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Changes in Cardiac Device Coverage

CMS, the Centers for Medicare and Medicaid, has finalized its changes to its Medicare coverage of implantable cardiac devices, which should reduce the wait-times required to get the implantation procedure done and cut the regulatory burden for providers that use the devices for their patients.

This “is the first major change to Medicare’s implantable cardioverter defibrillator, or ICD, coverage in more than a decade. The CMS wants to reduce some of the barriers to care outlined in its most recent coverage determination, issued in 2005.

“The CMS is eliminating waiting periods for device implantation and dropping a policy that requires patients to be tracked in a registry.”

“It is also requiring shared decision-making, which the agency said would empower patients…

“The agency is also looking to hasten access to ICDs by allowing patients with an existing ICD who suffer a heart attack or undergo a coronary revascularization procedure to obtain a replacement device without waiting. Previously, the devices could not be implanted within 40 days of a heart attack or 90 days of bypass surgery or angioplasty…

“ICDs have been used since the 1980s, and the CMS began covering them in 1986. Initially, they were mostly used in patients with recurrent cardiac arrest who were not responsive to drug treatments. In 2005, the agency finalized coverage for primary prevention of arrhythmia.

“The devices are wired to the heart and deliver an electric shock if they detect an abnormal rhythm. They are a significant revenue driver for hospitals. It’s estimated that 10,000 ICDs are implanted every month, and the average hospital stay after placement is eight days. That generates an average of $12,423 in hospitalization costs per patient.”
Source: Virgil Dickson, Modern Healthcare.

Approved! Glucose Monitor: No Sticks

In what could be the a huge relief for millions in America with Type 1 or Type 2 diabetes- the FDA has approved the first glucose monitor that doesn’t require a person to stick themselves with a needle daily, or regularly, to keep an eye on their blood sugar levels.  This is a major advancement in the healthcare industry because of the potential ease of use, the lack of additional durable medical equipment like testing strips and needles.   Not to mention that this has the potential to monitor glucose over time more accurately than just taking a one-moment-in-time kind of measurement.  For more details click here.

FDA Approves Gene Therapy

WASHINGTON — Opening a new era in cancer care, U.S. health officials on Wednesday approved a breakthrough treatment that genetically engineers patients’ own blood cells into an army of assassins to seek and destroy childhood leukemia.

The Food and Drug Administration called the approval historic, the first gene therapy to hit the U.S. market. Made from scratch for every patient, it’s one of a wave of “living drugs” under development to fight additional blood cancers and other tumors, too.

Novartis Pharmaceuticals set the price for its one-time infusion of so-called “CAR-T cells” at $475,000, but said there would be no charge for patients who didn’t show a response within a month.

“This is a brand new way of treating cancer,” said Dr. Stephan Grupp of Children’s Hospital of Philadelphia, who treated the first child with CAR-T cell therapy — a girl who’d been near death but now is cancer-free for five years and counting. “That’s enormously exciting.”

CAR-T treatment uses gene therapy techniques not to fix disease-causing genes but to turbocharge T cells, immune system soldiers that cancer too often can evade. Researchers filter those cells from a patient’s blood, reprogram them to harbor a “chimeric antigen receptor” or CAR that zeroes in on cancer, and grow hundreds of millions of copies. Returned to the patient, the revved-up cells can continue multiplying to fight disease for months or years.

FDA Warning: Homeopathic Teething Products

“The U.S. Food and Drug Administration has issued a warning against homeopathic teething tablets and gels, recommending that consumers cease letting infants and children use the products because they pose health risks.

“Homeopathic teething tablets and gels are readily available online and in retail stores but have not been proven to offer any health benefits, said the agency.

“‘Teething can be managed without prescription or over-the-counter remedies,’ said Dr. Janet Woodcock, Center for Drug Evaluation and Research director of the FDA.

“Reports of adverse effects after use of homeopathic teething tablets and gels are being investigated by the FDA and more information will be provided to the public once available.

“Parents and guardians are advised to seek medical attention immediately if a child experiences agitation, difficulty urinating, constipation, skin flushing, muscle weakness, excessive sleepiness, lethargy, difficulty breathing or seizures after using a homeopathic teething tablet or gel.”  Source: Family Medicine Smart Brief

– See more at: http://www.techtimes.com/articles/180469/20161002/fda-warns-against-homeopathic-teething-tablets-gels-for-babies.htm#sthash.RIkqmcJJ.dpuf

VA Same Day Appts Coming

“Veterans will have same-day access to primary care appointments and mental health services at Veterans Affairs facilities by December, VA Secretary Bob McDonald promised Tuesday.

Addressing the Veterans of Foreign Wars national convention in Charlotte, North Carolina, McDonald said veterans wait an average of five days for primary care, six days for specialty care and two for mental health services, but VA plans to reduce those further by the end of the year.”  Source: Military Times.  For details click here.

Humana Announces ACA Reduction

“Starting in 2017, Humana will only sell individual plans in 11 states, compared with 19 states for this year, the Louisville, Ky.-based insurer said in a release Thursday. The ACA retreat was revealed in a company update to increase its profit estimates for the year.

“The reduction is even starker at a local level. Humana’s individual plans will be offered in “no more than 156 counties” next year, compared with 1,351 counties this year. Humana expects to collect anywhere from $750 million to $1 billion in premiums from its individual ACA plans in 2017, a reduction of almost 80% from the $3.4 billion premiums projected for 2016.

“Humana pre-recorded a $176 million loss on 2016 ACA plans in February, and the insurer added another $208 million in expected losses Thursday…

“Humana, like its for-profit competitor UnitedHealth Group, enrolled many people who were sicker than originally expected. UnitedHealth will participate in no more than three ACA marketplaces for 2017.

“The individual market represents a small fraction of revenue for Humana and UnitedHealth.”  Source: Modern Healthcare

DOD Changes Tricare Insurance

“The U.S. Department of Defense has awarded multiyear contracts worth $58 billion to Humana and Centene Corp. to manage Tricare, surprisingly booting incumbent health insurer UnitedHealthcare in the process…

“In 2014, the Defense Department and Defense Health Agency decided to alter the structure of the Tricare program, which provides health coverage for U.S. military members and their families. Instead of dividing Tricare into three regions (North, South and West), the government wanted to consolidate to two coverage areas (East and West).

“Humana, which had managed the South region, will now provide coverage for 6 million Tricare members in the new 32-state East region, essentially absorbing most of UnitedHealthcare’s members. Centene will gain the 21-state West region, which covers about 3.4 million people. Iowa, Missouri and Texas will include both companies.

“The contracts are expected to start April 2017, pending the appeals process.”  Source:  Modern Healthcare.

Dept. of Justice Has Filed Lawsuits

“The U.S. action is “an unfortunate and misguided step backwards for access to affordable healthcare for America,” Anthem said. “The DOJ’s action is based on a flawed analysis and misunderstanding of the dynamic, competitive and highly regulated healthcare landscape and is inconsistent with the way that the DOJ has reviewed past healthcare transactions. ”

“Cigna said it was “evaluating its options consistent with its obligations under the agreement” and said it doesn’t expect the transaction will close in 2016. “The earliest it could close is 2017, if at all.”  Source:  Health Benefits Pro Alert.

Anthem, Cigna, Aetna, and Humana all have strong suits as an insurance company such that, if merged and administered properly, could be beneficial to the market and to consumers.  The battle for increased competition has already been lost in Indiana and Kentucky with the Affordable care Act law.  It seems there is a need now to focus on efficiency among the insurers that do exist.  We will continue to watch this news at it develops.

Generic Rx for Crestor May Be Coming

“Pharmaceutical giant AstraZeneca failed to block approval of generics for its best-selling cholesterol drug after a federal judge tossed out the company’s request.

“A federal judge in Washington, D.C., denied the drugmaker’s request Tuesday for a temporary restraining order against the Food and Drug Administration in an attempt to prevent generic manufacturing of its drug Crestor. The ruling allows generic companies to officially manufacture generics of the drug.

“In an emailed statement, AstraZeneca said, “While we are disappointed with this decision, we appreciate the court’s careful consideration in addressing these important issues. We are currently assessing our options.”  Source: Modern Healthcare

Justice Dept. Continues Against Anthem & Aetna

“Officials with the antitrust division of the U.S. Department of Justice likely will file lawsuits this month to block Anthem’s $53 billion acquisition of Cigna Corp. and Aetna’s $37 billion deal for Humana…

“Federal intervention would overturn the rulings of many state insurance departments, most of which have approved the mergers…

“Both deals have faced immense scrutiny from hospitals, doctors and consumer groups in the 12-plus months since they were announced. Critics have argued the pursuits of Aetna and Anthem to bulk up would result in higher premiums and anti-competitive behavior. But the CEOs of Aetna and Anthem each have said their respective deals would lower healthcare costs and balance out the effects of increased consolidation among hospitals and health systems.  Source: Modern Healthcare.  For more details, Click Here.