Author: Peter

A federal judge...dismissed a lawsuit seeking to block CMS from implementing a $1.6 billion cut to hospital reimbursements under Medicare's 340B drug discount program—although hospital groups suggested they may take further legal action to try to reverse the cuts...The lawsuit's dismissal meant CMS could implement the cuts as scheduled on Jan. 1...hospital groups argued the cuts could jeopardize services at safety-net hospitals...HHS in a motion to dismiss the lawsuit claimed that hospitals had "reaped substantial profits" from subsidies under the 340B program's previous system...U.S. District Judge Rudolph Contreras in his ruling said the hospital groups lacked standing...hospitals filed the suit prematurely since the rule did not take effect until Jan. 1, adding that the groups will have to reference specific reimbursement claims to move forward with a lawsuit.

Laura Joszt, assistant managing editor at The American Journal of Managed Care. Welcome to This Week in Managed Care from the Managed Markets News Network

The FDA is proposing a new risk-based enforcement approach to homeopathic drug products. Among the targets: products marketed for serious diseases without showing clinical benefits, products that contain potentially harmful ingredients, and products that don’t meet current good manufacturing practices...homeopathic drug products are subject to the same requirements related to approval, adulteration, and misbranding as any other drug product. However, prescription and nonprescription drug products labeled as homeopathic have been manufactured and distributed without FDA approval under the agency’s enforcement policies since 1988...“In recent years, we’ve seen a large uptick in products labeled as homeopathic that are being marketed for a wide array of diseases and conditions, from the common cold to cancer,” said FDA Commissioner Scott Gottlieb...“In many cases, people may be placing their trust and money in therapies that may bring little to no benefit in combating serious ailments, or worse—that may cause significant and even irreparable harm because the products are poorly manufactured, or contain active ingredients that aren’t adequately tested or disclosed to patients...The FDA intends to focus its enforcement authorities on the following kinds of products:

• Products with reported safety concerns
• Products that contain or claim to contain ingredients associated with potentially significant safety concerns
• Products for routes of administration other than oral and topical
• Products intended to be used for the prevention or treatment of serious and/or life-threatening diseases and conditions
• Products for vulnerable populations
• Products that do not meet standards of quality, strength, or purity as required under the law

Kmart Corp. has agreed to pay $32.3 million to settle a whistleblower lawsuit alleging its pharmacies overcharged federal health care programs and some private insurers for generic prescription drugs..."Pharmacies that are not fully transparent about drug pricing can cause federal health programs to overpay for prescription drugs," Chad Readler, the acting assistant attorney general of the department's Civil Division, said..."This settlement should put pharmacies on notice that there will be consequences if they attempt to improperly increase payments from taxpayer-funded health programs by masking the true prices that they charge the general public for the same drugs."...The complaint was filed on behalf of former Kmart pharmacist James Garbe. According to the suit, in one case, Kmart had sold a 30-day supply of a generic version of a prescription drug for $5 to customers of its discount program, but then filed for reimbursement from the government for $152 for that same drug for its Medicare customers...Garbe will receive a whistleblower award of $9.3 million, which amounts to 29 percent of the federal government's recovery...

U.S. drug approvals hit a 21-year high in 2017, with 46 novel medicines winning a green light -- more than double the previous year -- while the figure also rose...in the European Union...recommended 92 new drugs including generics, up from 81...Yet the world’s biggest drugmakers saw average returns on their research and development spending fall, reflecting more competitive pressures and the growing share of new products now coming from younger biotech companies...projected returns at 12 of the world’s top drugmakers were at an eight-year low of only 3.2 percent...

Nicole Crisano, PTNN. This weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.

With a new administrator at the helm, the U.S. Food and Drug Administration took steps toward regulating decision support, software-as-a-medical-device, mobile tech in clinical trials and more...the FDA had a full plate in 2017 as it sought to revise its regulatory processes for the shifting healthcare landscape...the new guard already had announced and implemented a firm-focused pre-certification program, released new guidances addressing provisions of 2016's 21st Century Cures Act, and outlined a handful of other ongoing initiatives that are sure to impact the digital health industry. Here's a rundown of the agency's actions and announcements during 2017.

• New leadership, new approaches
  ...a plan that included clear language on which devices the agency would look to regulate, an app regulation strategy involving postmarket data collection, and other idea designed to streamline the approval process...FDA opened up applications for a pilot of a firm-focused digital health pre-certification program...nine companies selected to participate: Apple, Samsung, Verily, Pear Therapeutics, Tidepool, Phosphorus, Fitbit, Roche, and Johnson & Johnson...draft of the long-awaited and somewhat controversial guidance on clinical decision support, which laid out the forms of clinical decision support that would or wouldn't be regulated based on the degree of human involvement (as opposed to risk)...draft guidance describing the FDA's new Breakthrough Devices Program...would supersede the Expedited Access Pathway and aims to push novel technologies presenting a significant improvement over status quo through the clearance process more quickly.

• FDA shifts toward digital, patient feedback
  ...the Clinical Trials Transformation Initiative – a public-private partnership of pharma companies, academics, and regulators including the FDA – released new endpoint recommendations for the use of mobile technologies in clinical trials... The guidelines, meant to be the first in a series of such documents, included suggestions for study designers when selecting novel endpoints, practical approaches when developing these endpoints...

Doctors have additional protocols to consider when writing and maintaining opioid prescriptions under a new law that took effect on New Year’s Day...The Prescription Drug Abuse Prevention Act, passed by the 2017 Legislature, outlines safeguards for doctors before they prescribe controlled substances to treat pain and increases requirements necessary to continue a prescription after one month, three months and a year...The additional paperwork is meant to curb the state’s opioid overdose problem and track down doctors who overprescribe...“It just provides a platform by which the provider can really have an in-depth discussion with the patient as to whether the use of a controlled substance is truly necessary, or whether there are alternatives, ” said Daniel Burkhead, a pain management specialist in Las Vegas...The guidelines require every doctor to perform a patient risk assessment before prescribing a controlled substance to treat pain...Nevada is among 17 states that have enacted legislation limiting the number of days of an initial opioid prescription or capping prescription strength...

The Dengvaxia debacle in the Philippines just keeps heating up, as more than 70 mothers with vaccinated children filed for criminal prosecution against former officials, including ex-President Benigno Aquino III, and Sanofi executives...In their legal complaint, which asks prosecutors to consider criminal charges, the families targeted Aquino, former Department of Health chief Janette Garin, M.D., and two other government officials, as well as five Sanofi executives including CEO Olivier Brandicourt and Asia-Pacific head Thomas Triomphe...Invoking the country’s Anti-Graft and Corrupt Practices Act, the families claim that the government officials are “guilty of gross inexcusable negligence” for rolling out the program without due diligence...adding that they gave “excessive accommodations” to the global drug giant. The families also questioned “whether [Aquino] acted in conspiracy with Sanofi officials” in purchasing about $70 million worth of Dengvaxia doses...after Sanofi released results from a new analysis indicating that its vaccine could cause more serious infections if given to those who haven't previously encountered dengue. The country immediately stopped its mass vaccination program, and government officials took a tough tone with the company

With $200 billion lost to counterfeit drugs annually and patient safety issues, a chain-of-custody log that blockchain could enable holds promise...Blockchain has the potential to transform healthcare in general and the pharmacy supply chain in particular...The distributed ledger technology could offer legislative, logistical and patient safety benefits for pharmaceutical supply chain management. From a regulatory perspective in the United States, blockchain technological and structural capabilities, in fact, extraordinarily map to the key requirements of the Drug Supply Chain Security Act...The DSCSA outlines a 10-year timeframe that will require elements including medication track-and-trace, product verification and notification of stakeholders about illegitimate drugs. A shared ledger of information to enable each of these steps is a foundational aspect of blockchain technology...“Logistically, blockchain aligns well with federal efforts like the National Strategy for Global Chain Security,”...“One of the most promising benefits of blockchain from a patient safety perspective is to help stem the tide of the so-called SSFFC medicines – substandard, spurious, falsely labeled, falsified and counterfeit – that continue to plague the pharmaceutical supply chain.”