Immunotherapy drug shows favorable safety profile in patients with advanced small cell lung cancer

The immunotherapy drug pembrolizumab has demonstrated a favorable safety profile and “promising durable clinical activity” in pretreated patients who exhibit high levels of the PD-L1 protein in advanced stages of small cell lung cancer (SCLC) – an aggressive form of the disease

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Eye surgeon offers tips for safe viewing of solar eclipse

On Monday, Aug. 21, a total solar eclipse will offer a rare -; although brief -; sight to millions when the sun disappears fully behind the moon. An otherwise bright summer sky will give way to total darkness.

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Nanobioelectronics to treat bacterial infection in the stomach

Nanotechnology has made another breakthrough at the University of California San Diego. For the first time the researchers have shown that micromotors or microscopic robots could be used to treat a bacterial infection in the stomach in mice models win the laboratory.

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Researchers discover new brain area involved in spatial memory and navigation

Navigation in mammals including humans and rodents depends on specialized neural networks that encode the animal’s location and trajectory in the environment, serving essentially as a GPS, findings that led to the 2014 Nobel Prize in Medicine.

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Liquid biopsies show potential use for cancer screening

A new study has shown the potential of analyzing cell-free DNA (cfDNA) present in patients’ blood for cancer markers in early cancer detection. This technique was used in some instances for patients who already were diagnosed with a cancer as reported by some studies.

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New study aims to provide clarification on concurrent surgery of mitral and tricuspid valves

Insufficiency (leakage) of the mitral valve in the left side of the heart can also lead to tricuspid valve insufficiency in the right side of the heart.

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Medicare Claims Appeals: D.C. Circuit Reverses and Remands in Case Seeking Relief From Processing Delays

Summary of AHA v. Price, 2017 U.S. App. LEXIS 14887 (D.C. Cir. Aug. 11, 2017)

 

On August 11, 2017, the D.C. Circuit reversed the district court and held that the district court abused its discretion by ordering the Secretary of HHS to clear the backlog of administrative appeals of denied Medicare reimbursement claims within four years, because it failed to seriously test the Secretary’s assertion that this result was impossible. The underlying action demanded relief to address the Secretary’s inability to keep up with “an unexpected and dramatic uptick in appeals [that] produced a jam in the process” starting in fiscal year 2011.

In the initial proceedings, a group of hospitals sought a judicial order compelling the Secretary to provide relief from what they considered to be unreasonable delays in resolving Medicare claims appeals at the administrative appeals level.  The federal district court for the District of Columbia granted the Secretary’s motion to dismiss for lack of jurisdiction, but the D.C. Circuit reversed. The Circuit Court remanded the case back to the district court, with instructions to consider the merits of appeal, i.e., whether relief should be granted and if so the form of the relief.

The Four-Year Plan to Reduce the Backlog

In addressing the merits of plaintiffs’ allegations on remand, the district court adopted the hospitals’ so-called four-year plan and ordered the Secretary to reduce the current backlog of cases pending at the Administrative Law Judge level by 30% by the end of 2017; 60% by the end of  2018; 90% by the end of 2019; and 100% by the end of 2020.  The Secretary then appealed the district court’s order to the D.C. Circuit.  On appeal the Secretary argued that it would be impossible to comply with the timetable, because the only means of meeting the timetable would be to pay claims through mass settlements regardless of their merits, which (according to the Secretary) would be in violation of the Medicare statute.

Without finding whether in fact the Secretary would be unable to lawfully comply with the district court’s order, the D.C. Circuit held that because the Secretary represented that lawful compliance with the district court’s order was impossible, the district court committed reversible error by ordering the Secretary to comply with the timetable without first finding that lawful compliance was indeed possible. The Circuit Court also held that it was an error for the district court not to evaluate the Secretary’s assertion that the timetable would increase, not decrease, the number of backlogged appeals, because the timetable would generate an incentive for claimants to file additional appeals and hold out for big payouts.

The Case is Remanded to District Court to Determine Feasibility of Compliance Timetable

The D.C. Circuit therefore remanded the case again to the district court and ordered the district court to determine whether the Secretary’s compliance with the timetable is impossible. However, the Circuit Court noted that the Secretary will bears a “heavy burden to demonstrate the existence of an impossibility.” The Court further noted that if the district court finds on remand that the Secretary failed to carry his burden of demonstrating impossibility, it could potentially reissue its order without modification.

What Does this Decision Mean for Hospitals?

Many Medicare coverage appeals involve a hospital appealing the denial of a short stay on the basis that admission was not medically necessary, and that the patient could be treated as an outpatient. However, because CMS does not allow hospitals to rebill under Part B (except during the one year period following discharge, which in the majority of cases will have expired long before the RAC reopens and denies the inpatient claim), hospitals  believe that they have no choice but to appeal. It is important to keep in mind that although the D.C. Circuit faulted the district court for not considering the issue of whether the Secretary could legally comply with the prescribed timetable, the fact that the Secretary will bear the burden of proof on this issue may mean that the district court may end up issuing the same type of relief as it did before.

We will be following this case as the district court determines whether the Secretary’s compliance with the timetable is legally possible and will follow up once a decision is rendered.

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Alaska’s Telemedicine Business Registry: What You Need to Know

telemedicine business registry

Alaska’s Department of Commerce, Community, and Economic Development has finalized new regulations to create a special Telemedicine Business Registry for health care providers delivering telemedicine services in the Frontier State. The regulations in Title 12, Chapter 02 of the Alaska Administrative Code were effective on April 28, 2017 and implement provisions of Alaska SB 74 that was signed into law last summer.

Under the regulations, companies must be registered with the telemedicine business registry before providing telemedicine services to patients located in Alaska. To register, a business performing telemedicine services must submit an application and registration fee. A telemedicine company operating under multiple names to perform telemedicine services must file a separate registration for each name.

If the name, address, or contact information of a business on the telemedicine business registry changes, the business performing telemedicine services must submit a Business Registry Change Form within 30 days of the change.

A business that fails to comply with the regulations section in a timely manner may not perform telemedicine services in Alaska and must submit a new application to the telemedicine business registry before resuming telemedicine services.

Telemedicine companies and health care providers offering services in Alaska should be mindful of these developments. We will continue to monitor Alaska for any changes that affect or improve telemedicine opportunities in the state.

For more information on telemedicine, telehealth, and virtual care innovations, including the team, publications, and other materials, visit Foley’s Telemedicine Practice.

 

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Cancer treatment with alternative medicine can double risk of dying: Study finds

A new study has found that patients who choose cancer treatment with alternative medicine more than double the risk of dying in five years compared to those who chose conventional cancer treatment for the treatable cancers. The study is published in the Journal of the National Cancer Institute.

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Evidence that cannabis use helps pain or PTSD is lacking, say researchers

Scientific evidence reporting on the use of cannabis for the treatment of chronic pain or post-traumatic stress syndrome (PTSD) is too limited to conclude its safety or efficacy, say researchers from the US Department of Veterans Affairs (VA).

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