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Tuesday, June 25, 2019

Hospital price transparency push draws industry ire, but effects likely limited

Far-reaching rules mandating industry price transparency could mark a major shift, but experts are skeptical the efforts will meaningfully lower prices for patients without a more fundamental system overhaul.
President Donald Trump’s executive order signed Monday directs HHS and other federal departments to begin rulemaking to require hospitals and payers to release information based on their privately negotiated rates. Providers would also have to give patients estimates of their out-of-pocket costs before a procedure.
Many details must still be worked out as HHS and CMS craft their proposals, but providers and payers were quick to condemn any notion of making negotiated rates public. A legal challenge to the rules is also likely.
Many policy analysts and economists said that while price transparency is good in theory, current evidence shows patients don’t take advantage of pricing information now available, said Ateev Mehrotra, associate policy of healthcare policy and Harvard Medical School.
Patients are wary of going against a doctor’s advice to undergo a certain procedure or test, and to get it done at a certain facility. A difference in price may not be enough to sway them.
Also, the healthcare system has so many moving parts and unique elements that understanding a medical bill and how the price was calculated is daunting, to say the least.
“That complexity hinders the ability of people to effectively shop for care,” Mehrotra told Healthcare Dive “It’s not like going to Amazon and buying a toothbrush or whatever.”

What the order actual does

The executive order has two main directives:
  • Within 60 days, HHS must propose a regulation “to require hospitals to publicly post standard charge information, including charges and information based on negotiated rates and for common or shoppable items and services, in an easy-to-understand, consumer-friendly, and machine-readable format using consensus-based data standards that will meaningfully inform patients’ decision making and allow patients to compare prices across hospitals.”
  • Within 90 days, HHS and the Departments of Labor and Treasury must solicit comment on a proposal “to require healthcare providers, health insurance issuers, and self-insured group health plans to provide or facilitate access to information about expected out-of-pocket costs for items or services to patients before they receive care.”
The order also outlines smaller steps, including a report from HHS on how the federal government and private companies are impeding quality and price transparency in healthcare and another on measures the White House can take to deter surprise billing.
It also directs federal agencies to increase access to de-identified claims data (an idea strongly favored by policy analysts and researchers) and requires HHS to identify priority databases to be publicly released.
The order requests the Secretary of the Treasury expand coverage options for high-deductible health plans and health savings accounts. It specifically asks the department to explore using HSA funds for direct primary care, an idea Senate HELP Committee Chairman Lamar Alexander, R-Tenn., said he “especially like[d].”

Industry pushes back

The order itself wastes no time in pointing the finger at industry players for current patient frustrations with the system. “Opaque pricing structures may benefit powerful special interest groups, such as large hospital systems and insurance companies, but they generally leave patients and taxpayers worse off than would a more transparent system,” according to the document.
As expected, payer and provider groups slammed any attempt to force them to reveal the rates they negotiate behind closed doors, though they expressed appreciation for the general push toward more transparency.
The American Hospital Association shied away from strong language as details are still being worked out, but did say “publicly posting privately negotiated rates could, in fact, undermine the competitive forces of private market dynamics, and result in increased prices.”
The Federation of American Hospitals took a similar tone in a statement from CEO Chip Kahn. “If implementing regulations take the wrong course, however, it may undercut the way insurers pay for hospital services resulting in higher spending,” he said.
Both hospital groups highlighted more transparency for patient out-of-pocket costs and suggests the onus should be on payers to communicate information on cost-sharing and co-insurance.
Mollie Gelburd, associate director of government affairs at MGMA, which represents physician groups, said doctors don’t want to be in the position of explaining complex insurance terms and rules to a patient.
“While physicians should be encouraged to talk to patients about costs, to unnecessarily have them be doing all this education when they should be doing clinical care, that sort of gets concerning,” she said.
Practices are more concerned about payer provider directories and their accuracy, something not addressed in the executive order. Not having that type of information can be detrimental for a patient seeking care and further regulation in the area could help, Gelburd said.
Regardless, providers will likely view with frustration any regulations that increase their reporting and paperwork burdens, she said.
“I think the efficacy of pricing transparency and reducing healthcare costs, the jury is still out on that,” she said. “But if you have that onerous administrative requirement, that’s certainly going to drive up costs for those practices, especially those smaller practices.”
Payer lobby America’s Health Insurance Plans was quick to voice its opposition to the order.
CEO Matt Eyles said in a statement disclosing privately negotiated rates would “reduce incentives to offer lower rates, creating a floor — not a ceiling — for the prices that hospitals would be willing to accept.” He argued that current tools payers use to inform patients of cost expectations, such as cost calculators, are already offering meaningful help.
AHIP also said the order works against the industry’s efforts to shift to paying for quality instead of quantity. “Requiring price disclosure for thousands of hospital items, services and procedures perpetuates the old days of the American health care system paying for volume over value,” he said. “We know that is a formula for higher costs and worse care for everyone.”

Limited effects

One potential effect of making rates public is that prices would eventuallytrend toward equalization. That wouldn’t necessarily reduce costs, however, and could actually increase them for some patients. A payer able to negotiate a favorable rate for a specific patient population in a specific geographic area might lose that advantage, for example, Christopher Holt, director of healthcare policy at the conservative leaning American Action Forum, told Healthcare Dive.
John Nicolaou of PA Consulting told Healthcare Dive consumers will need help deciphering whatever information is made available however. Reams of data could offer the average patient little to no insight without payer or third-party tools to analyze and understand the information.
“It starts the process, just publishing that information and just making it available,” he said. “It’s got to be consumable and actionable, and that’s going to take a lot more time.”
The order does require the information being made public be “easy-to-understand” and able to “meaningfully inform patients’ decision making and allow patients to compare prices across hospitals.” That’s far easier said than done, however, Harvard’s Mehrotra said. “We haven’t seen anybody able to put this information in a usable way that patients are able to effectively act upon,” he said.
Holt said patients are also limited in their ability to shop around for healthcare, considering they often have little choice in what insurance company they use. People with employer-based plans typically don’t have the option to switch, and those in the individual market can only do so once a year.
Another aspect to consider is the limited reach of the federal government. CMS can require providers and payers in the Medicare Advantage program, for example, to meet price transparency requirements, but much of the licensing and regulations for payer and providers comes at the state level.

Waiting for details, lawsuits

One of the biggest questions for payers and providers in the wake of Monday’s announcement is how far exactly the rulemaking from HHS will go in mandating transparency. One one end, the requirements could stick close to giving patients information about their expected out-of-pocket costs without revealing the details of payer-provider negotiations. Full transparency, on the other hand, would mean publishing the now-secret negotiated rates for anyone to see.
“I think it’s the start of a much longer process,” Holt said. “It’s going to depend a lot on how much information is going to be required to be divulged and how that’s going to be collected.”
It’s almost certain that as soon as any concrete efforts at implementation are made, lawsuits will follow.
That’s what happened after Ohio passed a price transparency law in 2015 that required providers give patients information on out-of-pocket costs before a procedure — a proposal the executive order also puts forward.
The law still has not been enforced, as it has been caught up in the courts. The Ohio Hospital Association and Ohio State Medical Association sued over the law, arguing it was too vague and could lead to a delay in patient care.

Acer Therapeutics cut to Hold from Buy by Needham

https://www.benzinga.com/stock/ACER/ratings

Rockwell Medical started at Overweight by Cantor

Target $11

Krystal target upped to $73 from $48 by Guggenheim

Maintains Buy

Cannabidiol shows promise against superbug infections

Smoking marijuana is believed to reduce the body’s ability to fight infections. But cannabidiol (CBD), a compound extracted from cannabis, might work as a powerful antibiotic against certain drug-resistant bacteria, scientists in Australia have found.
BTX1801, a new CBD-based therapy being developed by Australian biotech Botanix Pharmaceuticals, is effective against several Gram-positive bacteria, including Staphylococcus aureus and Streptococcus pneumoniae, in lab dishes and animal models, according to a team led by Mark Blaskovich at the University of Queensland.
Results from the preclinical study were presented at the annual conference of the American Society for Microbiology in San Francisco.
Even at low concentrations, the drug showed action against a diverse panel of 132 clinical isolates of S. aureus, including the difficult-to-treat methicillin-resistant S. aureus (MRSA), the researchers reported. What’s more, the bacteria didn’t develop resistance to the drug after 21 days of continuous treatment. Such an industry standard, extended-exposure challenge often leads to resistance against common antibiotics vancomycin and daptomycin.
The drug was also effective in a mouse wound model of skin infection, according to Botanix.
The exact mechanism of CBD’s antibacterial effect isn’t 100% clear—researchers did notice that CBD disrupted biofilms that bacteria use to shield themselves from antibiotics. But results from a phase 1b study on Botanix’s other therapy, BTX1308, in psoriasis, offered some clues that may also be relevant to infections.
Based on skin biopsies collected from 10 of the 15 patients enrolled in the phase 1b study, Rockefeller University researcher Jim Krueger and colleagues found that the p38 MAP kinase pathway and interleukin-6 (IL-6), both key pathways known to be involved in psoriasis, were significantly lowered in treated with BTX1308.
“This anti-inflammatory and immune modulation activity potentially makes BTX 1308 a very important treatment option for patients, not only with psoriasis, but other skin diseases that have an inflammation and/or an immune response component,” Krueger said (PDF) in a statement.

Since GW Pharmaceuticals won the first FDA nod for CBD drug Epidiolex in epilepsy, the interest in marijuana-based drugs has been mounting. Kalytera Therapeutics, for one, is testing its CBD therapy in graft-versus-host disease in a phase 3 trial.
As antibiotic-resistant bacteria, or superbugs, quickly develop, there’s been an urgent need to add new weapons to the antibiotic arsenal. And investments have followed. Novo Nordisk’s holding company recently unveiled investments in three antibiotic resistance startups under its REPAIR Impact Fund. Each shop gets about $16 million of the fund’s $165 million pool for research into antibiotics and vaccines.
Botanix’s quest is still in early stages with only preclinical results. The biotech is now conducting research aimed at finding the best dosing strategy for clinical development of BTX1801, with a plan to target skin infections.
“The fact that cannabidiol kills resistant bacteria quickly, when combined with the drug’s newly validated anti-inflammatory properties, gives us confidence that BTX 1801 has significant potential as a powerful new antimicrobial for use in skin and other infections,” Botanix founder and executive director, Matt Callahan, said in a statement (PDF).

Novartis sells Colorado site to maker of CBD products

A Colorado company will make CBD products at this Sandoz site near Boulder that it bought from Novartis for $18.75 million. It is not Novartis’ first brush with the marijuana industry. (Mile High Labs)

A manufacturing facility that Novartis discarded because of declining generics sales is getting a new life. The plant near Boulder, Colorado, will be converted to produce CBD products from hemp by a company riding that wave.
Mile High Labs says it closed the deal last week, paying Novartis $18.75 million for the 400,000-square-foot Sandoz production facility in Broomfield, Colorado, which it intends to use to make private-label CBD products.
“This transaction is the largest infrastructure purchase in the history of the CBD market and it’s only the beginning for Mile High Labs,” Stephen Mueller, chief technology officer and founder of Mile High Labs, said in a statement. “Over the coming quarters, we plan to leverage this tremendous infrastructure to build the global center for CBD products manufacturing.”
CBD is cannabidiol, an extract from hemp—a cousin of marijuana—and is commonly used as a home treatment for a wide variety of conditions. .
Novartis declined to comment, but Mile High spokesman Christopher Lackner said the transaction closed June 19 and includes the land, labs, buildings and all of the drug manufacturing equipment.
He said the company expects to have the facility operational within months and have 100 employees there by the end of the year. It intends to make products at the plant that include tinctures, capsules, tablets, topicals and gummies.
Mile High also hopes to hire some of the 450 former employees of the plant. “There is a lot of great knowledge about the operation of that plant and about quality,” Lackner said. “We hope to draw on that.”
The Swiss drugmaker signaled its plans to close the Sandoz plant in 2017 after generics prices crashed in the U.S. and the company decided to remake its generics business to focus on higher-margin, complex copies. Meanwhile, the branded company is moving to take the lead in the gene therapy field, which requires an entirely different kind of production.
Novartis closed or sold eight facilities last year and is restructuring eight others to be more efficient, moves that led to nearly 2,000 job cuts. More cuts are expected over the next 18 months as Novartis transforms Sandoz into an “autonomous unit within Novartis.”
Novartis and Sandoz already have some experience with the medical marijuana industry, having struck a deal last year to distribute products for a Canadian company that sells medical cannabis products in its home country and in Europe.

Eisai’s Fycompa shows positive effect in late-state epilepsy study

Eisai (OTCPK:ESALY -0.4%announces positive results from an open-label Phase 3 clinical trial in Japan and South Korea evaluating FYCOMPA (perampanel) CIII as monotherapy in new onset or untreated patients with partial-onset seizures. The data were presented at the International Epilepsy Congress in Bangkok.
63% (n=46/73) of treated patients with partial-onset seizures experienced seizure freedom at week 26. 65% (n=31/48) of patients with secondarily generalized seizures were convulsive seizure free.
The most common adverse events in 68 patients were dizziness (27%), nasopharyngitis (13%), somnolence (13%) and headache (10%).
FYCOMPA is approved in 55 countries.