Princess Health and AMA, led by Ky. doctor, says gun violence is public-health crisis; calls for research, background checks, waiting periods for all guns. Princessiccia

Princess Health and AMA, led by Ky. doctor, says gun violence is public-health crisis; calls for research, background checks, waiting periods for all guns. Princessiccia

Congress doctors guns lobbying physicians

Gusty 06:40 Add Comment

The American Medical Association, led by a Kentucky emergency-room physician, declared gun violence a public-health crisis last week and endorsed waiting periods an background checks for purchases of all firearms, not just handguns.

"The AMA, the country's largest doctor group, also vowed to lobby Congress to overturn a decades-old ban on gun violence research by the Centers for Disease Control and Prevention," two days after the Orlando shooting that left 49 dead and 53 wounded, reports Kimberly Leonard of U.S. News and World Report. "The AMA joins the American College of Physicians in its position, which has been calling gun violence an epidemic since 1995."

Dr. Steven Stack

AMA President Steven Stack of Lexington said the research "is vital so physicians and other health providers, law enforcement and society at large may be able to prevent injury, death and other harms to society resulting from firearms. . . . With approximately 30,000 men, women and children dying each year at the barrel of a gun in elementary schools, movie theaters, workplaces, houses of worship and on live television, the United States faces a public-health crisis of gun violence."

Leonard notes, "Federal law doesn't technically outlaw the CDC from studying gun violence, but prohibits the agency from using federal dollars to advocate or promote gun control. Though President Barack Obama lifted the research ban through executive order nearly three years ago, Congress has blocked funding for these studies."

The National Rifle Association has called the public-health approach a back-door path to more gun control, Leonard writes, and "has said that doctors shouldn't be asking patients about gun ownership because they are not gun safety experts."

"Who will Congress listen to now: the healers or the merchants of death?" Lexington Herald-Leader columnist Tom Eblen asked to start his Sunday column. "The AMA's stand is unlikely to change anyone�s mind about gun control. But it underscores the absurdity of Congress� two-decade effort to block legitimate scientific research that could reduce gun deaths and injury."

Suicides accounted for about two-thirds of the 33,390 firearms deaths in the U.S. in 2014. The CDC "said 627 people were killed in Kentucky that year with firearms, a rate of 13.8 per 100,000 population, higher than the national average of 10.2," Eblen reports. He said research on gun violence could reduce those figures, just as research into auto accidents has reduced such fatalities.

Read more here: http://www.kentucky.com/news/local/news-columns-blogs/tom-eblen/article84482382.html#storylink=cpy

Read more here: http://www.kentucky.com/news/local/news-columns-blogs/tom-eblen/article84482382.html#storylink=cpy

Princess Health and Full House has Senate bill to regulate how druggists dispense 'biosimilar' medication that hasn't even been approved by FDA . Princessiccia

Princess Health and Full House has Senate bill to regulate how druggists dispense 'biosimilar' medication that hasn't even been approved by FDA . Princessiccia

food and drug administration generic drugs legislation lobbying lobbyists pharmacists

Gusty 11:39 Add Comment

Update: SB 134 passed the state House 96-0 March 23 with a floor amendment that allows communication by fax, telephone, electronic transmissions or other prevailing means by the pharmacist to the provider to suffice as notice. The bill now awaits concurrence.  

Brand-name drugs called "biologics," because they are made from living tissues, have no competition from "interchangeable biosimilar" products in the U.S. because no interchangeable products have been approved by the U.S. Food and Drug Administration. But that hasn't stopped the drug industry and Kentucky lawmakers from moving a bill to regulate how pharmacists could dispense these drugs if and when they are approved.

"This bill allows Kentucky pharmacists the ability to dispense safe and less expensive biological medications by allowing substitution of interchangeable biosimilars," Sen. Ralph Alvarado, R-Winchester, told the House Health and Welfare committee, which approved it March 17.

Current law does not allow these substitutions without advanced approval from the prescriber, Alvarado said. "This bill removes that hurdle."

The most contentious part of Senate Bill 134 has been its requirement that pharmacists must notify prescribers when they make this substitution, which advocates say is necessary because there are slight variations between the drugs.

Alvarado, also a physician, said the notification comes down to a "safety mandate," noting that if the patient had a "bad outcome" while on one of these medications, it is important for the provider to know exactly what medication the patient is taking.

Democratic Rep. David Watkins, a retired physician from Henderson, voted for the bill and supported the provider notification requirement.

"We're not talking about generics where you have exactly ideal medications, you are talking about biosimilars . . . which would be in some instances different molecules and have some different aspects," Watkins said. " I think that not notifying my office would be a gross disservice to my patients."

But the pharmacists disagree, and want substitution of interchangeable biosimilars to be handled the same way as generic medications, with the prescriber able to place a note on the prescription that says "do not substitute," said Bob Oakley, chairman of the Kentucky Pharmacists Association.

Oakley told the committee that while pharmacists support automatic substitution of an interchangable biosimilar for the name-brand biologic, they do not support notification. "Therefore, we are here to ask that we just keep it simple and keep it seamless," he said.

Rep. Addia Wuchner, R-Florence, said the bill had accommodations to make notification manageable for pharmacists, and asked Oakley what their real problem was. He replied, "It just adds more work to . . . their busy day."

But the pharmacists' lobby has cited other reasons. KPhA Executive Director Bob McFalls told James McNair of the Kentucky Center for Investigative Reporting, "Prescriber notification requirements have shown to increase costs for the health-care system overall" since they cause more brand-name drugs to be dispensed.

SB 134 passed the Senate 36-1 March 2, with Republican Sen. Jimmy Higdon, the majority whip from Lebanon, the only one voting against it. Higdon had submitted several floor amendments to modify the notification requirements, but withdrew them before the final vote.

Higdon told McNair that he didn't understand the urgency to pass this bill, noting that its passage would have no immediate effect.

�It�s the kind of bill that should be discussed,� Higdon said. �This whole thing is very complicated and futuristic, and a lot of people are talking to us about passing this. I just want to err on the side of caution. It doesn�t need to be fast-tracked. We need to do it right.�

Higdon was referring to the many lobbyists hired by pharmaceutical manufacturers that have descended on Kentucky in support of this bill.

"At least nine drug companies and groups have stated an interest in the Senate bill, according to the Kentucky Legislative Ethics Commission, McNair reports. "The number of registered lobbyists hired by pharmaceuticals employers has nearly doubled, from 46 in 2011 to 83 today. Their annual spending has more than doubled, to $824,196 in 2015."

The bill now resides in the House. Speaker Pro Tem Jody Richards, D-Bowling Green, has filed a floor amendment to remove the notification requirements.

About biologics and biosimilars

While conventional medications are made from pure chemical substances and can be easily replicated, biologics are made from living tissues and each batch varies slightly from the last, according to the FDA. That's why these products can't be called generics, which are chemcially identical.

The most common biologics are Humira and Remicade for arthritis and Enbrel for psoriasis. They are very expensive and can cost thousands of dollars each month.

"Express Scripts, the pharmacy benefits manager, estimates that while biologics accounted for only 1 percent of all prescriptions in 2014, they accounted for 32 percent of all prescription-drug spending," McNair reports.

Biosimilars are medications that are "highly similar" to already FDA-approved biological products. To date, only one of these, Zarxio, used for certain cancer patients, has been approved by the FDA, but it was not designated as interchangeable. According to the Regulatory Affairs Professional Society, six biosimilars have applied for FDA approval.

Interchangeable biosimilars are expected to produce the same clinical results in any given patient as it's "highly similar" biologic. To date, no interchangeable biosimilar medications have been approved by the FDA. When appoved, Alvarado suggested that they will cost up to 40 percent less than the biologics.

Kentucky is home to the North American distribution hubs for Amgen, Genentech and Johnson and Johnson and is the primary distribution point for many of the biologics (and soon to be biosimilars) in the U.S., according to an e-mail from RunSwitch PR.

Princess Health and Princess Health andAltria, parent of Philip Morris, reports spending most on lobbying the 2014 legislature but says it didn't fight smoking ban.Princessiccia

Princess Health and Princess Health andAltria, parent of Philip Morris, reports spending most on lobbying the 2014 legislature but says it didn't fight smoking ban.Princessiccia

cigarettes e-cigarettes General Assembly legislation legislature lobbying smoking smoking ban smoking bans tobacco tobacco prevention

Gusty 13:53 Add Comment

The parent firm of the nation's largest cigarette company again reported spending more than anyone else on lobbying the Kentucky General Assembly, but says it did not fight the bill that would have imposed a statewide smoking ban in most public places.

"Altria Group, the parent company of Philip Morris USA and U.S. Smokeless Tobacco, reported spending $156,200, "far more than any other company or group, Tom Loftus reports for The Courier-Journal. "And it got the things it wanted from Kentucky lawmakers: tobacco taxes were not increased, no new tax was put on electronic cigarettes and the tobacco-industry supported bill to ban the sale of electronic cigarettes to minors passed."

Spokesman David Sutton "said not a penny of Altria's lobbying campaign went to defeat the so-called 'smoke-free' bill, though he said the company opposes such complete smoking bans within private businesses," Loftus reports. "He said he suspected Altria's lobby spending topped the list because 'We fully disclose everything'," including research time of its legal staff and its "grassroots activation" work to rally its supporters in Kentucky.

The Campaign for Tobacco Free Kids, "which reported spending $6,284 during the session, earlier this month blamed Altria for leading the successful defeat of the bill to ban smoking in indoor public places like bars and restaurants," The Courier-Journal reports.

"They've spent a lot of money on lobbying for years," the campaign's Betsy Janes told Loftus. "They've sent their message out for so long and have relationships with legislators. It's hard for us to compete with that." (Read more)

The campaign's Amy Barkley told Kentucky Health News that Altria's assertion "is very hard to believe. That said, I don�t have any hard evidence to dispute their claim. We all know the tobacco industry�s influence is very deep in Frankfort, so perhaps they didn�t need to overtly lobby against the smoke-free bill."

The Kentucky Farm Bureau Federation, which gets funding from Altria for some of its programs, lobbied against the smoking ban. It ranked eighth in lobbying expenses, with $68,821. For The Courier-Journal's lst fo top lobbying interests, click here.

Princess Health and Princess Health andActivist seeking stronger rules on reporting health-care infections says industry lobbyists misled legislative committee to kill bill.Princessiccia

Princess Health and Princess Health andActivist seeking stronger rules on reporting health-care infections says industry lobbyists misled legislative committee to kill bill.Princessiccia

health-care associated infections hospital acquired infections hospitals lobbying nursing homes

Gusty 17:51 Add Comment

"Health-care industry witnesses appeared to have presented incorrect information" to the House Health and Welfare Committee in speaking March 6 against House Bill 460, which would require all health-care facilities to report infections associated with their treatment, Dr. Kevin Kavanagh of Somerset writes in an op-ed piece in the Lexington Herald-Leader. The bill remains in committee, but its goal could be accomplished by regulation.

Dr. Kevin Kavanagh

Kavanagh is chairman of Health Watch USA, a group that tries to focus attention on the problem of health-care associated infections, also called hospital-acquired infections. He said the industry witnesses "were asked if any of the various types of facilities in Kentucky were exempt from reporting. The answer was no, that all facilities had to report through the Centers for Disease Control's national reporting system. However, critical-access hospitals and ambulatory-surgery centers are not required to report infection to the CDC. Nursing homes also do not have to report through the CDC's system."

Kavanagh writes that nursing homes report urinary-tract infections to the federal Centers for Medicare and Medicaid Services, but "there is no data on the deadly staph infection, MRSA," or a deadly gastrointestinal infection caused by the bacteria C. Difficile, "which can run rampant in some nursing homes."

Kavanagh said the industry witnesses also misled the committee when asked "asked if a patient who was going to have hip surgery could find information on infection rates on Hospital Compare," a Medicare website. He writes, "The answers appeared to indicate that such information was available," but is "woefully inadequate" because the state doesn't have an adequate reporting system.

"For acute-care hospitals, only, bloodstream MRSA infections (a relatively rare event), colon surgeries, abdominal hysterectomies, urinary tract infections and central-line infection data can be found. Little use for patients needing hip surgery. In the past, CMS has posted on the Hospital Compare website information regarding hospital-acquired conditions, and was slated in the future to have information on neck and spine surgery. However, this information is now gone from Hospital Compare. I can only assume it, too, has fallen to the legions of health-industry lobbyists." (Read more)

For Kavanagh's March 6 testimony to the committee, click here. For his March 13 rebuttal to industry witnesses, go here.

Read more here: http://www.kentucky.com/2014/03/13/3136695/mandate-reporting-of-ky-health.html#storylink=cpy

Read more here: http://www.kentucky.com/2014/03/13/3136695/mandate-reporting-of-ky-health.html#storylink=cpy

Princess Health and Bill to shield nursing homes from lawsuits clears Senate along party lines; not looking healthy in House despite TV, radio ads.Princessiccia

Princess Health and Bill to shield nursing homes from lawsuits clears Senate along party lines; not looking healthy in House despite TV, radio ads.Princessiccia

advertising health journalism health policy legislation legislature lobbying long-term care newspapers nursing homes politics state government; General Assembly tort reform

Gusty 13:52 Add Comment

Last week the state Senate approved on party lines a bill that would make lawsuits against nursing homes go through a review panel first. Republicans supported the bill and Democrats voted against it in a 23-12 vote that marked the clearest partisan split in the Senate in this year's legislative session.

Senate Bill 9 would create medical review panels of three physicians and an attorney moderator to hear complaints against long-term care facilities and vote on whether the suit had enough merit to go to court.  The bill's sponsor, Senate Health and Welfare Chairwoman Julie Denton, R-Louisville, declind to answer an opposign senator's questions about the bill. She said in introducing it that the panel would be advisory but its opinion would be admissible in court and would curb such lawsuits, reports Jack Brammer of the Lexington Herald-Leader.

Bills like this have failed in years past and could have diverse implications for Kentucky communities and nursing homes. At least one Kentucky newspaper looked around and found that lawsuits are one reason Extendicare Health Services Inc. shed management responsibilities last year for all 21 of its facilities in Kentucky, reports Nick Tabor of the Kentucky New Era in Hopkinsville.

Without Extendicare management in Western Kentucky, the volume of nursing-home lawsuits in the region appears to be shrinking, Tabor reports. In recent years, nearly all the Christian County cases that have been closed were dismissed through settlements, not by judges declaring them unfounded. This suggests the bill would minimally affect the county, writes Tabor. Other Kentucky communities may be affected differently; judges differ from circuit to circuit.

Although the bill passed the Senate, it appears to be on its deathbed in the House. Rep. Tom Burch, D-Louisville, who chairs the House Health and Welfare Committee, joked about its prospects to Tabor: �I can�t make any predictions about the bill this time, but I�ve called in three priests to have the last rites ready.� If nursing homes received this new layer of protection, he said, hospitals and day-care centers would want it too.

A similar bill died in Burch's committee last year; this version is being supported by television and radio commercials urging viewers and listeners to call their legislators in support. When Extendicare announced last spring it was transferring management of all its Kentucky facilities to a Texas company, it cited Kentucky�s �worsening litigation environment� and said tort reform seemed unlikely here.

Bernie Vonderheide, director of Kentuckians for Nursing Home Reform, said most so-called �frivolous� lawsuits would cease if the state imposed minimum staffing requirements on nursing homes, his group's main legislative goal. (Read more)

Princess Health and McConnell helped Amgen delay price limits on dialysis drug.Princessiccia

Princess Health and McConnell helped Amgen delay price limits on dialysis drug.Princessiccia

Congress lobbying lobbyists pharmaceuticals politics

Gusty 10:40 Add Comment

Senate Republican Leader Mitch McConnell of Kentucky, whose public statements usually emphasize the need to cut federal spending on entitlement programs, as they did in Lexington Friday, apparently passed up an opportunity to rein in Medicare spending when he signed off on a big favor for a significant campaign contributor in the fiscal-cliff deal.

The deal delayed for two years price controls on a class of drugs including Sensipar, used by kidney-dialysis patients and manufactured by Amgen, "the world's largest biotechnology firm," Eric Lipton and Kevin Sack of The New York Times reported Jan. 19.

"The news was so welcome that the company�s chief executive quickly relayed it to investment analysts," the Times reported. "But it is projected to cost Medicare up to $500 million over that period. Dennis J. Cotter, who studies the cost and efficacy of dialysis drugs, told the newspaper, �Everybody is carving out their own turf and getting it protected, and we pass the bill on to the taxpayer.�

McConnell spokesman Robert Steurer said the senator did not push for the provision. The Times story did not focus on McConnell, saying "Supporters of the delay, primarily leaders of the Senate Finance Committee who have long benefited from Amgen�s political largess, said it was necessary to allow regulators to prepare properly for the pricing change." And it noted the firm "also has worked hard to build close ties with the Obama administration." It did note that former McConnell chief of staff Hunter Bates is among "a small army of 74 lobbyists for Amgen, which was "the only company to argue aggressively for the delay, according to several Congressional aides of both parties."

According to the Center for Responsive Politics, which analyzes lobbying and campaign contributions, Amgen's political action committee gave McConnell $7,000 during the 2011-12 election cycle, an amount exceeded by only seven other senators, none of them in the Senate leadership. McConnell was the main negotiator on the fiscal-cliff deal with Vice President Biden.

UPDATE, Jan. 25: Writing on BillMoyers.com and then on Salon, Bill Moyers and Michael Winship report that since 2007, "Amgen employees and its political action committee have contributed $73,000 to Senator McConnell�s campaigns," almost $68,000 to Sen. Max Baucus, D-Mont., chairman of the Finance Committee, and $59,000 to Sen. Orrin Hatch, R-Utah. They also note that Republican Rep. Richard Hanna R-N.Y., and Democratic Reps. Peter Welch of Vermont and Jim Cooper of Tennessee have introduced a bill "to repeal the half billion-dollar giveaway to Amgen. The story includes Moyers' video interview with Welch.

Princess Health and Nursing home chain says it will lease its Kentucky facilities because legislature didn't pass bill to filter lawsuits.Princessiccia

Princess Health and Nursing home chain says it will lease its Kentucky facilities because legislature didn't pass bill to filter lawsuits.Princessiccia

courts General Assembly legislature litigation lobbying long-term care nursing homes state government tort reform

Gusty 15:23 Add Comment

A major nursing-home chain says it will lease all of its Kentucky properties to a Texas company because a bill to insulate nursing homes from lawsuits did not pass the General Assembly this year,

Extendicare Health Services owns Pembroke Nursing and Rehabilitation Center, Shady Lawn Nursing Home in Cadiz and 19 other facilities in Kentucky, reports Nick Tabor of the Kentucky New Era in Hopkinsville. The company has been riddled with problems. A 2009 study ranked three of its Kentucky facilities among the country's worst nursing homes.

"The combination of a worsening litigation environment and the lack of any likelihood of tort reform in the state of Kentucky has made this the prudent decision for our company and its unitholders," said Tim Lukenda, president and CEO of Extendicare.

In this year's legislative session, nursing homes lobbied for a law that would have created medical review panels to evaluate potential lawsuits against nursing homes, personal-care homes and some facilities for the intellectually and developmentally disabled. The goal of the panel was to help eliminate frivolous lawsuits against the long-term care industry.

The Pembroke facility has been sued 20 times in Christian Circuit Court since 2002, and seven of the suits are still pending, Tabor reports. The others were dismissed, most with confidential settlements. (Read more)