CALL TO ACTION: OKlahoma Independent pharmacists!!!

CALL TO ACTION: OKlahoma Independent pharmacists!!! (If I tagged you please share with your network of pharmacists!) I heard a great quote from Greg Reybold, “Everyone wants to fight until it is time to fight.” Well…. OKlahoma independent pharmacists now is as good of a time as any to get in this fight. PBMs are winning the fight in OKlahoma, and we need your help to turn the tide. We need your help

Is this who you are putting your health/live in their hands… hoping they fill your Rx correctly ?

Is this what happens when a highly automated mail order facility – HITS THE WRONG BUTTON ?

 

Nursing home whistleblower over NH deaths and COVID-19 vaccinations ?

Racial EQUITY: CVS workshop tells employees to hold each other ‘accountable’ for ‘non-inclusive’ acts

CVS workshop tells employees to hold each other ‘accountable’ for ‘non-inclusive’ acts

https://www.foxbusiness.com/politics/cvs-inclusion-training-critical-race-theory

FIRST ON FOX: CVS Health is holding a “conscious inclusion workshop” that aims to teach employees how to hold each other “accountable” for non-inclusive behaviors, FOX Business has learned.

An internal email obtained by FOX Business showed David Casey, SVP of Workforce Strategies and Chief Diversity Officer, discussing the four-week program. The first three weeks included 20-30 minutes of self-study per week, leading up to a two-hour virtual workshop in the fourth.

In the email, Casey continues by outlining different “skills” employees will build during the workshop’s fourth week. Those included: “Identify unconscious bias in your day-to-day interactions and experiences,” “[d]emonstrate bravery by speaking up and having difficult conversations when observing non-inclusive behaviors,” and “[c]ommit to holding yourself and your colleagues accountable to consistently embrace diversity of all kinds, and take swift action against non-inclusive behaviors.” 

Joseph Goode, who serves as CVS’ senior director for corporate communications, told FOX Business on Tuesday the “workshop was announced in July 2020 as part of our nearly $600 million commitment to address racial inequality.” He added that “our stated goal is 100 percent employee participation.”

It’s unclear how employees would be held accountable and CVS did not comment when asked about this. However, the language seemed to touch on concerns about institutions pressuring people to adopt or advocate certain beliefs.

A CVS Health employee, who spoke on the condition of anonymity, told FOX Business they took offense at the implications behind the training.

“I was brought up to judge people in their actions, not their skin color or anything else,” the employee said. “I’ve tried hard not to throw people into categories and then treat them as the worst in said category. Just as someone unfairly judged should be incensed about that judgement, I’m mad about the assumption being made that I judge people just based on looks or where they’re from, and that I need fixing.”

Chris Rufo, who is currently rolling out a series of reports about trainings at major corporations, told FOX Business on Tuesday that CVS’ program was based on “pseudoscientific nonsense.”

“And what does CVS mean by ‘swift action against non-inclusive behaviors’?” he asked. “Will they suddenly tolerate the expression of conservative, traditional, or religious beliefs in the workplace? Of course not. Corporate inclusion is a farce, inspired by ideologues and implemented by morons. CVS is simply another company who has bought the snakeoil of ‘DEI.’”
President and CEO Larry Merlow said last year his company’s $600 million investment would “harness the strength of that diversity and focus on the areas where we can have the greatest impact.”

Besides corporationwide trainings, the company intended to “expand [m]entoring, sponsorship, development and advancement of diverse employees.” The company’s press release highlighted other initiatives as well, such as building on its “supplier diversity” program. According to its website, that program focuses on “partner[ing] with our business units to integrate supplier diversity into procurement activities, and with national organizations to identify and develop diverse businesses.”

Last year’s investment was a part of the company’s overall inclusion efforts. CVS’ 2020 Corporate Social Responsibility Report claims that “senior leaders” completed “conscious inclusion training” late in the year. In early 2021, the training was introduced to vice presidents and colleagues and the company began rolling it out to other employees in June.

The report reads: “Developed in collaboration with leading third-party experts, the program explores the science of bias and where and how it shows up in our business, and it facilitates the development of personal action plans for inclusion.”

Under “communicating gender identity,” the corporation said it started optional inclusion of pronouns on email signatures and business cards. The report added that it used a field research study to “gather more feedback from colleagues and customers on the use of pronouns on colleague name badges” in retail pharmacies. 

A CVS spokesman said the loss of 7,000 doses of controlled substances at CVS stores is not a major problem

cvs-2.jpgCVS Lost More Controlled Substance Doses Last Year Than All Other Mass. Pharmacies Combined

https://www.wgbh.org/news/local-news/2021/08/24/cvs-lost-more-controlled-substance-doses-last-year-than-all-other-mass-pharmacies-combined

Nearly 7,000 doses of controlled substances went missing last year from CVS stores in Massachusetts — almost 70% of all drug doses lost by Massachusetts pharmacies last year, according to records obtained from the Massachusetts Board of Registration in Pharmacy.

CVS is the largest pharmacy chain in the state; Walgreens, its next largest competitor, lost about 1,300 doses from its pharmacies last year. In all, more than 10,000 doses of controlled substances went missing from all Massachusetts pharmacies in 2020.

The missing controlled substances from the CVS stores include oxycodone (brand name: OxyContin), amphetamine (Adderall), methylphenidate (Ritalin), morphine (Roxanol), methadone (Dolophine) and fentanyl (Abstral), all of which are extremely addictive. The missing controlled substances from the Walgreens stores include most of the same drugs.

“Anything more than zero is too much,” said Dr. Manuel Pacheco, a psychiatrist specializing in addiction psychiatry at Tufts Medical Center in Boston.

The lost — or stolen — pills can be extremely lucrative. The street prices of these drugs are significantly higher than what they go for in a pharmacy. One fentanyl patch, for example, purchased from the local pharmacy will cost $9.40; from a local drug pusher it’s $40. OxyContin dispensed at a pharmacy runs $6.50 a tablet; on the street, $15 apiece.

But Pacheco said lost pills are not the primary way people illegally obtain medications.

Pharmacies are required to adhere to rigorous procedures for keeping track of controlled substances, such as maintaining a perpetual inventory of the most addictive controlled substances, which include oxycodone and morphine. Yet the disciplinary reports from the pharmacy board reveal that in most cases CVS and Walgreens had no idea how the drugs vanished from their shelves.

A CVS spokesman said the loss of 7,000 doses of controlled substances at CVS stores is not a major problem.

“We have stringent policies and procedures in place to help prevent the loss of controlled substances, as well as to help detect it when it occurs,” CVS spokesman Michael DeAngelis said. “Drug diversion is typically discovered through our own internal processes and investigations. … We operate well over 400 pharmacies in Massachusetts.” Compared to other pharmacies, he said, “the number of controlled substance loss incidents we had last year was extremely low.”

CVS lost an average of 16 pills for each of its 420 stores in Massachusetts, while Walgreens lost an average of about 5 for each of its 245 stores. DeAngelis did not respond to follow-up inquiries about the disparity.

A Walgreens company spokesman declined to comment.

When Todd Brown, vice chairman of the Department of Pharmacy and Health Systems Sciences at the Northeastern University School of Pharmacy, was told of the large amount of missing controlled substances at a Massachusetts chain pharmacy, he said. “I know who it is — it’s CVS.”

“Historically, CVS has had a problem with missing controlled substances for some time now,” Brown said. “I don’t know why they can’t figure out a way to rectify everything. It’s not that complicated. The fact that you’re seeing one company continually having these issues means that they’re not exercising proper control. They’re simply treating the losses as a cost of doing business.”

CVS stores have been cited by the state pharmacy board for many years for the loss of controlled substances — ranging from five times in 2017 to 19 times in 2020. And Massachusetts is not the only place where CVS has had problems losing controlled substances. In New York, for example, CVS had to pay the federal government $1.5 million in 2018 after an investigation determined that the company failed to report the loss of controlled substances. In California, CVS shelled out $5 million in 2017 to the feds for various violations, including the loss of controlled substances.

John Burke, the president of Pharmaceutical Diversion Education in Ohio, said that the pharmacy board needs to get tough with pharmacies where controlled substances are disappearing.

“They need to clamp down hard by ramping up the penalties,” he said. “If I were running the board, I would call in the most senior pharmacy executive in the company and say, ‘Listen, here’s what you’ve done and not done. You’ve got to change this or there’s going to be drastic measures taken, even going so far as suspending the privilege of dispensing drugs.’”

Northeastern’s Brown also said that CVS is chronically understaffed, which often contributes to the loss of controlled substances. “Understaffing allows individuals to divert medications more easily because the rest of the staff in the pharmacy is busy trying to get everything done,” he said.

The pharmacy board has a wide range of punitive options available that it can impose on pharmacies and pharmacy personnel who commit controlled substance violations, including reprimands, censures, suspensions, revocations, probations, advisory letters and fines.

Of the board’s 70 total disciplinary and related actions against pharmacies, pharmacists and pharmacy technicians in 2020, more than half involved CVS and Walgreens, including

  • Nineteen CVS and 15 Walgreens stores that were issued reprimands, put on probation, or given stayed probation;
  • One CVS pharmacist who voluntarily surrendered his license;
  • Four CVS and three Walgreens pharmacy technicians whose licenses were revoked or voluntarily surrendered.

The executive director of the state pharmacy board, David Sencabaugh, refused multiple requests for an interview through a spokeswoman.

Some CVS and Walgreens stores were repeat offenders. CVS stores located in Natick and Northampton, for example, were both cited twice last year for the loss of controlled substances, as were the Walgreens stores in Attleboro and Beverly.

Not all pharmacy chains have the same degree of losses in the state. Stop & Shop, which has 83 pharmacies in Massachusetts, lost 550 units of controlled substances in 2020, while Rite Aid, with 10 stores here, lost 61 doses. The 48 Walmart stores in Massachusetts did not lose any controlled substances.

Of the 240 independent pharmacies in Massachusetts, two — Apothecare in Brockton and Preferred Pharmacy Solutions in Haverhill — were cited by the pharmacy board for controlled substances violations.

Burke, the expert on drug diversion, says it may be time to get tough not just with the pharmacies where the controlled substances go missing, but with the board itself. “Maybe the pharmacy board members themselves don’t take the losses seriously enough,” he said. “If that’s the case, then you need to find the right people who will take it seriously.”

The Opioids Crisis: Don’t TAX Pain Patients To Treat Opioid Addiction

For starters, I am rather disappointed with one of the authors of this article  Kate M. Nicholson, she is a chronic pain pt and a civil rights attorney and in this article it is reported that 93,000 drug overdose deaths in 2020- which includes an estimated 15,000/yr deaths from the use/abuse of NSAIDS – mostly from GI bleeds and untold number of other drugs – legal and illegal….. and in the article stated that OD’s were largely due to Fentanyl – not ILLEGAL FENTANYL…according to Wikipedia there is some 400 known fentanyl analogs and ONLY ONE ANALOG is FDA legal for human use.  Historically, bureaucrats have used what they considered “socially unacceptable behavior” as a vehicle to generate tax revenue.  Just look at the sin taxes that have been added to Tobacco, Alcohol, Gambling over the years.  After nearly a half century of damning Marijuana as a DANGEROUS DRUG and ILLEGAL… 40 states have not legalized it use in some form or another. Some states – like Ohio – apparently decided that MJ was going to be a sizeable revenue stream and established taxes and fees on all segments of the MJ growing/distribution system that ONE OUNCE of MJ in Ohio is abt FOUR TIMES what it is in Colorado. BUT… MJ is still ILLEGAL at the Federal level.

I find it interesting that Senator Manchin introduced this bill whose Daughter, Heather Bresch, was CEO of Mylan… at one time a large pharma that produced opiate dosing,  before the company merged with another and the WV plant was closed – 1400 workers lost their job and operations was moved to India and Australia.  One would think that these 11 Senators would take notice what happened when NY implemented a opiate tax… the state of NY largely became a opiate desert.  The taxes and fees were imposed on the pharma and wholesaler and while they could pass those taxes and fees along to the pharmacies, the insurance companies/PBM would not reimburse the pharmacy for those added costs of those opiate to the pharmacies…. so pharmacies stopped ordering and/or filling opiate Rxs for Rxs that were being paid for by the pt’s insurance/PBM.  How many other pts dealing with chronic diseases are being taxed to treat others dealing with a related chronic disease ? Why doesn’t the bureaucrats use the taxes generated from sin taxes on Alcohol, Nicotine, Gambling to help fund the treatment of those dealing with various mental health issues of addictive personalities ?

 

The Opioids Crisis: Don’t Punish Pain Patients To Treat Opioid Addiction

https://washingtonmonthly.com/2021/08/19/the-opioids-crisis-dont-punish-pain-patients-to-treat-opioid-addiction/

Why a sin tax on opioids is not like a sin tax on sugary drinks.

The U.S. is suffering not one epidemic, but two: The opioid crisis continues to rage through the Covid-19 pandemic. In 2020, opioid deaths surged 30 percent to 93,000, the Centers for Disease Control (CDC) just announced, due largely to fentanyl, a potent synthetic opioid trafficked from Mexico and China. Federal action to help Americans combat substance abuse is urgently needed.

But a sin tax imposed in a new bipartisan Senate bill, The Life Budgeting for Opioid Addiction Treatment (LifeBOAT) Act, is sorely misguided, robbing pain patient Peter to treat addiction patient Paul.

Introduced by Senator Joe Manchin (D-West Virginia), along with ten co-sponsors including Senators Mitt Romney (R-Utah), Elizabeth Warren (D-Mass.), and Amy Klobuchar (D-Minn.), the bill would establish a tax on sales of opioids (“stewardship fee”) of one cent per milligram. The revenue would be earmarked to fund drug treatment.

New York State tried an opioid sin tax; the results were not encouraging. In 2019, it imposed taxes and fees on opioid manufacturers and pharmaceutical distributors that deliver opioids to pharmacies and hospitals.  According to Kaiser Health News, “scores of manufacturers and wholesalers stopped selling opioids in New York,” among them Epic Pharma, a manufacturer, and Independent Pharmacy Cooperative, a wholesaler. AvKARE and Lupin Pharmaceuticals no longer ship to New York.

Unable to recover their higher costs from insurers, some pharmacies raised prices, while others ceased carrying the medication altogether. Pain patients who relied on these medications struggled to fill their prescriptions.

A tax of one cent per milligram might not seem prohibitive, but the tax will cost many patients hundreds if not thousands of dollars per year. Roughly one-third of people receiving opioids in the U.S. take a daily dose of 90 mg or higher, according to data from IQVIA. With 5.4 percent of all adults taking opioids for long-term pain, millions of people will pay a surcharge for their care.

Such fees have proved much more effective at reducing access to pain medications than at raising revenue for drug treatment. New York’s anticipated $100 million fell short by seventy percent in 2020. A similar tax imposed by Delaware in 2019 generated $1 million in one year, a slow start to the $8 million projected by 2022.

A sin tax on opioids is different from, say, a sin tax on sugary drinks to subsidize insulin costs for people with diabetes. Ginger ale is not a medical product; Percocet, Vicodin, and morphine are.

Taxing opioids would compound pre-existing barriers that legitimate medical users must surmount to get pain relief. Guidelines issued in 2016 by the CDC were widely misinterpreted by physicians as a federal mandate to reduce opioid medication or cut patients off altogether, as the agency itself has acknowledged. One survey found that 71 percent of patients with chronic pain were getting a lower dose or were cut off completely. Eight out of ten said their pain and quality of life were worse.

The barriers imposed on pain patients have been called a “humanitarian crisis” by Human Rights Watch. The American Medical Association has also raised alarm about the harm to patients who require opioids.

Opioid taxes might even undermine the bill’s goal of fighting addiction by pushing users into the cheaper black market. In a 2021 online survey of nearly 4,000 pain patients, nine percent reported seeking opioids illegally when they were unable to obtain their medication through normal medical channels – risking addiction in the process.

No one can dispute that the aggressive marketing conducted by OxyContin-maker Purdue Pharma did the country significant damage. Nor the harm done when providers routinely prescribed an entire month’s supply of pills for short-term pain. But excessive prescribing declined 60 percent between 2011 and 2020. That didn’t keep the overdose death rate doubling over the same period, driven overwhelmingly by illegally-produced fentanyl. Politicians seem to have conflated the corporate misbehavior of Big Pharma with the problem of pain itself, which afflicts 50 million Americans and disables nearly 20 million.

Some patients who use prescribed opioids might benefit from other forms of pain management, but many alternatives are not widely available and are poorly covered by insurers. Doctors treat patients with the tools they have, not those they wish they had.

Drug treatment for opioid addiction is needed urgently, but Congress can and should fund it from other revenue sources. On July 29, the House passed a 2022 appropriations bill (awaiting Senate action) that would increase by more than 50 percent funding for the Substance Abuse Prevention, Treatment and Recovery Block Grant, and boost funding for other treatment programs. That’s a much better approach. People battling addiction need our help, but pain patients need it, too. The lifeboat is big enough for both.

 

I have no way to verify this – but – it could explain a lot of deaths and blood clotting has been mentioned as a problem before

Tell Washington To Protect Medicare – unless you want a for profit insurance companies deciding what care you can get

This is MORE than just getting rid of Medicare Part D. Right now, the FEDS are at fiscal risk for the cost of covered services by Medicare parts A&B. Medicare Part D is provided by FOR PROFIT INSURANCE COMPANIES.  There seems to be nothing mentioned in this to suggest that Medicare ADVANTAGE is going to be changed or eliminated…. and that Medicare prgm is provided by FOR PROFIT INSURANCE COMPANIES and typically provides coverage for medications.

So many pts will have no choice but to move over to a Medicare Advantage prgm, to get their necessary medications covered…. to some degree.

When Obama first proposed Obama Care… Medicare Part D copays were suppose to gradually change until in 2020… it would be a 80%/20% payment schedule- for all medications… SURPRISE… when 2020 Part D info was released for open enrollment for 2020… we got notified that we would have a NEW $435 annual deductible.  For years, – 2006 for Barb – we had Silver Scripts… which is now owned by CVS Health and uses Caremark as the PBM – which CVS Health also owned.

In using the Medicare website to check for other Part D providers… I discovered that Silver Scripts had been financially SCREWING US… Human Part D estimated that our costs would be much lower… in reality, in 2020 our total out of pocket copays – including the $435 deductible that we did not have in 2019  — was MORE THAN HALF than Silver Scripts charged us in 2019 with NO DEDUCTIBLE… Human’s premium was abt $1.00/month more …  We are taking the same meds and using the same independent pharmacy.

Generally with Medicare Advantage prgms, they have limited networks of providers ( prescribers, pharmacies, labs, hospitals ) none could be providers that you prefer to use. You use a “out of network provider” your copay or deductible could be DOUBLE or TRIPLE what you have to pay by using a in network provider or get no coverage at all.

What happens if the reimbursement that the Medicare Advantage program drops the $$$ that they offer a prescriber is “too low” and they claim that >50% of practicing prescribers are 55 + y/o and decide to retire.  All of a sudden mid-level practitioners ( ARNP, NP, PA, PharmD) before the primary care provider….  After all, mid-levels currently get reimbursed at abt 85% of what a MD would get paid for the same/similar service/treatment.

What would happen if/when 10% or so of Medicare folks remain on Part A&B, could Congress just tell them … Medicare Part A&B will cease to exist as of a certain date… chose a Medicare Advantage prgm by a certain date or we will assign you to one.

Then there are Medicaid pts…. most are getting their medications via a Part D prgm.. are the states going to have to reinvent “the wheel” or just go along and put all their Medicaid folks into a Medicare Advantage prgm – and then we would have > 50% of the population covered by Medicare Advantage prgm.

We have, at most. a handful of insurance companies controlling the vast majority of health insurance coverage/policies.

what happens if Congress mandates that everyone MUST HAVE HEALTH INSURANCE and EVERYONE will pay a certain percent of the gross income for a Medicare Advantage prgm… that would make those who think that the RICH SHOULD PAY MORE…  that would be a VERY PROGRESSIVE TAX and another step toward a national health insurance. Do you know these 3 Tips for Driving Through Heavy Construction? Find more about insurance plans here.

The last segment is the companies that are self insured ( ERISA ) prgms… as the FEDS won’t increase what they pay these Medicare Advantage … they may increase what they pay by 2%-3% when overall medical care cost is increasing 6%-8%… so these insurance companies will have to look at their internal overhead costs…  They may have to come to the conclusion that they are going to have to increase their administrative costs to manage self insured programs… or elect to get out of that service all together and give these self funded programs to sign their employees up to a Medicare Advantage type program or tell the large employer to manage their program themselves.

The graphic at the bottom of this post show where the “lion’s share” of the $$$ when a pt gets a Rx filled at their local pharmacy.

We have to remember that all it takes is one earthquake to create a tsunami and one “loose flake” to generate a avalanche.

 

 

Tell Washington To Protect Medicare

https://p2a.co/yK8Vsrd

Tell Congress to Stand Up and Protect Medicare NOW!

Americans don’t need another barrier to their medicines. Despite this, some in Congress are considering legislation that would give the federal government unprecedented, sweeping authority to set medicine prices. These politicians want to repeal the provision of the Medicare Part D program that protects coverage and access to medicines for seniors and people with disabilities.

Seniors and people with disabilities have robust access to medicines in Medicare Part D due in large part to a protection known as the “noninterference clause.” This clause prohibits the Secretary of Health and Human Services from interfering in the private negotiations between manufacturers, pharmacy benefit managers and Medicare Part D plans. Unfortunately, some in Congress want to repeal this important element of Part D. Without this protection, government negotiations could directly and negatively impact access to lifesaving medicines for patients.

Congress must reject proposals that would repeal important protections for seniors and people with disabilities on Medicare and work on real solutions to improve the affordability challenges that many of them experience at the pharmacy counter.

Tell Congress there is a better way. Protect Medicare.

 

FDA Warns Again About Robotic Mastectomy, Breaks New Ground

FDA Warns Again About Robotic Mastectomy, Breaks New Ground

https://www.medscape.com/viewarticle/957002

The US Food and Drug Administration (FDA) today issued a new safety communication about the use of robotically assisted mastectomy, warning patients and physicians that the safety and effectiveness of such devices have not been established in the prevention or treatment of breast cancer.

The agency also called out robotically assisted surgical (RAS) device use in the United States that lacks proper federal oversight.

“The FDA is aware of allegations that clinical studies are being conducted” with RAS devices in breast cancer “without the FDA oversight required for such significant risk studies,” the agency said.

The new advisory comes 4 weeks after a Medscape Medical News exclusive story on a set of clinical trials recently underway using RAS devices for nipple-sparing mastectomy, both prophylactically and as a breast cancer treatment.

The report found that investigators are either not collecting cancer outcomes or not doing so as a primary measure — despite a stiff warning in 2019 from the FDA that those outcomes are important. 

“Congratulations to the press on doing its job well and informing government. I think this [safety communication] is a direct result of Medscape following up on this issue,” said Hooman Noorchashm, MD, PhD, a patient advocate from Philadelphia. He is a former surgeon and faculty member at the University of Pennsylvania.

In reviewing the FDA’s new warning, Noorchasm pointed out that the agency also stated unequivocally — after previously hinting — that any study of robotic mastectomy “must include monitoring of long-term clinical outcomes” such as cancer recurrence, disease-free survival, and overall survival.

That’s a change in approach — previously the FDA has typically approved/cleared RAS devices for use in cancer surgery based on 30-day complication rates (compared with standards of care) and had no requirement for cancer-related outcomes data.

“This [new] advisory reiterates the need for a clear focus on primary oncologic outcomes to, at the very least, demonstrate the noninferiority of robotic assisted surgical devices for performing mastectomy procedures,” said Noorchashm.

In a 2019 warning about robotic mastectomy, the FDA suggested that it would require oncologic measures moving forward, saying that it “anticipates” that any evaluation of new use of robotic devices in women’s cancer “would be supported” by long-term cancer outcomes. But it stopped short of publicly saying so. The new advisory changes that.

Direct Comparison With Traditional Mastectomy Needed

There are safety concerns with robotic mastectomy. Experts question whether a surgeon can easily remove a breast tumor in one piece through the small incision (a selling point of the robot). If the tissue cannot be removed in one piece, cancer fragments may be left behind.

As a result, a randomized trial with traditional open mastectomy as a comparator is needed, Noorchashm stressed. The current batch of clinical trials in the United States are all single-arm studies and as such are “totally inappropriate,” he said last month.

Julie Margenthaler, MD, a breast surgeon at Washington University in St Louis, Missouri, also believes in the importance of a randomized trial.

“I feel strongly that robotic-assisted mastectomy should only be performed in the setting of a well-designed clinical trial and that oncologic outcomes should be a primary or secondary endpoint analysis as part of that trial,” she said in an email.

Intuitive Surgical, a California-based manufacturer of robotic devices in healthcare and a pioneer in robotic-assisted surgery, is funding one of the current clinical trials of robotic mastectomy in the United States — a single-arm, five center trial examining use in the prophylactic setting. The two primary outcomes are conversions to open mastectomy (efficacy measure) and the incidence of adverse events during surgery to 42 days after surgery (safety measure).

Medscape Medical News previously asked the company, which manufactures the market leader da Vinci robotic surgical equipment, if it planned on conducting a randomized trial.

“Any plans for use of da Vinci Xi surgical system in nipple-sparing mastectomy will be based on these [single-arm] study results as well as other data and evidence,” said a spokesperson, who did not confirm use of a randomized trial.

The new FDA requirement for long-term oncologic outcomes also in part arises from “diminished long-term survival” that was associated with robotic surgery and other minimally invasive surgery for hysterectomy related to cervical cancer.

Nick Mulcahy is an  award-winning  senior journalist for Medscape, focusing on oncology, and can be reached at  nmulcahy@medscape.net  and on Twitter:  @MulcahyNick