13 June 2014


Original Story:  WSJ.com

Shortly after Valeant Pharmaceuticals International Inc.  bought Medicis Pharmaceutical Corp. two years ago, the new owner gathered staffers of the skin-products maker and started handing out envelopes. If you got a black envelope, it meant you were fired.

Most of the research-and-development staff at Medicis headquarters in Scottsdale, Ariz., got the black envelopes, according to people familiar with the matter. Soon, most of the roughly 30 research projects under way were also dropped, according to the people and physicians who conducted trials for Medicis.

Such cuts are a cornerstone of the hard-nosed strategy pursued by Valeant: buy up companies, shed most of their research operations and make money selling their products. It is "a business model that gets rid of the value-destroying part of pharmaceutical companies and keeps all the pieces that are value sustaining," said CEO Michael Pearson in an interview.

Mr. Pearson's method of buying products instead of investing in creating them is under examination as Valeant sets its sights on its biggest deal yet, a proposed $53 billion takeover of Botox maker Allergan Inc. with activist investor William Ackman.

Allergan's board rejected the offer Tuesday. CEO David Pyott said in an interview the bid undervalues the company and that Valeant's strategy of "financial engineering" doesn't sustain long-term growth.

Supporters say Mr. Pearson's approach should be a blueprint for the pharmaceutical industry's future: grow through serial deal-making, including tax "inversion" purchases of foreign companies to take advantage of lower tax rates. Cut costs aggressively. And, above all, stop spending so much money on risky research.

It has helped Mr. Pearson build Valeant into one of the fastest-growing pharmaceutical companies. Since the former drug-industry consultant took the company's helm in early 2008, Valeant's annual sales have risen sixfold, to $5.8 billion last year. During the span, its stock has jumped 848%.

Mr. Pearson is the "best CEO I've ever worked with," said former board member Mason Morfit, president of ValueAct Capital Management LP, which as of May held a 5.7% stake in Valeant. He praised Mr. Pearson's ability to be hands on as he "dives down into the minutiae" on deals, operations and financial decisions.

Yet last year Valeant reported a net loss of $866.1 million, which it said was due to restructuring charges from acquisitions like its purchase of Bausch & Lomb, for which it paid about $8.7 billion. Its debt, at $17.4 billion, was nearly three times annual sales

Some Wall Street analysts, credit-rating firms and industry officials question whether Valeant can sustain its heady growth without finding new products through research. Many pharmaceutical companies are making deals to acquire new medicines. But their deals usually bring along scientists, research programs and potential drugs farther out in the pipeline that, while an expensive investment, present long-term opportunities for the development of new products and markets.

Valeant, in contrast, targets cash-generating products, providing a quick boost to revenue, and cuts assets requiring more investment. Some analysts say the bigger the company gets, the harder it will be to strike deals with enough heft to fuel growth.

"It's why they want to buy something like Allergan, because after the dust settles it looks like you're growing," said David Maris, an analyst at BMO Capital Markets.

Valeant said sales of its ongoing product line are growing, and that sales and profit growth will come through acquisitions, good management of the existing portfolio and new product launches.

The debate is at the core of a larger argument that has convulsed the pharmaceutical industry for the past decade, as company labs struggle to find new drugs to replace aging blockbusters: How much spending on drug research is really worth it?

A string of costly drug discovery failures prompted some industry consultants and investors to argue against investment in R&D, especially in the earlier, riskier stages of drug research.

"You may as well just throw that money away," said Richard Evans, an analyst at Sector & Sovereign Research LLC who used to head business policy at Roche Holding AG's pharmaceuticals business. For every dollar pharmaceutical companies invest in R&D, they typically get back only 93 cents, according to Mr. Evans.

Mr. Pearson said pharmaceutical companies have been too fixated on how much they spend on R&D, rather than what they actually bring to market. He said Valeant aims to deliver 10 to 20 products each year but doesn't believe it has to discover all of them itself. Valeant spent 3% of revenue on R&D last year, compared with the industrywide median figure of 15%, according to analysts.

Other drug companies like Endo International PLC, now run by a former Pearson lieutenant, are emulating aspects of the Valeant approach by taking out costs and making deals to bulk up in areas of focus, including its own tax inversion deal that allowed it to move to Ireland.

Most big companies have refused to go so far. Although they have closed labs, big companies still spend billions of dollars on their own research, while also doing more deals to fill up their pipelines with drugs discovered at smaller companies and labs.

"Valeant will eventually run out of things to buy and once it does, it faces the problem of how does it keep on the trajectory," said Jeremy Levin, the former chief executive of Teva Pharmaceutical Industries Ltd. "A company without R&D short-term and mid-term can be viable, but long-term is not."

But Mr. Pearson said it is rival pharmaceutical companies that should worry about their viability. "The facts would suggest spending like pharmaceutical companies spend on R&D is not sustainable," Mr. Pearson said.

Valeant said its approach offers investors higher returns with a much lower level of risk than the traditional model used by pharmaceuticals.

Mr. Ackman, whose Pershing Square Capital Management LP fund is partnering with Valeant on the Allergan bid, has said he was wary of the risk of investing in companies with uncertain R&D prospects but was impressed with Valeant's ability to grow without R&D spending. He said Valeant's net loss last year was related to steep sales drop-offs tied to the expiration of several top patents, which he said masked organic growth in the majority of the company.

Valeant said it would find $2.7 billion in cost savings after combining with Allergan, which last year spent $1 billion on research and development, or about 17% of revenue. Valeant said instead it would spend more than $300 million a year focused on late-stage research programs and finding new uses for existing products.

The approach to research spending conflicts with Allergan's strategy. From the $7 billion that Allergan invested in R&D between 1992 and 2013, the company gained $50 billion in sales between 2007 and 2013, Mr. Pyott, the CEO, said. R&D turned Botox from a niche treatment for uncontrollably fluttering eyelids into a product with nine approved uses in the U.S., he said. Global sales for Botox were $2 billion last year. Allergan shares fell $1.06 Tuesday to $163.09.

When Valeant first approached Medicis about a deal in 2011, Medicis executives were concerned about Valeant's reputation for aggressive cost-cutting, people familiar with the matter said. But after an all-cash offer providing a 39% premium on Medicis shares, Valeant announced a $2.6 billion deal in September 2012.

Before the deal closed, Valeant reviewed Medicis's research pipeline, according to people familiar with the discussions. Medicis officials recommended Valeant finish about half its roughly 30 projects because they were so promising.

But Valeant officials made clear they weren't interested in anything that wasn't on the cusp of near-certain approval, the people said.

Mr. Pearson said Valeant invests in projects in the early stages of development so long as they warrant it, such as a toe nail-infection treatment approved Monday. Tage Ramakrishna, Valeant's chief medical officer, said many of Medicis's projects weren't commercially viable, and Medicis itself wasn't doing any work on 10 of its compounds. Valeant said it continued research on nine Medicis projects.

One research program Medicis argued strongly pressing forward on was a new use for its wrinkle treatment, Perlane, according to people familiar with the matter. The product was already approved to soften lines below the nose and around the mouth, and some physicians had also used Perlane to plump the cheeks. Medicis wanted to expand with official FDA approval for this use.

Speed was key, because competitor Allergan was already researching a similar product. But physicians involved in a trial of Perlane for the new use said Valeant let the study fall off the radar, failing to tell doctors of its plans, publish results or publicly pursue FDA approval—standard industry practice for laying the foundations of a new market for a product. As a result, doctors started turning to Allergan's filler, called Voluma, once it was approved last fall.

"We aren't as promotive as others in our industry," said Laurie Little, a Valeant spokeswoman. "We keep R&D pretty close to the vest."

Valeant said it finished the trial, after investing $5 million, about a year after buying Medicis, and said the results supported the new use for Perlane. On April 30, the company asked the FDA for approval, which Valeant expects will come late this year.

At the end of May, Valeant said it was selling Perlane and some other products to Nestle SA for $1.4 billion, to pave the way for the potential acquisition of Allergan and its competing products.

Valeant's share of the $490 million antiwrinkle filler market in the U.S. had fallen to 30.3% by April from 43% during the quarter the company bought Medicis, according to market research by Guidepoint Global reviewed by The Wall Street Journal. Perlane's share of the market dropped to 9%, down from 14.4%.

Meanwhile, Allergan's market share rose to 46.2% from 33.8%, according to the Guidepoint data. Voluma notched a 13.8% share in April, in just its third quarter on sale.

Mr. Pearson disputed the scope of the Guidepoint data, and said Valeant's own figures show sales of injectables including the fillers grew 20% over the prior year. Valeant doesn't break out sales for particular products.

Fredric Brandt, a cosmetic dermatologist with practices in Miami and New York City who had helped lead the Perlane testing, said he had been one of Medicis's biggest users of facial fillers before Valeant took over, but has since become a large customer of Allergan because of its product's approval for use in the cheeks.

Still, Valeant has supporters in the medical community. Joel Schlessinger, a dermatologist in Omaha, Neb., said Valeant may have trimmed in some areas, but the company has found other ways to appeal to patients and physicians, such as by rejiggering a patient loyalty program.

Mr. Pearson emphasizes cultivating relationships with customers and maximizing sales from existing products. It is part of a strategy honed while leading McKinsey & Co.'s global pharmaceutical practice before joining Valeant.

At Valeant, he sold off pieces that weren't performing well and focused on building up in fast-growing markets like eye health and skin care that it could dominate. He slashed spending on R&D from 11% of revenue the year before he came on board to last year's 3%.

Deal-making is at the heart of Mr. Pearson's strategy. Valeant said it has done more than 100 transactions including joint ventures for more than $19 billion. Successful acquisitions have expanded Valeant's products—and sales—without the company needing to wait long to see if research would yield new treatments.

In its much-copied tax-inversion strategy, Mr. Pearson used Valeant's 2010 deal with a Canadian company called Biovail Corp. to relocate from the U.S. to Quebec and lower Valeant's tax rate to less than 5%.

Valeant's growth-through-acquisition strategy has paid off for Mr. Pearson personally. This year, he is scheduled to receive a base salary of $2 million, according to the company's most recent proxy statement. At the end of March, Mr. Pearson owned 10.6 million Valeant shares and options worth more than $1.3 billion, according to Mark Reilly of human-resources consulting firm Verisight Inc.

Some Valeant takeover targets have resisted. In 2011, specialty pharmaceutical company Cephalon Inc. rejected a $5.7 billion offer from Valeant, eventually agreeing to be bought by Teva for $6.8 billion. Later that year, eye-care firm ISTA Pharmaceuticals Inc. rebuffed Valeant's hostile bid.

"There was no doubt that anything we were working on in R&D that wasn't near term would be shut down," recalled Vicente Anido, ISTA's CEO at the time.

On ISTA, "We didn't talk synergies or job cuts, we thought it would be a crown jewel for us to get our foot in the door on ophthalmology," said Valeant spokeswoman Ms. Little.

ISTA later agreed to be purchased by Bausch & Lomb—which Valeant took over last year.


Original Story: FreeP.com

The Henry Ford Health System had a $12-million operating loss last year amid the cancellation of its planned merger with Beaumont Health System, the installation of a pricey medical records system and decisions by more patients to cut back on hospital and doctor visits due to higher insurance deductibles and copays.

Total revenue for 2013 climbed $32 million to $4.52 billion. The hospital system's net income was a positive $500,000, as the sale of a dialysis unit in Toledo offset the operating loss.

Henry Ford CEO Nancy Schlichting said these latest financial results, released to the public this week, reflect challenges in the health care business that affected hospital systems across the country.

She said the Henry Ford system faced various new costs and Medicare reimbursement cuts in 2013 stemming from the Affordable Care Act, but had yet to feel the anticipated boost of having newly insured patients because coverage under the law didn't begin until this year. The Medicare cuts alone totaled $30 million.

"We're doing OK," Schlichting said. "Our balance sheet is stable. Our earnings are not what we'd like, but we anticipated them."

Bond rating agency Moody's Investors Service said last month that it had placed Henry Ford's credit rating under review for a possible downgrade because of an unexpected decline in the nonprofit health system's "already low operating cash flow."

The agency also pointed to the May 2013 cancellation of its planned merger with Beaumont as a cause for concern.

Yet in an interview this week, Schlichting recalled that Henry Ford was the one approached by Beaumont for a merger, and can easily go it alone.

"We never thought we were running to a merger to save us," she said.

Schlichting said Henry Ford is poised for a stronger 2014 because it is finally done installing the medical records system and anticipates new revenue from Michigan's recent expansion of Medicaid coverage to more low-income people.

Although Medicaid reimburses Henry Ford for only about 60% of the costs of a patient's hospital visit, that amount is better than getting nothing for a treatment that still would have been given if the patient lacked any health coverage.

The reported cost of Henry Ford's uncompensated care for underinsured and indigent people rose $18 million last year to $314 million. That figure includes charity care, bad debt and the unpaid cost of Medicaid and some Medicare procedures. Hospitals can sometimes net modest profits on Medicare procedures.

Schlichting said Henry Ford Hospital in Detroit experienced a significant decrease in patient admissions last year, and doctors throughout the system are getting fewer visits (yet more unpaid bills) from patients whose health insurance copays and deductibles have gone up.

What's more, Henry Ford surgeons are finding themselves much busier at the end of each year because by then patients are closer to fulfilling their annual deductible.

"Some people are choosing not even to go to their doctor for primary care visits because they can't afford the copays," she said.

One bright spot on Henry Ford's balance sheet was the cost of insuring its own 17,964 employees. The total cost of health care for those workers dropped 14% in the past three years, and Schlichting credits the organization's wellness initiatives, including a decision to stop hiring smokers and serve healthier food in its cafeterias.

"We got rid of the fryers," she said. "We don't have one fryer in this health system."

Henry Ford financial statistics

  • Had a $12-million operating loss last year
  • Revenue grew $32 million to $4.52 billion
  • Currently has 17,964 full time-equivalent employees
  • Spent $356 million in recent years on new electronic medical records system
  • 43% of its patients on Medicare

11 June 2014


Original Story: Chicago Tribune

Just days after Bernita Klokner's family moved her from Florida back to the Midwest last May, the 97-year-old fell and broke her hip.

After the ensuing surgery, Klokner was moved from a hospital in Milwaukee to a nearby rehabilitation center.

The ambulance company charged her $585.70 for the ride, but neither she nor her family was particularly worried. They submitted the claim to WellCare, the health insurance company administering her Medicare plan.

They had no idea there would be any trouble until they got a denial letter in July.

The letter informed Klokner that WellCare would not pay for the ride because she had not submitted proof that the ambulance company had gotten prior authorization.

Klokner's daughter, Sharon Reich, of Grayslake, was stunned. Reich, a registered nurse, said she has filled out similar forms many times for her patients.

She promptly requested, and received, the proper paperwork from her mother's doctor and, in early September, filed an appeal.

Ten days later, WellCare wrote back saying it would not consider the appeal because Reich wasn't authorized to represent her mother.

In late September, Reich sent paperwork proving she legally represents her mother. WellCare again dismissed the appeal in November, stating it had not gotten Reich's documents.

Reich said she called WellCare in December, and a representative told her she had found Reich's paperwork. The representative said the insurance company would reconsider paying the $585.70.

Months passed and Reich heard nothing. When she called, she was promised a return call within days. No one called back, Reich said.

By May, Reich still hadn't heard whether WellCare would pay the ambulance bill, and she was beginning to worry all hope was lost. She tried calling the insurance company again, but phone lines were jammed, she said.

"I can't get through on the 800 number," she said. "I call and you get these prompts. I go through the prompts. You get a recording. The phone rings 53 times, and then it hangs up."

Undaunted, Reich began calling WellCare's corporate headquarters. She had two brief conversations, then was disconnected both times, she said.

"Every time I call, there's a different reason why they're not paying it," she said. "I don't know what to do."

Tired of fighting a seemingly unwinnable battle with WellCare, Reich emailed "What's Your Problem?" in mid-May.

She said the ambulance company has been patient, but it has been more than a year.

"It's expensive," she said of the $585.70. "In short, this claim should be paid."

The Problem Solver called WellCare and explained the situation.

On Wednesday, WellCare spokeswoman Crystal Warwell Walker emailed with good news.

Walker said that although emergency health services do not require prior authorization, WellCare does require such authorization for some nonemergency services, such as ambulance transportation.

"When a pre-authorization is not obtained before a service is delivered, a claim may be denied," Walker wrote.

Members can appeal by providing proof of authorization, she said. Also, representatives wishing to address a matter on behalf of a member must provide proper paperwork, Walker said.

"Any time the processes and associated deadlines are not followed, a claim cannot be approved per the protocols," Walker said.

But after examining Klokner's case, the insurance company decided to overturn its initial decision.

"WellCare understands that there can be cases where protocols are followed, but the outcomes are not in line with a provider's intent and the member's health care needs," Walker said. "In this specific case, the matter has been reviewed and WellCare will pay the claim due to the unique circumstances."

Reich was shocked. She said her mother, now 98, could never have fought WellCare on her own.

"I don't know if an older person who qualifies for Medicare like my mother can deal with these people," Reich said. "They would just give up."

09 June 2014


Original Story: FreeP.com

CINCINNATI — A woman who was being treated for a sexually transmitted disease at the University of Cincinnati Medical Center is suing the hospital, accusing an employee of posting her medical records to Facebook.

According to the lawsuit, filed in Hamilton Common Pleas Court this week, a screen shot of the woman’s medical record showing her name and her diagnosis of syphilis was posted to the Facebook group “Team No Hoes” in September 2013.

An email that included the same screen shot was also sent to members of the closed group.

Shawntelle Turley is also suing Ryan Rawls, named as an employee of UC Medical Center, an unnamed employee at UC Medical and Raphael Bradley, her ex-boyfriend.

The lawsuit claims that Rawls, along with the unknown nurse at UC, posted records online at the request of Bradley. The lawsuit also claims the health system and UC Medical Center negligently supervised Rawls and has not done enough to identify the other unknown employee allegedly involved.

Officials at UC Health, which operates the hospital, said they could not comment on the pending litigation.

On Wednesday afternoon, UC Medical Center CEO Lee Ann Liska sent a memo to the hospital’s employees noting the lawsuit and its claims. The memo also reads:

“(W)e take the privacy and safety of our patients very seriously. While the allegations are isolated to the people named in the lawsuit and by no means reflect the conduct of UCMC associates, who are dedicated to serving thousands of patients annually and safeguarding their PHI (or personal health information), I would like to remind everyone that the unauthorized access or viewing of medical records, or the unauthorized sharing of PHI, is a serious violation of federal medical privacy laws and regulations and cause for immediate termination.”

“As this case is being handled through the legal system, we ask that you refrain from discussing it. Should any patients ask questions about the story or raise concerns about their PHI, please assure them that we strictly enforce our policies to safeguard their privacy.”

According to the suit, “as a result of the inaction (of the hospital) ... the plaintiff’s medical records are still in the possession of the other (unknown) employee and the plaintiff is receiving phone calls harassing her and her child,” according the lawsuit.

Turley, whose lawyer is former Hamilton County prosecutor Mike Allen, is suing for more than $25,000 in damages for invasion of privacy, emotional distress, malice and negligence.

Allen did not return a call seeking comment.