Search This Blog

Wednesday, July 4, 2018

States expand telemedicine to allow prescribing of controlled substances


Legislators are beginning to open up new avenues for providers to use telemedicine to prescribe medications, a move that’s indicative of growing acceptance of virtual care as a way to improve access.
On Sunday, Connecticut became the latest state to allow providers to prescribe controlled substances through telemedicine for treating psychiatric disabilities and substance use disorder. Seven other states have recently passed similar laws allowing the prescription of controlled substances via telemedicine.
“They’re recognizing that it’s a clinically meaningful part of taking care of patients,” said Nathaniel Lacktman, a partner and healthcare lawyer with Foley & Larder, whose telemedicine industry team helped the Connecticut Psychiatric Society write part of the bill. “The landscape has changed significantly over the last two years.”
This bill reflects a trend of incremental change, said Marki Stewart, an attorney with Dickinson Wright. “States are slowly and narrowly carving out certain circumstances where telemedicine could be used to improve care,” she said.
But patients and providers alike will still face limitations, despite bills like the one Connecticut just passed.
In most cases, prescribers must first have in-person visits with patients before prescribing them medications virtually, even in states whose laws don’t require preliminary in-person visits because of the federal Ryan Haight Online Pharmacy Consumer Protection Act, which was passed in 2008 and requires the practice.
Congress is considering relaxing some of the Ryan Haight Act’s restrictions, allowing certain facilities to qualify as Drug Enforcement Administration-registered clinics so providers could prescribe controlled substances to patients in those facilities.
The changes reflect legislators’ growing realization of how industry practices have changed since the act passed, said Jennifer Breuer, a partner with Drinker Biddle.
“When Ryan Haight was passed, telemedicine was this pie-in-the-sky idea, and there were online pharmacies letting you fill out a questionnaire and get whatever you asked for,” she said.
But telemedicine has matured, and the federal government has cracked down on online pharmacies.
Now, telemedicine visits can sometimes be recorded in electronic health records. When it comes to prescribing, that means more opportunity for verification, Breuer said.
The Connecticut law and others aren’t just a reaction to the changing technological landscape; they’re also a reaction to the shortage of psychiatric care in the country—a shortage made particularly acute by the opioid-addiction epidemic.
“The federal government is starting to recognize that telemedicine has a lot of benefits,” Stewart said. Though the CMS greatly limits what kind of virtual care can be reimbursed through Medicare, the agency is testing new use cases.
Private insurers are adding conditions for which telemedicine can be used, with a particular focus on chronic diseases.
“There’s a real understanding and data to show that people don’t have access to the care they need in real time and where they can access it,” Breuer said. “Telemedicine may not be a panacea, but at least it’s a step in the right direction.”

Agents and brokers flee ACA exchanges despite Trump administration support


The number of registered brokers and agents who help people sign up for coverage through the federal ACA insurance exchange continued to decline in 2018, despite the CMS’ efforts to encourage their participation by making it easier for them to sign up customers during open enrollment.
The number of agents and brokers participating in the Affordable Care Act open enrollment for 2018 dropped 24.8% to 49,100 from more than 65,300 during open enrollment for 2017 coverage, according to a CMS report released Monday. Since open enrollment for 2016 coverage, the number of registered agents and brokers has fallen by 38.3%.
Health insurer exits from the exchanges, expensive member premiums and limited commissions for those who enroll individuals in exchange plans have driven brokers and agents out of the market, the CMS said. The agency’s strategy to encourage shoppers to seek help from brokers while giving brokers more tools to engage consumers failed to stem the exodus.

During open enrollment for 2018 coverage, the Trump administration allowed consumers to bypass the federal HealthCare.gov platform and buy an ACA-approved plan directly from a broker or an insurer’s website.
It also introduced a tool called “Help on Demand” that connected shoppers to licensed agents able to help with application and enrollment questions. The CMS also began recognizing high-performing brokers and agents in 2018. On the flip side, the Trump administration slashed federal funding to ACA navigators, who receive grants to assist consumers during open enrollment. Some navigator groups were forced to cut staff or cancel outreach events because of the smaller budgets.
The administration has supported privatizing health insurance enrollment. But navigator funding cuts, along with dwindling broker participation have helped reduce ACA enrollment. Nearly 11.8 million people signed up for 2018 coverage, down from 12.2 million in 2017. So far 1.1 million people have dropped their 2018 plans as of mid-March, the CMS said Monday.
Still, the CMS said that though there are fewer agents and brokers participating, they are still supporting about 42% of HealthCare.gov customers.
Brokers help consumers navigate coverage options and also tend to advocate for their customers if claims get denied. They’ve historically signed up about half of all exchange enrollees. Before the ACA, insurance companies would pay brokers commissions based on monthly premiums for plans sold on the individual market. But insurers—many of which lost money on their individual insurance plans, but are now on track to make a profit—have increasingly chosen to stop paying those fees for all or certain types of health plans, saying its necessary for them to stay financially viable.
The CMS in December 2016 issued guidance instructing health plans to be consistent in how they pay commissions across all exchange plans, effective January 2018. But brokers say nothing has changed since the guidance came out. Groups representing agents and brokers have long complained that the CMS was unwilling to enforce commission payments for fear of discouraging insurer participation.
“Without a viable compensation structure for agents and brokers, it may be difficult for CMS to improve or stabilize agent and broker retention and achieve significant enrollment gains, leaving consumers with diminished access to insurance specialists willing to help them in their local communities,” the agency said in its report.
The CMS also said it would continue to streamline the HealthCare.gov platform for 2019 and give brokers and agents new tools to help them assist customers with eligibility determinations and plan selections while reducing the need to use the federal website or call center.

Malaysia firm IHH submits new bid for Fortis


Malaysia`s IHH Healthcare Berhad today said it has made a fresh binding offer to the board of Fortis Healthcare.
The binding offer is valid till July 16, 2018, IHH Healthcare Berhad said in a regulatory filing.
IHH today issued a letter to the board of Fortis “setting out a binding offer, which supersedes and replaces the enhanced revised proposal,” it added.
“In the event IHH does not receive any response from Fortis by no later than 5 pm ISTon July 16 2018, the binding offer shall be deemed to have been withdrawn,” IHH Healthcare Berhad said.
The company, however, did not provide any details about the size of the bid.
Cash-strapped Fortis Healthcare had set July 3 as the deadline for the submission of the fresh binding bids. The company had earlier scrapped its decision to opt for the offer by the Munjal-Burman combine to invest Rs 1,800 crore in the company.
Earlier, Fortis Healthcare had received binding bids from four suitors — Munjal-Burman combine, TPG-Manipal consortium, Malaysia`s IHH Healthcare Berhad and KKR-backed Radiant Life Care.
China`s Fosun Healthcare had not made a binding bid for the company.

Globus Medical Adds Two Innovative Solutions to Growing Trauma Portfolio


Globus Medical, Inc. (NYSE:GMED), a leading musculoskeletal solutions company, announced today the expansion of its orthopedic trauma product portfolio with two new product offerings, the ANTHEM Ankle Fracture System and the ANTHEM Proximal Humerus Fracture System, marking the Trauma divisions fourth and fifth comprehensive product launches over the last 10 months.
This is an exciting time for Globus Trauma as we continue to execute our product launch strategy and build a comprehensive Trauma product portfolio, said Barclay Davis, Vice President, Orthopedic Trauma. With each new product introduction, our goal is to design systems that help streamline the procedure, increase versatility, reduce operative time, and improve patient care.
ANTHEM Ankle Fracture Plating and other lower extremity systems will be exhibited at the annual American Orthopedic Foot and Ankle Society Meeting in Boston, MassachusettsJuly 11th-14th. Globus Medical invites meeting attendees to Booth 206 to experience its recent product innovations and discuss trauma advancements with the companys product development experts.
The ANTHEM Ankle Fracture System is an extensive range of 7 unique plating options for treatment of virtually any ankle fracture. Over 25% thinner than the market leaders plate, ANTHEMs low profile ankle fracture plates are designed to minimize soft tissue irritation from implant prominence. Anatomically contoured plates, extensive screw options and instruments specifically designed for ankle anatomy are rolled into one efficient and comprehensive system for treating ankle fractures.
The ANTHEM Proximal Humerus Fracture System is designed to treat a wide variety of shoulder fractures and streamline procedural flow. The unique polyaxial screw technology allows for more accurate targeting of dense calcar bone to enhance fixation, independent of plate position. Large suture holes simplify suture attachment for soft tissue or rotator cuff repair. This comprehensive stand-alone system includes small fragment instruments and innovative retractors to help streamline the surgical procedure, aid in visibility of the fracture site, and optimize surgical time.
Indications
The ANTHEM Fracture System is indicated for fixation of fractures, osteotomies, arthrodesis and reconstruction of bones for the appropriate size of the device to be used in adult patients, including the clavicle, scapula, humerus, radius, ulna, small bones (metacarpals, metatarsals, phalanges), wrist, pelvis, femur, tibia, fibula, ankle, and foot. The clavicle hook plate may be used for dislocations of the acromioclavicular joint.
Small fragment, proximal tibia, clavicle and distal fibula plates may be used in all pediatric subgroups (except neonates) and small stature adults. Distal radius plates may be used in adolescents (12-21 years of age). Plating may be used in patients with osteopenic bone.

Glaxo gets target lifts from Barclays, Deutsche Bank on growth expectations


FTSE 100 pharmaceutical group GlaxoSmithKline PLC (LON:GSK) has had its target price lifted by both Barclays and Deutsche Bank as both banks predicted upgrades to its earnings forecasts.
At Deutsche Bank, analysts upped their target to 1,525p from 1,420p while raising their earnings per share (EPS) forecasts by 6-7% on the back of foreign exchange weighting and the timing of the launch of GSKs Advair drug, which is expected from the fourth quarter of 2018.
They added that an update from the new head of research and development at GSK, Hal Baron, would also provide investors with insight into the future direction of the company, as well as an updated list of key pipeline assets, particularly plans for the firms oncology and immune-inflammation portfolios.
Meanwhile, Barclays analysts upped their target price to 1,750p from 1,700p, with the companys launch of its Shingrix shingles product playing out more favourably than expected.
They added that margin improvement was expected and a core EPS of over 120p was feasible.

Genmab Progress Triggers Milestone Payment to Seattle Genetics


Genmab A/S (Nasdaq Copenhagen: GEN) announced today that it will pay a milestone payment of USD 7 million to Seattle Genetics, Inc. (Nasdaq: SGEN) following progress in the HuMax-AXL-ADC development program.
The milestone payment was triggered by the initiation of expansion cohorts in the ongoing Phase I/II trial in solid tumors. Genmab originally licensed Seattle Genetics’ADC technology in September 2014, in order to combine it with Genmab’s proprietary HuMax-AXL antibody to target multiple tumor types.
‘This milestone payment marks the rapid progress of the development program for HuMax-AXL-ADC and we very much look forward to seeing data from this program in the future,’ said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. ‘This is the second development interaction we have with Seattle Genetics, who are experts in the field of antibody-drug conjugates. The licensing deal for the use of their ADC technology in our proprietary HuMax-AXL-ADC program allows us to pursue our goal of developing truly differentiated cancer therapeutics whilst retaining maximal ownership of our therapeutic products.’

HuMax-AXL-ADC is an ADC targeted to AXL, a signaling molecule expressed on many solid cancers and implicated in tumor biology. HuMax-AXL-ADC is in Phase I/II clinical development for seven different solid tumors: ovarian, cervical, endometrial, thyroid, non-small cell lung cancer (NSCLC), melanoma, and sarcoma. HuMax-AXL-ADC is fully owned by Genmab and the ADC technology used with HuMax-AXL-ADC was licensed from Seattle Genetics.

Alder Presents New Data on Efficacy in Phase 3 Trial for Chronic Migraine


Alder BioPharmaceuticals, Inc.(NASDAQ: ALDR), a biopharmaceutical company focused on developing novel therapeutic antibodies for the treatment of migraine, announced today new six-month data from its PROMISE 2 Phase 3 clinical trial in patients with chronic migraine following a second quarterly infusion of eptinezumab.
The data show that patients experienced a reduction of 8.8 monthly migraine days (MMDs) from baseline following the second quarterly infusion of 300 mg of eptinezumab. These results demonstrate a further numerical improvement in efficacy over the first infusion which resulted in a reduction from baseline of 8.2 MMDs in this trial. Eptinezumab is Alder’s lead investigational product candidate for migraine prevention targeting calcitonin gene-related peptide (CGRP). Detailed results will be presented today at the 60th AHS Annual Scientific Meeting in San Francisco, CA.
‘These data further add to the significant body of clinical evidence supporting eptinezumab’s encouraging clinical profile and reinforce our belief in the value it may provide to patients, if approved’ said Robert Azelby, chief executive officer of Alder. ‘The robust efficacy shown over the two quarterly infusions of eptinezumab in chronic migraine patients continues to support eptinezumab’s potential as an important treatment option for patients living with this debilitating condition.’