Is this the same HMO PIG with new shade of lipstick that was tried and failed back in the 70’s ?

I may be wrong, but this sounds like the “old HMO PIG” with a color of lipstick… that was tried back in the 1970’s and most of them failed because the organization became focused on cutting costs and rationing care to pts.  The only people happy with this system was those that had little need for serious healthcare and care for high acuity pts (sickest of the sick)

MedPAC Backs Simplifying Medicare Alternative Payment Models

https://www.medpagetoday.com/publichealthpolicy/medicare/99282

WASHINGTON — The Medicare Payment Advisory Commission (MedPAC) proposed streamlining Medicare alternative payment models (APMs), along with policy options for tackling pricey Part B drugs, in its June report to Congress Wednesday.

In the June 2021 report, MedPAC called for reducing the number of Medicare APMs so that models running concurrently could work better together. The 2022 report builds on that idea, offering strategies that “would represent a shift for CMS — moving away from temporarily testing a large number of model tracks on a small scale to permanently operating a small number of model tracks on a large scale.”

During a press call, James Mathews, PhD, executive director of MedPAC, stressed “that the Medicare alternative payment model landscape should be centered around a single population-based model — think ACOs [Accountable Care Organizations] — with a small number of easy-to-understand tracks embedded within that model that providers could participate in based on their ability to take on risk for a given population.”

CMS oversees a broad range of APMs with multiple tracks of the Medicare Shared Savings Program, such as the ACO Realizing Equity, Access, and Community Health Model, which has two tracks, and various episode-based payment models, such as the Comprehensive Care for Joint Replacement Model and the Bundled Payments for Care Improvement Advanced Model.

To address the “unnecessary complexity” of having so many different models, which can potentially “dilute incentives” from one to the next, MedPAC suggested centering all models around a single population-based model, with three tracks based on size of the provider groups and willingness to accept financial risk:

  • Track 1: Target small provider groups — such as independent primary care practices that join together to form an ACO — and offer the possibility of “modest shared savings,” without the responsibility of repaying shared losses
  • Track 2: Focus on midsize provider groups with the potential to earn a higher percent of shared savings and take on risk for shared losses
  • Track 3: Suitable for large provider groups that would be held accountable for full risk for all Part A and Part B spending for their beneficiaries

A second option would be to create a single-track population-based payment model, where the shared savings and loss rates differ based on the characteristics of the ACO, including its ability to assume financial risk. Under this single population-based model, the Commission suggested “rebasing” ACO spending benchmarks. Currently, benchmarks are updated every 3 years based on an ACO’s “actual recent spending,” according to the report, which leads to participants competing against themselves, and even penalizes their success with “harder-to-beat benchmarks.”

If an ACO can no longer reach its benchmarks, “it may create an incentive for ACOs to abandon the program,” Mathews explained.

Under the single model, benchmarks would be based on administrative updates instead of actual spending, he said. Historical spending could be “trended forward” to the current year using a growth factor, such as a price component or the volume and intensity of the service, the report noted. As a result, ACO participants would have a “clear and predictable” sense of the targets they need to shoot for in a given year, according to MedPAC.

The report highlights the need for mandatory episode-based models “that have been demonstrated to produce positive results in terms of savings or outcomes,” Mathews said. “Any beneficiaries who experienced a diagnosis that corresponded to one of these episodes, would be episode participants by default, and their care would be provided by episode participating providers.”

However, MedPAC did not cast the population-based or ACO models as mandatory in the immediate future, given that not all participants are ready to accept downside risks. However, the Commission encouraged the CMS Innovation Center to continue testing episode-based payment models with the goal of identifying episode types that could be added to the model in the future.

To prevent models from working against each other with conflicting incentives, “we would allocate any bonus payments so that episode participants would have a strong incentive to deliver care efficiently, that ACO participants would have an incentive to use low-cost, high-quality episode providers. And then lastly, we would assert that the total bonus payments made to each of the sets of participants should not result in increased Medicare spending,” Mathews explained.

Spending on Medicare Part B drugs, biologics, and other physician-administered medications increased by an average rate of close to 10% annually from 2009 to 2019. While spending ticked up around 4% in 2020 — likely due to reduced healthcare utilization during the pandemic — price concerns have not waned.

Medicare pays for most Part B drugs at a rate of the average sales price (ASP) plus 6% (106% in total). Currently, the program lacks the right levers to pay for these drugs in a way that appropriately captures different competing factors, such as the drug’s net clinical benefit, the manufacturer’s effort and innovation, and patients’ ability to afford the medications.

MedPAC proposed three strategies for addressing different aspects of the Part B drug space.

For “first-in-class” drugs, Medicare currently lacks the authority to weigh a new Part B drug’s net clinical benefit against the standard of care when setting payment rates. As a result, such rates can exceed a new drug’s clinical effectiveness.

To address those first-in-class drugs that have been approved with “uncertain clinical evidence” — for example, on surrogate or intermediate clinical endpoints through the FDA accelerated approval pathway — the Commission recommended two possible policy approaches, which Congress could give the HHS Secretary the authority to apply.

First, CMS could apply “coverage with evidence development” to the product, requiring the collection of additional clinical evidence about the new drug while allowing patients to access it. Such a process should be “clear,” “transparent,” and “predictable” and provide a medium for public input, the Commission said, adding that having a standard funding stream “might ease implementation.”

The Commission also suggested placing a cap on the drug’s payment rate based on information about the product’s “estimated net clinical benefit and cost” when measured against the current standard of care. Again, such a mechanism would benefit from a “clear and predictable decision-making framework” that enables transparency and public feedback, according to the report.

Separately, to increase competition among drugs with therapeutic alternatives, the Commission recommended “internal reference pricing” or “consolidated billing,” which involves Medicare issuing “a single reference price for drugs that have similar health effects based on the Part B drug payment rates of the products in the reference group.” Consolidated billing differs from internal reference pricing, in that the former calls for assigning clinically similar products to one billing code, whereas the latter allows products to stay in their own billing code.

“Under reference pricing policies for Part B drugs, manufacturers would have incentive to lower their prices relative to competitors to make their products more attractive to providers and garner market share, which would result in savings for beneficiaries and taxpayers,” the report noted.

Lastly, to correct certain incentives under the ASP system — Medicare’s 6% add-on to ASP implicitly rewards providers who choose higher-priced drugs over lower-priced drugs — MedPAC suggested putting a fixed-dollar limit on the add-on payment or replacing some portion of the add-on with a fixed fee, or combining these approaches. Placing a fixed-dollar limit on the add-on payment would mean very expensive drugs would become less pricey, while applying a fixed fee would raise payments for some inexpensive drugs but reduce payments for more expensive ones.

FTC to Ramp Up Enforcement Against Any Illegal Rebate Schemes, Bribes to Prescription Drug Middleman That Block Cheaper Drugs


Is the GRIM REAPER STALKING THE PBM INDUSTRY ?

FTC to Ramp Up Enforcement Against Any Illegal Rebate Schemes, Bribes to Prescription Drug Middleman That Block Cheaper Drugs

Agency puts drug industry on notice that paying rebates and fees to exclude competitors offering lower-cost drug alternatives can violate competition and consumer protection laws

https://www.ftc.gov/news-events/news/press-releases/2022/06/ftc-ramp-up-enforcement-against-illegal-rebate-schemes

The Federal Trade Commission announced that it will ramp up enforcement against any illegal bribes and rebate schemes that block patients’ access to competing lower-cost drugs. The enforcement policy statement issued today puts drug companies and prescription drug middlemen on notice that paying rebates and fees to exclude competitors offering lower-cost drug alternatives can violate competition and consumer protection laws. The agency will use its full range of legal authorities to combat illegal prescription drug practices that foreclose competition and harm patients.

“Today’s action should put the entire prescription drug industry on notice: when we see illegal rebate practices that foreclose competition and raise prescription drug costs for families, we won’t hesitate to bring our full authorities to bear,” said FTC Chair Lina Khan. “Protecting Americans from unlawful business practices that are raising drug prices is a top priority for the Commission.”

Most consumers have health insurance that covers some part of their prescription medicine costs. These health plans, usually through prescription drug middlemen like pharmacy benefit managers, use “formularies” to define which medicines they will cover. Drug companies use rebates to have their drugs placed on formularies or on preferred tiers of formularies to ensure those drugs are covered.

These rebates are often conditioned on the drug staying in a preferred position on the formulary. Some rebates and fees are conditioned on the volume of sales of certain high list price prescription medicines. In addition to other factors, some have suggested that high rebates and fees to PBMs and other intermediaries may incentivize higher list prices for drugs and discourage coverage of the lowest-cost products.

The FTC is concerned that rebate practices may be driving up the list price of insulin, a life-saving treatment for the roughly 8 million Americans who rely on it to control their diabetes. The list price of insulin has soared over the last two decades, increasing by over 300 percent. The rising list price of insulin may cause some patients to face increasing costs. On average, the list price of a one-year supply of insulin has risen to nearly $6,000 per year, with patient out of pocket costs ranging from $1,288 for the uninsured to $613 for the insured as of 2017.

The FTC’s enforcement policy statement outlines the legal authorities that may apply when dominant drug companies pay rebates and fees to middlemen to foreclose competition from less expensive generic and biosimilar alternatives:

  • Exclusionary rebates that foreclose competition from lower-cost medicines may constitute unreasonable agreements in restraint of trade under Section 1 of the Sherman Act; unlawful monopolization under Section 2 of the Sherman Act; or exclusive dealing under Section 3 of the Clayton Act.
  • Inducing prescription drug middlemen to place higher-priced drugs on formularies instead of lower-cost alternatives in a manner that shifts costs to payers and patients may violate the prohibition against unfair methods of competition or unfair acts or practices under Section 5 of the FTC Act.
  • Paying or accepting rebates or fees in exchange for excluding lower cost drugs may constitute commercial bribery under Section 2(c) of the Robinson-Patman Act, which prohibits compensating an intermediary to act against the interests of the party it represents in the transaction.

Whistleblower suit: CVS prevented Part D members from accessing generics: another PBM screwing pts and lining their pockets ?

Whistleblower suit: CVS prevented Part D members from accessing generics

https://www.fiercehealthcare.com/payers/whistleblower-suit-cvs-prevented-part-d-members-accessing-generics

A newly unsealed whistleblower suit claims that multiple CVS Health subsidiaries coordinated to prevent members from accessing generic drugs in a bid to boost the bottom line.

The suit, first obtained by Stat, was filed by Alexandra Miller, who worked at CVS for nearly two decades before leaving the company three years ago. Miller says that when she reported the behavior to a superior,

she was told that the company had decided the benefits of the alleged scheme outweighed the likelihood of being caught.

Miller claims that CVS’ SilverScripts Part D subsidiary as well as its Caremark pharmacy benefit manager and retail pharmacies worked together to prevent access to generics, which allowed it to pocket higher rebates because members were pushed to buy branded medications rather than lower-cost options.

Members were also often kept in the dark about potential authorized generic medications or identical drugs that are produced by the same manufacturer but offered at a lower cost.

The company violated Medicare regulations by failing to disclose this formulary distinction and felt that SilverScripts Part D customers were less likely to complain about the potential costs because many receive subsidies to cover their medication expenses, according to the lawsuit.

The Department of Justice declined to join the suit. CVS told Stat said it intends to “vigorously defend” itself.

The lawsuit was made public as policymakers put the pharmacy supply chain, and pharmacy benefit managers in particular, under the microscope. The Federal Trade Commission said last week that it would dig into the business practices of six major PBMs, including Caremark, as the industry becomes increasingly consolidated.

The PBM market is dominated by three companies, all of which are also integrated with a major health plan and other industry segments: Caremark, a sister company to Aetna; Express Scripts, which is owned by Cigna; and OptumRx, which is a sister company to UnitedHealthcare.

A recent Supreme Court decision granted states greater power to regulate PBMs, and with that have come multiple investigations into their role in Medicaid, including millions in settlements paid out by Centene in six states.

PBMs could be driving up plan sponsors’ drug costs

PBMs could be driving up plan sponsors’ drug costs

https://www.benefitspro.com/2022/06/15/pbms-could-be-driving-up-plan-sponsors-drug-costs/

Far too many pharmacy benefit managers (PBMs) thrive on opacity in their business operations, but sometimes public litigation shines the light of day on secretive practices.

Far too many pharmacy benefit managers (PBMs) thrive on opacity in their business operations, but sometimes public litigation shines the light of day on secretive practices. For example, a New York court recently refused to  release Express Scripts, Inc. (ESI), one of the most prominent PBMs in the nation, from a pending  litigation. The lawsuit, filed by the New York City Transit Authority (NYCTA), claimed that ESI  breached numerous contractual provisions by failing to identify fraudulent prescription claims paid by  the health plan. (See generally New York City Transit Authority v. Express Scripts, Inc., case no. 1:19-cv-05196 (S.D.N.Y. 2022).  Benefits advisors and employers/plan sponsors can learn from the suit.  

According to the lawsuit, NYCTA hired ESI to administer and manage the prescription drug benefits  NYCTA offered to its employees, retirees, and dependents. In the year prior to contracting with ESI,  NYCTA paid $6 million for compounded prescription claims. To the shock and awe of the NYCTA,  in the first year of its contract with ESI, NYCTA paid over $38 million for compounds. In fact, in  June 2016, only two months after the contract term began, an individual’s claim for an erectile  dysfunction compound medication totaled $405,325.43 over three months. Critically, a significant  portion of the compound claims contributing to the substantial increase in spending originated from  just three providers and were largely fraudulent. Disturbingly, ESI conducted its own  investigations into two of the providers and neglected to share the results with NYCTA. ESI  likely approved overpriced compounds because ESI may have earned “spread pricing” on such  claims—this litigation will reveal the truth. Plans should carefully monitor PBM spread pricing.  Similarly, after discovering the third provider had pleaded guilty to federal fraud charges arising out a  workers’ compensation kickback scheme, ESI is alleged to have withheld the information from  NYCTA.  

Blue Cross Blue Shield operator did not pay federal taxes in 2018, got $1.7B refund

I’m going “out on the third rail again”…  I have noticed our President telling the “rich” should pay their fair share – and the “rich” is undefined.  Current target of his “bully pulpit ” is the oil industry – for making excessive profits – and WH press secretary stated in the last day or two… that the oil companies should make less profit -and it is patriotic to do so.  He has made similar claims against the “beef industry”… same thing about the pharma industry…  one industry I have not seen him use his “bully pulpit” toward is the health insurance/PBM industry – YES – PBM’s are licensed insurance companies. To show you how crooked these PBM’s are… I just got a Rx refilled and our Part D said that they would only pay for a product from  a particular pharma and my copay would be $56.00 – because I am still meeting my deductible …BUT.. having the Pharmacist fill it for a generic – FOR CASH PRICE – my cost was $36.00.  I guess the rebates/kickbacks/discount that the Part D extracts from the one pharma was much greater than the pharma who makes the generic.  Months ago, I had a Rx for a 3% topical cm and the copay was $70.00 for ONE OUNCE tube and the pharmacy receipt showed that our Part D paid $-7.00 ..yep they charged me MORE THAN SOME ARBITRARY PRICE – again I was still in my deductible period..  I found out that a 5% – same topical cream OTC  – and was able to get TWO – SIX OUNCE TUBES for $70…

This Administration wants Congress to pass a law to mandate that Medicare Part D & Medicare Advantage prgms to negotiate prices, but both of these are FOR PROFIT INSURANCE COMPANIES and all Rx claims  are progressed by a PBM – who extract a discount, rebate, kickback from the pharmas – some have indicated that the total $$$ back to the pharma – can be up to 75% of AWP ( Average Wholesale Price) and most state that most of those $$$ goes into the PBM’s coffers and the major PBM’s are now owned by a insurance company.  When the Medicare Part D was signed into law, went into effect Jan 1, 2006 …Congress prohibited Medicare to negotiate discounts and then turned the Part D program over to FOR PROFIT INSURANCE/PBM industry. Which was SMOKE & MIRRORS… since Part D was NEVER part of Medicare… the Rx medications for Medicare folks – has always been handled by FOR PROFIT insurance companies.  I guess that it is just GOOD POLITICS – political theater – to point fingers at a industry who has little/no control over what they charge for a product.  When MIDDLEMEN – demand kickback/refunds/discounts of up to 75% for a pharma to have meds on the PBM’s approved formulary and will only pay for their other meds by requiring a prior authorization.

Blue Cross Blue Shield operator did not pay federal taxes in 2018, got $1.7B refund

https://thehill.com/policy/healthcare/433555-blue-cross-blue-shield-insurer-didnt-pay-any-federal-taxes-in-2018-got-17/

Health Care Service Corp., which operates Blue Cross Blue Shield plans in a handful of states, did not pay any federal taxes in 2018 and received a $1.7 billion tax refund, according to its latest financial report.

The tax refund boosted the health insurance conglomerate’s net profit to $4.1 billion last year, compared to $1.3 billion in 2017, according to Axios, which first reported about Health Care Service’s tax refund.

{mosads}Axios noted that Health Care Service was one of the biggest beneficiaries of the GOP tax cut and has experienced rising profits from its health plans in the Affordable Care Act marketplace.

Health Care Service oversees Blue Cross Blue Shield plans in Illinois, Montana, New Mexico, Oklahoma and Texas.

The company said it had benefited from the repeal of the corporate alternative minimum tax in 2018 after remaining credits were included.

“We historically paid the Alternative Minimum Tax (AMT) and because of the repeal of the corporate AMT system (the 2017 Tax Reform and Jobs Act), companies that had remaining AMT credits were able to recover those credits,” said Health Care Service communications director Greg Thompson in an email.

Imagine this: Another PBM – multi million settlement because of OVER CHARGING state’s Medicaid ?

Centene Corp. reaches $13.7M settlement with New Mexico over pharmacy benefit practices

https://www.bizjournals.com/stlouis/news/2022/06/14/centene-million-settlement-new-mexico-pharmacy.html

New Mexico is the latest state where Centene Corp. (NYSE: CNC) has reached a settlement over an investigation into its pharmacy benefit management practices for the Medicaid program.

Attorney General Hector Balderas on Monday announced a $13.7 million settlement with Centene over the state’s investigation of its subsidiaries’ pricing and reporting of pharmacy benefits and services to New Mexico’s Medicaid program.

“Vulnerable New Mexicans should not have to worry about paying surging prescription drug costs,” Balderas said in a written statement. “This investigation was necessary to shine a light on industry practices, ensure greater accountability and return $13.7 million back to New Mexico.”

Centene did not make an executive available for comment Tuesday. A company spokesperson said in a written statement: “We respect the deep and critically important relationships we have with our state partners. This no-fault agreement reflects the significance we place on addressing their concerns and our ongoing commitment to making the delivery of healthcare local, simple and transparent. Importantly, this allows us to continue our relentless focus on delivering high-quality outcomes to our members.”

The pharmacy benefits management practices of Centene’s subsidiaries have triggered investigations in other states and a shareholder lawsuit against the largest public company in the St. Louis area.

Last December, Centene reached a $27.6 million settlement with the state of Kansas over its pharmacy benefit management practices for its Medicaid program.

Also last December, a shareholder filed a lawsuit against Centene in the Court of Chancery of the state of Delaware.

The plaintiff, Robert Garfield, has sought “books and records in order to determine whether breaches of fiduciary duty or other wrongdoing have occurred in connection with fraudulent business practices alleged in connection with civil settlements between Centene and state attorneys general in several states, including Ohio, Mississippi, Arkansas and Illinois.”

The Court of Chancery website listed the status of the lawsuit as active. An attorney representing Garfield didn’t return messages seeking comment.

In June 2021, Centene agreed to pay $88 million to Ohio’s Medicaid program to settle a lawsuit over how it charged the state for prescriptions. In a similar settlement that month, Centene reached a $55 million settlement with Mississippi.

Centene last September entered into no-fault agreements with the attorneys general of Arkansas and Illinois to resolve claims related to services provided by its pharmacy benefit manager subsidiary, Envolve Pharmacy Solutions Inc. Centene agreed to pay $15 million to Arkansas and $57 million to Illinois.

In a regulatory filing last year, Centene said it had set aside $1.1 billion to resolve allegations from other states. Two law firms — Liston & Deas and Cohen Milstein in Chicago — have entered into talks with Centene to resolve those matters. Attorney William Liston III and Centene did not respond to messages seeking comment on the status of settlement discussions.

The investigation of Centene by New Mexico’s attorney general focused on concerns that the corporation was “layering fees and not passing on retail discounts to New Mexico’s Medicaid program,” known as Centennial Care.

Centennial Care provides health care services and medications to nearly 1 million New Mexicans, and Centene’s wholly-owned subsidiaries have provided pharmacy benefits and services to Centennial Care since 2019.

The settlement agreement states that Centene’s entities will comply with New Mexico law governing the operation of managed care pharmacy benefit operations and an “enhanced commitment from Centene to provide complete pricing transparency on all pharmaceutical benefits and services” provided to the New Mexico Human Services Department.

Centene provides managed care programs for government sponsored health care plans such as Medicaid and Medicare.

States are PUSHING BACK on DEA wanting to do “data mining” in their PDMP database without a warrant from a judge

The Government Needs to Get a Warrant if It Wants Access to Our Private Health Information

Signing Of Arizona SB1469 on Controlled Substances Monitoring Search Warrants, into Law by Governor Douglas Ducey

The Drug Enforcement Administration is once again trying to access private prescription records of patients — this time in New Hampshire — without a warrant, despite a state law to the contrary. Today the ACLU filed a brief in support of the state of New Hampshire’s fight to defend the privacy of our sensitive medical information against unwarranted searches by law enforcement.

New Hampshire — like 48 other states, the District of Columbia, and Puerto Rico — has established a statewide Prescription Drug Monitoring Program (PDMP), which logs records of every prescription for a long list of “controlled substances,” including Xanax, Ambien, and many painkillers, filled by pharmacists in the state. The PDMP is intended to function as a public health tool to allow physicians and pharmacists to look up their patients’ past prescriptions for medications that have addictive potential. Because these prescription records are so sensitive, New Hampshire law bars law enforcement agents from accessing the database unless they have a search warrant signed by a judge.

That rule has worked just fine for state and local police, but the federal Drug Enforcement Administration refuses to respect it. The DEA insists that, because it is a federal agency, it can ignore state law and request people’s PDMP records with an administrative subpoena instead of a warrant. Unlike a warrant, a subpoena is issued directly by the agency based on a low legal standard, without requiring the approval of a judge.

When New Hampshire received a DEA subpoena for a patient’s PDMP records last year, the state rightly refused to comply because doing so would violate the state law requiring a warrant. The DEA then sued in federal court, but New Hampshire stood firm, arguing that the subpoena was improper under federal law and the Fourth Amendment to the U.S. Constitution. After losing in trial court, the state appealed to the First Circuit Court of Appeals.

The DEA’s most galling argument in the case is that people have no reasonable expectation of privacy in their prescription records held in the PDMP because of the “third-party doctrine.” Under that doctrine, a person is considered to lose their Fourth Amendment protections in information voluntarily shared with a “third party,” like a company they do business with.

We’ve seen that argument before when the DEA tried to obtain PDMP records in Oregon and Utah without a warrant. But the legal landscape has now changed. That’s because last year in Carpenter v. United States, the Supreme Court made clear that the third-party doctrine does not automatically apply to sensitive agglomerations of digital-age records. That case was about people’s sensitive location records held by their cell phone companies, but the lesson of Supreme Court’s holding should apply equally to the sensitive digital database of prescription records at issue here.

Our amicus brief, filed with the ACLU affiliates in the First Circuit — New Hampshire, Maine, Massachusetts, Puerto Rico, and Rhode Island — as well as the New Hampshire Medical Society, argues that  law enforcement agencies, including the DEA, must get a warrant under the Fourth Amendment to access the private medical information in the PDMP database.

As we explain, information about the prescription medications we take can reveal a great deal of intimate and private details about our health, including our medical diagnoses and our doctors’ confidential medical advice. Indeed, this kind of medical information is among the most sensitive data about us. That’s why, for as long as there has been a medical profession, health care providers have been bound by a duty of confidentiality toward their patients’ medical information.

Moreover, this information is not voluntarily shared, in any meaningful sense, with the state’s database. The DEA suggests that people make a choice to give up their privacy protections when they share their medical information with their doctor and pharmacist. But as we write in our brief, choosing between obtaining health care and giving up one’s privacy rights is no choice at all.

The DEA’s aggressive position comes amid intensifying attention to the nation’s opioid addiction crisis. But far from hindering efforts to address that serious problem, strong Fourth Amendment protections are a crucial part of the solution. Successfully addressing drug addiction primarily requires public health approaches, not prosecutorial ones. Easy law enforcement access to medical records not only fuels mass incarceration, it deters patients from seeking necessary medical care.

Requiring the DEA to get a warrant ensures that people’s sensitive prescription records are only available to police when there is a real need. That’s good policy, and good Fourth Amendment law.

How many states are NOT PUSHING BACK on the DEA’s wanting to do a “fishing trip” into a state’s PDMP without having a valid reason and warrant signed by a judge ?  I have read that of the nearly 11,000 Federal DEA employees, >50% sit at a desk..  Is this how the DEA comes to a opinion that they can make allegations against prescribers – that the prescriber is not meeting some – undefined – standard of care and best practices and thus is prescribing one or more controlled substances without a valid medical necessity. They take the prescriber to Federal court, where it is common knowledge that 90%+ of people taken to federal court are FOUND GUILTY.  Apparently our Federal court system is similar to our Grand Jury system where it is claimed that a Grand Jury could indict a “ham sandwich “   https://www.thoughtco.com/grand-jury-in-the-united-states-3368320

 

Harms of Cancer Blood Tests? FTC Healthcare Crackdown: More Smoke Than Fire?

Harms of Cancer Blood Tests? FTC Healthcare Crackdown: More Smoke Than Fire?

https://www.medpagetoday.com/special-reports/exclusives/99249

Welcome to the latest edition of Investigative Roundup, highlighting some of the best investigative reporting on healthcare each week.

New Blood Tests for Cancer May Carry Risks

New blood tests, which look for tiny shards of cancer DNA or proteins, are “a new frontier in screening,” the New York Times reported. However, some experts say the risks of making the tests widely available at this point in time are substantial.

The companies developing the tests say they can find dozens of cancers, and supporters say they can “slash cancer death rates by finding tumors when they are still small and curable,” the article stated. A bill in Congress with more than 250 cosponsors would authorize Medicare to pay for the tests as soon as FDA approves them.

However, companies are not waiting for regulators, the Times reported. One developer, GRAIL, is selling its annual test with a list price of $949, and another company, Exact Sciences, expects to follow suit.

“The companies would like to get the tests approved with studies less rigorous than the FDA typically requires, and they stand to make huge profits if that happens,” according to the Times.

Critics say that finding cancers sooner could mean just as many deaths because, with current treatments, cancers destined to kill are not necessarily cured if found early, the Times reported. Additionally, some people will have a positive test, but their doctors will be unable to locate the cancer. And others will be treated aggressively with surgery or chemotherapy for cancers that would not have grown and spread.

Barnett Kramer, MD, MPH, a member of the Lisa Schwartz Foundation for Truth in Medicine and former director of the Division of Cancer Prevention at the National Cancer Institute, told the Times that he fears the tests will become widely used without evidence they are beneficial. Once that happens, “it is difficult to unring the bell,” he told the outlet.

“I hope we are not halfway through a nightmare,” he said.

More RED FLAGS rules being used by TX Board of Pharmacy – LEGAL or UNCONSTITUTIONAL ?

This appears to be from 2018,  I find it interesting that the TXBOP will hold a PHARMACY responsible for the failure to detect  patterns  of  inappropriate dispensing of prescription drugs is unprofessional practice and constitutes grounds for disciplinary action.  A person/entity that has a pharmacy permit to operate a pharmacy, can only do so.. if there is a state licensed Pharmacist on staff and there is a Pharmacist that is registered with the BOP to be “Pharmacist in charge” and responsible to the BOP for the legal operation of the Rx dept.  With the SCOTUS recently passing down a decision that “RED FLAGS” when involved in the confiscating a individual guns is UNCONSTITUTIONAL.  Could it be considered a “confiscation of a pt’s medication therapy” by a Pharmacist who fails to properly adjudicate perceived RED FLAGS and refuses to fill a pt’s  (controlled ) medication ? I am sure that other states have similar written “red flag rules” , implied or presumed to exist. Hopefully, that many of these – potentially unconstitutional laws/rules – will be challenged in the not too distant future.

 

Click to access You_might_be_a_pill_mill_if.pdf

Texas State Board of Pharmacy “Red Flags” Checklist for Pharmacies YOU MIGHT BE A PILL MILL IF… Check all that apply: (1) Your pharmacy fills a discernable pattern of prescriptions for prescribers who write essentially the same prescriptions for numerous persons, indicating a lack of individual drug therapy. (2) Your pharmacy operates with limited hours of operation or closes after a certain threshold of controlled substance prescriptions are dispensed, and has overall low prescription dispensing volume. (3) Prescriptions presented to the pharmacy are for controlled substances with popularity as street drugs, such as opiates, benzodiazepines, muscle relaxants, psychostimulants, and/or cough syrups, or any combination of these drugs. (4) The prescriptions for controlled substances contain nonspecific or no diagnoses. (5) The prescriptions are commonly for the highest strength of the drug and/or for large quantities. (6) Dangerous drugs or OTC products (such as multi-vitamins or laxatives) are added to the controlled substance prescriptions, maintaining relatively consistent 1:1 ratio of controlled substances to dangerous drugs and/or OTC products dispensed as prescriptions. (7) Prescriptions are authorized by the same prescriber with what appears to be different handwriting on the hardcopy prescription drug order forms. (8) Upon contact with the prescriber’s office, you are unable to engage in comprehensive discussion with the actual prescriber, or he/she is unconcerned about your apprehensions regarding his/her prescribing practices or unwilling to provide additional information, such as treatment goals and/or prognosis with prescribed drug therapy. (9) You rely solely on the prescriber’s representation, or on the representation of the individual answering the phone at the number on the prescription, that prescriptions are legitimate. (10) The prescriber’s clinic is not registered as a pain management clinic by the Texas Medical Board, despite routinely receiving prescriptions from the prescriber for opiates, benzodiazepines, and/or muscle relaxants. (11) Drugs prescribed are inconsistent with the prescriber’s area of practice. (12) The prescriber of the drugs is located a significant distance from your pharmacy. (13) The prescriber has been subject to disciplinary action by the licensing board, had his/her DEA registration removed, or been subject to criminal action. (14) The Texas PMP system indicates that persons are obtaining prescriptions for the same drugs from multiple prescribers or that persons are filling prescriptions for the same drugs at multiple pharmacies. (15) The person’s address is a significant distance from your pharmacy and/or from the prescriber’s office. (16) Multiple persons with the same address present prescriptions from the same prescriber. (17) Persons pay with cash or credit card more often than through insurance. (18) Persons presenting controlled substance prescriptions are doing so in such a manner that varies from seeking routine pharmacy services (e.g., willing to wait in long lines to receive drugs, persons arrive in the same vehicle with prescriptions from same prescriber, one person presents to pick up prescriptions for multiple others, persons refer to drugs by “street names” and/or comment on drug’s color, persons seek early refills, persons travel from outside reasonable trade area of pharmacy). (19) Your pharmacy charges and persons are willing to pay more for controlled substances than they would at nearby pharmacies. (20) Your pharmacy routinely orders controlled substances from more than one drug supplier, or your pharmacy has been discontinued by a drug supplier related to controlled substance orders. (21) Sporadic and non-consistent dispensing volume (including zero dispensing) varies from day to day and week to week, and your pharmacy does not maintain operational hours each week on Monday through Friday. (22) Your pharmacy employs or contracts security personnel during operational hours to prevent problems. (23) Your pharmacy has been previously warned or disciplined by the Texas State Board of Pharmacy for inappropriate dispensing of controlled substances (i.e., corresponding responsibility). If you checked any of the above items, you should review the laws and rules regarding corresponding responsibility and  non‐therapeutic dispensing, especially Board rule §291.29, in the law book or on our website:  www.pharmacy.texas.gov (click  on  Texas  Pharmacy  Rules  and  Laws).    Additional  educational  material  is  available  at:   http://www.pharmacy.texas.gov/Nontherapeutic.asp.    Failure  of  pharmacies  and  pharmacists  to  detect  patterns  of 

inappropriate dispensing of prescription drugs is unprofessional practice and constitutes grounds for disciplinary action.

 

PBM wanting chosen med to be entirely on COST… improved clinical outcomes… may be a distance SECOND CHOICE

Notice that this is a PBM (Express Scripts) is owned by the insurance company https://www.pharmacytimes.com/view/cigna-completes-purchase-of-express-scripts and has its own mail order pharmacy. Notice what was read from the letter from Express Scripts to the prescriber that they were MANDATING step therapy – step therapy is starting with the least expensive – or the PBM gets the largest kickback, rebate, discount from the pharma- for a particular med.  From what I heard from the prescriber reading the letter, the prescriber should chose the LEAST EXPENSIVE MEDICATION in this particular class/category.  The particular medication mentioned is typically used to treat ADD/ADHD, another subjective disease/mental health issue.  No test to determine how well – or poorly – the cheapest med would work for the pt and/or how much better that the med prescribed would have worked better than the cheapest med.  I have not had to deal with step therapy in years, but with subjective diseases, will/could the PBM decide any improvement in QOL issues – no matter how small… would/could decide that the particular least expensive med… is clinically significant enough to declare not necessary to try an more expensive meds.

It will be interesting how these PBM will deal with pts who have had pharmacogenomics testing done and this DNA test will clearly show which med  the pt’s metabolism would be the best metabolized …which would indicate optimal improvement of QOL, at lower doses and less side effects and should save all involved out of pocket costs.   https://www.nigms.nih.gov/education/fact-sheets/Pages/pharmacogenomics.aspx