I have read some of these small paragraphs several times and I WONDER what the final interpretation of what these small paragraphs are going to end up being what will be applied to many parts of our healthcare system and will that really mean better patient care and outcomes? Why am I skeptical?

White House unveils sweeping healthcare safety efforts: 8 notes

https://www.beckershospitalreview.com/patient-safety-outcomes/white-house-unveils-sweeping-healthcare-safety-efforts-8-notes.html

The Agency for Healthcare Research and Quality, a division of HHS, has partnered with other federal agencies and health systems to

create a national safety alliance as part of broader commitments from the federal government to reduce preventable harm and improve care quality industrywide.

The alliance was among efforts shared at the White House Sept. 17 during a forum on patient safety hosted by the President’s Council of Advisors on Science and Technology — a working group of more than two dozen thought leaders in the academic, government and private sectors. AHRQ first shared the concept of a national safety alliance in 2023, with more details emerging at the forum. 

Eight things to know:

1. The National Action Alliance for Patient and Workforce Safety is a collective of federal agencies, heath systems, medical associations, policymakers and patient groups that will work together to apply evidence-based harm reduction strategies across all populations and settings, according to an AHRQ overview. The first area of focus will be hospital care settings.

2. The alliance will rely on a total-systems approach to safety improvement and align with the  National Action Plan to Advance Patient Safety, which aims to reduce preventable harm by 50% by 2026. Participating systems will conduct a baseline safety assessment to identify priority areas for improvement. Through the alliance, they’ll have access to implementation support, funding opportunities and other resources to support improvement efforts.  

3. On Nov. 1, the alliance will release an initial version of a dashboard to monitor the nation’s progress toward eliminating preventable patient and workplace harms across all settings.

4. As part of the federal government’s broader efforts to improve safety in healthcare, the CDC has also released new guidance to support hospitals in reducing diagnostic errors — which are responsible for nearly 800,000 deaths per year. The CDC will also develop new measures to advance recognition and treatment of sepsis.

5. The White House also secured commitments from 22 national and regional organizations to promote a “whole-of-society approach” to healthcare safety. For example, Press Ganey has committed to building an AI-backed analytics dashboard next year that will integrate key safety data points on patient outcomes, the workforce, safety culture and more. The Association of American Medical Colleges also plans to share a revised set of education competencies that focus on safety and quality improvement skills for physicians. 

6. In addition, the White House said 16 systems have committed to safety improvement actions. Together, these systems provide healthcare to more than 30 million patients and employ hundreds of thousands of workers:

• Ascension (St. Louis)
• Baylor, Scott and White Health (Dallas)
• Beth Israel Lahey Health (Cambridge, Mass.)
• Braden Health (Ave Maria, Fla.)
• CommonSpirit Health (Chicago)
• Highmark Health (Pittsburgh)
• MedStar Health (Columbia, Md.)
• Mercy Health (St. Louis)
• Nemours Children’s Health (Jacksonville, Fla.)
• Novant Health (Winston-Salem, N.C)
• Prisma Health (Greenville, S.C.)
• Sanford Health (Sioux Falls, S.D.)
• SSM Health (St. Louis)
• Trinity Health (Livonia, Mich.)
• University of California Health (Oakland, Calif.)
• University Hospitals (Cleveland)

7. In another initiative, the Veterans Health Administration, a component of the Department of Veterans Affairs, will roll out a new national program next year to prevent falls across care settings. All VA health system leaders will also sign a safety culture commitment by mid-2025.

8. The patient safety alliance’s launch comes a little over a month after CMS added seven new measures to its hospital inpatient quality reporting program as part of its Hospital Inpatient Prospective Payment System final rule released Aug. 1. The patient safety measure will take effect in 2025. The patient safety structural measures assess whether hospitals have a structure and culture that prioritize safety through five domains: leadership committed to eliminating preventable harm; strategic planning and organizational policy; a culture of safety and learning; accountability and transparency; and patient and family engagement, according to a CMS final rule.

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CVS’ Oak Street Health to pay $60M to settle Medicare Advantage kickback allegations

https://www.beckershospitalreview.com/disruptors/cvs-oak-street-health-to-pay-60m-to-settle-medicare-advantage-kickback-allegations.html

CVS subsidiary Oak Street Health has agreed to pay $60 million to settle accusations that it violated the False Claims Act by offering kickbacks to third-party insurance agents in return for referring older adults to its primary care clinics.

The U.S. government claimed that in 2020, Oak Street Health, a primary care provider, launched a program to grow its patient base. According to a Sept. 18 news release from the Justice Department, as part of this program, third-party insurance agents reached out to older adults eligible for or enrolled in Medicare Advantage, promoting Oak Street Health’s services. 

These agents then allegedly connected interested individuals with Oak Street Health staff through a three-way phone call, known as a “warm transfer,” or by submitting their information electronically. In return, Oak Street Health paid the agents $200 for each person it referred. According to the release, these payments encouraged agents to prioritize financial gains for Oak Street Health over the best interests of the older adults. 

The settlement addresses allegations that, between September 2020 and December 2022, Oak Street Health knowingly submitted false claims to Medicare by offering illegal payments to agents, violating the Anti-Kickback Statute.

CVS acquired Oak Street Health for $10.6 billion in May 2023. 

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Texas system shutters Medicare Advantage plan

https://www.beckerspayer.com/payer/texas-system-shutters-medicare-advantage-plan.html

Southwestern Health Resources will not offer Medicare Advantage plans in 2025, D Magazine reported Sept. 17. 

In emails obtained by D Magazine, the company said it decided to sunset its Medicare Advantage plan because of increasing competition and utilization, and regulatory requirements. 

“Medicare Advantage plans continue to face significant headwinds nationally related to challenging regulatory changes and increasing benefit utilization,” a spokesperson for Southwestern Health Resources told Becker’s. “We remain committed to providing high-quality services to our partners and members through this enrollment period. There will be no change for our members in 2024.”

Farmers Branch, Texas-based Southwestern Health Resources operates Care N’ Care, an MA insurer. The company has around 26,000 Medicare Advantage members, according to CMS enrollment data. 

Southwestern Health Resources is a joint venture between UT Southwestern Medical Center and Texas Health Resources. 

In regulatory documents filed Sept. 5, Southwestern Health Resources said it would lay off 129 employees. D Magazine reported 125 health plan employees were notified their jobs would be eliminated. 

“After careful consideration, we adjusted our organizational structure and aligned the staffing model to meet current business needs as the health care landscape continues to evolve. We are working to maximize value, quality, and service for our customers,” a Southwestern Health Resources spokesperson told Becker’s. 

Most of these jobs will end in January, D Magazine reported, with some roles staying on to manage the wind-down of the plan.

“In an effort to give impacted employees the best opportunity to successfully transition to another role, we have provided more than the required 60 day notice, as well as support and resources. In addition, we are working to place them in open roles within the organization,” the spokesperson said. 

Several insurers have cut back on their Medicare Advantage offerings, facing increasing medical utilization and lower reimbursements from CMS. 

Humana, CVS Health and Centene have all said they will exit some markets in 2025. 

In June, Blue Cross and Blue Shield of Kansas City said it would exit the MA market at the end of 2024, also citing increasing regulatory requirements and financial headwinds. 

Other health systems have shut down their affiliated Medicare Advantage plans in recent years. In 2023, Fredericksburg, Va.-based Mary Washington Healthcare ended its MA plan. 

In 2022, Inter Valley Health Plan, affiliated with Pomona Valley Hospital Medical Center, ended its Medicare Advantage operations. 

Read more here. 

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2275 pharmacies have closed so far in 2024

https://benjaminjolley.substack.com/p/2275-pharmacies-have-closed-so-far

“It’s not the way I wanted it to go,” he says sadly. “You do what you’re supposed to do. You go to college, get a doctorate, start a small business in a small town, support the community and it’s not even close to being a viable option.”

“This isn’t because the community didn’t support us. It’s because we lose money on every prescription we fill.”

Those are the words of Tom Wullstein, owner of Brandon Pharmacy. He is talking about his own pharmacy, but the same words could have been said by over a thousand pharmacy owner/operators this year alone.

In pharmacy policy circles, a lot of numbers get thrown around trying to variously prove that a) small business pharmacy is dying and needs change or b) small business pharmacies are doing fine, there’s more of them than ever before! Whenever I see these white papers, especially those put out trying to prove hypothesis b, I feel like the authors are saying “who ya going to believe, me or your lying eyes?” So, I decided to tackle the question myself, recruiting help as I could from like-minded people.

Over the last several weeks, I’ve worked on a dataset of pharmacies that were active in the National Council of Prescription Drug Programs (NCPDP) database on 1/1/2024 and were no longer active on 9/1/2024. Pharmacies can be de-listed in NCPDP for basically 2 reasons:

1. The pharmacy closes
2. The pharmacy comes under new ownership and obtains new numbers (NCPDP, NPI, DEA, state license, etc.)

I wanted to sort out how many of the de-listings from NCPDP were closures and how many were changes of ownership, so here’s what I did (with help from a ton of volunteers):

1. Pull a list from NCPDP of Community/Retail Pharmacy NPIs that were present on 1/1/2024 and were no longer present on 9/1/2024. This yielded a list of 2577 pharmacies.
2. I assumed that CVS/Walgreens/Rite Aid don’t randomly get new NPIs and I assumed that their corporate HQ is competent in maintaining their NCPDP profiles so I just marked all of them as “Chain Closure.”
3. Winn Dixie very publicly closed all of their pharmacies and sold files to CVS/Walgreens in the process of selling their chain to ALDI, so I just marked all of theirs similarly as “Chain Closure”
4. I put out the list to a few groups of pharmacy employees nationally with ~6000 members total, and asked folks to mark stores they knew about from their local area
5. I googled every remaining pharmacy and marked as closed if the Google Maps location was permanently closed or the reviews said it was closed.
6. I ran the remaining phone numbers through a phone number validation service to weed out disconnected numbers, which were marked as closed.
7. I and several other volunteers placed phone calls to the remaining pharmacies. If the person on the other end answered “pharmacy”, I verified that they were still operating at the same address, and if not, I marked as closed — mostly those were scenarios where a location had acquired the records of a nearby pharmacy.

I estimate that in total, about 40 man-hours of effort was put into this project. The results are as follows:

• 1139 chain closures of large chain pharmacies as per my steps 2 and 3.
• 1136 Closures of independents and small to mid-sized chains as per steps 4-8.
• 298 changes of ownership
• 4 records were duplicates1

I’ve created a map here:

The raw spreadsheet where I did this work is available here.

Since starting this project, many people have asked how to interpret this information. To start with, this data shows that nearly 2300 pharmacies’ worth of employees have been laid off. Most pharmacies employ about 10 people, so that’s about 23,000 pharmacy staff laid off. Additionally, about 1100 entrepreneurs have had their dreams of pharmacy ownership crushed just this calendar year, and can probably resonate with Tom Wullstein’s comments.

For context, on 1/1/2024, there were 60,867 active Community/Retail NPIs/locations in NCPDP, and there have been 857 new NPIs added in the relevant time frame23. While I find “netting out” of openings and closures very distasteful, this means that there are 1720 net closures since 1/1/2024, or in other words a 2.8% drop in number of pharmacy locations nationwide. You can also contextualize this information against any number of academic papers on the same topic, Guadamuz, Alexandar, Zenk, et al. in JAMA in 2019, for example, shows that an average of 1631 pharmacies closed each year as reported in NCPDP from 2010 to 2015, with and average of 2435 pharmacies opening each year for a net average figure of 804 openings every year in that period.

To reiterate, on average every day since January 1, 2024:

• ~5 pharmacy owner-operators have closed their businesses permanently
• ~5 chain pharmacy Pharmacists-in-Charge have had their stores closed
• ~11 neighborhoods lost their pharmacy
• ~110 pharmacists and pharmacy technicians have been laid off

For those that have read this blog before, I think this is unnecessary to say, but the root causes of this incredible number of closures are obvious to me:

1. PBM reimbursements are insultingly low – see the bit about “dispense fee” here
2. PBM reimbursements are based on competition on nonexistent prices outside of 340b — AWP minus 26.3% is not reasonable or relevant, kids.
3. PBM reimbursements are unevenly distributed, with the lion’s share of the money going to “specialty drugs” instead of evenly across prescription drugs – see also: every drug that Mark Cuban talks about when he talks about PBMs.
4. The largest wholesalers charge prices to independents that are much higher than the prices charged to chains, which is visible in the NADAC fluctuations over the last 6 months
5. The opioid litigation has put the largest pharmacies into a lot of debt, which combined with 1, 2 and 3, has resulted in mass closures of pharmacies, particularly Rite Aid, which just exited bankruptcy.
6. Our payment system largely pays variable prices for the service of dispensing based on the exact identity of the pills in the bottle, not based on the service rendered. In other words, PBMs are concentrating all of the profit into a small fraction of items, which their integrated mail-service and “specialty” pharmacies can capture the lions share of the volume from.

I don’t know 100% how to solve this problem of pharmacy closures, but I have ideas about some good places to start:

• H.R. 9096, the Pharmacists Fight Back Act, would go a long way to resolving my concerns 1,2,3 and 6 – it would ensure payments to pharmacies be based on actual cost of goods plus a 2% markup plus a cost-of-dispensing based professional dispense fee across all of the major government programs: Medicaid, Medicare, Federal Employees and TRICARE. I think that if anything like this bill becomes law, ACA exchange plans should be included. This bill would make the pharmacy payments system fair and legible, instead of illegible and slot-machine-esque.
• A Glass-Steagall for Healthcare – Glass-Steagall was a New Deal era law that structurally separated community banking and investment banking. Similarly, I think that in healthcare, we desperately need to outlaw “payvidors.” The opportunities to take advantage of your competitors, evade reasonable regulation, and exploit anyone not inside your system are far too numerous and pervasive to continue to allow United Healthcare and OptumRx to own Optum Specialty Pharmacy and Optum Physicians Group, or to allow CVS/Caremark and Aetna to own CVS/Pharmacy. Pharmacies should not own PBMs, PBMs should not own pharmacies. Health Insurers should not own physician practices. In short, if your job is to manage other people’s money to buy healthcare products and services, you should not be ALLOWED to be in the business of selling those same products and services. These vertically integrated companies are simply too big to care.
• Robinson Patman Act enforcement – the existence of thousands of different prices for identical products in the PBM and pharmaceutical wholesaler businesses is proof that the big 3 in each market have far too much power to twiddle, and in a regime with visible and agressive enforcement of the RPA, none of this nonsense would exist.

All of these solutions are centered in government policy, because even the most red-blooded free-market fundamentalist has to recognize that pharmacy as it exists today is a product of government policy. Medicaid, Medicare, ACA, the FEHBP, state public employee plans, and TRICARE together account for somewhere north of 70% of a typical pharmacy’s revenue. My profession as it exists, exists primarily at the behest of and mercy of the folks in Washington DC and in the various State Capitols. The policy choices that have been made over the last 20+ years are why my profession is struggling and dying. We need help. I hope that we’ll be able to make it so that when an entrepreneurial person gets a doctorate, saves some money, opens a pharmacy to serve their community, and the community chooses to support that pharmacy, that pharmacy thrives.

Most likely for incorrectly coded Long Term Care/Retail “Combo Shops” – each of these were places with two discontinued NPIs for identical pharmacy names/addresses/phone numbers. If you run a combo shop, please make your Long Term Care NPI record have a meaningfully different name than your retail NPI, if only for the sake of seniors using Medicare.gov to compare prices at your pharmacy. If you are “Corner Drug” for the retail NPI, can you make the NPI record be “Corner Drug LTC” for your LTC? If this is not possible due to CMS/NPPES regs of some kind, can we please change that? LTC/retail combo shops are more and more common, and differentiating them in medicare.gov is important!

NCPDP is an excellent source of pharmacy OPENINGS, and less reliable for counting closures. This is because a pharmacy MUST be listed in NCPDP to be able to receive e-prescriptions via the Surescripts network. The NCPDP ID number assigned to the pharmacy can be thought of like a routing number for a bank – you want e-prescriptions routed to you, you get an NCPDP ID. Pharmacies are not under the same obligation to de-list their location in NCPDP, and so a decent fraction of pharmacies do not report their closure promptly to NCPDP.

A large fraction of the new pharmacies listed since 1/1/2024 appear to be 340b-covered-entity-owned pharmacies. This is not surprising, as the 340b program represents more than half of all gross margins earned in dispensing pharmacies today. It does, however, mean that the usual definition of “independent” vs. “chain” as “>5 pharmacies under common ownership” becomes a more fraught concept. When I think “independent pharmacy” I usually think of a small business, a mom-and-pop shop owned and operated by the pharmacists. Many 340b covered entity (340b-CE) owned pharmacies are certainly not small businesses by any stretch of the imagination – most frequently they are a relatively small business unit of an entity with hundreds of millions if not billions in revenue annually. In the ongoing argument between PCMA/PBMs and independent pharmacy advocacy organizations like NCPA, these 340b-CE-owned pharmacies are usually counted as “independents” because they may have 5 or fewer pharmacy locations. Additionally, a large and growing fraction of mom-and-pop independents that operate as contract pharmacies for 340b-CEs are being asked to sell to the CE. In some cases, where the pharmacy is co-located, the CE is pushing out the independent when the lease expires (I personally know of 5 such instances). I think that in NCPDP, if it doesn’t already exist, a flag of “is this pharmacy’s owner a 340b-CE” would be very helpful for teasing this out. I will also note here that comparing NPIs to OPAIS data is extremely difficult right now because OPAIS data has no NPIs. HHS’ OPA should include NPI numbers of contract pharmacies and CE-owned locations in OPAIS for a number of reasons beyond my desire to understand how many “independents” are 340b-CE owned, including facilitation of state medicaid programs’ efforts to ensure that FFS medicaid is not illegally a source of 340b discounts.

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Walgreens paying $106.8 million to settle US prescription billing fraud charges

https://www.reuters.com/legal/government/walgreens-paying-1068-million-settle-us-charges-over-prescription-billing-fraud-2024-09-13/

Sept 13 (Reuters) – Walgreens Boots Alliance (WBA.O)

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Pain med prescriptions did not cause opioid epidemic, courts rule

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PBM reform: The end of the beginning

https://chaindrugreview.com/pbm-reform-the-end-of-the-beginning/

The recent release of an interim report by the Federal Trade Commission about what the agency characterizes as “prescription drug middlemen” represents a vindication of sorts for pharmacy advocates who have long contended that PBMs employ business practices that skew the market to their advantage.

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