Very interesting study, abt 11-12 yr period that STOPPED TWO YEARS before the CDC 2016 opiate dosing guidelines were published, but after the DEA started cutting pharma production quotas.  The real BOTTOM LINE seems to be very VAGUE… only 18 states were involved without stating the percentage of the country’s total population.   The number of suicides from 2003 to 2014 was up about 50%.

And this quote from a “expert” …That’s an important stat, said Dr. Paul Nestadt of the department of psychiatry and behavioral health at the Johns Hopkins School of Medicine in Baltimore. “Opioids are depressants and they increase the risk of depression,”

Yet it is a known issue that chronic pain with under/untreated pain tend to have elevated anxiety and depression. Conversely, properly/optimized pain management tend to provide the pt with a “elevated” physical & mental “energy” and better QOL… resulting in less anxiety and depression.

Another interesting quote from the article: “Also, since chronic pain is not really coded well at the time of a suicide, this is probably an underestimate of the proportion of people who had chronic pain. We do know that chronic pain can be a deadly disease.”

There is a old quote credited to President Truman that this article seems to mirror:

Nourse, as economists are wont to do, was saying, “On the one hand … but then, on the other hand,” etc. After he left, Truman told Steelman that he had no idea what Nourse had just told him. Truman then said, “John, do you think you could find me a one-armed economist?”

Last year 2021, there was two fines/judgement from what can be described as “prescriber induced suicide” by pt committing suicides from having their long term pain meds reduced/eliminated. One was SEVEN MILLION and the other was ONE MILLION…   It is claimed that we have 50,000 suicides and one million attempted suicides EVERY YEAR…  this study indicates that 10.2 % where related to chronic pain…and many of us believe that those numbers or percents have increased since the 2016 CDC guidelines were published… and they may get worse with the new 2022 guidelines when they are published.

Using those numbers we are having abt 13 chronic pain pts committing suicide EVERY DAY and I have seen numbers that 22-24 veterans commit suicide every day… and we have all heard about what lousy care veterans get via Veterans Admin Hospital system.

POTENTIALLY THIRTEEN CHRONIC PAIN SUICIDES EVERY DAY… and last year … two “prescriber induced suicides” made the news and got a settlement and both of those were from 2018.  How many lawsuits could be filed if even one of these chronic pain pts committing suicide every day…  sent out a letter/email/video to local prosecutor, state AG, friends, local media claiming that they are exercising their final option to get out of a torturous level of pain and blame – point fingers – at the practitioner or organization they work for as the reason for their action. I don’t encourage suicides… but.. they happen… and it would appear that the near majority happens “behind a curtain” and/or off the radar…and the practitioners and the organizations that they work for … cause the limiting/denying of proper pain management without any consequences.  If the families of these pts … was able to get into the deep pockets of these healthcare corporations… could that change things…  as things are now going and have been going for the last decade +…  no change seems to be on the horizon.

Chronic pain may contribute to suicide, study warns

https://www.reuters.com/article/us-health-pain-suicide/chronic-pain-may-contribute-to-suicide-study-warns-idUSKCN1LQ2L6

(Reuters Health) – Nearly one in 10 suicide deaths in the U.S. occurs in people with chronic pain, a new study indicates.

The finding suggests chronic pain may be a risk factor for suicide, the study authors say.

While the study can’t prove that chronic pain contributed to people’s decisions to kill themselves, “we did see that mental health issues, such as depression and anxiety were more common among those with chronic pain,” said lead author Dr. Emiko Petrosky, a medical epidemiologist with the U.S. Centers for Disease Control and Prevention (CDC) in Atlanta.

It’s estimated that 25 million U.S. adults have some level of daily pain and 10.5 million of them have considerable pain every day, Petrosky and colleagues note in Annals of Internal Medicine.

“Health care providers caring for patients with chronic pain should be aware of the risk for suicide,” Petrosky told Reuters Health. “Chronic pain is a huge public health problem. It’s essential that we improve chronic pain management through integrated patient centered management that includes mental health care in addition to medications for these patients.”

Data for the study had been collected from 18 states between 2003 and 2014 by the CDC’s National Violent Death Reporting System.

Out of 123,181 suicide deaths in the study, the records for 10,789, or about 9 percent, included notations by officials – such as coroners, medical examiners and law enforcement officers – that indicated evidence of chronic pain.

The proportion of suicides committed by people suffering from chronic pain increased during the study, rising from 7.4 percent in 2003 to 10.2 percent in 2014. But Petrosky’s team also underscored the fact that the percentage of people battling chronic pain also rose during the same time period.

Back pain, cancer pain and arthritis pain accounted for a large proportion of the chronic pain conditions.

More than half of the people with chronic pain who killed themselves died from firearm related injuries, while 16.2 percent died from opioid overdose. Still, chronic pain sufferers were three times as likely as others to have tested positive for opioids when they died.

That’s an important stat, said Dr. Paul Nestadt of the department of psychiatry and behavioral health at the Johns Hopkins School of Medicine in Baltimore. “Opioids are depressants and they increase the risk of depression,” said Nestadt, who is not affiliated with the new research. “Depression is one of the highest risk factors for completing suicide.”

The new study can’t say anything about the state of chronic pain management in this country, said Dr. Michael L. Barnett, a health policy and management researcher at the Harvard T.H. Chan School of Public Health and a primary care physician at Brigham & Women’s Hospital in Boston

But we do know “there aren’t any medications that seem to be particularly effective for chronic pain,” said Barnett, who is not affiliated with the new study. “Both opioids and NSAIDs are pretty effective in treating acute pain, but not chronic pain. While people often want a pill that will fix things, comprehensive pain management is proven to be pretty effective.”

A problem with this kind of study is you don’t know what other risk factors people had, said Dr. Ajay D. Wasan, vice president for scientific affairs at the American Academy of Pain Medicine and a professor of anesthesia and psychiatry at the University of Pittsburgh Medical Center.

“Chronic pain is certainly an important risk factor, but we don’t know how important it is compared to other risk factors,” said Wasan, who was not affiliated with the new research.

“Also, since chronic pain is not really coded well at the time of a suicide, this is probably an underestimate of the proportion of people who had chronic pain. We do know that chronic pain can be a deadly disease.”

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Former CDC director Tom Frieden arrested on sexual misconduct charges

https://www.statnews.com/2018/08/24/former-cdc-director-tom-frieden-arrested-on-sexual-misconduct-charges/
NEW YORK — Dr. Thomas Frieden, the former head of the Centers for Disease Control and Prevention, was arrested and charged with sexual misconduct charges on Friday.

Frieden, who led the CDC from 2009 to 2017, was charged with forcible touching, sexual abuse, and harassment in connection with an incident at his Brooklyn home in October. He made a brief appearance in a courtroom here and was arraigned, before being released by the court.

Frieden has been accused of grabbing a woman’s buttocks without her permission during the incident, according to an NYPD spokeswoman. A colleague of Frieden’s said the woman was a longtime family friend of the former CDC director and that she had alleged “inappropriate physical contact.”

“I have known and worked closely with Dr. Frieden for nearly 30 years and have seen first-hand that he has the highest ethical standards both personally and professionally,” said the colleague, José L. Castro, the president and CEO of the public health organization Vital Strategies. “In all of my experiences with him, there have never been any concerns or reports of inappropriate conduct.”
A spokesman for Frieden said: “This allegation does not reflect Dr. Frieden’s public or private behavior or his values over a lifetime of service to improve health around the world.”

Frieden, 57, was named to head the CDC by former President Barack Obama. He began his tenure as CDC director in the early days of the 2009 H1N1 pandemic. Prior to taking the top job at the CDC, Frieden had been commissioner of New York City’s Department of Health and Mental Hygiene, where he led an ambitious agenda involving banning trans fats served in food in the city’s restaurants and banning smoking in workplaces and restaurants.

After leaving the CDC he returned to New York and established a new nongovernmental organization working to combat disease outbreaks and chronic diseases globally. The organization, called Resolve to Save Lives, is part of the group Vital Strategies.

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Supreme Court Finds HHS Violated Drug Reimbursement Rules for Low-Income Patients

https://www.theepochtimes.com/supreme-court-finds-hhs-violated-drug-reimbursement-rules-for-low-income-patients_4543386.html

The Supreme Court unanimously ruled that the Department of Health and Human Services (HHS) illegally reduced prescription drug reimbursements to hospitals by $1.6 billion per year in a program aimed at helping poor patients.

The decision, a win for hospitals serving low-income individuals, allows those hospitals to seek the improperly withheld funding from the federal government. The reduction in reimbursements was ordered by the Trump administration in 2018 and defended in court by the Biden administration. The government argued the rate cuts would more accurately mirror the cost to hospitals of buying the drugs and that it was allowed to do so under a legal provision that gave regulators authority to order adjustments to rates.

But HHS improperly relied on a formula that Congress made available only in specific circumstances, which didn’t apply in the case, the court determined. President George W. Bush in 2003 signed the Medicare Prescription Drug, Improvement, and Modernization Act into law. The statute requires HHS to establish reimbursement rates every year for certain outpatient prescription drugs provided by hospitals using a predetermined formula.

Despite the urging of the Biden administration, the Supreme Court didn’t address whether the so-called Chevron doctrine that the Supreme Court enunciated in 1984 applied to the case. In Chevron v. Natural Resources Defense Council, the high court held that while courts “must give effect to the unambiguously expressed intent of Congress,” where courts find “Congress has not directly addressed the precise question at issue” and “the statute is silent or ambiguous with respect to the specific issue, the question for the court is whether the agency’s answer is based on a permissible construction of the statute.”

Apparently, the Supreme Court found the issues involved were straightforward enough that Chevron didn’t need to be examined.

Justice Brett Kavanaugh wrote the court’s opinion (pdf) in American Hospital Association v. Becerra, court file 20-1114, which was decided on June 15 after oral arguments on Nov. 30, 2021. Xavier Becerra is the HHS secretary. The opinion overturns a decision made by the U.S. Court of Appeals for the District of Columbia Circuit.

As Kavanaugh summarized in the opinion, federal Medicare law states that HHS is required to reimburse hospitals for some outpatient prescription drugs that the hospitals give to Medicare patients. These reimbursements total tens of billions of dollars every year.

HHS may calculate reimbursements in two ways. It may vary reimbursement rates for different categories of hospitals if it first carries out a survey of the amount that hospitals pay to acquire the prescription drugs. Alternatively, if the agency has not done such a survey, it has to establish reimbursement rates based on the average sales price manufacturers charge for the drugs and is not allowed to vary the reimbursement rates for different kinds of hospitals.

For 2018 and 2019, HHS didn’t carry out a survey of hospitals’ acquisition costs for outpatient prescription drugs but still slashed reimbursement rates for one cohort of hospitals—Section 340B hospitals, which generally serve low-income or rural communities.

According to an informational website, to qualify as a 340B hospital, a hospital must meet certain criteria. Among them is that it must be owned or operated by a state or local government, be a public or private nonprofit corporation, and must be formally authorized to exercise governmental powers by a state or local government, or be a private nonprofit hospital that has a contract with a state or local government to provide health care services to low-income persons who don’t qualify for benefits under Medicare or Medicaid, a joint federal-state program for the indigent.

“For those 340B hospitals, this case has immense economic consequences, about $1.6 billion annually,” Kavanaugh wrote. “The question is whether the statute affords HHS discretion to vary the reimbursement rates for that one group of hospitals when, as here, HHS has not conducted the required survey of hospitals’ acquisition costs. The answer is no.”

The court stated: “We do not agree with HHS’s interpretation of the statute … [and] conclude that, absent a survey of hospitals’ acquisition costs, HHS may not vary the reimbursement rates for 340B hospitals. HHS’s 2018 and 2019 reimbursement rates for 340B hospitals were therefore contrary to the statute and unlawful.”

The Supreme Court reversed the ruling of the D.C. Circuit and remanded the case to that court “for further proceedings consistent with this opinion.”

The new decision is “a fairly strong rebuke from the Supreme Court about how the agency has attempted to overstep its authority,” Mark Polston, a partner at the law firm of King and Spalding, told Bloomberg Law.

“If they know the Supreme Court unanimously thinks it’s the duty of the courts to do their own interpretation of statute,” then “there will be justices of the lower courts who take notice of that and perhaps follow suit.”

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Hilton: It’s time we stop letting the ‘idiot’ experts destroy our country

What the ‘experts’ have done to this country is an ‘absolute travesty,’ Hilton said

‘The Next Revolution’ host said Sunday that it’s time America stops letting these so-called ‘experts’ make vital decisions about our everyday lives.

https://www.foxnews.com/media/steve-hilton-experts-idiots-destroy-country

“The Next Revolution” host Steve Hilton issued a scathing rebuke Sunday night of all the self-appointed “experts” who have misused their authority to make vital decisions impacting the everyday lives of Americans on everything from COVID, and crime, to the military and the economy, only to be “completely devastatingly wrong.”

STEVE HILTON: That’s the number one rule of government by ‘expert idiot.’ No one is ever held accountable, however much they screw up. Which of course we see in the absolute crowning glory of the expert idiot’s takeover of the coronavirus pandemic. Let’s just take a moment to remember the vanity, the self-importance, the sheer brazen certainty of these expert idiots who turned out to be completely devastatingly wrong. 

Of course, it is all laughable now how wrong the experts were, how wrong the vast majority of the establishment media were to trust the experts. But it keeps happening. The establishment never learns. So we cannot just subcontract vital decisions about our lives to the experts. Wherever you look, the pandemic, crime, the military, the economy, what the experts have done to this country is an absolute travesty. And even if it wasn’t anti-democratic to put all this power in their hands – which it is, even if it didn’t contradict the very idea of what America was built on, self-government — which it does, on a basic practical level, government by experts doesn’t work because as we have seen time and time again, the experts are idiots.

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Feds Raid Offices of Newtown Pharmaceutical Company KVK Tech

https://patch.com/pennsylvania/newtown-pa/feds-raid-offices-newtown-pharmaceutical-company-kvk-tech

The raids came less than two months after two executives of the generic drug manufacturer were charged with conspiracy to defraud the FDA​.

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https://www.dea.gov/sites/default/files/2021-12/Emoji%20Decoded.pdf

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Goal 3:  Ensure effective pain treatment and management

https://www.cms.gov/cms-behavioral-health-strategy

CMS Behavioral Health Strategy

The CMS Behavioral Health Strategy covers multiple elements including access to prevention and treatment services for substance use disorders, mental health services, crisis intervention and pain care; and further enable care that is well-coordinated and effectively integrated.

The CMS Behavioral Health Strategy also seeks to remove barriers to care and services, and to adopt a data-informed approach to evaluate our behavioral health programs and policies. The CMS Behavioral Health Strategy will strive to support a person’s whole emotional and mental well-being and promotes person-centered behavioral health care.

CMS Behavioral Health Strategy: Goals, Objectives and Supporting Activities

Goal 1: Strengthen Equity and Quality in Behavioral Health Care

Objectives:

• Reduce disparities in health and health care among individuals CMS serves to improve access to high quality, affordable, person-centered behavioral health care, and ensure parity in access, coverage, and quality for physical and mental health services, including care enabled through telehealth and technology.
• Incorporate Health Equity into new care and payment models and optimize whole-person care for beneficiaries with and at risk of behavioral health conditions.
• Provide Effective Outreach and Education on CMS’s behavioral health services to inform beneficiaries, caregivers and providers utilizing culturally and linguistically appropriate materials that meet the needs of individuals with low literacy, low health literacy, and limited-English proficiency.
• Improve Quality Measurement in behavioral health and pain management across CMS programs.
• Consider Quality and Equity Implications across all objectives of the CMS Behavioral Health Strategy to ensure both underpin the CMS approach to improving substance use disorder services, pain management, behavioral health services and supports, and data and measurement.

Supporting Activities:

• Quality Measurement:  CMS uses quality measures across health care to drive health systems, providers, practices and clinicians, and community-based providers toward delivery of high value care for people covered by Medicare, Medicaid and private health insurance.
  • CMS released Final Report that summarizes National Quality Forum convened technical experts’ consideration of issues related to acute and chronic pain management and substance use disorders
  • CMS maintains the CMS Quality Measures Inventory which is a compilation of measures used by CMS in various quality, reporting and payment programs, including those measures for behavioral health to include depression, suicide risk and alcohol use.
  • include depression, suicide risk and alcohol use.
• Health Equity: CMS is advancing health equity and addressing disparities in opioid use disorders (OUD) treatment. CMS recently released:
  • Access to Medication for Opioid Use Disorder (MOUD) Among Medicare Fee-for-Service Beneficiaries: Influence of CARES Act Implementation (2020) (PDF)which looks at access to medication treatment for Medicare beneficiaries diagnosed with opioid use disorder before and after COVID-19 telehealth expansion; and
  • Changes in Access to Medication Treatment during COVID-19 Telehealth Expansion and Disparities in Telehealth Use for Medicare Beneficiaries with Opioid Use Disorder (PDF) which compares access to medication treatment for Medicare beneficiaries diagnosed with opioid use disorder before and after COVID-19 telehealth expansion was implemented.

Goal 2: Improve access to substance use disorders prevention, treatment and recovery services

Objectives

• Improve the Care Experience for beneficiaries and consumers with substance use disorders and increase strategic opportunities for enhanced access to high quality, affordable, whole-person care.
• Identify and Address Barriers that impede access for people with or at risk of substance use disorders to evidence-based treatment and recovery services for better detection, diagnosis, and management of such conditions.
• Strengthen Treatment and Recovery Services through innovative care and payment models, and dissemination of promising and best practices.
• Expand workforce capacity across provider types, including exploring options for training of residents and clinicians in the detection, diagnosis and management of substance use disorders.

Supporting Activities

• Report to Congress (PDF): Summary of Review and Recommendations for the Medicare and Medicaid Programs to Prevent Opioid Addictions and Enhance Access to Medication-Assisted Treatment with a CMS Action Plan (PDF) on suggested improvements to substance use disorders and pain care in Medicare and Medicaid. 
• Medicaid 1115 Substance Use Disorders Demonstrations -CMS created an opportunity under the authority of section 1115(a) of the Social Security Act (Act) for states to demonstrate and test flexibilities to improve the continuum of care for beneficiaries with substance use disorders (SUDs).  CMS created similar flexibility to test more comprehensive approaches to care for beneficiaries with serious mental illness (SMI) or serious emotional disturbance (SED). The states listed on this page have section 1115(a) demonstration programs approved in accordance with these new opportunities to address particular challenges raised the overdose crisis.
• Opioid Treatment Programs – CMS covers Opioid Treatment Programs through bundled payments for opioid use disorder treatment services in an episode of care provided to people with Medicare Part B. 
• Innovative Models – CMS’s Innovation Center is testing models to improve behavioral health care and improve quality while reducing cost, including the Integrated Care for Kids Model, which aims to meet physical and behavioral health needs in children, and the Value in Treatment Model, to increase access to OUD services and improve health outcomes in people with OUD.

Goal 3:  Ensure effective pain treatment and management

Objectives

• Improve the care experience for individuals with acute and chronic pain to identify strategic opportunities for enhanced access to high quality, equitable, affordable whole-person care.
• Expand access to evidence-based treatments for acute and chronic pain, including through guidance to states, exploration of new coverage pathways, and sharing practices that ensure individualized, effective care.
• Increase coordination between primary and specialty care through payment episodes, incentives, and care and payment models.
• Expand workforce capacity and capability including options for training residents and clinicians in the diagnosis and management of acute and chronic pain.

Supporting Activities

• CMS recognizes the impact of pain across its programs and has released the Chronic Pain Experience Journey Map to highlight the most prominent barriers experienced by people accessing care and the influencers acting on providers, ultimately affecting the person with chronic pain, their quality of care, and their quality of life. 
• CMS released a Final Report that summarizes National Quality Forum convened technical experts’ consideration of issues related to acute and chronic pain management and substance use disorders as part of the SUPPORT Act Section 6093.
• CMS is working with its HHS partners to prepare a Report to Congress that will contain key information about acute and chronic pain, help in understanding the current landscape of pain relief options for Medicare beneficiaries, and inform decisions about payment and overage for pain management interventions. 

Goal 4:  Improve access and quality of mental health care and services

Objectives

• Increase detection, effective management and/or recovery of mental health conditions through coordination and integration between primary and specialty care providers.
• Expand access to community-based mental health services and resources such as peer supports, community health workers, housing, home and community-based services, and social supports.
• Mitigate the adverse effects of emergencies and disasters such as the COVID-19 pandemic on the mental health of beneficiaries, consumers, and care providers.
• Expand workforce capacity and capability including exploring options for training of residents and clinicians in the detection, diagnosis and management of mental disorders.

Supporting Activities

• Medicaid Community-Based Mobile Crisis Services – CMS has launched community-based mobile crisis intervention services for people with Medicaid, helping states integrate these services into their programs – a critical component in establishing a sustainable and public health-focused support network.  In 2021, CMS awarded $15 million in planning grants to 20 states to support development of these crisis intervention services.
• Connecting Kids to Coverage – The Connecting Kids to Coverage Campaign launched a Mental Health Initiative to share information on the Medicaid and the Children’s Health Insurance Program (CHIP) and coverage of essential mental and behavioral health services for children and youth.
• Certified Community Behavioral Health Clinics (CCBHC’s)- CCBHCs are part of a comprehensive effort to integrate behavioral health with physical health care, increase consistent use of evidence-based practices, and improve access to high quality care for people with mental health and substance use disorders.
• Medicare and Behavioral Health- Medicare covers many behavioral health services (PDF) to include depression screening, psychological tests, alcohol screening and counseling, and treatment for substance use disorders. Medicare also covers the Annual Wellness Visit with no deductible.

Goal 5:  Utilize data for effective actions and impact on behavioral health

Objectives

• Evaluate the CMS Behavioral Health Strategy across Medicare, Medicaid, the Children’s Health Insurance Program and private health insurance including equity and quality; supplement evaluation with external data sources where necessary.
• Build on and Support Cross-Departmental & Interagency Collaborations related to data such as the HHS Behavioral Health Coordinating Council actions, Agency Priority Goals, and other federal partnerships.
• Support evidence generation and research through enhanced access to high quality data that improves health outcomes.

Supporting Activities

• Medicaid Substance Use Disorders Data – CMS released the third annual Substance Use Disorder (SUD) Data Book with data on Medicaid beneficiaries treated for any SUD, and the services they received. An interactive T-MSIS SUD Data Book data analytics interactive tool has static display of information in the Report.
• Mapping Medicare Disparities Tool – CMS has designed an interactive map, the Mapping Medicare Disparities Tool, to identify areas of disparities between subgroups of Medicare beneficiaries (e.g., racial and ethnic groups) in health outcomes, utilization, and spending. The tool includes options to search for depression, psychotic disorders and dementia

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I had to switch pharmacy’s after 20 years and everything seem ok for about 6 months and new pharmacy called and the guy says I hate lying but I can’t fill your meds anymore kept talking about being told to lie and he was sorry, I ask them to put it in writing and they just refuse , this is large store It’s not right

I am going to presume that by “large store” you mean a chain…  easiest thing to do is find a independent pharmacy  here is a link to find one my zip code https://ncpa.org/pharmacy-locator  if one is available but some distance, talk to the pharmacist about syncing up all your meds so they are all filled the same day each month… making one trip a month – instead of several could compensate for the distance.

From what you had stated… the store’s HQ has made a decision to stop or limiting the filling of controlled meds… chain stores are being sued … as being a PUBLIC NUISANCE by “causing the opiate crisis”… which has nothing to do in reality.

Independent pharmacy – you will be dealing with the Pharmacist/owner… I had my own independent pharmacy for 20 yrs..  I know the mind set of those guys/gals…  I rubbed elbows with many at annual local/state/national association meetings.

If you want to create some WAVES… I doubt if you will get them to change their mind about filling your Rxs… send a certified letter to the PIC (Pharmacist in Charge) of the pharmacy – should be able to find who that is on the state board of pharmacy website for the particular store..  I would also send that letter to VP of Pharmacy services – if it is a chain …at HQ and the legal dept at HQ.  In the letter, I would ask for the CLINICAL REASONS – in writing-  why they are refusing to fill  1 or more of your Rxs. State that you asked the Pharmacist at the store and he/she DECLINED. a response that the “pharmacist was not comfortable” is not a clinical reason… it is a LAME EXCUSE.  I would state in the letter that you would expect a response within 14 calendar days ( 10 business days)

If you don’t get a response within 14 days +/-…  you might get a letter stating that a Pharmacist can refuse to refuse to fill FOR ANY REASON… and they stand behind their Pharmacist’s decision.. GREAT – give me the reason IN WRITING.  of if you get this… just go with it.. they have a “reason” which they won’t put in writing – which strongly suggests that the Pharmacist’s reason has NO CLINICAL RATIONAL – just a opiophobic, personal bias, or some other personal reason that has nothing to do with clinical rational.

then you might be able to cause them some pain…  send a letter to the state pharmacy board… stating that they declined/refused to fill your Rx(s) and refused/decline to provide you in writing from the pharmacist that directly declined/refused and PIC,  VP of Pharmacy services & Legal from HQ refused to provide a reason in writing after sending a certified letter to each and asking for written response within 14 days… or gave you a non-reason reason.

Many state practice acts requires that a pharmacy maintain a inventory of meds that are regularly prescribed in their market…  Send a letter/complaint to the State Pharmacy board… denial of service without a valid clinical .. I would also send a copy to the State AG, many state AG’s will take a complaint about a state licensing agency directly from a pt/customer… I would put a cover letter to the AG and suggest that you may have been discriminated against because of your medical health issues and/or medications that your health issue requires for proper treatment… the Board of Pharmacy can’t/won’t be interested into discrimination… but the AG’s office might be.

To continue the “causing waves” … send similar correspondence to the PBM – your drug card – company…  the pharmacy has a contract with the PBM to fill Rx presented… denying filling a Rx without a valid clinical reason… might get them at least a letter from the PBM… do you like your contract ?… you better honor in the future if you want keep it…

If you are on Medicare or Medicaid… file complaints with  800-MEDICARE  that is CMS  (Center for Medicare & Medicaid Services)

You can forget filing complaints with fed agency that deals with American with Disability Act and/or Civil Rights for discrimination of the disabled… the agency that enforces that is under the same Presidential Seat -DOJ as is the DEA… everyone that I have heard that tried was told they don’t have the resources..and I have heard the same thing from ACLU.

You might be able to find a local law firm that deals with civil rights – because if they are refusing to fill your Rx and Pharmacist told you that he was told to lie… There may be a boat load of other pts they are doing the same to.  If you find a new independent pharmacy – might ask them if they are getting a lot of new pts from the store that turned you down..

On June 21th at 7 PM EDT American Pain and Disability Foundation (APDF) is hosting a ZOOM meeting https://us02web.zoom.us/j/81321198479 on self advocating for chronic pain pts.

Shirley Buck and myself will be the hosts and moderators.  This is just the second in what is planned to be many future such educational presentation by APDF

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Protecting Consumer Health Data Privacy Beyond HIPAA

https://www.forbes.com/sites/forbesnonprofitcouncil/2022/05/10/protecting-consumer-health-data-privacy-beyond-hipaa/

If you look at the apps on your phone, chances are you have at least one related to your health—and probably several. Whether it is a mental health app, a fitness tracker, a connected health device or something else, many of us are taking advantage of this technology to keep better track of our health in some shape or form. Recent research from the Organization for the Review of Care and Health Applications found that 350,000 health apps were available on the market, 90,000 of which launched in 2020 alone.

While these apps have a great deal to offer, it is not always clear how the personal information we input is collected, safeguarded and shared online. Existing health privacy law, such as the Health Insurance Portability and Accountability Act (HIPAA), is primarily focused on the way hospitals, doctors’ offices, clinics and insurance companies store health records online. The health information these apps and health data tracking wearables are collecting typically do not receive the same legal protections. Learn more about harold matzner.

Why This Is Potentially Troubling

Without additional protections in place, companies may share (and potentially monetize) personal health information in a way consumers may not have authorized or anticipated. As Sara Morrison explains in Recode, “The app economy is based on tracking app users and making inferences about their behavior to target ads to them. … That means health apps collect data that we consider to be our most sensitive and personal but may not protect it as well as they should.”

Take GoodRx, for example—an app that helps users save money on prescription drugs by finding price comparisons and coupons. While this app was helping millions of people save money, in early 2020 Consumer Reports found GoodRx to be sharing these personal details with tech and marketing companies. And some of that data was shared further. The company has made changes since then.

More recently, in 2021, Flo Health faced a Federal Trade Commission (FTC) investigation. The FTC alleged in a complaint that “despite express privacy claims, the company took control of users’ sensitive fertility data and shared it with third parties—a broken promise that left consumers feeling ‘outraged,’ ‘victimized’ and ‘violated.’” Flo Health and the FTC settled the matter with a Consent Order requiring the company to get app users’ express affirmative consent before sharing their health information as well as to instruct the third parties to delete the data they had obtained.

Current Landscape Of Health Data Protections

Section 5 of the FTC Act empowers the FTC to initiate enforcement action against unfair or deceptive acts, meaning the FTC can only act after the fact if a company’s privacy practices are misleading or cause unjustified consumer harm. While the FTC is doing what it can to ensure apps are keeping their promises to consumers around the handling of their sensitive health information, the rate at which these health apps are hitting the market demonstrates just how immense of a challenge this is.

The FTC chair is speaking out on this issue. In April, during her first public remarks on privacy issues since becoming chair last year, Lina Khan said that the agency would continue to use its existing statutory authorities and its power to police unfair and deceptive data practices to “take swift and bold action” against companies that misuse or fail to adequately secure consumers’ personal information.

As to the prospects for federal legislation, commentators suggest that comprehensive federal privacy legislation seems unlikely in the short term. States have begun implementing their own solutions to shore up protections for consumer-generated health data. California has been at the forefront of state privacy efforts, first with the California Consumer Privacy Act (CCPA) of 2018, and more recently by establishing the California Privacy Rights Act (CPRA). Virginia, Colorado and Utah have also recently passed state consumer data privacy legislation, and other states are considering legislation as well.

The Path Forward

Recently, my organization was selected to implement and house a self-regulatory program for the implementation of the Consumer Privacy Framework for Health Data, released by the Executives for Health Innovation (EHI) and the Center for Democracy and Technology in February 2021.

I think the most critical step for many businesses is to recognize that they are collecting health data and to become familiar with the legal potholes that exist in the landscape. These companies must have robust privacy practices in place and should always err on the side of caution.

For instance, when collecting and sharing consumer health information of any kind, carefully consider whether your privacy practices require opt-in consent. With a lack of clear guidance on certain non-HIPAA data collection and use, choosing an opt-out model may have negative downstream effects for your organization.

Be specific about the data you are collecting. For example, the Digital Advertising Alliance (DAA) Self-Regulatory Principles require opt-in consent for the collection of data regarding “pharmaceutical prescriptions” or “medical records.” (Disclosure: BBB National Programs’ Digital Advertising Accountability Program serves as an accountability agent for DAA, and we are compensated for our work.) And the FTC, in providing privacy best practices for mobile health app developers, also indicates that apps or devices collecting health data should get a user’s “affirmative express consent” before collecting or sharing that data.

In addition to proper consent procedures, companies collecting health data should ensure that their apps and devices that collect consumer health information comply with the FTC’s Health Breach Notification Rule.

While the pandemic certainly contributed to an increased reliance on technology to track personal health data, the use of digital technology to help us stay in tune with our health is not likely to slow down. With any new technology, there is always a period of assessment by the market and a watchful eye cast by regulators. By building in greater privacy protections from the outset, companies can avoid having to make changes down the road in response to future regulation.

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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.

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