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Thursday, July 12, 2018

Verma: Changes Coming to Stark Self-Referral Law


The Centers for Medicare & Medicaid Services (CMS) is hoping to issue a proposed regulation by the end of the year that would loosen the “Stark law” prohibiting physician self-referral, CMS administrator Seema Verma said Monday.
“One of the barriers around [promoting] value-based care is burdensome regulations, and that’s where Stark comes into it,” Verma said at a briefing sponsored by the Alliance for Health Policy and APCO Worldwide, a public relations firm here. “We are going to do something on Stark — I’m very certain about that — and we hope to have something out by the end of the year.”
The 1989 law, named for former congressman Fortney H. “Pete” Stark (D-Calif.), “prohibits a physician from making referrals for certain designated health services payable by Medicare to an entity with which he or she (or an immediate family member) has a financial relationship (ownership, investment, or compensation), unless an exception applies,” CMS notes on its website.
Designated health services include clinical lab services, physical therapy, occupational therapy, radiology, durable medical equipment, home health services, outpatient prescription drugs, and inpatient and outpatient hospital services.
During a panel discussion following Verma’s remarks, Richard Deem, senior vice president for advocacy at the American Medical Association (AMA), pointed out that the Stark law “was created in a whole different environment than we’re trying to operate in now … Right now we’re talking about more collaboration, whether it’s an ACO [accountable care organization] or a bundled payment arrangement. Obviously we’re going to have to rethink things if we want to collaborate and coordinate.”
Verma also discussed other moves that CMS was making to lessen the regulation burden on providers. The agency had previously announced that it was doing away with some of the current quality measures for home healthcare and dialysis providers.
“We did a nationwide listening tour, and talked to providers from different settings across the system, and we heard about the burden of the reporting,” Verma told MedPage Today. “We went back and took a look at all of the measures.”
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When they did so, they found that many quality measures were “topped out” — 97% or 98% of providers had a positive score on the measure — “so why are we continuing to report [on it]?” she said. “The other thing we saw is that a lot of the measures were duplicative; providers were having to report the same thing across three or four programs, so we’re trying to eliminate that.”
In addition, “we need to think about the burden it’s creating on the healthcare system,” Verma continued. Providers “are spending so much time and energy reporting, when what we need providers to do is focus on patients. I was visiting a hospital in Ohio and they talked about having 14 or 15 people essentially in the basement working on quality measures and manually having to extract data from patient records. We need people on the front lines, not in the back room behind a computer screen.”
Eventually, “we want to get to a system where we can extract information from medical records, from claims data. That’s the overall direction we’re going in on quality measurement,” she said.
There is a tension between having too many quality measures and having enough relevant measures, said the AMA’s Deem. “We want to get out of checking the boxes, but if they parse down the measures too much, it may leave some physicians without a measure they can properly use.”
As for using claims data to do quality measurement, “the problem with claims data is that it doesn’t include a lot of the clinical data that you need to make the proper quality judgments,” he added.
Verma also hinted that the agency might be moving toward “site-neutral” payments, in which all Medicare providers are paid the same for a particular procedure or service no matter where it was preformed. As it stands now, “we’re paying differently for the exact same service in one setting versus another, and the provider community is responding to that,” she said. “You see hospitals buying up physician practices because then they can bill more for the exact same service.”
The idea of site-neutral payments did not sit well with Joanna Hiatt Kim, vice president for payment policy at the American Hospital Association. “The cost of care delivered in hospitals and health systems reflects the unique social goods that only they provide,” she said.
That would include “providing for standby capacity should a rare traumatic event occur, staffing and keeping the ED open 24/7, so if your child gets sick in the middle of the night or if you’re a victim of a hurricane or an earthquake or a wildfire, you can come in and a hospital is ready to care for you … we would [oppose site-neutral payment].”
Verma also responded to a question about a recent court ruling that invalidated Kentucky’s Medicaid waiver, which would have imposed work requirements — also known as “community engagement” requirements — on able-bodied Medicaid recipients. “This administration is committed to giving states flexibility, to giving people living in poverty a pathway out of that situation,” said Verma, who noted that she had recused herself from the Kentucky case and couldn’t talk about it specifically.
“States are trying to do innovative things … and we want to be supportive of that. This hasn’t changed our commitment to helping people rise out of poverty.”

Gilead gets Euro OK for HIV combo


Gilead Sciences, Inc. (NASDAQ: GILD) announced that the European Commission has granted Marketing Authorization for Biktarvy® (bictegravir 50mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg; BIC/FTC/TAF), a once-daily single tablet regimen (STR) for the treatment of HIV-1 infection. BIC/FTC/TAF combines the potency of the novel integrase strand transfer inhibitor (INSTI) bictegravir, with the demonstrated safety and efficacy profile of Descovy® (emtricitabine 200 mg/tenofovir alafenamide 25 mg; FTC/TAF), a guidelines-recommended dual nucleoside reverse transcriptase inhibitor (NRTI) backbone. Today’s decision makes BIC/FTC/TAF Gilead’s third FTC/TAF-based STR approved in the European Union in the past three years (see also Gilead Sciences Inc.).
In Europe, BIC/FTC/TAF is indicated as a complete regimen for the treatment of HIV-1 infection in adults without present or past evidence of viral resistance to the integrase class, emtricitabine or tenofovir. No dosage adjustment of BIC/FTC/TAF is required in patients with estimated creatinine clearance (CrCL) greater than or equal to 30 mL per minute. BIC/FTC/TAF has convenient dosing, does not require testing for HLA-B 5701, and has no food intake or baseline viral load or CD4 count restrictions.
“To help support the long-term health of people living with HIV, it is crucial to have regimens that deliver durable viral suppression with a high barrier to resistance,” said Professor Alan Winston, Professor of HIV and Genitourinary Medicine at Imperial College and Consultant Physician at St. Mary’s Hospital, London, UK. “In clinical trials through 48 weeks, BIC/FTC/TAF has shown high efficacy and zero resistance. With convenient dosing and few pre-screening or ongoing monitoring requirements, it has the potential to simplify treatment initiation, and follow-up over time.”
Today’s decision is supported by data from four ongoing Phase 3 studies: Studies 1489 and 1490 in treatment-naive HIV-1 infected adults, and Studies 1844 and 1878 in virologically suppressed adults. The trials are comprised of a population of 2,415 participants. BIC/FTC/TAF met its primary objective at 48 weeks in all four studies.
Through 48 weeks, no participants in any of the four studies failed BIC/FTC/TAF with treatment-emergent virologic resistance, no participants discontinued BIC/FTC/TAF due to renal adverse events and there were no cases of proximal renal tubulopathy or Fanconi syndrome. The most common adverse reactions in patients taking BIC/FTC/TAF were diarrhea, nausea and headache.
“We are pleased to offer BIC/FTC/TAF, the latest innovation in our comprehensive HIV research and development program, which encompasses prevention, treatment and cure,” said Andrew Cheng, MD, PhD, Chief Medical Officer, Gilead Sciences. “The approval of BIC/FTC/TAF demonstrates our continued commitment to improving care for people living with HIV, and we look forward to working with health authorities across Europe to ensure that BIC/FTC/TAF is made widely available as soon as possible.”
Additional studies not included in the marketing authorization application are also ongoing, including dedicated studies in women, and in adolescents and children.
BIC/FTC/TAF was approved by the U.S. Food and Drug Administration (FDA) on February 7, 2018.

Xencor doses 1st patients for Phase 1 cancer antibody study


Xencor, Inc. (NASDAQ: XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies for the treatment of autoimmune diseases, asthma and allergic diseases and cancer, today announced that the first patient has been dosed in XmAb20717-01 (DUET-2), a Phase 1, first-in-human, clinical trial of XmAb®20717, a bispecific antibody that simultaneously targets PD-1 and CTLA-4 immune checkpoints for the treatment of multiple advanced solid tumors.

“Built on the scaffold of Xencor’s XmAb® bispecific Fc domain, XmAb20717 is the most advanced candidate in our suite of tumor microenvironment activators,” said Paul Foster, M.D., chief medical officer at Xencor. “The dual blockade of PD-1 and CTLA-4 with XmAb20717 may promote superior T cell activation and proliferation compared to anti-PD-1 alone, and we look forward to studying its safety, tolerability and therapeutic activity in clinical trials.”
By the end of 2018, Xencor expects to file Investigational New Drug applications for two additional tumor microenvironment activators including XmAb®23104, a PD-1 x ICOS bispecific antibody, as well as XmAb®22841, a CTLA-4 x LAG-3 dual checkpoint inhibitor.
DUET-2 is a Phase 1 multiple-dose, dose-escalation study that will characterize the safety and tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and preliminary anti-tumor activity of intravenous administration of XmAb20717 in patients with selected advanced solid tumors. For more information about DUET-2 please visit to https://clinicaltrials.gov (identifier: NCT03517488).
As opposed to traditional monoclonal antibodies that target and bind to a single antigen, bispecific antibodies are designed to elicit biological effects that require simultaneous binding to two different antigen targets. Xencor’s XmAb bispecific Fc domain technology is designed to maintain full-length antibody properties in a bispecific antibody, potentially enabling favorable in vivo half-life and simplified manufacturing.

Insulet Extends Links with Glooko in Europe for Diabetes Data Management


Insulet Corporation (NASDAQ: PODD) (Insulet or the Company), the global leader in tubeless insulin pump technology with its Omnipod® Insulin Management System (Omnipod System), today announced that it has partnered with Glooko®, Inc. to connect Insulet’s Omnipod System user data with Glooko+diasend®, the most comprehensive diabetes data management system available, across Europe.
“Insulet and Glooko are dedicated to bringing innovation to diabetes management around the world. We are delighted to work together to provide Omnipod users across Europe the ability to remotely sync data from their Omnipod Systems using Glooko+diasend,” said DJ Cass, General Manager, Insulet Europe. “This combined platform makes their lives easier by allowing people with diabetes to review their blood glucose patterns on their smartphones and monitor the impact of their insulin regimen, diet and physical activity on their diabetes management.”
Insulet’s partnership with Glooko is further proof of its commitment to putting customers first, as it ensures Insulet can continue to be closer to the diabetes community and provide personalised support for Podders™ across Europe.
“Glooko has a long-standing relationship with Insulet and we are very excited to now expand our collaboration even further within the European markets,” said Anders Sonesson, General Manager Glooko Europe. “We are proud to support the Omnipod System with our universal data management solution and our seamless user experience will appeal to numerous health care providers and their patients throughout Europe, taking clinic workflow, remote patient monitoring and overall diabetes treatment plans to new heights.”
Glooko+diasend is currently used at approximately 7,000 provider sites by over 1.5 million users in 23 countries, and the system is offered in 15 languages.

Natural Grocers target hiked by RBC


To $16.

Fentanyl Deaths Double in 10 States, Present in 21% of Deaths: CDC


The number of opioid overdose deaths in which fentanyl was detected in 10 states doubled during the first half of 2017 compared with the second half of 2016, according to the CDC’s Mortality and Morbidity Weekly Report — putting numbers to a trend already known qualitatively.
The number of deaths from carfentanil nearly doubled, too.
Fentanyl analogs were present in 21% of 11,045 opioid overdose deaths in 10 states during a 1-year period ending July 2017, the CDC reported. Carfentanil was found in 11.2% of those cases. The largest numbers and most substantial increases in fentanyl-related deaths were in Ohio.
In more than 95% of cases where a fentanyl analog was detected, medical examiners or coroners said it contributed to the cause of death, supporting other reports that fentanyl may be fueling the surge in opioid deaths.
New fentanyl analogs continue to be identified, and it’s possible fentanyl was missed in some cases: “The increasing array of fentanyl analogs highlights the need to build forensic toxicological testing capabilities to identify and report emerging threats and to enhance capacity to rapidly respond to evolving drug trends,” the CDC researchers wrote.
In addition, the potency of many fentanyl analogs, especially carfentanil, “might warrant multiple administrations of the effective opioid overdose reversal medication naloxone.”
No conflicts of interest were reported.

Aetna, CVS jump after report says DOJ won’t oppose merger


Shares of Aetna (AET) are rallying after Reorg Research, according to Bloomberg, reported that the Department of Justice is not, “at this point,” looking to challenge in court CVS Health’s (CVS) planned takeover of the company. Reorg cited an official with Washington State Office of the Insurance Commissioner for story. Shares of Aetna are up $4.25 to $191.81 in midday trading while CVS is up $2.15 to $69.45. Express Scripts (ESRX), which reached an agreement to be acquired by Cigna (CI), is up $1.43 to $82.00.