republished for free (details).

“Everything they say, not knowing who to trust — it would just lead me not to cast a vote,” he said.

This reaction highlights one of the difficulties of tasking voters with sorting out such a complex issue. But what they decide will likely have implications well beyond the state’s borders.

In the absence of federal action, states have begun taking legislative steps to address the toll of rising drug costs on their budgets — a trend that raises concerns among pharmaceutical companies.

If Issue 2 passes, this ballot-question strategy may also gain momentum. Advocates in South Dakota and the District of Columbia are already pushing for such a drug pricing initiative in the November 2018 election.

But California voters rejected a similar measure last year, noted Jane Horvath, a senior policy fellow at the National Academy for State Health Policy. A second failure could have a chilling effect on the idea of using the ballot to push drug-pricing reform, she added.

That’s part of the reason why this ballot-question campaign has drawn attention and contributions from outside the state. Supporters have raised more than $14 million, with most of that money coming from the California-based AIDS Healthcare Foundation. Opponents, bankrolled by the pharmaceutical industry, have raised $58 million.

But during a recent water aerobics class at a suburban Cincinnati gym, participants — mostly women who said they were reading daily newspaper coverage and watching local news to figure out how to vote on the ballot initiative — said they were fed up with all of the campaign noise.

The exercisers — fit, mostly retirees bouncing up and down in the water — even peppered a reporter with questions: Do you understand it? Can you explain it to me?

If enacted, Issue 2 would prohibit state programs, such as Medicaid and state employee health plans, from paying more for a medication than does the federal Veterans Health Administration. The Department of Veterans Affairs receives heavily reduced prices for prescription drugs.

But analysts are divided over whether this would work, or what amount of relief it could provide to the state budget.

An analysis by the nonpartisan Ohio Office of Budget and Management said it’s unclear whether the change would actually save any money and, if so, how much.

Supporters, who include Vermont Sen. Bernie Sanders and Ohio’s former Republican Party chairman, counter that their calculations indicate savings of about $400 million — and that, they say, is why drug companies have spent so much fighting the initiative.

“Our opponents say it’s unworkable or — they’ve created a word — ‘unimplementable.’ We believe it will work,” said Dennis Willard, a spokesman for the Yes on 2 campaign.

Meanwhile, critics worry Issue 2 would be nearly impossible to enforce.

For one thing, the VA’s final discounts are deemed proprietary and kept secret. For another, it’s unclear which state agencies would be included under the initiative.

In addition, the state’s Medicaid program already receives discounts from drug companies. Unlike the VA, though, federal law requires it to cover the vast majority of drugs, making price negotiation more difficult.

“You can’t get the VA prices if you don’t do VA things,” said Walid Gellad, co-director of the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh. “To just say, ‘We’re not going to pay more than the VA’ is difficult.”

But those are nuances that are tough to explain in a radio spot, or on a mailed flyer. And that means the dueling media blitz is leaving many Ohio voters at a loss.

Take Barbara Herr, a 64-year-old paralegal. She’s a lifelong Democrat, she said, and in some ways the issue’s target voter: a self-described “political junkie” who voted for Sanders in his presidential campaign.

She has a shellfish allergy so she carries an EpiPen — a medication for which drugmaker price hikes sparked national scorn and a congressional hearing. Even though the ballot question would not likely directly affect her medication spending, she thinks prescription drug pricing is a “grave concern” and must be addressed.

So far, though, she’s a likely no vote.

“It just is very confusing,” Herr said, reflecting on her impending Election Day decision. “I have read quite a bit about it, and I don’t think it achieves much of anything.”

In some ways, experts said, this response is to be expected.

Drug pricing is complex and already has caused head-scratching among policymakers and academics, noted Rachel Sachs, an associate professor of law at Washington University in St. Louis, who studies the issue. In a recent congressional hearing, lawmakers struggled to identify the key source of price spikes, or the best place to attempt regulation.

“Confusion is a very normal thing to feel when looking at this,” Sachs said. “And a concern I might have is whether the parties on either side, when they’re spending on advertisements — either for or against the initiative — are really seeking to stoke that confusion.”

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

Liquid Gold: Pain Doctors Soak Up Profits By Screening Urine For Drugs

Kaiser Health News:Marketplace - November 06, 2017

The cups of urine travel by express mail to the Comprehensive Pain Specialists lab in an industrial park in Brentwood, Tenn., not far from Nashville. Most days bring more than 700 of the little sealed cups from clinics across 10 states, wrapped in red-tagged waste bags. The network treats about 48,000 people each month, and many will be tested for drugs.

Gloved lab techs keep busy inside the cavernous facility, piping smaller urine samples into tubes. First there are tests to detect opiates that patients have been prescribed by CPS doctors. A second set identifies a wide range of drugs, both legal and illegal, in the urine. The doctors’ orders are displayed on computer screens and tracked by electronic medical records. Test results go back to the clinics in four to five days. The urine ends up stored for a month inside a massive walk-in refrigerator.

The high-tech testing lab’s raw material has become liquid gold for the doctors who own Comprehensive Pain Specialists. This testing process, driven by the nation’s epidemic of painkiller addiction, generates profits across the doctor-owned network of 54 clinics, the largest pain-treatment practice in the Southeast. Medicare paid the company at least $11 million for urine and related tests in 2014, when five of its professionals stood among the nation’s top billers. One nurse practitioner at the company’s clinic in Cleveland, Tenn., single-handedly generated $1.1 million in Medicare billings for urine tests that year, according to Medicare records.

Dr. Peter Kroll, one of the founders of CPS and its medical director, billed Medicare $1.8 million for these drug tests in 2015. He said the costly tests are medically justified to monitor patients on pain pills against risks of addiction or even selling of pills on the black market. “I have to know the medicine is safe and you’re taking it,” Kroll, 46, said in an interview. Kroll said that several states in which CPS is active have high rates of opioid use, which requires more urine testing.

A sign hangs in the lobby of the Comprehensive Pain Specialists clinic in Hendersonville, Tenn., advising patients about urine drug screening. (Heidi de Marco/KHN)

Urine drug testing has become particularly lucrative for doctors who operate their own labs. (Heidi de Marco/KHN)

Kaiser Health News, with assistance from researchers at the Mayo Clinic, analyzed available billing data from Medicare and private insurance billing nationwide, and found that spending on urine screens and related genetic tests quadrupled from 2011 to 2014 to an estimated $8.5 billion a year — more than the entire budget of the Environmental Protection Agency. The federal government paid providers more to conduct urine drug tests in 2014 than it spent on the four most recommended cancer screenings combined.

Yet there are virtually no national standards regarding who gets tested, for which drugs and how often. Medicare has spent tens of millions of dollars on tests to detect drugs that presented minimal abuse danger for most patients, according to arguments made by government lawyers in court cases that challenge the standing orders to test patients for drugs. Payments have surged for urine tests for street drugs such as cocaine, PCP and ecstasy, which seldom have been detected in tests done on pain patients. In fact, court records show some of those tests showed up positive just 1 percent of the time.

This KHN story also ran on Bloomberg. It can be republished for free.

Urine testing has become particularly lucrative for doctors who operate their own labs. In 2014 and 2015, Medicare paid $1 million or more for drug-related tests billed by health professionals at more than 50 pain management practices across the U.S. At a dozen practices, Medicare billings were twice that high.

Thirty-one pain practitioners received 80 percent or more of their Medicare income just from urine testing, which a federal official called a “red flag” that may signal overuse and could lead to a federal investigation.

“We’re focused on the fact that many physicians are making more money on testing than treating patients,” said Jason Mehta, an assistant U.S. attorney in Jacksonville, Fla. “It is troubling to see providers test everyone for every class of drugs every time they come in.”

‘It Was Almost A License To Steal’

As alarm spread about opioid deaths and overdoses in the past decade, doctors who prescribed the pills were looking for ways to prevent abuse and avert liability. Entrepreneurs saw a lucrative business model: persuade doctors that testing would keep them out of trouble with licensing boards or law enforcement and protect their patients from harm. Some companies offered doctors technical help opening up their own labs.

A 2011 whistleblower lawsuit against one of the nation’s top billers for urine tests, a San Diego-based laboratory owned by Millennium Health LLC, underscores the potential for profit. “Doctor,” one lab representative said during sales calls, according to an affidavit, “drug testing is not about medicine but about making money, and I am going to show you how to make a lot of money.”

Millennium Health, billing records show, took in more than $166 million from Medicare in 2014 despite being the target of at least eight whistleblower cases alleging fraud over the past decade. A Millennium sales manager involved in a 2012 case in Massachusetts reported earning $700,000 in salary and sales commissions in the previous year.

Millennium encouraged doctors to order more tests both as a way to lower patients’ risks and to shield the physicians against possible investigations by law enforcement or medical licensing boards, according to court filings. Millennium denied the allegations in the whistleblower suits and settled all of them with the Justice Department in 2015 by agreeing to pay $256 million; its parent company, Millennium Lab Holdings II, declared bankruptcy.

(Garth Superville for KHN)

Tests to detect drugs in urine can be basic and cheap. Doctors have long used testing cups with strips that change color when drugs are present. The cups cost less than $10 each, and a strip can detect 10 types of drugs or more at once and display the results in minutes.

After noticing that some labs were levying huge charges for these simple urine screens, the Centers for Medicare & Medicaid Services moved in April 2010 to limit these billings. To circumvent the new rules, some doctors scrapped cup testing in favor of specialized — and much costlier — tests performed on machines they installed in their facilities. These machines had one major advantage over the cups: Each test for each drug could be billed individually under Medicare rules.

“It was almost a license to steal. You had such a lucrative possibility, it was very tempting to sell as many [tests] as you can,” said Charles Root, a longtime lab industry consultant whose company, CodeMap, has tracked the rise of testing labs in doctors’ offices.

Voluminous Drug Tests 

The CPS testing lab in Tennessee opened in 2013, not long before a pain specialist named William Wagner moved from New Mexico to open a CPS clinic in Anderson, S.C. He was lured by the promise of $30,000 a month in salary, which would grow as the clinic added patients and revenue, along with other benefits. His contract said he could be on-site for as little as 20 percent of the clinic’s operating hours.

A sign for responsible opioid treatment is displayed in an exam room of the Comprehensive Pain Specialists clinic in Hendersonville, Tenn. (Heidi de Marco/KHN)

When the company recruited him, Wagner said, he was told the job offered “potential to earn a great deal of money” from bonuses he would receive from services he generated, including a share of collections from lab services for urine tests done at the new Tennessee facility.

That did not happen, according to Wagner. He is suing CPS, saying that it failed to collect bills for services he rendered and then closed the clinic. CPS refutes Wagner’s claims and says it fulfilled its obligations under the contract. In a counterclaim, CPS argues that Wagner owes it $190,000.

“All of their money was being made off of urine drug screens. They weren’t doing anything else properly,” Wagner said. The lawsuit is pending in federal court in Nashville.

Former CPS chief executive John Davis, in an interview, described the urine-testing lab as part of a “strategic expansion initiative” in which the company invested $6 million to $10 million in computerized equipment and swiftly acquired new clinics. Kroll, one of the owners of CPS, said the idea was to “take the company to the next level.”

Davis, who led the initiative before leaving the company in June, would not discuss the private company’s finances other than to say CPS is profitable and that lab profits “to a great degree” drove the expansion. “Urine screening isn’t the reason why we decided to grow our company. We wanted to help people in need,” Davis said.

Kroll acknowledged that urine tests are profit-makers, but stressed that verifying that patients aren’t abusing drugs gives him a “whole different level of confidence that I’m doing something right for the patients’ condition.”

He said his doctors try to be “judicious” in ordering urine tests. Kroll said some of his doctors and nurses treat “high-risk” patients who require more frequent testing. The company said that its Medicare billing practices, including urine screens, had withstood a “very in-depth” government audit.  The audit initially called for repayment of $25 million but was settled in 2016 for less than $7,000, according to the company. Medicare officials had no comment.

Kroll’s orthopedic career took a sharp turn more than a decade ago after watching his brother suffer through multiple surgeries for muscular dystrophy, along with bone fractures, stiffness and pain. His brother died at age 25, and Kroll decided to switch to anesthesiology and become a pain specialist.

“It sensitized me to the plight of people with chronic conditions that we have no medical answer for,” Kroll said. His brother “battled for his whole life.”

Kroll’s career change coincided with a national movement to establish pain management as a vital medical specialty, with its own accrediting societies and lobbying and political arm to advance its interests and those of patients.

Joined by three other doctors, he formed Comprehensive Pain Specialists at a storefront in suburban Hendersonville, Tenn. It quickly gained a foothold on referrals from local doctors unsure, or uneasy, about treating unyielding pain with heavy narcotics such as oxycodone, morphine and methadone.

In 2014, when CPS was among Medicare’s major urine-test billers, Tennessee led the nation in Medicare spending on urine drug tests run by doctors with in-house labs, according to federal billing records.

A urine specimen is prepared for shipment to the CPS lab to be tested. (Heidi de Marco/KHN)

How Much Is Too Much?

There is wide disagreement among legislators, medical trade associations and the state boards that license doctors over the best approach to urine testing. One association of pain specialists argued in 2008 that urine testing could be done as often as weekly, while others have balked at that frequency.

Indiana’s medical board ordered mandatory urine tests for all pain patients in late 2013, only to face a lawsuit from the American Civil Liberties Union, which argued that the policy was unconstitutional and an unlawful search. Officials backed down the next year, and current policy states that testing can be done “at any time the physician determines that it is medically necessary.”

The federal Centers for Disease Control and Prevention, wary of both cost and privacy concerns, declined to set a definitive national standard despite years of debate. In long-awaited guidelines issued in March 2016, the CDC called for testing at the start of opioid therapy and once a year for long-term users. Beyond that, it said, testing should be “left up to the discretion” of the medical professional.

Doctors who receive the lion’s share of their Medicare funds from urine drug testing would certainly raise a red flag.

Donald White, spokesman for the Department of Health and Human Services’ Office of the Inspector General

There is likewise little scientific justification for many of these new types of drug testing that have made their way onto doctors’ order sheets and laboratory menus.

Many pain patients on opioids are routinely tested for phencyclidine, an illegal, hallucinogenic drug also known as PCP, or angel dust, Medicare records show. Yet urine tests have rarely detected the drug. Millennium, the San Diego-based company that once topped Medicare billings for urine tests, found PCP in fewer than 1 percent of all patient samples, according to federal court filings.

In a tour of the CPS lab, Chief Operations Officer Jeff Hurst, who has more than two decades of experience working for commercial labs, rattled off a list of drugs ranging from cocaine to heroin and methamphetamine, which he said was “really big in East Tennessee.”

How often urine tests reveal serious drug abuse — or suggest patients might be selling some of their medications instead of taking them — is tough to pin down. Asked during a tour of the laboratory in Tennessee if CPS could provide such data, Hurst said he did not have it; Kroll said he didn’t either.

Hurst said the lab often ends up doing a “long list of tests” because CPS doctors are prescribing dangerous drugs that may be deadly if abused and “need to know what patients are taking.” Prescribed drugs, such as opiates and tranquilizers, are also measured at the CPS lab.

Government officials have criticized the explosive growth in testing for some prescription drugs, notably a class of tranquilizers known as tricyclic antidepressants. Medicare paid more than $45 million in 2014 for more than 200,000 people to be tested for tricyclic drugs, often multiple times. Medicare was billed for 644,495 tests for one tricyclic drug, amitriptyline, up from 6,173 tests five years earlier.

The Department of Justice argued in a 2012 whistleblower case that these tests often couldn’t be justified because of “low abuse potential” of the drugs and a “lack of abuse history for the vast majority of patients.”

Income Breakdown Raises ‘Red Flag’

When told that drug screens accounted for most of the Medicare income for dozens of pain doctors, federal officials said that was troubling.

“Doctors who receive the lion’s share of their Medicare funds from urine drug testing would certainly raise a red flag,” said Donald White, a spokesman for the Department of Health and Human Services’ Office of the Inspector General. “Confirmation of fraud would require federal investigation and a formal judicial proceeding.”

In a report released last fall, the watchdog office said some uptick in testing might be justified by the drug abuse epidemic, but noted that the situation also “could provide cover for labs that might seek to fraudulently bill Medicare for unnecessary drug testing.”

(Heidi de Marco/KHN)

Medicare pays only for services it considers “medically necessary.” While that sometimes can be a judgment call, pain clinics that adopt a “one-size-fits-all” approach to urine testing may find themselves under suspicion, said Mehta, the assistant U.S. attorney in Florida.

Mehta’s office investigated a network of Florida clinics called Coastal Spine & Pain Center for alleged over-testing, including routinely billing for a second round of expensive tests simply to confirm earlier findings. In a press release in August 2016, the government argued that these tests were “medically unnecessary.” The company paid $7.4 million last year to settle the False Claims Act case. Coastal Spine & Pain, which did not admit fault, had no comment.

Four Coastal Spine & Pain doctors were among the top 50 Medicare billers during 2014, when they charged nearly $6 million for drug tests, according to Medicare billing data analyzed by KHN.

Starting in 2016, Medicare began to crack down on urine billings as part of a federal law that is supposed to reset lab fees for the first time in three decades. Now tougher scrutiny of urine testing, and cuts in reimbursements, may be threatening CPS — or at least its profits.

CPS closed nine clinics last year and told its doctors that urine-testing revenue had dropped off 32 percent in the first quarter of the year, according to a letter then-CEO Davis sent its physician partners.

Davis said the company had to “make some changes” because of cuts in Medicare reimbursements for urine tests and other medical services. A company spokeswoman told KHN that the drop in urine revenue worsened through 2016 but has bounced back somewhat this year.

Despite the cuts, privately held CPS plans to open new clinics this year. Urine testing will remain a key service — for keeping patients safe, it said. CPS is just playing by the rules of the game. “Tell us how often to test,” said Hurst, the operations officer, “and we’ll be happy to follow it.”

KHN’s coverage related to aging & improving care of older adults is supported by The John A. Hartford Foundation.

‘Liquid Gold’ Investigation: Sifting Through The Data

Kaiser Health News relied on payment data from Medicare’s fee-for-service program, available from the Centers for Medicare & Medicaid Services to analyze the prevalence and cost of urine drug testing and related genetic testing. Doctors and laboratories bill Medicare using standard codes. KHN consulted with several billing experts in the field and used government documents to identify relevant billing codes for this analysis.

Medicare reimburses providers for each code they bill based on a standard amount that allows for some geographic variation. Each code represents a type of test, and multiple tests can be done on a single urine sample; therefore, the amount that providers bill for a single sample of urine varies greatly.

Medicare’s Part B payment data is publicly available only for the years 2012 through 2015. KHN acquired historical data from the consulting firm CodeMap going back to 2005 to analyze trends in billing.

KHN also teamed up with researchers at the Mayo Clinic to analyze claims data for private insurers and Medicare Advantage to estimate the total cost per year, which in 2014 was roughly $8.5 billion for private plus government payers. Mayo Clinic researchers accessed data from the OptumLabs Data Warehouse, which includes health insurance claims that cover about 20 million patients per year. The analysis included claims from physicians and independent labs, and excluded any facility (hospital or outpatient) fees. To estimate the yearly cost, KHN took the total cost per enrollee from the Mayo Clinic data analysis and applied it to the estimated populations for both private insurance (from the Current Population Survey) and Medicare Advantage (from CMS’ Beneficiary Public Use File). This is a rough estimate because the OptumLabs claims might not reflect some variations in medical care costs and health conditions across the country.

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