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Mylan has cleared another hurdle in its ongoing attempt to acquire Perrigo, announcing Tuesday that the Federal Trade Commission had given the deal its OK, as long as Mylan divests itself of some products following the acquisition’s completion. With the completion of this step — and the recent U.S. court decision not to issue an injunction on behalf of Perrigo against Mylan — all Mylan needs is word from Perrigo’s shareholders on whether or not they will accept the company’s $27 billion acquisition offer…

On Jan. 1, 2015 hospitals became eligible for reimbursement when treating patients with two or more chronic conditions…Under CPT code 99490, in fact, the Centers for Medicare and Medicaid Services will pay clinicians an average of $43.12 for spending at least 20 minutes in non-face-to-face consults…CMS could pay out as much as $17 billion a year under chronic care management…a surprisingly small number of providers have thus far taken to 99490…While there is a strong appreciation of the benefits of chronic care management, both as fee-for-service revenue...and as a foundation for population health management, providers are struggling to incorporate CCM in their current operations…What's the hold up?...three obstacles: insufficient reimbursement for the time required, lack of awareness about the opportunity, and compliance concerns…the median time spent delivering the service is 35 minutes per patient per month...although non-face-to-face services may be furnished by any qualified clinical staff member, half…are using registered nurses – a more expensive resource than other types of clinical staff – to engage patients.

U.S. Food and Drug Administration inspectors at Zhejiang Hisun Pharmaceutical Co….according to agency documents describing problems at the company...There was evidence that quality control staff deleted records of tests that might show a drug was impure. Audit trails disappeared. A paper shredder was kept close by machines that recorded quality data…U.S. and the rest of the world are more dependent than ever on China for medicine. Along with India, the country is one of the top two producers of base ingredients for drugs in the world…the FDA has made inspections there a priority to keep patients safe. It’s found plenty -- the agency has barred 38 plants in China from exporting some or all of their products to the U.S. for manufacturing violations. And 34 facilities are banned from exporting a blood thinning ingredient, after a past scandal, according to the FDA’s import alert list.

For those concerned about the rising cost of pharmaceuticals, Congress is proposing some relief. The two-year budget deal proposed by lawmakers this week unexpectedly includes a provision that would require generic drug makers to pay additional rebates to state Medicaid programs for any medicine that increases in price faster than the inflation rate…The cost of new medicines for hard-to-treat diseases, such as cancer and hepatitis C, worry public and private payers, who call them budget busters. And there is growing outrage at companies such as Valeant Pharmaceuticals and...Turing Pharmaceuticals for buying drugs and then boosting the prices to sky-high levels.

Late last week, Walgreens Boots Alliance filed an 8-K with the full text of its merger agreement with Rite Aid….The document containing the Agreement and Plan of Merger weighs in at a hefty 137 pages. Below, I highlight four fun facts about the deal’s timing, its termination fees, and what the companies will do to achieve antitrust approval.

1. The deal must be completed before Halloween 2016.
2. If Rite Aid backs out of the deal, then it owes as much as $370 million to Walgreens Boots Alliance.
3. WBA could owe Rite Aid a termination fee as large as $650 million.
4. To get the deal approved, WBA is willing to dump as many as 1,000 stores.

What’s in a name?..A contentious debate over identifying biosimilars is sparking concern from antitrust regulators. These drugs are designed to emulate expensive biologics and are forecast to save billions of dollars in US health care costs. But finding the best approach for naming biosimilars has confounded regulators and divided the pharmaceutical industry amid clashes over patient safety and the potential for big profits…At issue is whether biosimilars should be given the same name as biologics. Two months ago, the Food and Drug Administration issued draft guidelines that suggested both biologics and biosimilars can use the same name. But the agency also proposed that biosimilar names add a four-letter suffix that differs from the four-letter suffix that should follow a biologic brand name medicine…

FDA has once again delayed its enforcement of product tracing requirements for pharmacies under the Drug Supply Chain Security Act...Although these track-and-trace requirements took effect on July 1, 2015, the FDA said it would not enforce the product tracing obligations for pharmacies until November 1, 2015, which it has now extended to March (March 1,2016)…FDA granted this latest extension because “some dispensers—primarily smaller, independent pharmacies and health systems—have expressed that they need additional time,” …In the meantime, pharmacies that do not capture and maintain product tracing information, or accept prescription drugs without product tracing information prior to or during a transaction, will not be penalized…this compliance policy does not extend to other requirements for dispensers under the DSCSA, which include verification related to suspect and illegitimate product (including quarantine, investigation, notification, and record keeping) and engaging in transactions only with authorized trading partners.

Valeant Pharmaceuticals International Inc sought to reassure doctors…that the company's decision to cut ties to a controversial specialty pharmacy would not disrupt doctors' ability to prescribe the company's drugs to patients…In a letter to healthcare professionals…Valeant would pay for the cost of its products through Nov. 8 and make sure patients could fill their prescriptions with no out-of-pocket expenses, wherever possible. Patients on government-run health plans such as Medicare are not eligible…Philidor Rx Services, will file no further insurance claims.

Six Southern Nevada hospitals are among hundreds of U.S. facilities (457 hospitals in 43 states) that will pay a total of more than $250 million stemming from allegations that they implanted cardiac devices in Medicare patients in violation of coverage requirements, the U.S. Justice Department said…Medicare guidelines provide that doctors should not implant ICDs (implantable cardioverter defibrillator) in patients who have recently suffered a heart attack or had other procedures, such as heart bypass surgery. Each of the hospitals…had implanted ICDs during 40 day waiting periods that Medicaid requires for heart attack patients and 90 day waiting periods for bypass patients…Las Vegas-area hospitals involved include Centennial Hills, Desert Springs, Summerlin, Valley, Sunrise, and North Vista...

Food and Drug Administration warned Novartis AG last week after the Swiss firm was found in violation of manufacturing practices last year at two of its India drug-making plants…The warning, issued to Novartis's generic drugs unit Sandoz on Oct. 22, came after FDA officials inspected its Turbhe and Kalwa sites in western India…The FDA has banned more than 30 drug manufacturing plants in India since 2013, as it ramps up inspections of foreign facilities that supply to the United States. Several of India's largest drugmakers have faced rebukes, hurting the reputation of the industry, an important supplier of cheap generics.