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Thursday, July 25, 2019

Telemedicine reimbursement, coverage is better than ever

“The question of how telehealth can improve hospital revenue cycles is an evolving area worthy of additional study beyond the ATA Report,” says the American Telemedicine Association’s CEO.

More states than ever are expanding telehealth coverage and reimbursement, according to a new report from the American Telemedicine Association (ATA).
It shows that since 2017, 40 states and the District of Columbia have adopted substantive policies or received awards to expand telehealth coverage and reimbursement.
That friendlier reimbursement environment is combined with ramped-up physician adoption: an American Well surveyreleased earlier this year showed that physician adoption of telehealth increased 340% between 2015 and 2018, far outpacing adoption rates in the early years of EHRs.
But what that might mean for the revenue cycle needs a closer look.
“The question of how telehealth can improve hospital revenue cycles is an evolving area worthy of additional study beyond the ATA Report,” Ann Mond Johnson, CEO of the ATA, tells HealthLeaders via email.
One of the answers likely lies in one of the report’s key findings: “that a growing number of states allow for insurance reimbursement parity,” Johnson says.
Specifically, the report found:
  • 36 states and the District of Columbia have parity policies for private payer coverage
  • 21 states and D.C. have coverage parity policies in Medicaid
  • 28 states have Medicaid payment parity policies
  • 16 mandate payment parity for private payers
Johnson notes that “increased reimbursement parity laws can be seen as a positive development for all providers, including hospitals, because they can generate revenue from payment from third parties (e.g., insurers) in addition to patient cost sharing for services rendered at a lower cost to providers.”
More broadly, she points out that anytime a service is provided on a cash-pay basis, the revenue cycle stands to benefit, since providers can often request payment upfront, rather than wait for an insurer to process a claim.
“It has been argued a hospital’s ability to improve its revenue cycle is likely stronger in a cash-pay setting where patients are more likely to pay for services up front; cash-pay telehealth services are no different in this regard,” Johnson says.
The survey also found that:
  • The majority of states have no restrictions around eligible provider types; 10 states have authorized six or more types of providers to treat patients through telehealth.
  • Only 16 states limit telehealth to synchronous technologies while most of the country recognizes the benefits of remote patient monitoring and store and forward.
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FDA Approves First Needle-Free ‘Rescue’ Drug for Low Blood Sugar Episodes

In what could prove to be a real advance for Americans with diabetes, the U.S. Food and Drug Administration on Wednesday gave the nod to a needle-free method of helping people recover from an episode of dangerous low blood sugar.
The new formulation, called Baqsimi, contains the rescue medication glucagon, but is instead given as a nasally inhaled powder, the FDA said.
“Until now, people suffering from a severe hypoglycemic episode had to be treated with a glucagon injection that first had to be mixed in a several-step process,” explained Dr. Janet Woodcock, who directs the FDA’s Center for Drug Evaluation and Research.
Baqsimi “may simplify the process, which can be critical during an episode,” she said in an agency news release.
One diabetes expert agreed.
The new drug’s approval is “a great boon for people with diabetes at risk for low blood glucose [hypoglycemia], as well as for their families and their health care providers,” said Dr. Minisha Sood. She’s an endocrinologist at Lenox Hill Hospital in New York City.
Sood noted that very often, a diabetic person is incapacitated by hypoglycemia — meaning that a friend, family member or other bystander must administer injected glucagon.
That means “training friends and family of patients” on how to inject the drug intramuscularly, which can be a real “limitation,” she said.
Having a more “straightforward” option of administering glucagon “is a game-changer when it comes to treating severe hypoglycemia outside of a hospital or doctor’s office,” Sood said. “I look forward to using this for my patients.”
As the FDA explained, “severe hypoglycemia occurs when a patient’s blood sugar levels fall to a level where he or she becomes confused or unconscious or suffers from other symptoms that require assistance from another person to treat. Typically, severe hypoglycemia occurs in people with diabetes who are using insulin treatment.”
Baqsimi will come in a single-use dispenser easily administered to deliver glucagon-containing powder into the nose. The drug “increases blood sugar levels in the body by stimulating the liver to release stored glucose into the bloodstream,” the FDA said.
Wednesday’s approval was based on findings from two studies involving 83 and 70 adults with diabetes. Baqsimi was found to work as well as injected glucagon to raise blood sugar levels.
Similar results were found in a study involving 48 children with type 1 diabetes, the FDA added.
Baqsimi, made by Eli Lilly and Co., does have some restrictions. According to the FDA, it shouldn’t be used by people with a rare condition known as pheochromocytoma, a tumor of the adrenal gland, or people with a pancreatic tumor known as an insulinoma.
People with known allergies to glucagon shouldn’t take Baqsimi, nor should people who’ve been fasting for a long period, or those with chronic forms of hypoglycemia.
Side effects of Baqsimi were similar to those of injected glucagon, the FDA said.
More information
The U.S. National Institute of Diabetes and Digestive and Kidney Diseases offers more about low blood sugar, including how to prevent it.
SOURCES: Minisha Sood, M.D., endocrinologist, Lenox Hill Hospital, New York City; U.S. Food and Drug Administration, news release, July 24, 2019
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AbbVie Q2 Earnings Preview

AbbVie (NYSE:ABBV) is scheduled to announce Q2 earnings results on Friday, July 26th, before market open.
The consensus EPS Estimate is $2.21 (+10.5% Y/Y) and the consensus Revenue Estimate is $8.09B (-2.3% Y/Y).
Over the last 2 years, ABBV has beaten EPS estimates 88% of the time and has beaten revenue estimates 75% of the time.
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Phase III Success for Novel Anemia Drug

The investigational treatment roxadustat was effective for treating anemia in patients with chronic kidney disease, two phase III trials in China indicated.
In a 27-week trial involving patients on hemodialysis, roxadustat was noninferior to standard epoetin alfa therapy in patients on hemodialysis (difference 0.2±1.2 g/dL, 95% CI -0.02 to 0.5), reported Nan Chen, MD, of Shanghai Jiao Tong University School of Medicine, and colleagues. From baseline through the end of follow-up, patients on dialysis receiving roxadustat three times per week saw a mean hemoglobin increase of 0.7±1.1 g/dL versus 0.5±1.0 g/dL seen in those receiving epoetin alfa thrice weekly.
In a second phase III trial conducted by the same team in patients not on dialysis, roxadustat was superior in raising hemoglobin levels by 1.9±1.2 g/dL compared with a decrease of 0.4±0.8 g/dL seen with placebo.
Reports on both trials appeared in the New England Journal of Medicine.
Roxadustat is part of a new therapeutic class, acting as an inhibitor of hypoxia-inducible factor prolyl hydroxylase administered orally.
“HIF prolyl hydroxylase inhibitors treat anemia of chronic kidney disease through multiple pathways, beyond increasing erythropoietin levels, by means of effects on inflammation and iron handling, and particularly by decreasing the hepcidin level,” explained accompanying editorial author Joshua Kaplan, MD, of Rutgers New Jersey Medical School in Newark.
“This treatment with HIF prolyl hydroxylase inhibitors differs from treatment with erythropoietin and intravenous iron in two potentially critical factors,” he wrote: “patients receiving HIF prolyl hydroxylase inhibitors have lower serum levels of erythropoietin than those receiving erythropoietin, and HIF prolyl hydroxylase inhibitors lead to decreased levels of hepcidin.” These effects should help patients dodge some of the adverse effects associated with erythropoiesis-stimulating agents, Kaplan suggested.
The trial results in dialysis patients also indicated that, compared with the standard therapy, roxadustat treatment was tied to a greater increase in transferrin levels (difference 0.43 g/L, 95% CI 0.32-0.53). This novel treatment also helped to maintain serum iron levels (difference 25 μg/dL, 95% CI 17-33) and helped to reduced the drop in transferrin saturation (difference 4.2%, 95% CI 1.5%-6.9%) versus epoetin alfa therapy.
In the trial of dialysis patients — 90% of whom were on hemodialysis and about 10% on peritoneal dialysis — Chen’s group enrolled 305 patients who had been receiving an erythropoiesis-stimulating agent therapy with epoetin alfa for a minimum of six weeks. At baseline, average hemoglobin levels were about 10.5 g/dL.
Two-thirds of this cohort were then randomized to receive oral roxadustat, with a starting dose of 100 mg for those weighing from 99 to 132 lb (45 to <60 kg) or a starting dose of 120 mg for those over 132 lbs. The other participants remained on epoetin alfa at their pre-randomization doses, which was an average of 7,597±2,931 IU/week. Patients that had hemoglobin levels dip below 8 g/dL were given rescue therapy in the form of intravenous iron, a blood transfusion, and/or erythropoiesis-stimulating agents.
As Kaplan noted, those on roxadustat saw a significantly greater average reduction in hepcidin after 27 weeks of treatment (-30.2 ng/mL, 95% CI -64.8 to -13.6, with roxadustat vs -2.3 ng/mL, 95% CI -51.6 to 6.2, with epoetin alfa). Roxadustat therapy was also associated with a decrease in LDL cholesterol (difference -18 mg/dL, 95% CI -23 to -13) and total cholesterol (difference -22 mg/dL, 95% CI -29 to -16).
As for adverse events, the majority of patients on dialysis receiving either treatment experienced at least one adverse event. The most common event reported in those on roxadustat included hyperkalemia and upper respiratory infection. The most common serious adverse event reported was vascular-access complication, which had a similar occurrence rate between the treatments.
Similar outcomes were seen in the team’s other trial in patients with kidney disease not on dialysis. The 8-week trial also found a greater average reduction in hepcidin level compared with placebo (56.14±63.40 ng/mL vs 15.10±48.06 ng/mL). Those not on dialysis also saw a significant drop in total cholesterol (-40.6 mg/dL vs -7.7 mg/dL) while on treatment.
After the 8-week randomization phase, most of the participants entered an additional 18-week open-label phase. During this time, the effects roxadustat had on hemoglobin levels was maintained, reaching an overall 1.9±1.3 g/dL increase from baseline in hemoglobin by the end of this extension.
The safety profile was similar among those not on dialysis, with hyperkalemia and metabolic acidosis being two of the most commonly reported events occurring among those on roxadustat.
“Although the present trials indicate that roxadustat effectively treated anemia while reducing hepcidin levels and maintaining lower levels of erythropoietin, adverse events may yet appear when larger, longer trials are completed,” Kaplan wrote.
However, he added that if additional studies of HIF prolyl hydroxylase inhibitors “fulfill their promise and facilitate normalization of hemoglobin levels in patients with chronic kidney disease and reduce cardiovascular morbidity related to anemia without the increased risks that have been seen in trials of erythropoietin-stimulating agents, there might ultimately be a revolution in the treatment of anemia of chronic kidney disease.”
The trials were funded by FibroGen and FibroGen (China) Medical Technology Development.
Chen reported no disclosures. Other co-authors reported disclosures.
Editorialist Kaplan reported personal fees from Keryx.
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Sage Therapeutics Updates Pipeline to Focus on Treatment-Resistant Depression

In March, SAGE Therapeutics received approval from the U.S. Food and Drug Administration (FDA) for Zulresso (brexanalone) to treat postpartum depression (PPD). Although an important approval that drove the company’s market value to almost $9 billion, PPD is a relatively small market. Now the company is working to break into the broader depression market with SAGE-217. The company discussed its pipeline at its “FutureCast.”
“Our goal at Sage has always been to step into the void in CNS drug development through an innovative approach we believe to be unique,” stated Jeff Jonas, Sage’s chief executive officer. “By thinking differently about brain disorders, we’ve built a pipeline with the potential to deliver a broad range of new medicines across multiple indications. The clinical findings presented today are a result of our differentiated approach to discovery and translation. While these are still early data, we believe these data not only meaningfully expand our pipeline opportunities, but more importantly, represents the potential benefits our medicines may provide for patients if we’re successful in our development efforts.”

SAGE-217 is the company’s next-generation positive allosteric modulator (PAM) of GABAA receptors. It is in a Phase III trial for major depressive disorder (MDD), PPD, and comorbid MDD and insomnia. It is also being studied for bipolar depression and additional affective disorders, including treatment-resistant depression (TRD) and generalized anxiety disorder (GAD). It has received Breakthrough Therapy Designation from the FDA for MDD.
In the ARCHWAY trial, a Phase II study of SAGE-217 in adults with moderate to severe bipolar I/II disorder with a major depressive episode, patients showed a rapid and durable response to treatment and statistically significant improvement compared to baseline. About a third of subjects discontinued the study, however, for a variety of “social/personal reasons,” which the company notes is consistent with other studies in bipolar depression. No dropouts were made over adverse side effects.
In a trial of patients who didn’t respond to a single anti-depressant, SAGE-217 ran a post hoc analysis of 51 patients from the MDD-201B and ROBIN (PPD) trials. Patients receiving the drug had a 7.2-point greater decrease in Hamilton Rating Scale for Depression (HAM-D-17) compared to the placebo group at Day 15. At Day 42 or 45, the last day of the study, patients receiving the drug had a 4.9-point greater reduction in HAM-D-17 compared to placebo.
In the anxiety comparison, patients receiving the drug had a 4.6-point greater reduction in HAM-A score and 3.9-point greater reduction in HAM-A compared to placebo in the MDD-201B and ROBIN studies, respectively, and at Day 42, a 2.3-point greater reduction in HAM-A and a 5-point greater reduction in HAM-A, respectively, compared to placebo.
The company plans to also develop the drug for TRD but expects to discuss it in the future.

“We interpret these data as consistent with a very respectable signal suggesting a potential development opportunity in bipolar depression for SAGE-217,” the company’s Robert Lasser, head of late-stage development, said during the webcast. “However, that potential development opportunity is balanced against the depth of other work which is still possible, we think, within MDD.”
Which might be another way of saying post-hoc analyses don’t prove much, and the company will need to actually conduct prospective clinical trials in TRD. But from a practical strategy, there are advantages to TRD development. Sage’s Jonas noted that if the ongoing trial in MDD reads out equivocal results, that trial could permit filing of SAGE-217 in depression when coupled with the positive trial data in PPD. It would also make Sage more likely to get insurers to support their drugs over a variety of current generic offerings.
“We think it is the nearest term value driver and we believe that it will position SAGE-217, if and when it launches, to really be, we hope, one of the most valuable assets to be introduced in the major depression space,” Jonas said in the webcast.
It’s not an empty market, though. In March, Johnson & Johnson received approval for Spravato (esketamine) for treatment-resistant depression.
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Natus Medical EPS beats by $0.04, beats on revenue

Natus Medical (NASDAQ:BABY): Q2 Non-GAAP EPS of $0.34 beats by $0.04; GAAP EPS of $0.12 misses by $0.02.
Revenue of $125.54M (-3.9% Y/Y) beats by $2.69M.
Press Release
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Universal Health Services EPS beats by $0.26, beats on revenue

Universal Health Services (NYSE:UHS): Q2 Non-GAAP EPS of $2.76 beats by $0.26; GAAP EPS of $2.66 beats by $0.19.
Revenue of $2.86B (+6.7% Y/Y) beats by $50M.
Press Release
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