California High Court To Consider Limits on Regulators’ Access to Prescription Database

The case against Dr. Alwin Lewis started with a patient’s complaint  about his unorthodox diet plan.
But it landed at the California Supreme Court with a much broader issue at stake: Whether  regulators should have unrestricted access to a state database detailing doctors’ prescribing practices.

Investigators with the Medical Board of California ran Lewis’ name through the database after a patient complained he pushed her to get on his “five-bite” diet program – no breakfast, then just five bites of any food for lunch and dinner. The diet complaint itself got little traction, but investigators did spot in the database possible problems in how the Burbank physician was prescribing medications to other patients.

Partly as a result of that search, the board in 2013 found Lewis kept poor records and had briefly overprescribed medications to two patients, placing him on three years’ administrative probation.

That’s when Lewis turned to the courts, arguing the board had gone fishing for a case against him. In a twist, he asserted that regulators violated not his rights, but those of his patients under the state constitution’s privacy provisions.

Lewis’ lawyer, Ben Fenton of Los Angeles, said regulators should get a court order or a signed patient release to look through the databases, just as they must do for a patient’s medical records. After losing at lower court levels, Fenton took the case to the state Supreme Court, which has agreed to hear it this year but not scheduled a date.

Though access by law enforcement officials to prescription databases has been challenged in various states – successfully in Oregon —  the California case is believed to be among the first in the country to challenge unrestricted access by medical boards to state prescription drug databases.

Legal fallout of the case would be limited to California but the court battle has drawn national interest, with the American Medical Association weighing in with an amicus brief on Lewis’ behalf, along with the California Medical Association.

The California database, maintained  by the state Department of Justice, contains details including physicians’ and patients’ names and is based on weekly reports from pharmacies about prescriptions they have filled for certain high-risk drugs including powerful painkillers. By law, the justice department must provide reports to certain civil and criminal investigators and no court order or warrant is required for access, including for medical board investigators.

Like California, nearly every state now  has prescription drug monitoring programs, often known by their acronym PDMP. PDMPs were set up to detect “doctor shopping” by addicts and dealers who seek pain prescriptions from multiple physicians – the purpose that often gets the most attention. But those databases also give licensing boards and law enforcement a way to spot and rein in reckless prescribing by doctors.

In other states, the American Civil Liberties Union and others have argued that law enforcement ought to meet a  “probable cause” standard before getting such records. But Nate Wessler, an ACLU attorney who has brought such cases, agreed with Fenton that  medical licensing officials, as well, should meet some legal standard before getting into the records. check

“At the end of the day, it’s patients’ records that are being searched,” Wessler said.

As it stands, states tend to put up few barriers to medical licensing boards seeking  information as part of their duties. Experts at the PDMP Center for Excellence at Brandeis University outside Boston knew of only one state — Iowa – that requires medical boards get a court order before looking at the databases.

Thomas Clark, a researcher at the center, said he worries a decision in Lewis’ favor could encourage states to erect new hurdles to  licensing boards, which can use the databases to monitor how medical providers are prescribing some of the most dangerous and addictive medications.

“That kind of monitoring is extremely important to make sure doctors aren’t overprescribing,” he said.

Lewis’ lawyer, Fenton, noted that the original complaint against his client had nothing to do with drug prescriptions, yet the board still ran Lewis through the voluminous database, which contains patient names and medications.

According to testimony cited in court papers, an  investigator with the medical board said officials routinely check the names of physicians under investigation in the database.

None of Lewis’ patients complained about the board’s actions.

The AMA weighed in in support of Lewwis. While the organization supports keeping drug prescription databases,  “allowing unfettered access by those outside of the health care system to use information in [the databases] violates essential legal and ethical standards of patient privacy,” said Dr. Stephen Permut, chairman elect of the AMA’s board of trustees, in a written statement.

The California board, supported by a series of lower court rulings, says getting a court order could stall the release of records, imperiling patient safety. And  it argues the comparison to private medical records is not apt.

The state appeals court agreed. Unlike medical records, prescriptions of controlled substances “are subject to regular scrutiny by law enforcement and regulatory agencies,” the court wrote when turning down Lewis’ appeal. As a result, the court said, patients have a “diminished expectation of privacy” about their information in the databases.

The court added: “If the privacy issue were litigated before accessing [the database], the prescribing physician under investigation could stall the release of these records, which would prevent the state from exercising its police power to protect the public health.”

Clark, of  Brandeis, said viewing prescribing data can provide the first sign of a problem with a particular physician or pharmacy. Regulators wouldn’t necessarily know there might be a problem — and know to bother seeking a court order – before they looked at the database, he said.

Requiring a court order first “puts the cart before the horse,” he said,  noting that he was offering  his personal opinion and not that of  Brandeis’ PDMP center.

Privacy concerns have been raised since the prescription drug monitoring programs programs began getting  more federal grant money about a decade ago to help deal with prescription drug abuse, Clark said.

Although he calls the patient privacy argument “bogus,” he suggested there is likely some middle ground. Perhaps the reports could shield certain identifying information from investigators before they get court orders, he suggested.

Too much is at stake to weaken the programs, he said, calling them valuable tools in checking for wrongdoing among patients, doctors and pharmacies alike.

“Any one of them could be doing something potentially risky,” he said.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation.

Hospitals Increasingly Turn To Patients For Advice

Jane Maier was one of a select group of patients invited in early 2012 to help Partners HealthCare, Massachusetts’ largest health system, pick its new electronic health record system – a critical investment of close to $700 million.

The system, which is now being phased in, will help coordinate services and reshape how patients and doctors find and read medical information. The fact that Partners sought the perspective of patients highlights how hospitals increasingly care about what their customers think.

“It’s such a great experience,” Maier said. “They treat us as a member – a partner – in their review process.”

Patient advisory councils, like the one Maier belongs to, often serve as sounding boards for hospital leaders – offering advice on a range of issues. Members are usually patients and relatives who had bad hospital experiences and want to change how things work, or who liked their stay and want to remain involved.

For Maier, it all started in 2009 when she had surgery at Brigham and Women’s Faulkner Hospital, a Partners facility. Her husband wrote to the hospital’s CEO, praising her experience. The couple was then invited to speak at a hospital leadership retreat, sharing with top executives both the good and the not-so-good, and Maier was recruited to serve on a new patient advisory panel.

This hunt for patient perspective, which is becoming more and more common, is fueled in part by the health law’s quality-improvement provisions and other federal financial incentives, such as the link between Medicare payments and patient satisfaction scores.

“It’s a change in culture,” said Jayne Hart Chambers, senior vice president for quality at the Federation of American Hospitals, which represents for-profit hospitals.

Data from 2013 suggested that 40 percent of hospitals had some kind of patient council, said Mary Minniti, a program and resource specialist at the Institute for Patient and Family Centered Care, a Maryland-based nonprofit organization. Though councils appear to have become more common in the past few years, experts say it’s too early to know whether they typically improve hospital practices.

“A lot of hospitals right now are very concerned because of the direction of [Medicare] payments,” said Carol Cronin, executive director of the nonprofit Informed Patient Institute, an advocacy group. “They’re very concerned about patient experience and patient satisfaction.”

But it’s not just federal incentives. Patients have greater expectations as they shoulder larger shares of health care costs, said Richard Evans, chief experience officer at Massachusetts General Hospital, another Partners facility. This, he added, leads hospitals to focus on customer service.

Cronin, who has had a relative stay for an extended time in the hospital, volunteers on the patient advisory council at Johns Hopkins Hospital in Baltimore. She was struck, she said, by the “meaty” topics the group addresses. Hopkins’ medical researchers have even pitched their projects to the council to find out what patients and families think are worthy of scientific investigation.

To have an impact, though, these groups can’t operate in isolation.

Patient and family advisory councils are useful if they have the ear of hospital leaders, Minniti said. But the groups also have to be integrated into decision making.

Andy DeVries joined the first patient advisory council at Michigan’s Spectrum Health about 10 years ago, after he was hospitalized with life-threatening injuries from a motorcycle accident.

“Initially, nobody knew who we were and we had to sell ourselves,” said DeVries, who now serves on one of Spectrum Health’s 13 patient groups. Now, by contrast, his group offers input “any time there’s something new that involves patient or family care,” adding that the panel of patient advisers has tackled issues ranging from beefing up the facility’s security to how the hospital should give patients billing information. He’s even worked with the human resources department on what to look for when hiring doctors and nurses.

Such feedback led to marked increases in patient satisfaction scores, said Deborah Sprague, Spectrum Health’s program manager for patient and family services.

For instance, she said, a member of the orthopedics and neuroscience patient council noticed slow responses when he pushed the call button in his hospital room, a problem staff hadn’t noticed. The council worked with hospital employees to speed up response times. After the fix, positive patient assessments of the hospital jumped.

Maier, from the Faulkner council, recalled a time when hospital executives asked for help with patient complaints regarding nighttime noise levels. Late-night talking by staff was keeping patients awake.

The group discussed potential nighttime “quiet times” and other strategies to minimize noise without keeping doctors from doing their jobs. Once changes were made, patient satisfaction scores went up, Maier said — and a council member noticed a definite improvement the next time he was a patient.

Meanwhile, MedStar Health, which serves the District of Columbia and Maryland, has targeted advisory panels’ efforts to improve both the quality and safety of its care. The system has emerged as a model for finding ways to incorporate patients’ opinions, which was noted in a report from the American Hospital Association.

In one recent case, said David Mayer, MedStar’s vice president of quality and safety, patient advisers helped brainstorm ways to soothe the confusion and stress that often sets in when people have been in the ICU for more than a day. When implemented, the ideas led to reduced instances of patient confusion – known as delirium – which is linked to more destructive behavior, like patients trying to leave the room or bed before they should.

But even as the role of patient advisory committees grows, recruiting members continues to be a challenge. Finding people from diverse backgrounds with both inclination and time can be tricky, Cronin said. As a result, council members are often “middle-aged and older, white and English-speaking, and a lot of women,” said Deb Wachenheim, health quality manager at the Massachusetts-based advocacy group Health Care For All.

For some hospitals and health systems, though, these panels are just the beginning. Massachusetts General puts patients on various policy setting committees, and Faulkner has a non-voting patient board member.

“As we continue to evolve,” Maier said, “the hospital looks to us more and more.”

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation.

Thousands May Have Been Shorted On Insurance Subsidies After Calculation Error

Thousands of families with a disabled or deceased parent may have received a lower subsidy than they deserved to buy health coverage through the federal insurance marketplace as a result of a calculation error by the federal government.

In addition, some who should have been eligible for Medicaid may have been turned away, leaving them on the hook for higher-priced private insurance coverage. The Centers for Medicare & Medicaid Services has acknowledged the glitch but many details about how the agency will fix it remain unclear.

For months, health insurance assisters who help enroll people in coverage on the federal marketplace, which is relied upon by residents of about three dozen states, noticed that healthcare.gov seemed to be making a mistake in how it calculated some families’ income to determine whether they qualified for subsidized marketplace coverage, or whether family members might be eligible for Medicaid.

Healthcare.gov seemed to be tripping up in cases where children were receiving Social Security income, generally because a parent has died or is disabled.That’s because eligibility for marketplace subsidies or Medicaid is based on a household’s modified adjusted gross income, known as MAGI: generally, adjusted gross income plus tax-exempt Social Security benefits, interest and foreign income.

The government was including that Social Security income when it computed a family’s MAGI figure. However, a child’s income should only be included if the child (or other tax dependent) was required to file his or her own tax return. A child who only receives Social Security benefits wouldn’t be required to file.

By adding the child’s Social Security income to the family’s income, the marketplace was inflating the family’s income. The result: Some people were wrongly turned down for Medicaid coverage and others received less in premium tax credits and cost-sharing subsidies than they were eligible for.

In March, the Centers for Medicare & Medicaid Services acknowledged the calculation error. CMS has advised assisters to help consumers remedy the error by submitting an appeal to the federal marketplace or applying through healthcare.gov or the state for a Medicaid determination.

Now that officials have acknowledged their error, healthcare.gov should do a computer search to identify families that have been affected, and ensure they’re enrolled in the right coverage and receiving as much financial help as they’re eligible for, says Tricia Brooks, a senior fellow at the Georgetown University Center for Children and Families, who has blogged on this subject.

CMS hasn’t released a tally of how many families were affected by the glitch, but Brooks estimates the number at about 40,000 households. “The biggest step they can take is to go back and fix this problem for everyone who’s currently enrolled and has a wrong determination,” she says.

Please contact Kaiser Health News to send comments or ideas for future topics for the Insuring Your Health column.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation.

Americans Are Drinking More Heavily, Especially Women

Whether quaffing artisanal cocktails at hipster bars or knocking back no-name beers on the couch, Americans are drinking more heavily – and binge-drinking more often, concludes a major study of alcohol use.

Heavy drinking among Americans rose 17.2 percent between 2005 and 2012, largely due to rising rates among women, according to the study by the Institute for Health Metrics and Evaluation at the University of Washington, published Thursday in the American Journal of Public Health.

The Centers for Disease Control and Prevention defines heavy drinking as exceeding an average of one drink per day during the past month for women and two drinks per day for men. Binge drinking is defined as four or more drinks for women and five or more drinks for men on a single occasion.

The increases are driven largely by women’s drinking habits as social norms change, researchers found. In Santa Clara County, Calif., for example, women’s binge drinking rates rose by nearly 36 percent between 2002 and 2012, compared with 23 percent among men.

Nationwide over the course of the decade, the rate of binge drinking among women increased more than seven times the rate among men.

“It seems like women are trying to catch up to the men in binge drinking,” said Ali Mokdad, a lead author of the study. “It’s really, really scary.”

The study is the first to track adult drinking patterns at the county level. Despite the increases in heavy drinking, the percentage of people who drink any alcohol has remained relatively unchanged over time, it found.

Madison County, Idaho, reported the lowest rate of binge drinking in 2012, at 6 percent, while Menominee, Wis., had the highest, at 36 percent. Hancock County, Tenn. had the fewest heavy drinkers (2 percent of residents) and Esmeralda County, Nev., recorded the most (22 percent).

About 88,600 U.S. deaths were attributed to alcohol in 2010, the researchers note, and the cost of excessive drinking has been estimated at more than $220 billion per year.

The increase in binge drinking doesn’t surprise Terri Fukagawa, clinical director of the New Life Recovery Centers in San Jose, Calif., where 15 of her 24 treatment beds are filled with clients primarily addicted to alcohol. She said she’s seen more people seeking treatment for alcoholism in the past four years.

Still, she noted, “there are a lot of people still out there needing treatment, but they won’t come in unless they have a consequence like losing a job or [getting] a DUI. They think they have control over it.”

Public health experts offer a number of cultural and economic explanations for the increase in excessive drinking.

As a result of changed social norms, it’s now more acceptable for women to drink the way men traditionally have, said Tom Greenfield, scientific director at the Alcohol Research Group at the Oakland, Calif.-based Public Health Institute.

Young people are more likely to binge drink, and affluent people have the money to drink more. So the influx of wealthy professionals in cities like San Francisco, San Jose and Oakland – many in hard-working, hard-partying tech jobs – may have helped spur significant spikes in drinking rates in the Bay Area and similar communities, experts said.

Taxes on alcohol have not risen along with the Consumer Price Index, so wine, beer and liquor have gotten cheaper over time in real dollars, he said.

Alcohol advertising, particularly for hard liquor, has increased in recent years. A Federal Trade Commission study found that companies spent about $3.45 billion to advertise alcoholic beverages in 2011.

Alcohol control policies, such as limits on when and where alcohol can be sold and how long bars can stay open, have weakened in past decades, Greenfield said. That may partly explain rising consumption nationwide, particularly in some states where “blue laws” once prohibited alcohol sales on Sundays or in supermarkets.

To conduct the study, researchers analyzed data on about 3.7 million Americans aged 21 and older from the Behavioral Risk Factor Surveillance System, an ongoing telephone survey of health behaviors conducted by the U.S. Centers for Disease Control.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation.

Officials Weighing Options To Hold Down Medicare Costs For Hospice

Medicare officials are considering changes in the hospice benefit to stop the federal government from paying twice for care given to dying patients. But patient advocates and hospice providers fear a new policy could make the often difficult decision to move into hospice care even tougher.

Patients are eligible for hospice care when doctors determine they have no more than six months to live. They agree to forgo curative treatment for their terminal illness and instead receive palliative or comfort care. However, they are also still allowed Medicare coverage for health problems not related to their terminal illness, including chronic health conditions, or for accidental injuries.

Medicare pays a set amount to the hospice provider for all treatment and services related to the terminal illness, including doctor’s visits, nursing home stays, hospitalization, medical equipment and drugs.  If a patient needs treatment that hospice doesn’t provide because it is not related to the terminal illness — or the patient seeks care outside of hospice — Medicare pays the non-hospice providers. The problem is that sometimes Medicare pays for care outside the hospice benefit that it already paid hospice to cover.

To reduce the chances of these duplicative payments, Medicare officials have announced that they are examining whether to assume “virtually all” the care hospice patients receive should be covered under the hospice benefit.

Medicare has been paying millions of dollars in recent years to non-hospice providers for care for terminally ill patients under hospice care, according to government reports.

The Medicare Payment Advisory Commission (MedPAC), an independent organization that advised Congress, found that in 2012, Medicare paid $1 billion to hospitals, nursing homes, therapists and other providers for services for hospice patients unrelated to their terminal illness.

The commission did not estimate how much of that was incorrectly billed and should have been covered by hospices. Prescription drug plans received more than $33 million in 2009 for drugs that probably should have been covered by the hospice benefit, according to an investigation by the Department of Health and Human Services’ inspector general.

Hospice is growing rapidly among older Americans. Of those Medicare beneficiaries who died in 2013, nearly half used hospice, double the rate in 2000, MedPAC also found. Over the same time period, Medicare spending for hospice services grew five-fold, to $15 billion.

Medicare officials initially mentioned last year that they were exploring possible changes. Concerns about duplicative payments “strongly suggests that hospice services are being ‘unbundled,’ negating the hospice philosophy of comprehensive, holistic care and shifting the costs to other parts of Medicare, and creating additional cost-sharing burden to those vulnerable Medicare beneficiaries who are at end-of-life,” they wrote in regulations containing this year’s hospice payment rates and other program rules. Officials have not yet issued a formal proposal.

“There will always be exceptions for people who have terminal conditions and have other conditions that need to be attended to,” said Sean Cavanaugh, deputy administrator at the Centers for Medicare & Medicaid Services. “But the majority of their services would be provided through hospice.”

Seniors’ advocates are worried that putting all coverage under the hospice benefit will create obstacles for patients. Instead, Medicare should go after hospice providers who are shifting costs to other providers that Medicare expects hospice to cover, said Terry Berthelot, a senior attorney at the Center for Medicare Advocacy, who urged the government to protect hospice patients’ access to non-hospice care.

“The easiest thing for CMS to do is to say everything would be related to the terminal illness and then there would be no billing problems,” Berthelot said. But federal law, guarantees hospice patients Medicare coverage to control diabetes, blood pressure or other conditions not related to their terminal illness.

“If your blood sugar gets out of control, that could hasten your death,” she said. “But people shouldn’t be rushed off to die because they’ve elected the hospice benefit.”

Cavanaugh said the government is not trying to restrict drugs or other Medicare benefits for hospice patients.

“It’s more about getting the payment right,” he said. “The question is how to clearly circumscribe the benefit, to define what’s in the hospice benefit and what is not.”

That’s not always easy to figure out.

If a cancer patient in hospice slips on some ice and breaks her wrist, the injury could have happened because the cancer has attacked the bones, making them thin and brittle, said Dr. May Al-Abousi, medical director for hospice services at University Hospitals in Cleveland. Treatment for the injury would be covered by hospice.  But the injury would not necessarily be part of the hospice benefit for someone with a terminal illness other than cancer, she said.

“Medicine has no cookbook, where we can apply all-or-none rules,” she said.

Sometimes a hospice provider may not even know when a patient has gone to the hospital and there’s usually no way the hospital knows the patient is in hospice unless the patient makes that clear, said Judi Lund Person, at the National Hospice and Palliative Care Organization,  [http://www.nhpco.org/ ]  which represents nearly 2,000 hospice companies.

“The emergency room physician should be aware that this is a hospice patient with lung cancer as opposed to an 85-year-old male who fell at Denny’s,” she said.

Patients and their families may be afraid to volunteer that information, said Dr. Al-Abousi.  “A lot of people get scared when they hear the “H” word,” she said.  “They think once they sign that paper for Medicare, nothing else is going to be covered.”

Contact Susan Jaffe at Jaffe.KHN@gmail.com

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation.