Wednesday, December 5, 2018
Bausch Health reports FDA clearance for ULTRA Multifocal for Astigmatism lenses
Bausch + Lomb, a wholly owned subsidiary of Bausch Health Companies, announced that it has received 510(k) clearance from the U.S. Food and Drug Administration for Bausch + Lomb ULTRA Multifocal for Astigmatism contact lenses, which it said is the first multifocal toric lens to be available as a standard offering in the eye care professional’s fit set. “The most advanced soft contact lens design in the history of Bausch + Lomb, this monthly silicone hydrogel lens builds upon the success of Bausch + Lomb ULTRA for Presbyopia and Bausch + Lomb ULTRA for Astigmatism lenses,” the company stated. Bausch Health anticipates Bausch + Lomb ULTRA Multifocal for Astigmatism will be available to eye care professionals and their patients by mid-2019.
https://thefly.com/landingPageNews.php?id=2832443
Tuesday, December 4, 2018
CityMD may soon be out-of-network for UnitedHealthcare members
“We are working diligently to continue our contractual relationship with CityMD, a physician group with whom you or a dependent has a relationship,” United wrote in a letter obtained by Crain’s. “Unfortunately, we have not yet reached an agreement with them, and the deadline for the contract is rapidly approaching. We assure you we are making every effort to reach a successful resolution.”
The letter, dated Nov. 26, warns members that they might need to seek out other providers. “Utilizing an out-of-network provider may result in higher costs for you,” United wrote.
CityMD has more than 100 locations in New York, New Jersey and Washington. In Manhattan, the urgent-care chain dots the map like subway stops, with 22 clinics. Private-equity firm Warburg Pincus acquired a majority stake in CityMD for an undisclosed price in 2017.
“We are making every effort to reach a successful resolution with UnitedHealthcare so that its members, our patients, continue to have access to CityMD,” Angela Profeta, senior vice president of strategy at CityMD, said in a statement.
Hospitals sue feds over site-neutral payment policy
The American Hospital Association on Tuesday led a lawsuit against the Trump administration over the CMS’ final rule imposing a site-neutral payment policy, which cuts some Medicare rates for outpatient hospital sites to match the rates for physicians’ offices.
The lawsuit, filed in the U.S. District Court for the District of Columbia, challenges the “serious reductions to Medicare payment rates” as executive overreach. The rate reduction is scheduled to start Jan. 1. In 2019, hospitals’ reimbursements will drop approximately $380 million in 2018, according to the CMS.
“This court should reject CMS’ attempts to replace Congress’s unequivocal directives with the agency’s own policy preferences,” the hospitals wrote in their complaint. “CMS may not contravene clear congressional mandates merely because the agency wishes to make cuts to Medicare spending.”
The outpatient pay rule was finalized in November. The timing and strategy of this lawsuit resembles the hospitals’ effort in late 2017 to block roughly $1.6 billion in Medicare Part B drug reimbursement cuts for 340B providers before they went into effect in early 2018. At the last minute, the presiding federal judge tossed that suit as premature because the cuts had not yet gone into effect. Hospitals lost their appeal over the summer and in September lodged their complaint again.
The Association of American Medical Colleges, the trade group of academic centers that will see a big hit from the site-neutral policy, joined AHA, along with three independent health systems: Michigan’s Mercy Health Muskegon, Washington State’s Clallam County Public Hospital and Maine’s York Hospital.
The policy roiled the hospital industry when it was introduced in a proposed rule over the summer. Hospitals have been lobbying Congress to intervene with the administration and reverse the policy.
“These cuts directly undercut the clear intent of Congress to protect hospital outpatient departments because of the real and crucial differences between them and other sites of care,” Rick Pollack, AHA president and CEO, said.
The same day hospitals filed their lawsuit, HHS Secretary Alex Azar promised that the administration would continue its work on site-neutral payment policies despite intense industry opposition.
“Fixing this perverse situation has been talked about for years, by administrations of both parties—and yet this administration is the one finally bold enough to do it,” he said Tuesday in a speech at the right-leaning American Enterprise Institute.
This week the White House released its sweeping policy wish list, which included a push for site-neutral payment policies at the federal level and on the state level through Medicaid.
The most common provider services governed by the outpatient pay rule are clinic visits, or checkups. Under the finalized regulation the CMS will cut reimbursements for hospital outpatient facilities by 60% over a two-year period. This translates to about 70% of the current outpatient rate.
The final rule also extended 340B providers’ Part B cuts to their off-campus facilities, in order to block the hospitals from moving their pharmacy dispensing elsewhere as a pre-emption.
Takeda shareholders give nod for $59 billion Shire acquisition
Takeda Pharmaceutical <4502.T> shareholders approved on Wednesday its $59 billion takeover of London-listed Shire (NYSE: SHP), creating a global powerhouse with a stronger drugs pipeline but one that is saddled with massive debt.
Almost 90 percent of Takeda shareholders voted to approve the deal at an extraordinary general meeting held in Osaka, western Japan, the company said.
Takeda will be joining the ranks of the world’s top 10 drugmakers and gaining expertise in rare diseases through the deal, the biggest overseas acquisition by a Japanese company.
It will also become one of the most indebted. In addition to issuing new shares, the company has secured $30.9 billion in bank loans.
Takeda shares have fallen around 25 percent since the drugmaker revealed its interest in the acquisition in March, with investors worried about whether the company can cope with high financing costs and challenges of integration.
While Wednesday’s approval was expected, a small group of investors had actively voiced opposition.
“We are definitely against this because the financial risks are too great and the expected benefits are quite limited,” said Kazuhisa Takeda, a former director of the drugmaker and a member of the founding family, ahead of the meeting.
“I think M&A is quite necessary for Takeda’s future but Shire is not the answer.”
Chief Executive Christophe Weber has promised to turn the deal profitable by slashing costs. It predicts annual savings of at least $1.4 billion three years after completion, and expects to boost underlying earnings significantly from the first full year after closing.
Takeda also has a plan to sell up to $10 billion worth of non-core assets to pay back debt. Andy Plump, Takeda’s global head of R&D, told Reuters that it’s necessary to accelerate deleveraging for keeping its credit rating at safe level.
“We have a plan for divestiture that gets us to a place in three to five years… that our credit agencies are OK with. Our credit rating is likely to tick down a notch, but still above junk bond status, which is critical for us,” he said in an interview.
Analysts have said it may be difficult to integrate the two companies. Toshiba Corp’s <6502.T> acquisition of Westinghouse over a decade ago and Japan Post Holdings Co’s <6178.T> $4.9 billion bet on Toll Holdings are widely seen as examples of many Japanese companies having paid high valuations in cross-border deals only to face massive write-downs later.
But they also said Takeda has little choice but to seek growth abroad, with industry pressure to gain access to cutting-edge treatments amid declining revenue from older drugs that must compete with cheaper generics.
Even with the acquisition of Shire, some said Takeda will need to bolster its lineup of experimental therapies to compete in the longer term.
Shire’s hemophilia business, for example, is already starting to face strong pressure from a competing drug being marketed by Roche (NYSE: ROG) as well as new gene therapies now in development.
“It’s crucial whether the drugmaker can reinvest profits from the deal into seeds for developing future drugs,” said Kazuaki Hashiguchi, a senior drugs analyst at Daiwa Securities.
“The benefits of the deal will last for a limited time, as no treatments can avoid patent expiration.”
Kroger (KR), Walgreens (WBA) Expand Exploratory Pilot
The Kroger Co. (NYSE: KR) and Walgreens (Nasdaq: WBA) today announced two initiatives, building on the exploratory pilotthe companies announced in October, combining America’s food and grocery authority with Walgreens global expertise in pharmacy, health and beauty.
“We are redefining the customer experience in a variety of ways through Restock Kroger, including innovative partnerships like our test-and-learn pilot with Walgreens. We are excited to enter the next phase of the pilot,” said Robert Clark, Kroger’s senior vice president of merchandising. “The Kroger Express concept creates easy access to our most popular Our Brands products through a fill-in grocery shopping experience for Walgreens customers, and our Home Chef Express meal kits provide customers with an on-demand solution for tonight’s dinner.”
“We’re pleased to continue working together to explore new concepts that expand product selection to provide a better shopping experience and greater value for our customers,” said Richard Ashworth, Walgreens president of operations.
Kroger Express Coming to Walgreens
Kroger Express—a curated assortment of 2,300 products, selected using customer data and insights provided by Kroger subsidiary 84.51°—will soon be offered at the 13 Walgreens test stores in Northern Kentucky, near Kroger’s Cincinnati headquarters. The Kroger Express selection will include Home Chef meal kits, national products and Kroger’s popular Our Brands products, highlighting America’s largest natural and organic brand Simple Truth, along with dairy, meat, produce, frozen and meal solutions.
The first concept is operational in Florence, Kentucky. The remaining 12 pilot stores will be operational early next year.
As announced in October, the participating pilot stores are offering a one-stop shopping experience where customers can access products from both brands and order groceries
on kroger.com for pickup at Walgreens. Kroger Express marks an expansion of the original offering.
Home Chef Express Meal Kits Now Available at 65 Chicago Walgreens Stores
Today also marks the launch of Home Chef Express meal kits in 65 Walgreens locations in the Chicago area.
The new offering enhances the reach of Home Chef’s Express products, already available at certain Kroger Family of Stores, including select Mariano’s stores in the Chicago area. During the pilot, Walgreens will offer three unique Home Chef Express meal kit options, with recipes rotating bi-weekly. Other recipes are available for delivery through homechef.com, where shoppers can find additional weekly variety.
Each meal serves two and starts at $8.50 per serving. Information about participating locations is available at homechef.com/grocery.
“Customers have responded favorably to the retail meal kits at our Mariano’s stores in the market and other Kroger Family of Stores located in different cities. The Walgreens expansion provides more Chicagoans convenient access to a quick, simple meal,” added Clark.
“Making Home Chef Express meals available at Walgreens is another way Home Chef is making meal time easy,” said Pat Vihtelic, Home Chef CEO and founder. “The Express recipes, which cook in 15 minutes, are meals anyone can cook and everyone will love.”
Planet Fitness (PLNT) PT Raised to $65 at Cowe
Best Idea for 2019: Cowen analyst Oliver Chen raised the price target on Planet Fitness (NYSE: PLNT) to $65.00
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