Pharmacy benefit managers' group ranked No. 7 in spending for lobbying the General Assembly, after laying out $53,634 for ads

Commonwealth Fund flow chart, amended by Kentucky Health News to include patients and employers

By Al Cross
Kentucky Health News

The lobbying organization for pharmacy benefit managers, the middlemen between insurance companies and drug manufacturers, spent $86,168 in its successful effort to defeat a bill in the recent legislative session that would have reined them in. They prevailed over pharmacists with the help of insurers, who argued that the bill would raise costs.

The Pharmaceutical Care Management Association ranked seventh in spending by lobbying interests in the session that ended in mid-April, mainly because it spent tens of thousands of dollars in television commercials attacking the bill. The ads started the day the bill overwhelmingly passed the House, where a pharmacist-legislator was the sponsor. PCMA said it spent a total of $53,634 on TV, internet and newspaper ads.

The bill got nowhere in the Senate, where President Robert Stivers said "When it got here, we started getting, from business sector and provider sector, various questions and comments about what the overall cost would be to various plans."

Tom Stephens, executive director of the Kentucky Association of Health Plans, cited a state Department of Insurance statement that a family of four would have paid up to $167 more a year for coverage if the bill had passed.

House Bill 457 would have ensured that patients could pick their pharmacy, instead of being required to use one affiliated with a pharmacy benefit manager; increase transparency between insurers and PBMs; and ban PBMs from retroactively denying a pharmacy claim after adjudication, commonly referred to as "clawing back." It passed the House 88-3.

The Federal Trade Commission voted Tuesday to investigate how pharmacy benefit managers affect the cost of prescription drugs and consumers' access to the drugs.

Several other health-care interests, or lobbying groups with interests in health care, were big spenders on lobbying the session, according to their post-session reports. The Kentucky Chamber of Commerce was again No. 1, spending $183,949; the Kentucky Hospital Association was second with $149,046. Third and fourth were the American Civil Liberties Union of Kentucky, whose issues include abortion rights, $128,258, and Altria Client Services (Philip Morris Cos.), $126,793. Insurer Anthem Inc. ranked 10th by spending $70,597.

Other big health spenders were the Kentucky Medical Association, 16th, at $54,044, and HCA Healthcare, 22nd at $48,832. The state Legislative Ethics Commission’s searchable register of lobbyists, employers and lobbying expenses is online at http://apps.klec.ky.gov/searchregister.asp.

Nursing homes say they need more help from the state; their residents have accounted for 58.6% of covid-19 deaths in Ky.

By Melissa Patrick
Kentucky Health News

As they remain the main sites for deadly infections of the novel coronavirus, Kentucky's nursing homes are asking for more help from the state, which says much of the help they seek has already been provided or can't be rendered.

At a legislative committee meeting Aug. 26, the head of Kentucky's main nursing-home association said nursing homes are grateful for the federal dollars and testing programs the state has funneled to them during the pandemic, but it's not enough.

Betsy Johnson told legislators, "I believe
the toughest days are actually ahead of us."

"We still need help," Betsy Johnson, president of the Kentucky Association of Health Care Facilities, told the Interim Joint Committee on Health, Welfare and Family Services.

"We need a lot of help, mainly funding to retain our workforce, which has been decimated, funding to require additional PPE and to support ongoing covid testing," she said. PPE, personal protective equipment, includes masks, gloves and gowns.

Johnson also pointed to research that found quality ratings of facilities was not a factor in coronavirus outbreaks. The Centers for Medicare and Medicaid Services five-star quality rating system gives 69 of the state's nursing homes a two-star or below average rating and 61 of them a one-star or much below average rating. 

"The experts agree covid-19 cases in the community are top factors in whether there is a covid outbreak in a facility," she said. "Covid deaths in a long-term-care settings have nothing to do with the quality of that facility."

WKYT-TV image

The day before the hearing, the Georgetown News-Graphic reported that the death toll at Dover Manor, a long-term care facility in Georgetown, had reached four, and all the deaths had occurred within four days of each other. On Aug. 26, WKYT-TV reported the long-term care facility's fifth death. 

On Aug. 29, the state's daily long-term care report showed 26 residents and 12 employees at Dover Manor had active cases of the virus. Since March, 59 residents and 26 staff have tested positive.

“You don’t have this many positive cases in a facility without a breach in your infectious-disease protocols, so we're very concerned," Crystal Miller, public health director at the WEDCO District Health Department, told WKYT. She said some employees have quit and the department is educating the remaining employees about PPE and how to isolate residents who test positive.

Scott County's coronavirus case numbers started rising in late June and didn't come back down till mid-August, according to the WEDCO covid-19 report. The CMS five-star rating system gives Dover Manor one star. 

At the committee meeting, Johnson said a July survey of nursing homes showed that their labor and benefit costs had risen 8 percent since the pandemic hit in March; nearly 51% of homes had less staff; nearly 21% saw an increase in use of employment agencies; and such agencies had increased their costs between 10% and 75%.

Johnson reminded the lawmakers that her association has warned them for some time that there is a "workforce crisis" in long-term care, and "Covid-19 has only made this worse." 

She also pointed to the state's use of federal relief money to pay for its "strike teams," which help with staffing issues in nursing homes hit hard by the virus but put them in direct competition with the state for much-needed employees.

An advertisement in Madisonville showed the state is paying registered nurses $65 an hour, licensed practical nurses $50 an hour and nursing assistants $32.50 an hour, "significantly higher than the average nursing facility can pay," Johnson said, while still expressing thanks for the help the teams give.

Asked about the strike teams at the governor's daily press conference later that day, Cabinet for Health and Family Services Secretary Eric Friedlander said they have been used, but not recently. "That has obviously been a very controversial piece, " he said.

Johnson said an April survey of her association's members found 87% were in need of some form of personal protective equipment; 9% said they didn't have a week's supply of surgical masks; 10% didn't have a week's supply of N95 respirator masks; and 10% didn't have a week's supply of gowns.

The survey also found PPE costs had increased by 10% or more. Sen. Danny Carroll, a Paducah Republican who owns a non-profit agency that provides therapy and medical-based child care, said he had been told the cost of a case of gloves had increased from $49.70 to $108. 

Johnson added that nursing home are also squeezed financially by an 8% drop in their patient numbers, caused not only by deaths, but by a decrease in elective surgeries because these patients often rehabilitate in nursing homes. 

Association offers ideas, state explains why they won't work

Johnson said the best way to help nursing homes would be increasing the amount the state pays for residents covered by Medicaid by $12.55 per resident per day, instead of the additional $270 per day it is paying for positive covid-19 residents only.

“We were grateful for this funding, but we found it a little problematic,” Johnson said. “Not everybody in a facility is Medicaid eligible; a lot of them are Medicare or private pay. A lot of people went immediately out to the hospital, so it really wasn’t providing the necessary funding to arm ourselves in fighting off covid-19.”

She said the association has asked twice for the change, has been denied once and expects that the second request will also be denied, based on an Aug. 13 letter from Friedlander. 

She suggested that the payment boost could come from the 6.2% increase in Medicaid contribution that the federal government is paying states during the pandemic, since it "was intended to assist providers in fighting covid-19."

Secretary Eric Friedlander

However, Friedlander told Kentucky Health News in an interview that states got the increase to cover the cost of expanding their Medicaid populations during covid-19, not to pay providers.

Many people who have lost their jobs have become Medicaid beneficiaries, and Kentucky has led the nation in the percentage of people gaining Medicaid coverage during the pandemic, according to a July 24 report by the Kaiser Family Foundation. It found that Kentucky Medicaid, which now covers more than 1.5 million people, grew 7% from March to April.

Friedlander had another reason to oppose Johnson's request: "When you give a provider group a raise, you can't ever take it back. And then it becomes a matter of, 'Do you have the budget to support that, ongoing?' And I think we know, Kentucky's got a lot of budget challenges and so it's pretty clear that we wouldn't have that ongoing." 

In an email, Johnson offered an alternative, that the state use federal relief money to help nursing homes "acquire (and/or maintain) these important things to continue to fight covid-19," including "needed PPE, testing beyond what the state or the federal governments are willing to pay for, and to continue to pay 'heroes pay' to staff." 

That doesn't seem to be an immediate option. Some have criticized Gov. Andy Beshear for spending only about 6% of the state's relief money, but he has held firm that Kentucky and other states are stuck between "a rock and a hard place" not knowing whether Congress will provide more money to stabilize state budgets, or allow states to do that with money they already have. The way it is now, "it doesn't allow for an informed decision," Beshear said Aug. 19. 

Money from the Coronavirus Aid, Relief and Economic Security Act can be spent only on programs that directly respond to effects of the virus. In addition to the strike teams, the state has used it to finance testing and surveillance at long-term-care facilities. States are also waiting on the details around another $5 billion in federal funding that has been promised to skilled nursing facilities.

Friedlander said the state has also done other things to help nursing homes, like allowing them to hold beds longer for patients who leave temporarily, making Medicaid enrollment easier, and increasing their Medicaid payments. The inspector general's written presentation to the committee, which wasn't presented for lack of time, says this increase was 8.5%. 

Impasse in committee

Greensburg Republican David Givens, president pro tem of the Senate, said Johnson's request for state funding of PPE, testing and personnel "sounds like it is a very critical ask for them, and a very appropriate ask in use of CARES money," and asked Adam Mather, the cabinet's inspector general, to respond. 

Insp. Gen. Adam Mather

Mather said he could not speak about Medicaid, but said "large swaths" of federal money have been provided to nursing homes and that a "significant amount" of PPE has been distributed. Johnson's slides showed the federal government has provided $33.6 million to skilled nursing facilities in Kentucky, an average of $169,000 each.

Mather said the state used CARES Act money to test every long-term care facility resident and employee and is using it for testing through the end of the year. 

He said the state's universal testing was "one of the more robust programs in the country" and that its current testing is happening "at a much quicker swath and more appropriate swath than many other states." 

Givens asked, "So then why would she make the ask if the need has already been met?"

Mather said he didn't know, adding that he recognized that while there is always a need for more PPE, "I don't know what to say about the ongoing testing; it is there, and available." 

"We seem to be at an impasse," Givens said.

Sen. Ralph Alvarado

Sen. Ralph Alvarado, R-Winchester, said an unnamed Lexington nursing home didn't follow the local health department's covid-19 guidelines, but did what it had found to be successful in the past to control infectious diseases, and got a much better outcome than another Lexington facility that followed the health department's guidelines.

Alvarado would not share the names of the two nursing homes with Kentucky Health News, but said he was the medical director of one and had patients in the other.

Friedlander said in the interview that many factors influence covid-19 outcomes in a facility, such as employees carpooling or socializing in the break room without PPE. "Sometimes even the best intentions, if they're not implemented fully, don't always yield the perfect results or the optimal results," he said, adding later, "We know . . . we're making sub-optimal decisions sometimes, but it's the best decision we can make." 

Alvarado asked Johnson and Mather if the state requires a "one size fits all approach" for every facility. 

Johnson said, "It's not a one-size-fits-all kind of solution. So it would be nice to have more of a listen to what we need and you all provide support rather than dictating what should happen inside that building." 

Mather, a former nursing-home executive, told a different story. He said long-term-care facilities work with state and local health departments to make an action plan to address a case of covid-19, and with a team that fights infections associated with health care and includes Dr. Kevin Spicer of the federal Centers for Disease Control and Prevention. Mather noted his experience in the industry and that of Keith Knapp, coordinator of the state's nursing-home task force.

He said the Centers for Medicare and Medicaid Services recently commended Kentucky on what a good job it's done with long-term care facilities. "It's a very robust program," he said. "It's a best-in-class, through-all-the-states program," he said.

Most covid-19 deaths are in long-term care

During her presentation, Johnson displayed a map that showed Kentucky has one of the highest covid-19 death rates in long-term care. She was using mid-July data that showed such facilities accounted for 63% of the state's covid-19 deaths. By Aug. 29, that had declined to 58.6%.

Mather said Johnson's data was outdated, and now "We're doing much better than many states around us." The most recent CMS covid-19 nursing home data webpage, using data from the week ending Aug. 16, shows Kentucky with 107.3 cases per 1,000 residents and 23.8 deaths per 1,000 residents, ranking 21st for both measures. Friedlander said the state has been ranked about 20th for several weeks.

Beshear, asked about the topic on the day of the meeting, said "I believe the amount of assistance, the amount of expertise, the amount of resources we provided to our long-term care facilities here in Kentucky battling covid rivals if not exceeds what any other state has done, and they continue to work on that."

At least 3,415 residents and 2,029 employees at 303 nursing homes have tested positive for the coronavirus, and 535 residents and five employees have died from it.

A seat at the table

Johnson said several times that the association should have been included in state decision-making about long-term care in the early days of the coronavirus, adding that she would like a dementia expert and a long-term-care expert on staff at the state health department. "There's been a serious lack of understanding of how skilled nursing facilities operate during the covid-19 pandemic," she said. 

Friedlander said in the interview that he intentionally did not include a lobbyist on the long-term-care task force, but his cabinet has been in regular communication with Johnson's association and Leadingage Kentucky, a lobby for nursing homes and assisted-living centers. 

Friedlander said the task force includes medical personnel, a member from the association that includes medical directors for long-term care, a provider, an owner, an operator, a person from the University of Kentucky and cabinet personnel.

"We think we have a really strong representations of folks who know, one, how to operate; and then, two, on the medical side," he said. "This is a medical group, it isn't a political group. So those are the representatives that we have. So we don't have any associations on there." 

Johnson replied in an e-mail, "We want to have a true collaboration – where they ask what we need, and work with us to achieve a compromise on the “asks.”

She concluded her at times emotional presentation at the meeting by saying, "I believe the toughest days are actually ahead of us."

Michael Rust retires as head of Kentucky Hospital Association; Nancy Galvagni was appointed new president and CEO in May

By Melissa Patrick
Kentucky Health News

Michael T. Rust, who led the Kentucky Hospital Association for 24 years, has retired.

Rust said it was a privilege to have worked for the KHA for 24 years, and attributed the bulk of his success to his communication and listening skills.

Michael T. Rust

"You can be the smartest person in the world, but you've got to stay in touch with these guys, the administrators and the hospitals, and you've got to listen to them," he said. "And that I think was the biggest part of my career, that I really listened to these guys. I may not have had the answer all of the time, but at least I listened and got back to them and communicated with them pretty well."

Rust added that one of his greatest accomplishments was that he was able to recruit and maintain 100 percent of the state's 127 hospitals as members of the association, which he said is quite rare among hospital associations.

Rust said he came to Kentucky by way of Florida, where he had been the senior vice president of the Florida Hospital Association. He worked there for 13 years. Prior to that he served as an administrator of a small rural hospital and the vice-president of operations for a 300-bed hospital, both in West Virginia.

He was also a member of the American College of Health Care Executives and became a fellow of that organization in 1998. In 2001, he was elected to the Council of Regents, the legislative body of the American College of Health Executives.

Asked about challenges facing Kentucky hospitals, Rust said the state's shift from a fee-for-service payment system to a "value-based" system in Medicaid remains a big challenge, largely because 70 percent of Kentucky's patients are covered by a government payor whose payments to hospitals don't cover the full cost to treat patients.

He said the state also struggles with healthcare workforce shortages, but “The hospitals of Kentucky are resilient and staffed with outstanding leadership and the highest quality providers. I have the utmost faith that they will face all these challenges head on and continue to succeed at providing outstanding health care for every citizen of the commonwealth.”

Nancy Galvagni

Nancy Galvagni was appointed KHA's new president and chief executive officer in May. “I am pleased to pass the baton to Nancy Galvagni as I know she will serve the association and its members with distinction," Rust said.

Galvagni joined KHA since 1979 and was senior vice president for the past 20 years, She has served as the executive director of the Kentucky Institute for Patient Safety and Quality, a federally certified patient safety organization and a subsidiary of KHA.

Galvagni is a graduate of Pennsylvania State University, is a past president of the Kentucky Society for Health Care Planning and Marketing and is a member of the American Association of Hospital Accounts. Prior to joining KHA, she worked at the New York Hospital Association.

KHA represents hospitals, related health-care organizations and integrated health-care systems. It is celebrating its 90th year. Galvagni is only the fourth chief executive officer in its history.

Lobbyists and others create tracking tables that make it easier to keep up with bills; legislature also offers free 'Bill Watch' service

As the 2019 General Assembly moves into the second half of its session, it can be easy to lose track of the many health-related bills, but a contract lobbying group and a progressive media organization have bill trackers to make that easier.

A small part of the tracking table for health-care bills
(For a larger version of the image, click on it)

The Government Strategies tracking tables are broken down into several categories: education, energy/environment, general business, health care, health insurance, insurance and transportation. The bills are chosen by the lobbyists, so it's worth taking a look in every category.

For example, House Bill 11 and Senate Bill 27, the measures to make all schools tobacco-free, are in the "general business" category instead of health care or education.

Each list links to the bill number, names the sponsor, offers a short summary of the bill, and records the last action, which is updated nightly. Click here to see.

Forward Kentucky, which describes itself as a progressive "media operation," also offers a bill tracker on its website. In addition to a list of all bills, bills in committee and bills that have crossed over, this tracker offers a list of what Forward Kentucky considers key legislation. Click here to see.

Another way to track bills is to go to the Kentucky General Assembly website and click on "Bills." This will take you to a page where you can click on "Bill Watch," which will then require you to register in order to track the specific bills that interest you.

Ky. legislators mull cigarette tax hike of 40 cents or more as way to close deal on budget, pensions; top Philip Morris lobbyist visits

Kentucky Health News

FRANKFORT, Ky. – As legislators scrambled to meet a deadline to pass a budget they can protect from the governor's line-item vetoes, they revived the idea of a higher cigarette tax -- but perhaps less than the 50 cents-a-pack increase passed by the House with its version of the budget.

That brought the top state-government lobbyist for the nation's largest tobacco company to Frankfort, and renewed pleas by advocates of a $1 increase that only such a large hike would make a real difference in Kentucky's smoking rate, second in the nation. They did that in response to talk of a 40-cent boost, which would make the tax $1 a pack, still well below the national average of $1.72.

The Coalition for a Smoke-Free Tomorrow argued afresh that unless the price goes up by at least $1, tobacco companies can keep smokers hooked by giving discounts to retailers and coupons to consumers, then gradually raising prices. The coalition said a $1 boost could be "the most significant and proven health-improvement measure the General Assembly could enact in their lifetimes."

Altria VP John Rainey
(Va. Public Access Project photo)

Top legislative leaders met separately Wednesday with John Rainey, director of state-government relations for Altria Group, the parent company of Philip Morris USA, U.S. Smokeless Tobacco Co. and other tobacco firms, Tom Loftus of the Louisville Courier Journal revealed.

The accounts by Senate President Robert Stivers and acting House Speaker David Osborne indicated that Altria can live with a 40- or 50-cent increase, but wants to make sure that it is limited to cigarettes, as the House bill did. The last hike, in 2009, applied to all tobacco products.

"They're interested in different components of the tax code, including what might happen with the cigarette tax, e-cigarettes, smokeless [and] products that haven't even been marketed," Stivers told Loftus. Altria has invested heavily in electronic cigarettes and is planning to introduce a "heat not burn" nicotine-delivery device.

House Majority Leader Jonathan Shell, who also met with Rainey, said "Tobacco taxes are just part of the conversation we're having."

Osborne told Loftus that an Altria lobbyist "was here to talk about a facility they own in Western Kentucky and just wanted to give his opinions on things and a perspective on how that impacts them," Osborne said. Altria's U.S. Smokeless plant in Hopkinsville uses the area's dark-fired tobacco.

Loftus noted that Altria spent $156,650 lobbying the legislature in the first two months of the session, "far more" than any other lobby, "but the second-largest spender on lobbying for the first two months of the session was a group on the other side of the tobacco-tax debate – the Foundation for a Healthy Kentucky, which reported spending $107,336 during the two months." The foundation staffs the smoke-free coalition.

The Senate initially rejected the House's tax plan, but now it and the budget appear to be the secodn step of "a grand bargain" that helped pass a surprise pension-reform bill Friday, Loftus reports: "The House accepts a pension bill, the Senate accepts some kind of tax increase — which would be styled as 'tax reform' by all who vote for it. Bottom line: The 2018-20 state budget would have enough revenue to fund education along the lines of the House plan while also addressing the needs of the state's beleaguered pension plans."

The House and Senate did not meet Friday. They are set to meet Monday, the last day they can pass a budget and still have time to override any line-item vetoes issued by Gov. Matt Bevin, who has 10 says (not counting Sundays) to act on bills once he gets them. The last day the General Assembly can meet this year is Saturday, April 14.

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

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.

McConnell helped Amgen delay price limits on dialysis drug

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.

'Meds for meth' bill is about to become law despite heavy lobbying campaign by pharmaceutical companies

The bill to limit purchases of a popular cold medicine used to make methamphetamine passed the General Assembly today and Gov. Steve Beshear said he would sign it.

The Senate voted 29-8 to approve changes the House made in Senate Bill 3, sponsored by Senate Majority Floor Leader Robert Stivers, R-Manchester, left. The bill would require a prescription to buy more than 7.2 grams of pseudoephedrine in a month and 24 grams in a year. "A generic box of pseudoephedrine with 48 pills, each with a 30-milligram dosage, contains 1.44 grams of the medicine," Jack Brammer of the Lexington Herald-Leader reports. ""Gel caps and liquid pseudoephedrine would be excluded from the limits in SB 3 because making meth from those forms is considered more difficult."

The bill’s sponsors had wanted lower limits, and initially a prescription for any amount, "but they compromised with opponents who worried about inconveniencing cold and allergy sufferers," Brammer notes. "The pharmaceutical industry has lobbied aggressively against the state requiring prescriptions for pseudoephedrine at any level," ranking first in reported lobbying expenses without even counting its extensive advertising campaign. The industry apparently viewed Kentucky as a sort of firewall, the absence of which could make passage of similar "meds for meth" bills in other states. Only Oregon and Mississippi now have such legislation.

Health care is top-spending legislative lobby in Kentucky

Kentucky's health-care industry spent about $1.5 million, more than any other industry, to lobby state legislators in  in the first four months of the year.

"Health care spending was led by hospital operators, who spent about $300,000, including Kentucky Hospital Association ($56,000), Norton Healthcare ($44,631), Baptist Healthcare System ($42,800) and St. Elizabeth Healthcare ($28,182)," the Lexington Herald-Leader's Jack Brammer writes, from a report by the Kentucky Legislative Ethics Commission.

Pharmaceutical companies and pharmacies spent the second highest amount, about $281,000. That includes contributions from the Consumer Healthcare Products Association ($67,333), Pharmaceutical Research & Manufacturers of America/PhRMA ($23,362), Amgen ($19,389), Glaxo SmithKline ($18,500), American Pharmacy Cooperative ($18,000) and Pfizer ($15,000).

Other big spenders include the Kentucky Medical Association ($71,415); All Things Good, a Louisville-based chiropractic business ($65,000); Kentucky Optometric Association ($61,604); and Kentucky Academy of Eye Physicians & Surgeons ($26,000).

A total of about $7 million was spent on legislative lobbying in Kentucky in the first four months of 2011. About $6.5 million of that was spent by 660 employers of lobbyists and about $445,000 was spent by lobbyists themselves. The insurance industry, which is often related to the health industry, spent about $354,000. Energy and utility interests like coal and natural gas spent $516,000. Reports filed by employers and legislative agents are compiled on the Legislative Ethics Commission's website. For the Herald-Leader story, go here.

Philip Morris's parent company and drug makers spent the most on lobbying the state legislature last year

The two biggest-spending lobbies of the state legislature last year were a tobacco company that opposes a statewide smoking ban and a group of drug makers who oppose a bill to require prescriptions for decongestants used to make methamphetamine.

The biggest spender, dropping $357,433 to lobby the General Assembly, was Altria Group, the parent company of Philip Morris USA. Altria is also a significant owner of SABMiller, and alcohol lobbies always have interests in play. The Consumer Healthcare Products Association was the second-biggest spender of 2010, paying $343,377. CHPA represents manufacturers and distributors of non-prescription, over-the-counter medication, who fear a loss of decongestant sales if the anti-meth bill becomes law.

All told, companies and advocacy groups spent $16.65 million lobbying the General Assembly last year, down about 3 percent from the last long session, in 2008. That session occurred before the economic recession, and the amount spent in 2010 on receptions, meals and events dropped significantly — by 24 percent — from 2008. In 2009, when a short session was held, about $15.3 million was spent on lobbying.

The Kentucky Chamber of Commerce, which spent the most on lobbying in 2010, ranked third with spending of $211,935. University Health Care, which operates the Passport Health Plan, was fourth with $190,840. Passport came under fire last year after state Auditor Crit Luallen uncovered unnecessary spending on travel and entertainment, inflated salaries and a lack of oversight. After that review "and a change in management, UHC reduced its lobbying presence in the State Capitol from 13 lobbyists in 2010 to two lobbyists in 2011," says the January edition of Ethics Reporter, the monthly publication of the Kentucky Legislative Ethics Commission. (Read more)

The other organizations and businesses that spent more than $100,000 on lobbying last year are: Kentucky Medical Association ($133,274); Houchens Industries, a Bowling Green conglomerate ($132,000); the Kentucky Retail Federation ($127,803); the Keeneland Association ($121,661); the Kentucky Hospital Association ($120,113); CSX Corp. ($116,405); Kentucky Farm Bureau ($109,373); the Kentucky Justice Association, plaintiffs' lawyers ($105,543); Kentucky Education Association, teachers ($105,353); the Home Builders Association of Kentucky ($103,437); and Res-Care Inc., which operates residential programs for the disabled ($100,289).

To read a report from the Lexington Herald-Leader on the lobby spending, click here.