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Theranos!While it may not be the biggest deaths in the history, it’s the biggest ever in the present decade.It is an American company based in Palo Alto, CA. Founded in 2003 by Elizabeth Holmes when she was just 19 after dropping out from Stanford University, with plans of revolutionizing the diagnostic test market. The company made headlines because of its fingerstick and small sample volume blood test technology. By 2014, the company had raised around $400 million in funding and valuated at $9 billion. The success of the company raised hopes of many biotech enthusiasts back then. And, Elizabeth Holmes topped the Forbes list of America’s richest self-made woman, with a net worth of $4.5 billion.So, what happened after that?Series of events during downfall:It was all started in 2015, when it hit with allegations that its tests are inaccurate. FDA (Food and Drug Administration) inspection reports from 2014 and 2015 stated that its containers for blood collection were "not validated under actual or simulated use conditions" and "were not reviewed and not approved by designated individual(s) prior to issuance". After the inspection, Theranos announced that it would voluntarily suspend its tests apart from the FDA-approved herpes simplex virus (HSV-1) test.Company records reviewed during the inspection showed that its California lab ran about 890,000 tests a year. The inspection found that Edison machines in the lab often failed to meet the company’s own accuracy requirements. In other words, Theranos may have put as many as 890,000 lives per year in jeopardy with its fake technology.The Arizona Department of Health Services reported issues with the company's Scottsdale lab meeting regulations in October 2015.In January 2016, the Centers for Medicare and Medicaid Services (CMS) sent a letter to Theranos based on an inspection of its Newark, California lab in the fall of 2015, reporting that the facility did not "comply with certificate requirements and performance standards" and caused an "immediate jeopardy to patient health and safety" due to a test to determine the correct dose of the blood-thinning drug warfarin.In March 2016, CMS regulators announced plans to enact sanctions that included suspending Holmes and Balwani from owning or operating a lab for two years and that they would revoke the lab's license.Walgreens and Capital BlueCross announced a suspension of Theranos blood tests from the Newark lab.In May 2016, Theranos announced that it had voided two years of results from its Edison device.The company announced that about 1 percent of test results had been voided or corrected from its proprietary machines in June 2016.Present situation:Now, Therano’s shares are not traded in stock market. In June 2016, Forbes magazine consulted VCs, analysts and industry experts and came to a conclusion that the realistic valuation for Theranos would be $800 million. Since Theranos' VC investors own preferred shares, they would get paid back before Holmes. This would imply Holmes' shares are virtually worthless. At such a low valuation, Holmes’ stake is essentially worth nothing.On January 6, 2017, Theranos announced that it had laid off 41% of its workforce, or approximately 155 people. This is following prior events in October of 2016 where the company fired 340 people following the closure of its Wellness Centers. The company also faced lawsuits from several different entities including Walgreens and the Arizona Attorney General.In January 2017, the Wall Street Journal reported Theranos is closing down the last remaining blood-testing facility after the lab reportedly failed a second major U.S. regulatory inspection.References:Theranos - WikipediaFrom $4.5 Billion To Nothing: Forbes Revises Estimated Net Worth Of Theranos Founder Elizabeth HolmesThe Rise and Fall of TheranosElizabeth Holmes Admits Theranos' "Technology" Is A Fraud: Restates, Voids Years Of Test ResultsThank you.

I can’t speak as to how things are recently but think readers might be amused at the following true story (I was far from amused at the time):About 30 years ago I had a patient in Kentucky who had lung disease from working in a coal mine and required oxygen. The Black Lung Act had been passed in 1972 and supposedly the dept of labor would pay for the home oxygen. Prior to getting approval I had to produce the following items (I’m not making this up):The original lab slip the blood gas showing low oxygen was reported on - NOT just the results, but the original report itself (this was before we had oximetry)The name of the respiratory technician drawing the blood gasThe time it took to get the sample from the patient to the analyzerThe last time the analyzer had been calibrated before the test was runA copy of the calibration manual of the blood gas analyzerThe height above sea level of the analyzerThe barometric pressure when the gas was runThe handwritten signature of the doctor running the laboratory when the blood gas was analyzed.I collected all this data and received approval for oxygen for three months. The patient expired before I had to run through all this bullshit a second time. It sounds funny now, but I was furious at the time.At about the same time a local MD received a letter from Medicare delaying payment for the last week of a patient’s hospitalization because they could “find no evidence in the medical record that the patient belonged in the hospital”. The patient in question was in the ICU for the last week of hospitalization, where he died. The doctor responded to the letter by copying the death certificate and in bold red ink writing on it, “Just how damn sick do you have to be?” This was a mistake. The bill was paid but the doctor got put on “intensive review” by Medicare. I had a few similar letters but a polite letter back explaining things usually resulted in a quick resolution of bills by Medicare. I really think the medicare reviewers were swamped and not trained adequately in these situations but that’s just an opinion. I have no idea how things are now.

A federal inspection report said a Theranos Inc. laboratory ran an important blood test on 81 patients in a six-month period despite erratic results from quality-control checks meant to ensure the test’s accuracy, people familiar with the report said.The report hasn’t been publicly released but is far more detailed than the letter that summarized the results of last fall’s inspection of the Newark, Calif., lab by the federal Centers for Medicare and Medicaid Services and was sent to Theranos in late January, these people said.That letter cited “deficient practices” in five categories. In one of them, hematology, the problems found by inspectors posed “immediate jeopardy to patient health and safety,” regulators said.The test that inspectors found Theranos kept doing despite the erratic quality-control results was a hematology test that measures how long it takes blood to clot, the people familiar with the matter said.The test is an important part of the treatment regimen for patients who are at risk of strokes or have blood disorders.Inaccurate results from the test can be especially serious for patients taking blood thinners such as warfarin, also known by its brand name Coumadin. Too much warfarin can cause fatal bleeding, while too little can leave patients vulnerable to clots and strokes, according to medical experts.People who have seen the Theranos inspection report said it seems to indicate the company ignored quality-control results for the blood-clotting test that fell short of its own criteria.The results produced in the quality-control checks repeatedly deviated from the lab’s typical result by more than two standard deviations, those people said.The erratic quality-control results occurred between April 1 and Sept. 23, 2015, the people said. Despite those problems, inspectors found that Theranos sent blood-test results to the 81 patients, according to the people familiar with the report.“We have conducted assessments to identify any patients affected or having the potential to be affected by the issues identified by CMS, and we have no reason to believe that these issues have affected patients’ health,” said Kingshuk Das, director of Theranos’s lab in California.Dr. Das added: “At its heart, the CMS report is about people and processes in one Theranos lab in the past, and does not reflect the current state of that lab.” Theranos, based in Palo Alto, Calif., and one of the highest-profile startups in Silicon Valley, was founded by Elizabeth Holmes and has another lab in the Phoenix area.Theranos spokeswoman Brooke Buchanan said: “The PT/INR issues identified by CMS related to tests run on conventional equipment using venipuncture samples.” A CMS spokeswoman declined to comment.Some deviation in quality-control test results is normal, and labs set their own ranges for how much variation to tolerate, lab directors said. Most laboratories use the two-standard-deviation criterion, according to those lab directors.To ensure the accuracy of the blood-clotting test, called “prothrombin time,” labs typically run several quality-control checks each day. These checks often involve performing the test on a sample of preserved blood plasma with a predictable result to see if the lab’s test matches the expected outcome.The Theranos lab was using machines made by Siemens AG to perform the prothrombin time test, people familiar with the report said. To help gauge accuracy, the lab used a preserved blood product from Siemens called Ci-Trol Coagulation Control Level 3.Labels for Siemens prothrombin time testing products recommend that labs that see aberrant quality-control results refrain from reporting patient data until documenting and correcting possible problems.At Theranos, there were seven quality-control failures in a single day, said a person familiar with the report.The agency’s findings for the blood-clotting test were detailed in a section of the inspection report titled “Failure to Ensure that QC Test Results Met the Lab’s Criteria for Acceptability,” according to the people who saw the report.Timothy Hamill, professor emeritus at the University of California, San Francisco’s department of laboratory medicine, said continuing to test live patient samples despite repeated quality-control failures is a serious breach of the protocols used by labs to ensure test accuracy.Dr. Hamill said any doctors who received prothrombin time test results from the Theranos lab during the six-month period shouldn’t rely on them and should have their patients retested as soon as possible. “Those results are not worth anything,” he said.Ms. Buchanan of Theranos said the company “has notified any potentially affected patients.”Vanderbilt University cardiologist Christopher Ellis said inaccurate results could lead doctors to increase or decrease warfarin doses. Such changes would likely be made cautiously, he added, and an inaccurate test result wouldn’t necessarily result in harm to the patient.Still, some patients are predisposed to respond more dramatically to the drug than other patients, and even small dosage changes based on faulty tests could be dangerous, he added.The federal inspectors also concluded that the Theranos lab in California used expired reagents, or substances added to blood samples to elicit chemical reactions, for some prothrombin time tests, according to the people familiar with the inspection report.Those people said the report also found that the lab’s director didn’t have responsibility for the lab’s quality-control program and the lab’s quality-control manager was unqualified. Theranos has since hired Dr. Das as a new lab director.CMS warned Theranos in late January that the California lab could lose its certification if it didn’t remedy the problems promptly. The agency is reviewing a formal plan of correction submitted by Theranos last month.The company has asked CMS not to publicly release the inspection report on the grounds that doing so would compromise Theranos trade secrets, according to people familiar with the company’s position. The agency usually makes inspection findings public after a period of time.