CVS Health is standing up to protect their own profits – using a “smoke screen” and accusing others of profiteering

CVS Health is standing up for Louisianans

https://www.cvshealth.com/news-and-insights/articles/cvs-health-is-standing-up-for-louisianans

“By inserting themselves in the state’s process of selecting a firm to manage prescription drug coverage for the Office of Group Benefits, special interest groups representing Louisiana’s independent pharmacists attempted to line their own pockets at the expense of the state’s taxpayers, employees and retirees.

“Following a fair and competitive procurement process, CVS Health stood ready to provide a prescription drug benefit plan for state employees that the state’s independent analysis estimated would save more than $100 million in the first year, while also including a fair and market-based rate for reimbursing independent pharmacists. Instead, those same pharmacists opted to put profits over patients – inserting themselves into a process where the state had already outlined providing them fair compensation.

“This situation has set a dangerous precedent, endangering the healthcare coverage of state employees, threatening the fiscal solvency of the state employee and retiree benefit plan, and emboldening special interest groups whose sole concern is lining their own pockets. This bullying behavior, at a time when the state is facing unparalleled economic uncertainty from a global pandemic and countless natural disasters, is nothing short of shameful. Moreover, it represents an alarming trend that all states should be concerned about.

“While we are disappointed in the outcome, we remain fully committed to working with public and private clients across Louisiana to deliver pharmacy coverage that puts patients first and brings down the costs for prescription drugs. Sadly, the independent pharmacists cannot say the same.”

Several years ago, the Treasurer of Arkansas and the Arkansas Pharmacist Association did a price survey on the cost of the state employee medication costs. The program was managed by Caremark – which is owned by CVS Health.  The survey involved 250-260 different medications and the prices that were being paid by Caremark to the various local pharmacies where state employees got their medications filled.

ON AVERAGE, a medication filled at a CVS community pharmacy got paid by Caremark abt 60.00 MORE than what was paid to other pharmacies in the state that were competitors of CVS health drug stores for filling the same medication, strength and quantity.

Does this suggest that CVS Health is well versed in how a corporation can line their own pockets at the expense of the state’s taxpayers, employees and retirees”

There is THREE PBM’S that control abt 75% of the Rx market place, both in what medications are covered and what they pharmacies get paid for filling such medications.  If you include the TOP 5 PMB’S you are talking about controlling abt 90% of the market.

If anyone questions the “bad financial behavior ” of the PBM industry just do a web search using the phrase “prescription benefit managers law suits”.

Over the last 5 yrs, the top 5 PBM companies are now owned by companies that are in the insurance business.  Before this, PBM’s and insurance companies were suing each other over claimed over charging or under payments.

The “BAD AND THE UGLY – there is NO GOOD” of the PDMP’s and Narxcare and the INACCURATE CONCLUSIONS from those databases


This is a video about ONE HOUR LONG… normally, I don’t sit thru such a long video.  This is a VERY INTERESTING presentation put on by Dr. Jennifer Alva – an attorney with a very broad legal background. She talks about how the various state PDMP who has apparently turned their data collecting responsibility over to  Experian   who now owns Bamboo Health 

who owns/operates  Narxcare  that produces a SUBSTANCE ABUSE SCORE.. on pts prescribed controlled substances.

You just have to listen to Dr Alva’s explanation of how faulty data is collected and assigned to pts and prescribers and how the DOJ/DEA is accepting the conclusions from data mining these faulty data points and use it to go after prescribers to prove that the prescribers are illegally prescribing controlled substance

 

https://stanford.zoom.us/rec/share/F6IC_Sitiu4lmGQgBbD9wVvOb5iG9Eal7fnJrqC2G2lMMEjDM8H4mv4D_hOjD6mY.jqBbyLkUm9RvzhKS

Here is a up coming seminar concerning the MME system

Guest Speaker Series

Wednesday, November 16, 2022

Dr. Nabarun Dasgupta

Nabarun Dasgupta, MPH, PhD

Dr. Nabarun Dasgupta is a scientist at the Opioid Data Lab (OpioidData.org) at the University of North Carolina with 2 decades of experience in opioid epidemiology and overdose prevention. His passion is telling true stories about health, with numbers. Centered in epidemiology, his multidisciplinary approach draws on large database analytics, qualitative field studies, laboratory investigations, randomized trials, and community-based interventions. Through his work he aims to amplify community and patient voices in public health. He works closely with patients with pain conditions and believes they can be equal partners in scientific research. His lab at UNC tests street drugs (https://streetsafe.supply) from around the country to understand the implications of illicit drug supply fluctuations on health. He also tracks street prices for prescription medications (StreetRx.com). He is the co-founder of Remedy Alliance For The People, a ground breaking national naloxone bulk distribution non-profit supplying millions of doses of the opioid reversal antidote to harm reduction programs (RemedyAllianceFTP.org). Follow him on Twitter @nabarund

FREE VIRTUAL CME LECTURE | November 16, 2022

Inches, Centimeters, and Yards: How MME Hidden Variations in MME Calculations Influence Opioid Safety

ACCREDITATION

In support of improving patient care, Stanford Medicine is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

CREDIT DESIGNATION

American Medical Association (AMA)
Stanford Medicine designates this Live Activity for a maximum of 1.0 AMA PRA Category 1 CreditsTM.  Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Accreditation Council of Pharmacy Education (ACPE)
Stanford Medicine designates this knowledge-based activity for a maximum of 1 hour. Credit will be provided to NABP CPE Monitor within 60 days after the activity completion.

Universal Activity Number List: UAN: JA0000751-0000-22-017-L08-P

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Stanford Medicine designates this live activity for a maximum of 1.0 ANCC contact hour.

ASWB Approved Continuing Education Credit (ACE)
As a Jointly Accredited Organization, Stanford Medicine is approved to offer social work continuing education by the Association of Social Work Boards (ASWB) Approved Continuing Education (ACE) program. Organizations, not individual courses, are approved under this program. State and provincial regulatory boards have the final authority to determine whether an individual course may be accepted for continuing education credit. Stanford Medicine maintains responsibility for this course. Social workers completing this activity receive 1.0 general continuing education credits.

American Psychological Association (APA)
Continuing Education (CE) credits for psychologists are provided through the co-sponsorship of the American Psychological Association (APA) Office of Continuing Education in Psychology (CEP). The APA CEP Office maintains responsibly for the content of the programs.

American Academy of PAs (AAPA)
Stanford Medicine has been authorized by the American Academy of PAs (AAPA) to award AAPA Category 1 CME credit for activities planned in accordance with AAPA CME Criteria. This live activity is designated for 1 AAPA Category 1 CME credits. PAs should only claim credit commensurate with the extent of their participation.

Physical/Occupational Therapy
Stanford Health Care Department of Rehabilitation is an approved provider for physical therapy and occupational therapy for courses that meet the requirements set forth by the respective California Boards. This course is approved for 1.0 hour CEU for PT and OT.

 

CDC Just Changed Its Opioid Prescribing Guidelines. Here’s What to Know

CDC Just Changed Its Opioid Prescribing Guidelines. Here’s What to Know

https://www.medpagetoday.com/neurology/opioids/101559

Guidance covers acute, subacute, and chronic pain and replaces 2016 guidelines

Hard thresholds for pain medication doses and duration are no longer promoted through the CDC’s new Clinical Practice Guideline for Prescribing Opioids for Pain.

The new guidance — which covers acute, subacute, and chronic pain for primary care and other clinicians — updates and replaces the controversial 2016 CDC opioid guideline for chronic pain. The 2016 guideline was interpreted as imposing strict opioid dose and duration limits and was misapplied by some organizations, leading the guideline authors to clarify their recommendations in 2019.

The 2022 recommendations are voluntary and give clinicians and patients flexibility to support individual care, said Christopher Jones, PharmD, DrPH, MPH, acting director of CDC’s National Center for Injury Prevention and Control in a CDC press briefing. They should not be used as an inflexible, one-size-fits-all policy or law, or applied as a rigid standard of care, or replace clinical judgement about personalized treatment, he emphasized.

“Patients with pain should receive compassionate, safe, and effective pain care,” Jones stated. “We want clinicians and patients to have the information they need to weigh the benefits of different approaches to pain care, with the goal of helping people reduce their pain and improve their quality of life.”

The guidance, published in Morbidity and Mortality Weekly Report, addresses four key areas: initiating opioids for pain, selecting opioids and dosages, deciding prescription duration and conducting follow-up, and assessing risk and potential harms of opioids. It suggests that clinicians work with patients to incorporate plans to mitigate risks, including offering naloxone.

The 100-page document indicates opioids should not be considered as first-line or routine therapy for subacute or chronic pain, and points out that non-opioid therapies often are better for many types of acute pain.

“For patients receiving opioids for 1 to 3 months (the timeframe for subacute pain), the 2022 guideline recommends that clinicians avoid continuing opioid treatment without carefully reassessing treatment goals, benefits, and risks in order to prevent unintentional initiation of long-term opioid therapy,” wrote Debbie Dowell, MD, MPH, chief clinical research officer for CDC’s Division of Overdose Prevention, and guideline co-authors in a commentary published in the New England Journal of Medicine.

For chronic pain, clinicians should maximize use of non-opioid therapies and consider initiating opioid therapy only if the expected benefits for pain and function are anticipated to outweigh the risks, Dowell and colleagues noted. When opioids are needed for chronic pain, clinicians should start at the lowest effective dose, evaluate benefits and risks before increasing dosage, and avoid raising dosage above levels likely to yield diminishing returns, they added.

“These principles do not imply that nonpharmacologic and non-opioid pharmacologic therapies must all be tried unsuccessfully in every patient before opioid therapy is offered,” Dowell and colleagues wrote. “Rather, expected benefits specific to the clinical context should be weighed against risks before therapy is initiated.”

The new guideline offers tips for tapering opioids when warranted, but is not intended to lead to rapid opioid tapering or discontinuation, Jones noted. The recommendations do not apply to sickle cell disease-related pain, cancer pain, and palliative or end-of-life care.

The 2022 document incorporated feedback from approximately 5,500 public comments since the new version was first proposed in February, including reactions from people who discussed their experiences with pain or opioid addiction and barriers to pain care. An independent federal advisory committee, four peer reviewers, and members of the public reviewed the draft version.

“The science on pain care has advanced over the past 6 years. During this time, CDC has also learned more from people living with pain, their caregivers, and their clinicians,” Dowell said in a statement. “We’ve been able to improve and expand our recommendations by incorporating new data with a better understanding of people’s lived experiences and the challenges they face when managing pain and pain care.”

The clinical practice guideline supports the HHS Overdose Prevention Strategy, the CDC said. The agency also is providing additional information associated with the guideline to clinicians and patients.

With inflation running 8% – CMS going to CUT physician reimbursement by 4.48%

CMS releases final payment rules for 2023: 15 takeaways

https://www.beckershospitalreview.com/finance/cms-releases-final-payment-rules-for-2023-15-things-to-know.html

CMS has published its annual payment updates for physicians, the Medicare shared savings program and outpatient and home health services for 2023. 

Here are 15 takeaways from the final rules, published Oct. 31 and Nov. 1: 

Physician Fee Schedule rule

1. The conversion factor used to calculate physician reimbursement will decline by $1.55 to $33.06 in 2023, representing a 4.48 percent decrease. CMS said the conversion factor accounts for the expiration of the 3 percent increase in physician fee schedule payments for 2022 — as required by the Protecting Medicare and American Farmers From Sequester Cuts Act — and the budget neutrality adjustment for changes in relative value units.

2. The agency finalized several policies related to telehealth, including extending numerous temporarily available telehealth services during the public health emergency through at least 2023. CMS said this will provide more time to collect data that could support their inclusion as permanent additions to its telehealth services list

3. In response to the increasing demand for behavioral health services, CMS said it will allow these services to be provided under the supervision of a physician or nonphysician practitioner — rather than under direct supervision — when such services are provided by “auxiliary personnel,” such as licensed professional counselors or family and marriage therapists.

4. In an update to the Medicare Shared Savings Program, providers new to the initiative that are not renewing or reentering as an ACO and qualify as low revenue can receive a one-time payment of $250,000 and quarterly payments for the first two years of a five-year period. The advance payments would be recouped once an ACO begins generating shared savings in their current and next agreement periods. CMS said it will not move to recoup money from ACOs that do not generate savings, but those ACOs must remain in the program for the full five years.

Outpatient Prospective Payment System rule

5. CMS is increasing outpatient payment rates for hospitals that meet applicable quality reporting requirements by 3.8 percent. 

6. In line with the 2019 OPPS final rule — which finalized a proposal to apply the productivity-adjusted hospital market basket update to ASC payment rates through 2023 — CMS is also increasing pay rates by 3.8 percent for ASCs that meet applicable quality reporting requirements.

7. CMS is finalizing a general payment rate of average sale price plus 6 percent for drugs and biologicals acquired through the 340B drug pricing program.

8. The agency is finalizing separate payment in ASCs for five non-opioid pain management drugs that function as surgical supplies, including certain local anesthetics and ocular drugs.

Rural Emergency Hospitals rule

9. The agency established a new Medicare provider type called rural emergency hospitals, effective Jan. 1, to address concerns that rural and critical access hospital closures are reducing access to care for people in rural areas. 

10. The final rule broadly defines “REH services” to include all covered outpatient department services when provided by rural emergency hospitals, which will be paid for at a rate equal to the OPPS payment rate — for the equivalent covered outpatient department service — increased by 5 percent, according to the agency. Beneficiaries will not be charged coinsurance on the additional 5 percent payment. 

11. In 2023, rural emergency hospitals will receive a monthly facility payment that will increase in subsequent years by the hospital market basket percentage increase.

Home Health Prospective Payment System rule 

12. Home health agencies will receive a 0.7 percent Medicare payment boost, translating to an extra $125 million next year, according to the agency.

13. CMS said the increase reflects a 4 percent home health payment percentage, which will add $725 million, and a 0.2 percent increase because of an update to the fixed-dollar loss ratio used in calculating outlier payments, which will add $35 million. 

14. CMS payments to home health agencies will drop 3.5 percent next year after the agency found it has paid far more under the new patient-driven groupings model. An estimated $635 million will be docked from home health agency payments in 2023 and more cuts may be coming in the coming years. 

15. To make home health payments more predictable, the agency is finalizing a budget-neutral 5 percent cap on negative wage index changes for home health agencies to facilitate yearly changes in the pre-floor, pre-reclassified hospital wage index.

 

The Opioid Crisis Is Still a National Threat

Once again Congress is GIVEN A PASS over their contributions to the opiate crisis in the early 2000’s.  In 1999-2000 Congress passed the DECADE OF PAIN LAW… and The Joint Commission (JC) got involved and declared that pain was THE FIFTH VITAL SIGN – on par with the importance of  a pt’s Body Temperature, Pulse Rate, Respiration Rate, Blood Pressure.  JC made adequate pain management a MAJOR STANDARD for hospital to meet in order to attain certification by the JC.  Pt surveys given to pts on being discharged from the hospital were required to have questions about how their pain was treated while in the hospital. When the Decade of Pain Law expired, the politically party in the majority of Congress had FLIPPED and refused to renew the law.  Once that law was not renewed, JC disavowed any ownership of the 5th vital sign and pain was no longer a major standard for hospitals to meet when pts were in the hospital.  I guess that is no small coincidence that the number of opiate Rxs peaked a couple of years after the Decade of pain law expired and have continued to drop annual ever since.  Currently about 60% less from the earlier peak. While OD/poisoning from illegal fentanyl has increased around FOUR TIMES in a similar time frame. 

The Opioid Crisis Is Still a National Threat

https://www.medpagetoday.com/opinion/focusonpolicy/101502

Its shape is changing slightly, but we must continue to battle this scourge

Midterm election madness is in full swing and the incipient cold/flu/COVID season is looming. Our national opioid epidemic has largely disappeared from the headlines with the exception of local coverage when drugs are associated with a crime.

How are we faring in this longstanding battle?

First, a brief recap of what brought us to this point. Beginning in the late 1990s, pharmaceutical company misinformation about the addictive properties of opioid pain medications led providers to prescribe them at higher rates. This precipitated an alarming increase in the use and misuse of these highly addictive medications and, in 2017, prompted the Department of Health and Human Services to declare a public health emergency.

Since then, a great deal of effort and financial capital has gone into understanding the “upstream” conditions that fueled the crisis, and implementing interventions to resolve problems. However, the challenges are formidable; for instance –

  • Addressing social determinants such as poverty, joblessness, disparities, and crime
  • Changing long-established provider prescribing practices
  • Disrupting the supply chain for illegal manufacture and distribution of deadly opioid and synthetic preparations on a nationwide basis

On the “downstream” side, some interventions have been effective in preventing deaths and reducing recidivism. Consider the relative speed with which opioid antagonists (i.e., naloxone and naltrexone) have become an integral part of training for many police officers, emergency medical technicians, and non-emergency first responders. In fact, most states now permit people who are at risk — or who know someone at risk for an opioid overdose — to be trained in administering naloxone. There has also been a sizable uptick in the availability of mental health support services and medication assisted treatment options for people who have experienced a non-fatal opioid overdose.

So, back to my original question: are we any closer to winning the battle?

A quick scan of recent national statistics suggests that, rather than abating, the crisis may be undergoing a subtle transformation. A Substance Abuse and Mental Health Services Administration survey estimates that 9.5 million Americans age 12 and over misused opioids in 2020, down from 10.1 million the previous year. While this is encouraging, the survey data also show a disturbing increase in heroin use.

National hospitalization and mortality data provide a more robust assessment of the situation. From 2010-2018, opioid-involved overdose deaths rose from 21,088 to 46,802 in the U.S. Recent statistics paint an increasingly bleak picture. During the first year of the COVID pandemic, there was an increase of 30.6% in 12 months (68,630 overdose deaths through 2020). The increase was not confined to a few hot spots; statistically significant increases in drug overdose death rates were reported in 40 states.

Homing in on a specific locale, the Pennsylvania Health Care Cost Containment Council recently released its report on opioid overdose hospitalization trends in the state. In addition to differentiating between pain medication and heroin overdose hospitalizations, the report highlights trends across race/ethnicity and poverty levels from 2016 to 2021.

Over the 6-year period, there are indications that the crisis as we know it might be waning. For example, there was a 27% decrease in hospitalizations for opioid overdose (from 3,342 in 2016 to 2,429 in 2021), and the percentage of overdose hospitalizations associated with heroin also declined (from 47% of cases in 2016 to 30% of cases in 2021).

Analysis of demographic data suggests a worsening of “upstream” conditions. While hospitalization rates for opioid overdose decreased in the white, non-Hispanic population, they increased for both Black and Hispanic residents. Similarly, increased rates over time were observed for residents living in high-poverty areas (i.e., areas with a poverty rate >25%).

The statistics I find most alarming in this report relate to the drug fentanyl, a powerful and highly addictive synthetic opioid. In 2021, approximately 18% of all opioid overdose hospitalizations were for fentanyl overdose; and, of all opioid overdose hospitalizations that ended in death, 34% were for fentanyl overdose. National data reinforce these concerns; the CDC reports that overdose deaths from synthetic opioids (primarily fentanyl), psychostimulants (such as methamphetamine), and cocaine continued to increase in 2021 compared to 2020.

Inevitably, there is no simple answer to the question I raised. Although national- and state-level reports show hopeful declines in death rates from prescription opioids, the crisis appears to be evolving. We now face the prospect of rising deaths from fentanyl and other addictive substances.

The message is clear. Substance misuse is now –- and will likely remain — a serious threat to national and local population health. We cannot afford to avert our eyes!

If you sit on the sidelines… sitting on your hands… if nothing changes… if you are not part of the solution… you may be part of the problem

Just have to follow the $$$ trail

Posted by Steve Ariens on Sunday, October 30, 2022

‘Pill Mill’ Docs, You May Be in for a Big Scare

What has changed in the short time since the Ruan case faced the Supreme Court is that the opioid epidemic has gotten even worse. This puts pill mills and the doctors who fuel them firmly in the crosshairs of the media and the law.

Whether, if a physician’s good faith is a complete defense to a prosecution for prescribing controlled substances without a legitimate medical purpose or outside the usual course of professional practice.

The issue with “good faith” is that it’s simultaneously fact-based and subjective. Ten cases presenting 10 different fact sets are going to have some commonalities but also some critical differences. Of course, this is the case with Santos and Ruan.

The above statements from this article – are concerning -with recent CDC reports that AT LEAST 70%-75% of OD/poisoning involved illegal fentanyl yet in this article it is stated that “pill mills and doctors prescribing opiates has fueled this epidemic”. Rx opiate prescribing peaked in 2011-2012 and has been declining every year since and the DEA’s opiate productions quotas on the pharma have been cut abt 60% over the last 5 yrs +/-.  Are these attorneys that ill informed or the FACTS about opiate OD/poisoning no longer aligns with the agenda that the DEA created FIVE DECADES ago ?

maybe the details were in the transcript of the trial/testimony, but I have never any specifics from the DEA as to what they consider prescribing controlled substances without a legitimate medical purpose or outside the usual course of professional practice.  By and large when dealing with subjective diseases (pain,anxiety, depression, ADD/ADHD, various mental health issues) there is no real definitive tests that will signify the impact the particular disease issue is having on a pt’s QOL. Asking the pt is the only real indication that the prescriber has.  It is much like going to get your eyes tested for glasses.. the pt gets asked several times.. ” is one or two better ?”  Has anyone ever had a optometrist tell you.. this particular lens combination will let you see 20/20 and never put you thru the options of the optical variations  where the pt believes a particular combination is where they can see the best.

The same goes when a pt sees a psychiatrist about depression, anxiety or other various mental health issues. The psychiatrist prescribes one or more medications and sees the pt back in the office in a few weeks and asks the pt how their perception of  “how are you feeling”.. The Prescriber will increase, decrease the dose of the meds the pt is taking and/or change the medications the pt is taking and repeat the process every so many weeks or months.

When I first started working in a pharmacy all prescriptions were CASH. most stores had their own “store charge” and plastic charge cards were in their infancy, so were most physicians’ practices cash only or the practice had office charge account, but back then there was no PBM’s nor DEA.

Our Daughter, has a Masters in Psychology and when she decided to open her own private practice – for once in her life – she listened to me when I told her “if you can avoid it – don’t sign any insurance contracts – Her practice is now some 8 yrs old, she is only CASH up front and she will submit the pt’s insurance claims electronically – non assigned – the pt pays her up front and the pt’s insurance will send $$ to the pt for whatever the insurance allows for “talk therapy”.

Being a Psychologist, she has no prescriptive authority and there is some licensing board over Psychologists.  Bureaucratic oversight is minimal,  Does anyone else find it strange that there are certain healthcare professionals can have a CASH ONLY BUSINESS but others … because they are prescribing controlled substances… the law enforcement agency – THE DEA – can determine what is  a legal, valid activity of a medical practice ?

 

‘Pill Mill’ Docs, You May Be in for a Big Scare

https://www.medpagetoday.com/opinion/second-opinions/101457

Two recent Supreme Court cases have major implications for physician practice

Last week, in an otherwise unremarkable order list, the Supreme Court remanded a case involving a “pill mill” doctor to a lower court for further consideration, in a move that could impact previous precedent-setting decisions on prescribing liability.

The ultimate decision in the case, Santos, Medardo Q. v. United States (Santos), will have important implications for care.

Details of the Cases

Counsel for Medardo Queg Santos, MD, filed a writ of certiorari — a petition for review — with the Supreme Court earlier this year. The counsel argued that if the court were to decide that “pill mill” doctors could not be convicted absent a jury finding that they subjectively believed the doctor was wrongfully dispensing pills, then Santos should be cleared of his conviction.

I wrote about a similar case, Ruan v. United States, back in March, the day after the Supreme Court heard oral arguments.

In Ruan, the Supreme Court upheld a federal law making it illegal for doctors to prescribe opioids to patients without a legitimate medical purpose, but held, in a 9-0 ruling, that Xiulu Ruan, MD, the “pill mill” doctor in question, indeed had a good faith defense. He was, however, convicted for unauthorized distribution of controlled substances.

The historical context in which Ruan was charged was part of a push by the federal government to crack down on so-called “pill mills” or “opioid mills,” which are clinics where doctors prescribe opioids to patients without conducting any real examination, often with no regard for their long-term health or safety.

As for Santos, given that he had a pending application for certiorari in front of the Supreme Court and given the decision in Ruan, it should be a fait accompli that he and his conviction should have a similar fate.

Not so fast.

As I mentioned at the outset, last week the Supreme Court vacated the judgment against Santos and remanded the case to the 11th Circuit. I don’t believe that “further consideration” is going to result in the 11th Circuit simply aligning Santos with Ruan.

My theory is that Santos may again be considered by the Supreme Court after the 11th Circuit’s decision. This is because the Supreme Court might have seen something factually interesting in Santos that presents the Ruan issues in a different light. In other words, the settled law of Ruan might not be so settled, even after a 9-0 decision.

This could have serious implications for physician practice and care.

The Broader Context

What has changed in the short time since the Ruan case faced the Supreme Court is that the opioid epidemic has gotten even worse. This puts pill mills and the doctors who fuel them firmly in the crosshairs of the media and the law.

This zeitgeist speaks to the main issue presented to the Supreme Court in Santos, which mirrors that in Ruan:

Whether, if a physician’s good faith is a complete defense to a prosecution for prescribing controlled substances without a legitimate medical purpose or outside the usual course of professional practice.

The issue with “good faith” is that it’s simultaneously fact-based and subjective. Ten cases presenting 10 different fact sets are going to have some commonalities but also some critical differences. Of course, this is the case with Santos and Ruan.

In the recent ruling, the federal trial court found Santos (as well as a co-defendant) guilty of three counts of illegally distributing and dispensing controlled substances for no legitimate medical reason (similarly to Ruan’s conviction). However, unlike Ruan, Santos was also found guilty of conspiracy to distribute and dispense controlled substances outside the normal course of his professional practice.

Testimony at trial, which led to Santos’ conviction, spoke to his abuse of the system. Santos was director of a cash-only pain management clinic in Tampa, and over a 3-year period he and his co-defendant allegedly spent very little time with their patients and took little to no medical history or documentation. After this cursory medical attention, they allegedly prescribed what the trial court decided were excessive amounts of controlled substances, including morphine, oxycodone, hydrocodone, methadone, and more.

So, it was no surprise that the trial court found Santos guilty of these charges. This is not dissimilar to what happened at the trial court in Ruan’s case.

It’s critically important to understand that the 11th Circuit is a superb example of how a U.S. president can reshape a court. As Bloomberg Law recently highlighted, Trump nominees dominate the 11th Circuit Court of Appeals. Over half of these judges “got their posts through Trump’s aggressive remaking of the U.S. judiciary.”

Simply put, the 11th Circuit is a perfect venue to re-examine and realign Ruan.

As we examine this today, it’s worth considering whether the Supreme Court remanded this to the 11th Circuit because they see a factual basis for overturning Santos’ conviction (and aligning the decision with Ruan) or whether the Supreme Court sees a way for the 11th Circuit to distinguish this case from Ruan. In this latter instance, the 11th Circuit would, again, affirm the District Court’s decision and essentially take a bite out of Ruan.

Implications for Physician Practice

If the Santos decision holds, the implications for physician practice and care are immediate. Every bite that gets taken out of the Supreme Court’s decision in Ruan takes agency away from doctors to practice medicine as they see fit, using their best judgment and good faith as their north stars. But court decisions impact medical practice, and there is no denying that court decisions are influenced by the times we live in.

Ruan was one of Justice Stephen Breyer’s final decisions on the Supreme Court. While last term’s Supreme Court ruled that even doctors in a pill mill could be convicted only if a trial court jury found that they subjectively believed they were wrongfully dispensing pills, by the time Santos is decided by the 11th Circuit, close to a year will have passed since the Ruan decision.

As long as the U.S. government continues to crack down on illegal opioid production and distribution and opioid-related overdoses continue to rise, legislatures and courts will drive new regulation aimed at curbing opioid distribution and use.

In that context, doctors need to ask themselves whether they believe the scrutiny of their dispensing practices is the same, better, or worse than it was in March when the oral argument in Ruan was heard. They need to be responsive to the signals courts are sending about the good faith defense in Ruan and to keep a close eye on the impact of the upcoming Santos decision.

Joe Froetschel, JD, an experienced medical malpractice lawyer, observes that: “The Supreme Court’s decision in Ruan essentially established a rebuttable presumption that prescriptions from doctors are legitimate. The holding requires the government to prove, beyond a reasonable doubt, that an individual doctor ‘knowingly or intentionally’ acted in an unauthorized manner, which established an extremely high bar for prosecutors to meet in criminal cases.”

Ultimately, these cases present an ultimately more important question for doctors to consider:

Can it ever be good faith (and medically justifiable) for a physician to prescribe controlled substances without a legitimate medical purpose or outside the usual course of professional practice?

Reframing the question in this way makes the correct answer obvious, as it would to the 11th Circuit and the Supreme Court if they undertake a similar exercise.

The “good faith” standard is invariably subjective and a subjective standard should never operate as an absolute defense when assessing physician conduct. Why? Because a subjective good faith standard erodes patient safety.

For example, it’s not a valid defense in a traditional malpractice case for a doctor to say, “Well, I tried my best.” While that may be true, the real issue is whether the doctor’s care complied with the accepted standard of care. This is why objective standards are necessary to ensure safety, and allowing subjective defense will erode any culture of safety.

So, were I advising the Supreme Court in Santos, I would suggest that the standard of care remains the same: the care that a reasonably prudent physician would provide under the same or similar circumstances. By this logic, Santos should not be of much concern to physicians as it will not alter the standard of care in their practice area. Convictions should remain limited to the “pill mill” line of cases.

But, as last term’s Supreme Court reminded us again and again, nothing they do is predictable, and while not every decision defies logic, some of their more controversial ones clearly test its elasticity.

Aron Solomon, JD, is the chief legal analyst for Esquire Digital and the editor of Today’s Esquire. He has taught entrepreneurship at McGill University and the University of Pennsylvania, and was elected to Fastcase 50, recognizing the top 50 legal innovators in the world.

The Medicare Advantage Trade-Off: Saving Money, Losing Access

Medicare Advantage Prgms. (Medicare Part C) is provided by FOR PROFIT INSURANCE COMPANIES – who get so many $$/pt/month IF they spend less per pt per year they make money… if they spend more $$ per pt per year… they lose money…  the more expensive the cost to provide treatment to a pt’s particular health issue… more likely it will requrie a prior authorization and the pt just gets a denial… the most profittable thing that a Part-C can do is JUST SAY NO/Deny claims… hoping that the pt will just…GO AWAY

The Medicare Advantage Trade-Off: Saving Money, Losing Access

https://www.medpagetoday.com/special-reports/exclusives/101213

Beneficiaries may spend less on premiums, but care delays are common. Do worse outcomes follow?

From their ads, Medicare Advantage (MA) plans may seem like a low-cost, easy, and efficient way for America’s seniors to get healthcare. But Barry, a recently retired software executive, tells a cautionary tale.

When a gastric issue led the 65-year-old (his name has been changed to protect his privacy) to the hospital this summer, a CT and biopsy revealed pancreatic cancer. His oncologist came to his bedside to discuss next steps.

“We’ll need to do a PET scan to see if the tumor is localized, and that will determine whether we should do chemo or surgery,” he was told. With pancreatic cancer, the oncologist said, “the faster we move, the better.”

But the oncologist frowned. Unfortunately, the scan couldn’t be scheduled for 3 or 4 weeks.

“You’re the Cleveland Clinic,” Barry responded.

“We’re not the problem,” the oncologist replied. “We have to get approval from your insurance. We’ll submit it, they’ll reject it. There’s a lot of back and forth.”

Barry was puzzled. He had avoided signing up with an MA plan after his broker warned him that those enrollees often had to wait for prior authorization review, which delayed care for weeks to months.

“Just to be clear,” he said, “I’m not in Medicare Advantage. I have regular Medicare with a supplemental.”

The oncologist’s “whole demeanor changed,” he told MedPage Today. The frown became a smile.

“Well then, we can go a lot faster,” he was told.

He got his PET study 3 days later. Barry said a 4-week wait would be intolerable. More importantly, he said, “The sooner I could begin, the less chance the tumor would have to grow or spread elsewhere and become much more difficult to treat.”

With beneficiaries rapidly joining MA plans by the millions each year, more than half of those eligible will be in MA plans rather than traditional Medicare as soon as next year. By 2032, that number is projected to hit 61%, according to a Kaiser Family Foundation (KFF) analysis based on a Congressional Budget Office report.

They are wooed by ads promising low- or no-cost premiums, money added to their Social Security checks, free dentistry, home meals, prescriptions, and rides to the doctor. But those ads and marketing schemes don’t tell the whole story.

There is a greater, and less well-publicized, problem with MA plans — denial of physicians’ referrals for care. Even after appeals and approval, there are delays in scheduling. It’s a game that gobbles up huge amounts of staff time, clinicians complain. One physician said he expects all MA referral requests to be denied at least once.

“We hear about MA policies that seem to purposefully use all sorts of protocols to deny people care, or at least delay it, and we’ve seen more and more complaints,” said David Weil, program manager for the San Diego-based Health Insurance Counseling and Advocacy Program, a federally funded service that provides free, impartial insurance advice and education for Medicare beneficiaries.

Even when services are finally approved, Weil continued, “some MA beneficiaries go to schedule their test or procedure and find it’s nearly impossible.”

The advertisements on TV are particularly misleading and worrisome, he said. Featuring stars like Joe Namath, William Shatner, or Jimmie Walker, they urge beneficiaries to “call the number on your screen,” reassuring that “It’s free.”

“We’re seeing this all the time – people who have been taken in by advertising that changes their Medicare benefits to a Medicare Advantage plan to the detriment of their medical outcomes,” Weil said.

“They can’t see their doctors that they had been going to, and they have to work up all the tests and everything has to be redone with new providers. We continue to see clients who have been harmed by brokers who switch them to a plan that doesn’t work for them. They just sign them up for the highest commission that they’ll be paid.” (For a sidebar on incentives that lead brokers to steer new beneficiaries toward Medicare Advantage plans, click here.)

A Good Idea Gone Bad

The goal in creating the MA concept in 1997 appeared to be a noble one. As of 1999, new Medicare+Choice plan patients would get all their care from providers who talked with each other and coordinated services, thereby reducing waste and overuse. While absorbing risk of taking on sicker patients, they’d be incentivized to use resources judiciously, thus reducing harm from unnecessary care, and cost the Medicare program much less.

But that’s not how it’s worked out.

According to a KFF report, in 2019, Medicare spent an average of $321 more for an MA enrollee than if that enrollee was in traditional Medicare.

Subsequent to a flurry of Congressional hearings earlier this year, CMS recognized a problem with MA plans and in April acknowledged a growing number of complaints, some 15,497 in 2020 and 39,617 in 2021, excluding December.

On August 1, it asked for public input on some 46 potentially problematic aspects of MA plans. For example, it asked about the plans’ “specific prior authorization and utilization management techniques.” And on marketing, it asked, “How well do MA plans’ marketing efforts inform beneficiaries about the details of a given plan?” with specific examples of effective or ineffective techniques.

In a 42-page response, the Center for Medicare Advocacy said while there are barriers in traditional Medicare, those barriers are worse for MA enrollees.

In a nutshell, its attorneys David Lipschutz and Kata Kertesz wrote, MA plans seem to work well for the young and healthy, but not so well for many who are not.

“This is a population that is falling through the cracks when it comes to accessing medically necessary care in MA plans.” “Much more drastic changes are needed in order to adequately protect Medicare beneficiaries against an onslaught of overly aggressive and often misleading Medicare Advantage marketing performed by those who have significant financial stakes in steering people towards MA plans, regardless of whether such option is the best course for an individual,” they wrote.

Delays and Denial of Care

It is also of concern because of several reports suggesting that some MA plans deny care.

One Government Accountability Office analysis conveyed concern about the inordinate disenrollment of enrollees from MA plans, and into fee-for-service, in their last year of life. The report raised questions about whether they were able to get timely, needed care before they died.

Another report from the OIG in April found numerous examples of MA plans denying or delaying approval for enrollees’ recommended services, even though they were legitimately covered under Medicare benefits.

“We found that, among the prior authorization requests that MAOs [Medicare Advantage organizations] denied, 13% met Medicare coverage rules; in other words, these services likely would have been approved for these beneficiaries under” fee-for-service or traditional Medicare, the report said.

Mary Beth Donahue, President and CEO of Better Medicare Alliance, which represents more than 180 provider groups, health systems, and health plans, objected to the criticism of MA plans.

“More than 29 million seniors and individuals with disabilities make an active choice to enroll in Medicare Advantage because it provides a 94% consumer satisfaction rate, supplemental benefits that meaningfully improve beneficiaries’ health, fewer avoidable hospitalizations, and annual savings of nearly $2,000 per year – demonstrating an affordability that is particularly important for seniors on fixed incomes in a period of inflation on household costs,” she said.

She disputed the KFF report that MA enrollees cost more than those in traditional Medicare, saying that the plans receive “support from a record-setting bipartisan supermajority in Congress because it delivers lower per-beneficiary government spending while bringing coverage to a more diverse, lower-income, and more medically complex beneficiary population, all while taking important strides on policymakers’ health equity goals. These are the facts on Medicare Advantage conspicuously missing in recent misleading media reports.”

Three Years to a Diagnosis

Craig Rose, a 74-year-old San Diego man with a SCAN MA plan, started having recurring bouts of pneumonia just over 3 years ago. None of his doctors could identify the cause, and Rose wondered if the network’s pulmonologists were rigorously investigating his symptoms, or taking it slow, since Rose, a former runner, is trim and otherwise healthy.

While traveling in New York last June, Rose noted traces of blood in his sputum. He called his pulmonologist who advised him to stick with the plan, which meant undergoing a lung scan the following month but if he began coughing up blood, he should go to an ER.

Within 36 hours, Rose was coughing up blood. He spent four days at NYU Langone Health with pneumonia. Doctors there told him to get a bronchoscopy as soon as he got home. After another brief delay, that procedure revealed a rare case of nontuberculosis mycobacterial (NTM) infection.

Rose’s MA network did not have an NTM specialist but his internet search found one at UC San Diego Health, Wael El Maraachli, MD, just a few miles away. Rose’s MA plan denied him coverage since he was not in network, then rejected his appeal.

He scheduled anyway and paid nearly $900 out of pocket including labs, and will continue his care at UCSD. Now, he questions whether his diagnosis might have come months — if not years — sooner, and less costly had he been insured through traditional Medicare with a supplement.

Numerous beneficiaries told MedPage Today that they signed up for their MA plans when they were younger and healthier. Their premiums were zero or low. But after they needed care for newly diagnosed chronic conditions, they found themselves paying far more in co-pays and deductibles than a supplemental plan would have cost them. Now with pre-existing conditions they’re ineligible to sign up for a supplement. They’re stuck.

Saving Money, Losing Access

Paul Speckart, MD, a San Diego endocrinologist, told MedPage Today that prior authorization — the ritual of applying for approval, being denied, and reapplying — is a frustrating process he must endure for many of his patients regardless of their coverage. But it’s always worse when the patient has an MA plan, he said.

He tells those patients in or considering MA that “they’re trading money for access,” that is low or no premiums for a limited network, and they may not be able to see the best specialist for their problem. “I have to tell them, ‘Your plan does not offer that,'” he said.

And there are longer delays in scheduling when contracted providers are backed up, creating a logjam for those waiting to be seen. A recent patient complained to him that after waiting to see a dermatologist, he felt like “an object who got a cursory exam.”

The plans collect a per capita sum from Medicare, but can delay paying money out — “all to cut down on usage and save money,” Speckart said.

In recent months, several Congressional hearings and inquiries have focused on the dozens of Office of Inspector General reports that found MA companies submitted fraudulent diagnosis codes that were not supported in patients’ medical records. In less than two years, according to a MedPage Today search, the OIG accused some 20 MA companies that received overpayments from Medicare trust funds of at least $461 million, five of them last month.

Diagnosis codes exaggerated patients’ health status to make them appear sicker and more expensive than they were, and thus, they’d receive hundreds of dollars per enrollee more each month than audits of their health records justified.

On September 20, 2021, the OIG quantified their concern. “We found that 20 of the 162 MA companies drove a disproportionate share of the $9.2 billion in payments from diagnoses that were reported only on chart reviews and HRAs [health risk assessments], and on no other service records.”

“One company further stood out in its use of chart reviews and HRAs to drive risk adjusted payments without encounter records of any other services provided to the beneficiaries for those diagnoses,” the agency said.

A recent New York Times investigation quoted a former government official that estimated MA plans overbilled the government’s Medicare funds as high as $25 billion in 2020 alone.

Wendell Potter, former executive with two large health plan companies, Cigna and Humana, said on Democracy Now that MA plans “will be recognized in years to come as the biggest heist, the biggest fraud, and the biggest transfer of wealth from taxpayers, middle-income, low-income Americans” to corporate executives and shareholders.

TRICARE changes force 15,000 pharmacies out of network

TRICARE changes force 15,000 pharmacies out of network

https://www.legion.org/veteransbenefits/257335/tricare-changes-force-15000-pharmacies-out-network

Nearly 15,000 independent pharmacies are no longer in the TRICARE retail pharmacy network, as of Oct. 24. This is due to a change in the contract with Express Scripts, the Department of Defense TRICARE pharmacy contractor.

TRICARE says that over 90% of beneficiaries will still have an in-network pharmacy within 15 minutes from their home. However, the impact on veterans living in rural areas — who already face barriers in access to care — remains to be seen.

“The Defense Health Agency is confident that the new pharmacy contract maintains the quality of the TRICARE retail pharmacy network,” said Edward Norton, Jr., chief of the Pharmacy Operations Division at the Defense Health Agency. “Some independent pharmacies are leaving, but TRICARE families will continue to have access to an excellent network of pharmacies.”

Express Scripts sent letters to beneficiaries notifying them of the change.  If you have a prescription at one of the pharmacies leaving the network and would like to transfer it to a new retail network pharmacy, beneficiaries may use the Find a Pharmacy tool to find retail network pharmacies in your area.

Here are three easy ways to move your prescription:

– Take your medicine bottles to another participating network pharmacy. The pharmacy will inform you of their process.

– Call your doctor’s office. Ask them to send your prescription to your new in-network pharmacy.

– Call your new in-network pharmacy and ask them to transfer your prescription.

If you experience difficulties filling a prescription due to your pharmacy being removed from the TRICARE retail pharmacy network, The American Legion wants to hear from you by reaching out to the National Security Division email at  NationalSecurityDivision@legion.org.