Feds Raid Offices of Newtown Pharmaceutical Company KVK Tech

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​.

NEWTOWN, PA — Federal agents served search warrants at the offices of a Bucks County pharmaceutical company Thursday morning in connection with ongoing investigations into the company’s alleged conspiracy to defraud the U.S. Food and Drug Administration.

Around 7 a.m., the Newtown Township Police Department assisted federal agents from the FDA, Homeland Security, the Department of Labor, Health and Human Services and other federal branches with three search warrants at each of the KVK Tech facilities located within Newtown Township: 100 Campus Drive, 110 Terry Drive and 114 Pheasant Run.

The warrants were executed simultaneously at 7 a.m. at all three sites, police said.

The raid comes less than two months after two executives of the generic drug manufacturer were charged with conspiracy to defraud the FDA. Murty Vepuri, 69, and Ashvin Panchal 50, were charged in June by the U.S. Attorney’s Office with distributing unapproved drugs and misleading the agency by concealing information about its products.

From October 2010 through at least March 2015, Vepuri and Panchal, the company’s de facto owner and head of quality assurance, respectively, conspired to defraud the U.S. by impeding, impairing, and defeating FDA’s mission to protect the health and safety of the public by ensuring that drugs marketed and distributed in the U.S. are safe and effective for their intended uses, according to the June indictment filed by federal prosecutors.

Vepuri, who previously owned a drug company in New Jersey that was subject to a restraining order due to FDA violations, is charged with hiding his involvement in the Newtown company by placing its ownership in private trusts to benefit his children. Vepuri then allegedly represented to the FDA that he was merely an advisor or consultant to KVK Tech, when in reality he exercised unchecked authority over the company, federal prosecutors said.

Under his control, the company ignored regulatory requirements that had the potential to slow the manufacture, distribution and sale of its drugs, authorities said. Vepuri and Panchal are also charged with having provided false explanations to the FDA when inspectors identified violations. Often, Vepuri and Panchal attributed regulatory failures to a mistake or misunderstanding, and the company would falsely assure the FDA that violations had been addressed when they knew no corrective and preventative actions had been taken, the U.S. Attorney’s Office said.

The indictment highlighted the company’s conduct with regard to Hydroxyzine, a prescription drug to treat anxiety, for which Vepuri purchased an ingredient made in Mexico that was not an FDA-approved source, authorities said.

If convicted, Vepuri and Panchal each face a maximum possible sentence of five years in prison, three years of supervised release, a $250,000 fine and other financial penalties including forfeiture. KVK Tech faces fines up to $4 million and other financial penalties such as forfeiture and probation. The parties also face mandatory exclusion from participating in federal programs.

All public information regarding the specifics of the warrants are being referred to the U.S. Food and Drug Administration, Office of Criminal Investigations Philadelphia office, at 215-597-4390.

DEA: How people use emoji to order illegal drugs on line

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

CMS Behavioral Health Strategy: Goal 3: Ensure effective pain treatment and management

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:

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

When BIG ASS CHAIN PHARMACY: tells R.Ph. to refuse to fill control meds for pts and just refuse to give reason- JUST LIE TO PT ?

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

Protecting Consumer Health Data Privacy Beyond HIPAA

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.

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

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

MedPAC Backs Simplifying Medicare Alternative Payment Models

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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


Is the GRIM REAPER STALKING THE PBM INDUSTRY ?

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

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

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

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

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

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

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

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

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

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

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

Whistleblower suit: CVS prevented Part D members from accessing generics

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

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

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

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

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

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

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

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

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

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

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

PBMs could be driving up plan sponsors’ drug costs

PBMs could be driving up plan sponsors’ drug costs

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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