Senate bill to shed light on Medicaid prescription costs and help small druggists moves to House for a vote with price tag removed

By Melissa Patrick and Al Cross
Kentucky Health News

FRANKFORT, Ky. -- A new version of a Senate bill to put the state back in direct charge of its Medicaid drug program, with a big price tag removed, went to the House floor in a specially called committee meeting March 16.

Sen. Max Wise

Senate Bill 5, sponsored by Sen. Max Wise, R-Campbellsville, has evolved into a "transparency bill" that, if passed, will allow the state to find out how pharmacy benefit managers are spending the $1.7 billion a year they get for Kentucky Medicaid prescriptions.

Wise told the House Banking and Insurance Committee that he filed the bill because independent pharmacies are being paid such low fees for dispensing Medicaid prescriptions that many are at risk of closing, despite a 2016 bill aimed at price transparency. The fees are as low as 85 cents per prescription, though the federal Centers for Medicare and Medicaid Services says it should be around $10.64.

Wise's original bill would have mandated that amount, but to get it through the House, he had to overcome objections of the Cabinet for Health and Human Services, which said it would cost $36 million a year. The committee substitute bill would let the Department for Medicaid Services set the fee.

Deputy Medicaid Commissioner Anne-Tyler Morgan told the committee that any rate increase will largely be determined by what the department finds in its investigation and by what the budget allows. Wise, who is on the budget committee, said it is addressing the issue.

The bill would require pharmacy benefit managers (PBMs) to report their average reimbursement and fees paid to their affiliated pharmacies and to those with more than 10 locations and 10 or fewer locations. The state's current contracts with the managed-care organizations (MCOs) that handle Medicaid don't allow access to such information.

The bill would give the Medicaid department and the Department of Insurance authority to penalize the MCOs and PBMs for noncompliance.

Wise said lawmakers in other states are considering similar legislation. He said CVS Caremark, which contracts with four of Kentucky's five MCOs and has a chain of retail pharmacies, has been found in other states to reimburse them at a much higher rate. "We don't know if that's happening in Kentucky or not, but we need to find out," he said.

He said CVS Caremark has been sending letters to independent pharmacies across the state offering to buy them out. CVS did not make an appearance at the committee meeting.

Rep. Jeff Greer, D-Brandenburg, suggested that CVS was able to buy health-insurance company Aetna Inc. by taking advantage of the taxpayers.

Greer, an insurance agent who chaired the committee when Democrats controlled the House, told Morgan, "I hope you guys are able to get answers and get 'em fast."

"So do we," Morgan replied.

Lexington will host two health conferences in November: one on immunization, one on health-care associated infections

Lexington will host two health conferences in November, one focusing on immunizations and the other on health-care transparency and patient advocacy.

The 2016 Kentucky Immunization Conference, titled "Educate, Immunize, Protect: Kentucky's Immunization Trifecta," will be held Nov. 2-4 at the Embassy Suites in Lexington.

This conference will feature nationally known speakers who will discuss all areas of immunization from infants to adolescents to adults.

A keynote speaker for this event is Dr. Ari Brown, a pediatrician, childcare advocate and author of the bestselling "411" parenting books. Brown also serves as a medical advisor for Parents magazine and a spokeswoman for the American Academy of Pediatrics.

Another keynoter, Rayna DuBose, is a meningitis survivor who will share her story about overcoming adversity and talk about the importance of vaccination.

This conference is sponsored by the Kentucky Rural Health Association in collaboration with the Kentucky Immunization Program. The cost is $100 through Oct. 15, when it will increase to $150. Continuing education credits will be offered. Click here to register.

Health Watch USA Conference

The annual Health Watch USA Conference for Healthcare Transparency and Patient Advocacy will be held Nov. 4 at the Four Points Sheraton in Lexington. This year's conference is titled, "Full Disclosure and Healthcare Associated Infections."

This conference will focus on the impact and magnitude of adverse events in health care, the importance of creating cultures of safety, patient advocacy, medical device patient safety issues and healthcare associated infections.

Keynote speakers include Dr. Jim Bailey, a fellow in the American College of Physicians and professor of medicine and preventive medicine at the University of Tennessee Health Science Center in Memphis; Dr. Lars Aanning, a medical/surgical consultant; and Dr. Mark Davis, an operating-room safety consultant specializing in reducing injuries from sharps and exposure to blood.

The conference is paid for in part by a grant from the Foundation for a Healthy Kentucky. Click here or call 606-425-7278 to register. The cost to attend is $48. Continuing educations credits are offered.

Pharmacy benefit managers secretly decide which prescription drugs are covered or not, critics call for more transparency

lexisnexis.com

Every year, pharmacy benefit managers in the United States decide which prescription drugs are excluded from health insurance plans, and this list is determined by a secret board of doctors and pharmacists, Samantha Liss reports for the St. Louis Post-Dispatch.

Pharmacy benefit managers process prescriptions, manage billing, decide which drugs will be covered (or not) and negotiate pricing for health insurance companies and corporations.

Executives at Express Scripts, the nation's largest pharmacy benefit manager, told Liss that the secrecy is necessary to "shield experts from the 'tremendous' influences of lobbyists," she writes.

Express Scripts provides prescriptions to about 85 million Americans each year through its employer-based prescription drug coverage, Liss reports.

To be included on Express Scripts' national list of covered drugs, known as a formulary, "The drugs are reviewed by three different committees during a four-step process," Liss reports, with the national pharmacy and therapeutics committee making the final recommendations.

The 16-member P&T committee is "independent and objective," Express Scripts says. It is comprised almost entirely of physicians who represent a broad rage of specialties and each member serves a three-year term, Liss reports.

The committee is self-perpetuating. Members are elected by current members, who are required to disclose their financial relationship with drug and device makers annually as well as their stock ownership and research-grant awards.

Dr. Steve Miller, Express Scripts’ chief medical officer, told Liss it was impossible to find experts who hadn’t received money from the industry.

“If you’re going to have some of the best experts, they’re going to be asked to speak and they’re going to be asked to be in (clinical) trials,” he said. “If they have no conflict at all, are they truly the experts in the field that people are turning to?”

Liss explains that "The P&T committee does not review any pricing information or potential discounts Express Scripts would receive. . . . After reviewing relevant scientific information on particular drugs and a review of its competitors that treat the same issues, the committee either recommends to include or exclude the drug from the annual list." Drugs can also be recommended as an optional choice.

After the committee makes its recommendations, another committee, comprised of Express Scripts employees, analyzes the recommended drugs compared to the optional drugs, based on pricing. These recommendations then go back to the P&T committee for final approval, Liss reports.

Critics call for more transparency

Express Scripts, like its rivals, does not disclose the names of its committee members or any actual or potential conflicts of interest they may have, Liss notes.

Critics question why this secrecy is allowed when the rest of the industry is required to publicly disclose its financial relationships, Liss reports: "For example, drugmakers and device makers must report how much they pay doctors for perks such as food and beverage, travel and speaking engagements."

“All of us are subject to reporting on what money we receive. These folks should do the same,” Dr. Adrian Di Bisceglie, co-director of St. Louis University Liver Center, told Liss.

It's big money. "In 2015, about $2.6 billion in general payments were funneled to doctors and teaching hospitals across the United States, according to data from the Centers for Medicare and Medicaid Services. And another $4.8 billion in payments were made for research and ownership or investment interests," Liss reports.

Others told Liss that such secrecy is not common in other parts of the world.

Steve Morgan, professor of health policy at the University of British Columbia and an expert on international pharmaceutical policy, said other countries name the members their expert panels, and “I can’t think of an exception to the rule. . . . You know who they are, you know about their conflict of interest.”

However, Morgan also told Liss that some countries allow the committee to cast their final votes anonymously. “The professionals who are on these committees are put under enormous pressure – political pressure, lobbying pressure from patient groups and industry,” Morgan said.

Why does it matter?

Pharmacy benefit managers say that having a national preferred formulary "curbs the rising costs of prescription drugs" and that "the threat of being excluded pressures drugmakers to lower their prices," Liss writes.

Express Scripts recently released its 2017 list of preferred drugs, which excludes 85 medications.

That means if you are on one of these excluded drugs, you will have to switch medications. Express Scripts told Liss this would affect about 0.12 percent of its clients, or about 30,000 people.

Patients can also appeal.

“In the instances when a patient has a rare medical need that requires that she be treated with a drug that has been excluded, we have an exception process in place to ensure the patient can have that drug covered,” Express Scripts spokesman David Whitrap told Liss.

For drug manufacturers, being excluded from Express Scripts’ list of preferred drugs has financial consequences. “Usually the stock drops; usually investors react negatively toward that news,” Vishnu Lekraj, an analyst covering Express Scripts for Morningstar, told Liss.

For example, "shares of Gilead Sciences Inc. plummeted 14 percent on Dec. 22, 2014, when Express Scripts moved to exclude the drugmaker’s new, high-cost hepatitis C drug (Sovaldi) in favor of a different version from Gilead’s rival (Viekira Pak made by AbbVie)," Liss writes.

Executives told Liss that this decision "saved the health care system $4 billion in 2015."

Feds issue ratings on 3,662 hospitals, 82 in Ky.; none get top rank, 16 get second rank; industry says ratings oversimplify

By Danielle Ray
Kentucky Health News

The Centers for Medicare and Medicaid Services on Wednesday released its Overall Hospital Star Ratings, just two days after two U.S. House members introduced a bill that would delay the release for a year.

The ratings aim to give consumers a simple measure of hospital quality. Critics say they are too simple.

They rate 3,662 U.S. hospitals from one to five stars, with the latter representing the highest quality of care. Each hospital's rating is based on 64 measures of safety and performance in seven categories: mortality, safety of care, readmission within 30 days, patient experience, effectiveness of care, timeliness of care and efficient use of medical imaging.

"These easy-to-understand star ratings are available online and empower people to compare and choose across various types of facilities from nursing homes to home health agencies," Dr. Kate Goodrich, director of Medicare's Center for Clinical Standards and Quality, said Wednesday on CMS's official blog.

Many hospital performance experts have opposed the rankings, calling them skewed and unreliable.

"Hospitals that reported on the majority of metrics tended to get one, two or three stars," Dr. Janis Orlowski, chief healthcare officer of the Association of American Medical Colleges, told Steve Sternberg of U.S. News & World Report. "Hospitals that reported on less than 40 percent of the metrics accounted for almost half of those that got five stars."

CMS planned to release the ratings April 21, but delayed them so Medicare officials could respond to criticism, which included a letter from 60 of the 100 U.S. senators and 225 of the 438 representatives calling for a delay, plus pressure from some of the nation's largest hospital organizations.

Two days before the release, Reps. James Renacci (R-Ohio) and Kathleen Rice (D-New York) introduced a bill that would have forced its delay until at least July 2017.

“I still have real concerns that this system could unfairly penalize teaching hospitals and hospitals that serve poor communities, and that patients will ultimately pay the price," Rice told Elizabeth Whitman of Modern Healthcare.

That may have been reflected in the Kentucky rankings. The hospitals at the University of Louisville and University of Kentucky got one star and two stars, respectively.

The agency chose to go ahead with the release, Goodrich said in the CMS blog, because officials "have received numerous letters from national patient and consumer advocacy groups supporting the release of these ratings." She said the ratings improve transparency and accessibility of information about hospital quality.

Of the 94 Kentucky hospitals that CMS evaluated, 82 were rated, and 12 did not have enough data to generate a rating.

Twin Lakes Regional Medical Center (Photo from abelconstruct.com)

No Kentucky hospital earned a five-star rating. Sixteen hospitals got four stars: Baptist Health Lexington, Baptist Health Louisville, Casey County Hospital in Liberty, Clark Regional Medical Center in Winchester, Flaget Memorial Hospital in Bardstown, Greenview Regional Hospital in Bowling Green, Hardin Memorial Hospital in Elizabethtown, Harrison Memorial Hospital in Cynthiana, Marcum and Wallace Memorial Hospital in Irvine, Methodist Hospital in Henderson, Pineville Community Hospital, St. Joseph Martin, St. Elizabeth Fort Thomas, St. Elizabeth Medical Center North in Edgewood, TJ Health Columbia (now only a behavioral-health facility) and Twin Lakes Regional Medical Center in Leitchfield.

The majority of the Kentucky hospitals rated, 52, earned three stars. A complete list of those hospitals can be found here.

Twelve hospitals got two stars: Ephraim McDowell Regional Medical Center in Danville, Harlan Appalachian Regional Healthcare Hospital, Hazard ARH Regional Medical Center, Jennie Stuart Medical Center in Hopkinsville, Jewish Hospital & St. Mary's Healthcare in Louisville, Kentucky River Medical Center in Jackson, Lourdes Hospital in Paducah, Monroe County Medical Center in Tompkinsville, St. Joseph Hospital in Lexington, St. Joseph East in Lexington, St. Claire Regional Medical Center in Morehead and the University of Kentucky Hospital.

Two hospitals earned just one star: University of Louisville Hospital, where a recent state inspection found problems with nursing; and Lake Cumberland Regional Hospital in Somerset, which ranked very poorly in the 2014 ratings by Consumer Reports magazine. It got two stars last year, one of only six Kentucky hospitals to do so.

Rick Pollack, president and CEO of the American Hospital Association, said he fears the ratings could mislead patients.

"The new CMS star ratings program is confusing for patients and families trying to choose the best hospital to meet their health care needs," Pollack said in a news release. "Health care consumers making critical decisions about their care cannot be expected to rely on a rating system that raises far more questions than answers."

A comprehensive list of Kentucky hospital CMS ratings can be found here. Nationally, Medicare gave five stars to 102 hospitals, four to 934 hospitals, three stars to 1,770 and one star to 133. Many hospitals did not produce enough data in the measured areas to warrant a rating.

Health Watch USA to hold major conference on health-care transparency and patient safety Friday, Nov. 13 in Lexington

Health Watch USA will hold its annual conference, "Healthcare Transparency & Patient Safety," Nov. 13 at the Four-Points Sheraton in Lexington, Kentucky. The Somerset-based organization tries to promote health care value, transparency, quality and patient advocacy, says its website.

The conference will address the importance of full disclosure and its importance to both the patient and in quality assurance; the lax oversight of medical device safety; the importance of strong infectious disease safety standards; healthcare policy issues that came to light during the Ebola Outbreaks in the U.S.; and the current problems related to healthcare quality assurance. Click here for the agenda.

Keynote speakers include Peter Eisler, investigative reporter for USA Today, who will discuss the newspaper's role in assurance of medical quality; Briana Aguirre, nurse and health-care quality advocate, who treated the first patient with Ebola in Texas; and Kaci Hickox, nurse and health-care quality advocate, who treated patients with Ebola in Africa and was quarantined upon her return to the U.S, despite being asymptomatic and with no history of breaking any contact precaution protocols.

There will also be presentations by Dr. Joycelyn Elders, former U.S. surgeon general; Dr. Richard Wild, chief medical officer in the Atlanta Regional Office Centers for Medicare and Medicaid Services; Rice Leach, health commissioner for Lexington and Fayette County; Dr. Stephen Tower; Dr. Daniel Saman; Patient Advocate David Antoon; Patient Advocate Kathy Day, RN; and Dr. Kraig Humbaugh, deputy commissioner of the Kentucky Department for Public Health.

The registration fee varies, with group discounts available. Attendance without CEUs is $48; attendance with CEUs is $96; and the full-time student rate is $35. Click here to register. For more information, contact Cathy Kavanagh at 606-426-7278 or send e-mail to info@healthconference.org.

Online database lets you check on your surgeon; some surgeons say methodology used in analysis of data isn't adequate

A new online database is available to help consumers choose a surgeon, but surgeons are pushing back and asking for a peer-reviewed study of the data.

The searchable database, "Surgeon Scorecard," was created by ProPublica, a nonprofit journalism organization, by using five years of Medicare records to calculate the death and complication rates for nearly 17,000 surgeons performing one of eight elective procedures including knee replacements, the data include knee replacements, hip replacements, cervical spinal fusion, two types of lumbar spinal fusions, gall bladder removal, prostate resection and prostate removal. The website says the scorecard was "guided by experts" and the data were adjusted for differences in patient health, age and hospital quality.

Click here to find data on Kentucky surgeons.

This analysis comes at a time when federal health officials are focusing more attention on these common surgeries, Laura Ungar reports for The Courier-Journal.

"This month, the U.S. Centers for Medicare and Medicaid Services announced a proposal to cut Medicare payments to hospitals with high rates of complications for hip or knee replacements," Ungar reports. "About a quarter of the 400,000 hip and knee replacements Medicare patients undergo each year will be affected by the proposed rule."

ProPublica's report comes with mixed reviews. Health and Human Services Secretary Sylvia M. Burwell told Ungar that this model would "reward providers and doctors for helping patients get and stay healthy."

Leah Binder, president and CEO of the Washington-based Leapfrog Group, a nonprofit organization that rates hospitals, told Ungar that she commended ProPublica for analyzing the data in a way that's useful for consumers. "Complication rates are a strong sign of a certain skill level," she said. "This information is housed by our government, and as taxpayers, we deserve to know how surgeons are doing."

Charles Mick, a spine surgeon in Massachusetts who advised on the project, told Nick Penzenstadler of USA Today that the project is "long overdue. Consider baseball, if you're a batter but never knew if you hit the pitch, how could know you know if you're getting better?" Mick argued that the "uncomfortable public exposure is a small price to pay for better patient care."

But surgeons have taken to the Internet with complaints about the report with editorial headlines like: "ProPublica's Surgeon Score Card: Clickbait? Or Serious Data?" written by Dr. Benjamin Davies for Forbes; "Why the Surgeon Scorecard is a journalistic low point for ProPublica" by Dr. Jeffry Parks on his medical blog; and an open letter titled "ProPublica's Surgeon Scorecard: Call for Peer Review" by Dr. Edward J. Schloss, to name a few.

These physicians argue that there are problems with the methodology, such as overly wide statistical confidence intervals for complication rates, questions about using readmission rates as a measure of complications, considering readmission as equal to death, and not using enough criteria to make these claims.

"ProPublica rightly has high expectations for surgeons and has courageously started a worthwhile process," Davies writes for Forbes. "What they have not done is given pause — or honest reflection — on the obvious harsh limitations of the data they have processed. Instead, we got a clickbait video and a parboiled dataset."

Health foundation says consumers need price transparency; Medicaid health officer says some commercial interests want it

Kentucky Health News

The Foundation for a Healthy Kentucky says a major step needed to improve the health of Kentuckians is transparency of their health-care cost and quality.

"Consumers can (then) compare apples to apples," Susan Zepeda, the Foundation's president and CEO, told Greg Stotelmyer of Public News Service. "What is a particular procedure going to cost if I have it at this hospital versus that outpatient surgery center? What are my co-pays going to be or my deductibles under my insurance plan?"

The foundation recently recommended that Kentucky develop and establish an all-payer claims database, or APCD, for consumers and stakeholders as a tool for transparency. John Langefeld, chief medical officer of the state's Department of Medicaid Services, told Stotelmyer that "support for the idea is growing, including from many on the commercial side of health care."

But this type of transparency is not likely to happen without a law to require it, which Kentucky does not have, Stotelmyer reports.

Massachusetts is the only state that requires the type of health-care transparency the foundation is talking about. And while it is not a perfect system, with reported prices not reflecting all of the involved charges, frequent price changes and weak information about the quality of care, it is still "unlike anything else in the country," Martha Bebinger reports for Kaiser Health News.

Oregon could possibly become the second state to require health-care transparency. Two bills for it are pending in the current legislative session. One that would require hospitals to reveal their median prices for common inpatient and outpatient procedures, "is expected to get very little opposition as it makes its way through the legislative session," Chris Willis reports for KGW in Portland.

But physician and system theorist Deane Waldman argues in the Huffington Post that price transparency won't work. She says that transparency can't reflect the real cost of health-care, doesn't reflect health outcomes or quality of care, and when it does reflect outcomes, it only reflects the average outcome and not individual probabilities. She also says that because the current health-care in the U.S. is not a free market, consumers have no reason to economize.

The Foundation for a Healthy Kentucky disagrees. "Sunshine on pricing will make sure that we're all playing by the same rules," Zepeda told Stotelmyer. Kentucky has the ability to gather the data, but it still needs "the political will" to do so, she said.

Foundation for a Healthy Kentucky wants a claims database to increase transparency about health-care cost and quality in Ky.

Kentucky has experienced rapid changes in health care since the implementation of the Patient Protection and Affordable Care Act, and the next step is to implement a program that will provide more transparency about the cost and quality of health care so consumers can make informed, value-based health decisions, says a news release from the Foundation for a Healthy Kentucky.

A recent Kentucky Health Issues poll found that most Kentuckians think they can find out what doctors charge for treatments and procedures if they need this information. They seem to believe that transparency already exists, but this is often not the case.

The foundation recommends that Kentucky develop and establish an all-payer claims database, or APCD, for consumers and stakeholders as a tool to address this issue of price transparency.

"Clear, factual information about the cost and quality of health care is necessary for consumers to select value-driven care and for consumers and providers to be involved and accountable in their decision about their health and health care services," says the release.

The APCD Council defines APCDs as “large-scale databases that systematically collect health-care claims data from a variety of payer sources which include claims from most health-care providers," says the news release. The information includes patient demographics, provider codes, and clinical, financial and utilization data. This information is then made available to the public.

The foundation said it analyzed national and state expert presentations, reviewed studies and held a meeting in October with more than 60 Kentucky leaders in government, business, policy and health care to discuss the issue.

Participants discussed barriers, feasibility, solutions and other factors in implementing price transparency in Kentucky from the perspectives of the consumer, provider, policymaker and researchers. Here are some of their collective findings, according to the release:

• Current cost and health service information are difficult to understand. 
• Price and quality data need to be useful to the consumer through simple, useful tools, currently it is not. 
• The state must be involved in implementing an APCD by passing laws to require the collection and sharing of data and requiring the data to be reported publicly. 
• An effective APCD would allow estimates and cost comparisons between providers; would include expected out-of-pocket costs and quality measures that can be compared across providers; would have the ability to see spending patterns over time for all enrolled under one policy; would offer individual level data; and would offer health care value-based cost saving tips.
• There is a significant variation in health-care pricing, and physicians may need an incentive to consider cost when making decisions for patients.

Colorado was one of the first states to establish price transparency legislation, data collection and reporting on a state-wide level. Representatives from that state's APCD said it was initially funded by foundations, but will use fees to sustain itself going forward.

New rule will improve reporting of antibiotic-resistant infections in health-care facilities, which are getting worse in Kentucky

By Melissa Patrick
Kentucky Health News

FRANKFORT, Ky. — Kentucky will have a new weapon, in the form of data, to fight infections acquired in hospitals and other health-care facilities, with legislative approval of a regulation that changes the way antibiotic-resistant infections such as MRSA and C. difficile are reported.

Health Watch USA chart, Centers for Disease Control data

The new rule comes at a time when Kentucky has the third highest rate of MRSA bloodstream infections in the nation, according to the National Healthcare Safety Network. The state was ranked fourth last year.

Kentucky hospitals are 27 percent worse for MRSA (methicillin-resistant Staphylococcus aureus) and 21 percent worse for catheter-associated urinary tract infections than they were two years ago, according to the federal Centers for Disease Control's National and State Health-care Associated Infection Progress report.

The legislature's Administrative Regulation Review Subcommittee approved the regulation, which has been in the works since 2008, at its Jan. 13 meeting. In the meantime, hospitals have succeeded in changing the term "hospital-acquired infections" to "healthcare-associated infections" to indicate that not all such infections occur in hospitals.

"The emergence of these dangerous organisms is really a problem of our entire heath care system and it can't be fixed by any single facility or facility type," Kevin Kavanagh of Somerset, chairman of Health Watch USA, a non-profit organization that promotes health care transparency and patient advocacy, told the committee. For his testimony, click here.

The regulation redefines HAIs and HAI outbreaks for infections, and requires simultaneous data reporting to the CDC and the state Department for Public Health. The CDC already has the data, but has "no authority" to act on it, while the state health department has the authority but not the data, Kavanagh wrote in an opinion piece for the Lexington Herald-Leader. "It is imperative that we know what is happening and where, so effective action can take place."

He told the committee, "Data for action is critical. It is the first step to confront these dangerous organisms."

The regulation also will require electronic reporting via the Kentucky Health Information Exchange beginning 2016. It now goes to Gov. Steve Beshear for final approval, which is expected.

Rep. Tom Burch, D-Louisville, chair of the House Health and Welfare Committee, told the joint House-Senate regulations committee that he had worked on the regulation for many years and that the Kentucky Hospital Association supported it. It had lobbied against such regulations. "There is nobody against it right now," Burch said.

However, Sen. Alice Forgy Kerr, R-Lexington, said "This regulation seems to have caused a lot of indigestion for a lot of people," and asked for a "statement of confirmation" from someone representing a group that might have opposed it in the past.

The hospital association's vice president of government relations, Sarah Nicholson, was at the meeting but didn't speak. Dana Stephens, director of infection prevention and control at St. Joseph East Hospital and St. Joseph Jessamine, told the committee, "I have had the great pleasure and honor of working with this multidisciplinary team for the past many years to really develop legislation and regulatory language that will provide information that will improve the health of those citizens we serve."

Kerr commended the groups on reaching a compromise, but the elements of the compromise were unclear. Nicholson declined to comment after the meeting.

Kavanagh said afterward that the regulation is needed to reverse the apparent increase in hospital infections, based on the CDC data from 38 of the state's 93 hospitals. "We are going in the wrong direction, with Kentucky 27 percent worse than it was two years ago," he noted. "This regulation will help with that."

Centers for Disease Control graphic reports Kentucky data on health-care-associated infections

The regulation is expected to improve the accuracy of Kentucky's HAI data because it requires all health-care facilities to submit reports and more clearly defines HAIs, which Kananagh said will help with under-reporting of infections.

New regulations often raise questions about the cost of enforcing them. Kavanagh told the committee that the CDC had told him that it would be allocating "a lot of federal money" to state health departments through grants to confront infectious disease issues, a result of the lessons learned from Ebola. Better HAI data will support Kentucky's need for these grants, he said.

"So, I do believe the state health department, along with other entities, will have access to funds to implement this regulation change,” he said.

Health care's culture doesn't encourage doctors to report medical errors of colleagues; article says patients should come first

By Melissa Patrick
Kentucky Health News

Doctors are often aware of their colleagues' medical errors, but fail to report them because of a culture that does not support or encourage such actions, Marshall Allen writes for ProPublica, a non-profit, non-partisan journalism organization.

Medical errors are estimated to kill 400,000 people in U.S. hospitals each year according to an online article by John T. James in the Journal of Patient Safety, causing some to say that medical errors are one of the nation's leading causes of death, Allen reports.

According to a report from the U.S. Department of Health and Human Services, most health-care providers employ a philosophy of "deny and defend" when confronted with issues related to medical errors. Providers fear full disclosure will lead to more lawsuits, higher jury awards, higher insurance premiums, and the loss of reputation or coverage for the provider, the opposite is true, the HHS report says. It says honest and open communication helps to lessen malpractice costs.

The Department of Veterans Affairs Medical Center in Lexington has led the way in the move toward health-provider transparency. It has worked under a philosophy of full transparency and disclosure since 1987, requiring prompt reporting and investigation of medical errors and near misses, full investigation, full disclosure of investigation results to the patients and families who have been injured because of accidents and medical negligence, and expressions of apology and  fair remedy, including compensation for injuries, according to the HHS report.

Several years ago, Allen contacted a Las Vegas surgeon to follow up on hospital data that showed peers of this surgeon that had high rates of surgical injuries. Allen reported that before he could reveal the list of peers to the surgeon and request his services in the investigation, the surgeon shared stories of the many surgeries he and his partners did to "clean up" the mistakes of "the worst surgeons in town" and said "he did not need a database to tell him which surgeons made the most mistakes."

An article in the New England Journal of Medicine, “Talking With Patients About Other Clinicians’ Errors,” says that although there is a common belief that there is an ethical duty to inform patients who have been harmed by medical errors, physicians often do not.

The existing guidelines emphasize ethical duties related to self reporting when physicians make  errors, says the report, but offers little guidance about what to do when they discover someone else's mistake.

In a survey separate from the New England Journal of Medicine report, but led by the same main author, more than half of doctors said that in the previous year they had identified at least one error by a colleague.  Gallagher told Allen that the survey did not ask what the doctors did about it.

For the New England Journal report, Dr. Thomas Gallagher, an internist and professor at the University of Washington, led a team of 15 experts who identified possible reasons doctors stay silent about errors by their peers. One reason is the system of referrals on which doctors depend, Allen reports; if a physician "becomes known as a tattler" he or she will lose referrals, and thus suffer financially.

The report lists other reasons for not reporting colleagues' medical errors, such as lack of time to investigate, a culture that promotes loyalty and solidarity, concerns about harming one's institution or becoming involved in a medical malpractice case,  concerns about causing a colleague to face legal issues,risk of acquiring an unfavorable reputation with colleagues and issues related to cultural differences, gender, race and seniority.

The bottom line, Gallagher told Allen, is that "physicians are not learning from their errors and patients are not getting the information they need to receive proper treatment or compensation when the outcome is harmful."

Dr. Brant Mittler, a cardiologist who works as a medical malpractice attorney in Texas, told Allen that in almost four decades in medicine he often saw errors and stayed quiet because "there would have been hostility" if he had reported them. “There’s not a culture where people care about feedback,” Mittler said. “You figure that if you make them mad they’ll come after you in peer review and quality assurance. They’ll figure out a way to get back at you."

Gallagher told Allen, "The result of this culture is too much leniency toward mistakes."

The New England Journal article said that despite the challenges of disclosure, the patient comes first, and doctors should "explore, not ignore" a colleague's error, Allen notes.

Once an error is suspected, the report suggests, the doctor recognizing the error should find the facts, starting with a direct conversation with the physician who made the error so together they can decide how to inform the patient. The article also suggests that hospitals and other health-care institutions lead by supporting transparency.

Dr. David Mayer, vice president of quality and safety at Medstar Health, which runs 10 hospitals in Maryland and Washington, D.C., told Allen that "reporting of medical errors (and near misses) is a top priority at the organization so everyone can learn from mistakes, saying that each month there are about 1,400 reported safety events."

The safety events are analyzed for trends, Mayer told Allen.  If a patient is harmed, an investigation is conducted and the information is disclosed to the patient and family, an apology can be made and compensation can be offered.

Dr. Humayun Chaudhry, president and CEO of the Federation of State Medical Boards, which provides guidance for how state boards regulate doctors, told Allen that doctors and other providers should be more assertive about reporting errors. "Failing to tell a patient about another doctor's mistake undermines the doctor-patient relationship," Chaudhry told Allen. "It makes patients wonder if they can trust their own physicians and the profession of medicine."

New survey shows physicians feel need to limit health-care costs but make that secondary to the interests of their patients

A new survey about health-care costs reveals that 85 percent of U.S. physicians feel a responsibility to address costs but say other professionals have more of a responsibility to do that, because physicians' obligation toward patients' interests is more important than cost reductions.

While 36 percent of physicians said they have a "major responsibility" to reduce costs, other major players in health care, such as lawyers, insurance companies, hospitals and drug companies, bear that major responsibility, says the study published in this week’s Journal of the American Medical Association.

“Physicians feel stuck in a difficult position,” lead author Dr. Jon Tilburt says in a Mayo Clinic release. “Despite their sense of responsibility to address health care costs, physicians consistently express a commitment to the best interests of patients even when it is expensive. Given this finding, we recommend that cost-containment strategies aimed at physician behavior should focus on innovations that not only promote savings but also preserve physicians’ commitment to individual patients.”

Physicians expressed general agreement with quality initiatives that may also reduce health costs, but were less enthusiastic about cost-containment measures involving changes to payment models, says an American Medical Association release. For example, physicians opposed the idea of cuts in Medicare fees for hospital readmissions and eliminating fee-for-service models.

A strong majority of physicians (69 percent) were enthusiastic about promoting chronic disease care coordination and limiting corporate influence on physician behavior (63 percent). The survey also found that 76 percent of physicians are aware of the costs of tests or treatments they recommend, says the Mayo release.

Physicians said costs can be reduced by improving quality, efficiency and continuity of of care through evidence-based initiatives and cost transparency, says the AMA release. Results of the random survey of 2,500 U.S. physicians indicate ways in which policymakers can collaborate with physicians to address rising health care costs.

“Moving toward cost-conscious care in the current environment in which physicians practice starts with strategies for which there is widespread physician support might create momentum for such efforts...," writes the study's authors in the journal article. Tilburt says physicians want to do the right thing, but when push comes to shove, they will do what's best for patients. Let's start with win win strategies that physicians support and that will cut costs and improve care, he said in a MedPage Today video interview. Click here to watch that video.

Health Watch USA hosts chief medical director of Center for Medicare and Medicaid Services in Lexington and online July 31

Dr. Patrick Conway, chief medical director of the federal Center for Medicare and Medicaid Services, will be presenting to Kentucky-based Health Watch USA on July 31 at 5 p.m., and with a few clicks on the computer, you can attend virtually.

Conway will be discussing CMS goals and the results of its value-based quality improvement programs, physician fee schedule quality proposals and future opportunities for CMS collaboration aimed to drive health-care quality.

Using your computer, you can attend and participate in the discussion through an online chat while listening to Conway's presentation and viewing the slides. Just click here to log into the conference's webpage and Adobe Connect will download to your computer free of charge.

The online login will be active 15 minutes before the presentation on July 31, and the presentation slides will be available to download as a PDF from the conference page. You can also attend the presentation at the Northside Library in Lexington. Click here for more information.

Health Watch USA, based in Somerset, was founded by Dr. Kevin Kavanagh to promote health care transparency and patient advocacy, says its website.

Kentucky and online audiences hear discussion of proposed system for patients to report medical errors; comments due July 8

By Molly Burchett
Kentucky Health News

The Obama administration is creating a new system for patients to report medical mistakes because existing systems fail to do so, and if all goes as planned, the pilot program will launch this fall, a federal official told a Health Watch USA meeting in Kentucky and online Wednesday night.

Research suggests that many adverse medical events go unreported in current systems that don't allow patients to provide input about their care, said James Battles, Ph.D., of the Agency for Healthcare Research and Quality. To fix this problem, AHRQ has funded the development of a prototype patient reporting system through a contract with RAND Corp.

Called the Consumer Reporting System for Patient Safety, the project is designed to collect information from patients "about medical errors that resulted or nearly resulted in harm or injury” and can also secure reports from family members, said Battles. The data will be available for use by providers and health systems that wish to create or enhance their own local reporting systems.

Here's how the system will work: When a patient recognizes a medical error, an intake form will ask what happened, including questions about the details of the event and the health care provider(s). Providers and patient safety officers are expected to follow up with the patient, which AHRQ estimates would add 28 hours to the provider's annual work load. The collected data will be analyzed to produce estimates about the patient safety events, which will be shared with health institutions.

There is concern about how the project findings will be used and that "frivolous" patient reports may lead to increased medical malpractice liability for providers. Despite apprehension that findings could possibly be linked to financial or legal penalties for poor performance, hospitals say they are receptive to the idea, Robert Pear of the New York Times reported last fall when project was first posted in the Federal Register.

"The question then would become, frivolous to whom?" Battles said when asked what he would say to concerned providers. Patient input is critical to gaining a full understanding of an adverse event, he said, and the overall project will include public awareness campaigns to let patients know their care experience is valued: "The purpose of the system is to improve patient safety, develop ways to prevent future harm and inform policy."

Patients, physicians, hospitals and other health care providers have until July 8 to comment on revisions to the government proposal, says the notice published in the Federal Register. (Click here for more information.) Battles said AHRQ has made substantial changes to the proposed reporting system's data collection tools, based on comments received last fall when the project was originally outlined.

After approval from the federal Office of Management and Budget, Battles said, a pilot program will be launched this fall near Philadelphia, then the system will be tested on a regional basis while considering reports from providers and patients.

Health Watch USA, based in Somerset, was founded by Dr. Kevin Kavanagh to promote health care transparency and patient advocacy, says its website. The organization's next meeting will be held July 31 at 5 p.m. and will feature Dr. Patrick Conway, chief medical officer for the federal Center for Medicare and Medicaid Services.

Calls for hospitals to reveal more about errors, infections are getting louder; feds plan more data, but hospitals fight state rules

By Tara Kaprowy
Kentucky Health News

LEXINGTON, Ky. -- The stories are hard to hear.

A little girl is taken to the hospital after she turns on the water and burns herself in the bathtub. After being admitted, her mother notices she looks dehydrated but nurses and doctors don't respond to the mother's pleas for help. A few days later, the girl dies.

While in the hospital, a father gets a gastric tube that is mistakenly inserted into his lungs. He soon passes away.

A friend goes into the hospital to get a knee replacement. He gets an infection from which he never recovers.

These scenarios are all the result of medical errors and hospital-acquired infections. The Centers for Disease Control and Prevention report nearly 100,000 Americans die each year from such infections alone. Calls for hospitals to be more transparent about what happens behind the curtain are growing more insistent, and the concern was the focus of last month's Health Watch USA conference in Lexington.

"This isn't a political issue, this is a real human issue," Rosemary Gibson, author of The Wall of Silence, a book about the problem, told those in attendance. "We need to do better here."

For the past several years, Frances Griffin, a faculty member with the Institute for Health Improvement, has been teaching hospitals how to measure harm, which IHI defines as an "unintended physical injury" that requires additional monitoring, treatment or hospitalization. "We're not getting into blame here," she said. "We just counted all the unintended consequences of medical care that required intervention."

For a study published in Health Affairs in April 2011, Griffin and her team reviewed 795 records from three large hospitals. They found 33 percent of patients experienced an adverse event, ranging from temporary harm that required intervention to an event that resulted in death. The findings were eye-opening, showing "adverse events in hospitals may be 10 times greater than previously measured," she said.

And, despite hospitals "pouring a lot of money into patient safety," Griffin said studies show that many patients are still being harmed. "We may not be applying our efforts to the right areas," she said.

Lack of transparency

Though data have been collected from hospitals around the country for many years — either through voluntary reporting or to comply with state laws — much of it has not been available to the public.

The only data on adverse events that is available now for Kentucky is based on Medicare billing claims and can be viewed at hospitalcompare.hhs.gov. It shows numbers about urinary catheterizations, central-line infections, pressure ulcers (bedsores), falls, blood incompatibility and foreign objects left in the body after surgery. But these claims might not tell the whole story, said John Santa, director of the Health Ratings Center for Consumer Reports, because "They're not being submitted to describe what happened accurately; they're being submitted to get payment."

Starting next year, the Centers for Medicare and Medicaid will release data that are collected by the CDC's National Health Safety Network and are based on actual patient records from acute-care hospitals, including ones in Kentucky. Information will be released on central-line bloodstream infections that occur in the ICU. In 2012, hospitals will then be required to collect information about surgical-site infections and catheter-associated urinary infections, which will later be released.

"I think we have gotten to a turning point," said Dr. Kevin Kavanagh, chairman of Health Watch USA. "It's become evident that states need to be engaged in their reporting efforts so the quality of data that's reported to the federal government is as good as it can possibly be and be reflective of what's going on in the states."

In Kentucky, there are no mandatory public reporting requirements for hospitals. In fact, hospitals must only inform the Department of Public Health about infectious outbreaks, but the definition of an outbreak varies from facility to facility based on the number of patients seen in a specific period of time. Though almost 100,000 people die each year nationwide from hospital-acquired infections alone, Kentucky hospitals only reported four outbreaks between Oct. 1, 2009 and Sept. 31, 2010.

"Without data, it's hard to know where our problems are," said Fontaine Sands, who manages the Kentucky Department for Public Health's program to prevent infections associated with health care. "We don't have anything specific on Kentucky and where (problems) are occurring on different levels of care."

Still, Sands isn't necessarily pushing for a state law, which could be overly burdensome. "The thing we don't want to do is put a mandate out there that is, one, too difficult to implement, and, two, doesn't give what the consumer needs."

Hospitals fight state attempts to require reporting

State Rep. Tom Burch, chairman of the House Health and Welfare Committee, is in favor of state monitoring, but said hospitals are generally reluctant to do it. But the Louisville Democrat, who was a quality-control supervisor at General Electric Appliance Park, said "It's just good business that you put out a quality product. If you've got nothing to hide, then why not put it out there?"

Burch introduced a bill last session that would have required reporting of infections acquired in health facilities acquired infections. "I ran into a buzz saw, needless to say," Burch said. The Kentucky Hospital Association was against the bill. "We support reporting but we want a national standard," said Nancy Galvagni, senior vice president of the KHA. "The federal government has already set up a standard, and we see no reason to duplicate it."

She added that most of Kentucky's hospitals have 100 beds or less and can't afford the money it takes to track the data. "We have to be recognizing the limited resources that are out there," she said.

The two hospital systems in Kentucky that have opted to release their own data — Norton Healthcare and Saint Joseph Health System — are large ones. Norton released its data, which are updated on a monthly basis, in October 2005. The move was not without its anxieties. "The fear is: What if we report it and the other guy doesn't?" said Ben Yandell, division director of clinical information analysis for Norton.

Since it started tracking its data, Norton has improved on many measures, Yandell said. Bluegrass Oakwood in Somerset has had the same outcome, with fewer bedsores, ear infections and urinary tract infections. The numbers have improved because the tracking system has improved, Oakwood Medical Director Keith Sinclair said.

Facilities that have full-disclosure policies also tend to spend less on malpractice litigation. After the University of Michigan Health System adopted a full-disclosure policy, "There was a 50 percent drop in medical malpractice suits, a lower mortality and much better, stronger defense when there was litigation," said Helen Gulgin Bukulmez, board member and patient advocate at Health Watch USA.

But there are drawbacks to reporting, which can "lead to hiding flaws instead of tracking them," Yandell said. It also might reduce access to care if providers avoid high-risk patients in order to keep scores up and could lower the quality of care if good care conflicts with what would give a good score.

Still, there is power in knowing how a hospital is performing, Santa said, citing data that was collected by the Society of Thoracic Surgery. As part of the analysis, which looked at such measures as whether patients were getting the correct medicines, the probability of survival 30 days after bypass surgery and the probability of major complications, 10 Kentucky hospitals allowed their data to be released. At Central Baptist in Lexington, there was an 89 percent probability of avoiding complications. At Hardin Memorial Hospital in Elizabethtown, there was a 73 percent probability. "Now ask yourself," Santa said. "Who would you rather go to? Hardin Memorial or Central Baptist?"

A culture of silence remains about medical errors, but things are slowly improving, physician-activist says

There has been a culture of silence when it comes to talking about medical errors, but things are slowly changing, writes Dr. Kevin Kavanagh, right, in an op-ed piece in the Lexington Herald-Leader.

Kavanagh, who is chairman of Health Watch USA, recalls an incident in which a patient came to be treated for a severe sinus infection. Upon being rushed to surgery, Kavanagh discovered "an old smelly gauze pack" had been left in the sinus from a previous operation. When an assistant asked Kavanagh what he should tell the patient, "I answered, 'The truth'," for which he was disciplined by a senior surgeon.

"Years have passed, and things are starting to change in medicine," Kavanagh writes. "Telling patients that something went wrong is slowly being accepted — a revolutionary idea to medicine."

Studies have shown that hospitals with full-disclosure policies actually have lower patient death rates, which Kavanagh just called "common sense." "If preventable patient harm occurs on a ward and the patient is not told, almost all of the employees on the ward will know about the cover-up," he writes. "How then will the administration garner the respect to effectively oversee the functioning of personnel? If hospital staff are not performing adequately, how do you discharge them when there are skeletons in the closet?"

Full disclosure also lowers malpractice expenses, Kavanagh contends. Stanford University hospitals had a 36 percent drop in malpractice claims and has saved $3.2 million since it adopted a full-disclosure policy in 2007. University of Michigan had a 40 percent drop in new claims and saves $2 million each year.

But full disclosure is not common in Kentucky, despite the Veterans Affairs hospitals in Lexington being the first to implement full disclosure in the country. "Instead of this practice spreading throughout Kentucky, the next health-care system to implement it was the University of Michigan," Kavanagh writes.

Things need to change, especially in the face of superbugs like MRSA. As he looked back at the incident involving the botched sinus surgery, "I am most bothered that I apologized for my actions," Kavanagh writes. "Now I would reserve the words, 'I'm sorry' for the patients who have been harmed." (Read more)

Health Care Transparency and Patient Advocacy Conference to be held Nov. 11 in Lexington

Focusing on issues like hospital- and health care-acquired infections, the impact of medical errors and infections on patients, and the importance of transparency, the Health Care Transparency and Patient Advocacy Conference will be held Nov. 11 in Lexington.

Speakers include John Santa, director of the Health Ratings Center for Consumer Reports, who will discuss the principles of transparency; author Maryn McKenna, who will present the history of MRSA; Dr. Keith Sinclair, medical director of Bluegrass Oakwood in Somerset, who will speak of how transparency has nearly eliminated pressure sores at his institution; and Frances Griffin, a faculty member at the Institute for Healthcare Improvement, who will present on the IHI global trigger tool.

The gathering is from 8:30 a.m. to 5 p.m. at Embassy Suites in Lexington. Registration is $50 and includes a box lunch. Physicians, physician assistants, nurse practitioners, nurses, physical therapists and human resource managers attending the conference will receive 6.5 hours of continuing education credits. To register, click here.