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HHS Loosens Reins on Buprenorphine Prescribing

https://www.medpagetoday.com/psychiatry/opioids/90718

WASHINGTON — X will mark the spot for physicians who will be newly able to prescribe buprenorphine for opioid use disorder under guidance announced Thursday by the Department of Health and Human Services (HHS).

The guidance, outlined in a press release, eliminates a requirement known as an “X waiver” for physicians who want to prescribe buprenorphine for opioid use disorder (OUD), as long as they meet certain requirements:

• They only treat patients located in the state in which the physician is authorized to practice

• They will be limited to treating no more than 30 patients with buprenorphine for opioid use disorder at any one time

• They cannot prescribe or dispense methadone for OUD

Physicians using the X-waiver exemption must put an “X” on the prescription, clearly state that the prescription is being written for opioid use disorder, and maintain separate charts for patients being treated for OUD, according to the release. HHS will also establish an interagency working group to monitor the implementation and results of the guidance, as well as the impact on diversion.

“Regulation stands in the way of connecting individuals suffering from substance use disorder with this lifesaving care,” Jim Carroll, director of the White House Office of National Drug Control Policy, said on a phone call with reporters. “Improving the X waiver is a major action, and it’s one that has broad support.”

Currently there are numerous bills circulating on Capitol Hill that would remove the X waiver entirely, Carroll continued, adding that the legislation is supported by both Republicans and Democrats. “There is an urgent need to remove it, especially now with COVID and people being cut off,” Carroll said. In the meantime, “we took this strong action, and this will continue to reap benefits for those who need help the most.”

“There’s been an analysis of the barriers that have limited access to buprenorphine for those that need it, and one of them is there are not enough clinicians to provide the buprenorphine; there are not sufficient physicians that are waivered to provide it,” said Nora Volkow, MD, director of the National Institute on Drug Abuse. “And yet we know from research that the healthcare system, whether it’s primary care physicians or specialists in emergency departments, can play a key role in providing this medication to patients.”

The guidelines “will make it much easier to bring buprenorphine and treatment of OUD into the healthcare system that exists through the country,” she added. “It will enable primary care physicians to provide this treatment, which research has already shown they are as able to do as specialized treatment programs.”

Asked by MedPage Today why physicians would only be allowed to treat 30 patients at a time, Adm. Brett Giroir, MD, assistant secretary for health at HHS, said that the normal X waiver process begins by letting physicians treat 30 patients, and then 100 patients, and then 250. “What we’re doing here is creating an exemption so if you have not gone through that process, we’re giving you that limit of 30 to start with.”

“We’re not at all decreasing what can be done through the traditional process; we’re allowing an exemption,” he continued. “And again, we anticipate that this is going to be primary care providers who may be in rural areas that may treat 5 or 10 people within their practice with this. If they’re going to get into the business of 40 or 50 or 80 or 100, right now we think they should go through the X waiver process with all the controls on that, but this is a first step that we’ll evaluate.”

Carroll added that “We’re encouraging more and more providers to be able to provide this; we think as their practice builds naturally, we would want them to get additional training once they start hitting that 30 folks and over.”

“This is a compromise,” said Volkow. “We’re changing a practice, and by doing it in a conservative way, we can ensure that we’re not producing harm by practices of things that we may not know. Initially the X waiver was also starting with 30, and I assume that that’s because there was experience with that; that made a reasonable, justifiable number.”

The guidance comes as deaths from drug overdoses continue to rise. “Beginning in the October-November timeframe in 2019, after a flattening of our mortality, we started to see mortality go up,” Giroir said. “We saw that overdose mortality was going up before the pandemic, but it has actually gone up significantly more since the pandemic.”

Data released Wednesday for the time period ending in June 2020 show that “our mortality has gone up over 21% from overdoses, with over 83,000 Americans dying during that period of time,” he said. “The increase of synthetic overdose mortality from synthetic opioids like fentanyl is up 44.75%. If this rate continues, we could see losses of between 85,00 and 90,000 Americans in 2020 due to overdoses.”

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Mark Cuban launches generic drug company

https://www.beckershospitalreview.com/pharmacy/mark-cuban-launches-generic-drug-company.html

Billionaire investor and Shark Tank star Mark Cuban has launched a generic drug company called the Mark Cuban Cost Plus Drug Company.

The new company’s website says it is dedicated to producing low-cost versions of high-cost generic drugs and pledges to “provide radical transparency in how we price our drugs.”

The Cost Plus company will publish the costs to manufacture, distribute and market its drugs to pharmacies. It said it adds a 15 percent margin to get its wholesale prices and make sure it remains profitable, but that

there are no middlemen and no rebates for insurance companies. 

“Everybody gets the same low price for every drug we make,” the company website states. 

The first drug it will produce is albendazole, an antiparasitic drug. The company is hoping to introduce more than 100 drugs by the end of 2021, as well as build a pharmaceutical factory in Dallas by 2022. 

The Mark Cuban Cost Plus Drug Company has also partnered with Baylor College of Medicine in Houston to aid researchers in providing care for children with hookworm infection in rural Alabama.

This should be interesting, Mark Cuban is going to take on the entire insurance/PBM industry… just read the RED sentence above.  A year or so ago Lilly announced that it was going to introduce their Humulin insulin as a generic and included in the the announcement that there was not going to be any rebate/kickback/discount to the insurance/PBM industry.  In response to that announced the insurance/PBM industry replied NON COVERED ITEM.

This should be interesting as this unfolds

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As many of you know the “little boys” in Silicon Valley have shutdown reportedly a large number of people and groups on the various websites ( Face Book, Twitter and others) according to reports on TV today, have compromised the “intelligence” that law enforcement, FBI, Secret Service and other entities that are in charge of keep us safe.  Now with the inauguration coming up, law enforcement has lost their ability to monitor what some “crazy groups” were planning via these sites.

I don’t know about the rest of you, but that information does not give me any “warm fuzzy” because

before this was done by those “little boys” there was rumors of some of these “crazy groups” were going to have some sort of rallies/protests at EVERY STATE CAPITAL.

Looking at the stock market today all of these BIG TECH’S stock prices are DOWN as much as 11%.

I am getting out of this mess !

I made this post below a few days ago and will allow everyone who wishes to follow me to shift over to following my blog. I have already stopped making any new post on BIG TECH and by the end of the month will stop making comments on the posts of others .  There is a place on the front page of my blog  – right hand column – to sign up to be notified by email when I make a new post.

Some of my readers have expressed concern/dislike of me posting more about politics in place of pain issues… Whereas, there is not much new going on in regards to pain pts and the denial of care.   We are in a transition between two different administrations and a Congress that both houses have a <D> majority.  In fact, it has been stated that those in the Senate was not expecting nor prepared to become the majority.

In Congress offices and staff size is determined by which party that is in the majority and the seniority of the particular member.  Over the next couple of weeks in the Senate, there is going to be a lot of office shuffling and those who are in the majority don’t have the staffing levels that they now need. In the Senate, those 50 members have to hire new/additional staff and just about every member of the Senate is going to have to shuffle offices..   The placement and size of a Senator’s office totally depends on who is in majority and how much seniority that particular Senator has.

As soon as all the dust settles, they will get back to fighting the war on drugs/pts.  A few weeks ago Eliz Warren and 4 of her colleagues released a press release that they were going to introduce a bill that will interfere with chronic pain pts getting their pain meds.   Of course, if that bill get signed into law … it will be in direct conflict with the ADA and Civil Rights law on discrimination of disabled… Also, as I remember all of the <D> candidates running for President agreed that HEALTHCARE IS A HUMAN RIGHT…  So is denial of pain management part of “healthcare is a human right” ?

I hate to remind everyone, chronic pain management and politics are attached at the hip.  How many in the community are suffering, bed/chair/house confined or died/committed suicide because of the unintended consequences of politicians/bureaucrats and their decisions about ending the war on pts/drugs ?

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Since Twitter, Face Book and others have banned the leader of our country from using the web… I thought that I would share this here

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For those of you who have not been following the things in/around BIG TECH….there is a law that is referred to as SECTION 230, which basically prohibit big tech (Amazon, Google, Face Book, Twitter) from being sued for what is posted on their websites, unlike newspapers and magazines.  After the “dust up” on the capital last week, those big tech companies decided to terminal a number of accounts including President Trump, a group called WALKAWAY, a whole litany of some very known and powerful people.  There is a alternative website to www.parler.com that is a competitor to twitter.   President Trump and thousands of other people – including myself – dropped off Twitter and opened an account on PARLER – actually I have had an account on that website for a few months…  It appears that the “big boys” at the BIG TECH companies was not happy with this…  Apple & Android took the PARLER app off their app store. and a couple of days later, Amazon which is where PARLER had hired Amazon Web Services (CLOUD) as to where PARLER’s system/data storage was located. Amazon decided that they no longer wish to have PARLER on their web service and they gave PARLER a 24 hr notice to transfer their data off of their Cloud and then they pulled the plug…  At last word, every entity in the BIG TECH part of the world, is treating PARLER like they have leprosy. A company that is estimated to be worth a BILLION DOLLARS the “little boys” in BIG TECH… IMO – COLLUDED to get rid of some competition and get back at some politicians whose beliefs did not sync up with those “little boys”

After the vote of Congress last week, that challenged the outcome of the Nov election… a large number of companies announced publicly that they are cutting off their financial contribution to those same member of Congress we don’t know how many are going to do the same thing only why hiding in the shadows. For those of you in the community believes that the members of Congress who are suppose to represent you… are really representing those who contribute large sums of money to members of  Congress.  It is claimed that lobbyists spend 9+ million/day to try and influence the 535 members of Congress.  One can only come to the conclusion that those who pay lobbyist must believe that they are getting their money’s worth from Congress.

I wrote my Senators and Representative in DC…  about repealing section 230.  Rick Scott is the first response I got.  A letter explaining the outcomes of the recent ELECTIONS and the “dust up” at the capital last week…  NOT ONE WORD about SECTION 230 in Senator Scott’s letter. So is Senator Scott’s not well trained or since Scott is a Republican and those “little boys” in silicon valley gave NINE OUR OF EVERY TEN DOLLARS in the last election to DEMOCRATS campaign coffers ?

Those of you in the community who think that politics have no business in the community… IMO… are really not paying attention. Recently Senator Eliz Warren and four of her colleagues did a press release about a bill that they intend to introduce that would INTERFERE with chronic painers getting their pain medications.  Apparently, they are intending to stop the fabricated “opiate crisis” by denying chronic pain pts their necessary medications.   NO POLITICS INVOLVED HERE !

Dear Mr. Ariens,

          Thank you for contacting me regarding the 2020 presidential election. I appreciate the opportunity to respond.

          On January 6, 2021, the United States Congress convened in a Joint Session to count the states’ electoral votes for president and vice president. What transpired that day, as criminals and thugs stormed the United States Capitol, was disgraceful and un-American. It is not what our country stands for. Those responsible for inciting violence should be prosecuted to the fullest extent of the law. We must always strive to protect our nation and the peaceful preservation of our rights, and we will never accept violence.

          I am eternally grateful for Capitol Police and all responding law enforcement officers for their tireless service. Their efforts kept us safe and allowed Congress to return the same evening to finish our work to finalize the electoral count for the 2020 election.

          Throughout the proceedings, I listened to all of the objections that were raised and the evidence and arguments that were presented on both sides. I heard from constituents across Florida and across the country and I’ve listened to their concerns about the way this election was carried out. I share many of their concerns.

          Specifically, the situation in Pennsylvania was of particular concern to me. The actions of the Pennsylvania Governor’s Administration and the courts in Pennsylvania pose a serious threat to the integrity of future elections. The Governor of Pennsylvania, along with state courts, made a decision to allow votes to be counted that came in after Election Day, even if they did not have a postmark, in defiance of state law. This is absurd, and cannot be tolerated. It also appears that Pennsylvania enacted policies in direct conflict with its own state constitution, which is also unacceptable. We simply cannot tolerate partisan political attempts to change the rules and tip the scales in our elections. In October, Supreme Court Justices Alito, Gorsuch and Thomas warned that the reckless actions of Pennsylvania’s Governor and Secretary of State might result in ‘serious post-election problems’ and they were right. Both of these matters are still pending at the United States Supreme Court. I voted to sustain the objection to Pennsylvania’s slate of electors because these important constitutional questions are still unresolved.

          This election has shown us that we need major reforms to our electoral system and that is why I proposed the Verifiable, Orderly, & Timely Election Results (VOTER) Act, which would address systemic problems in voting systems across the country and rebuild trust in our electoral process. It would mandate Voter ID in every state, institute measures to ensure timely results and create uniform national standards for voting by mail. I believe it is a strong path forward to prevent a repeat of the 2020 election and ensure Americans have faith in free and fair elections.

          Voting is fundamental to our democracy, and it is a sacred right that we must protect and cherish. I look forward to working with my colleagues in the Senate to get this legislation passed and ensure smooth and secure elections.

          Again, thank you for contacting me regarding your concerns. I am proud to represent all Floridians.

Sincerely,

Rick Scott
United States Senator

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