March 10, 2022 — It’s not your typical theft, however it’s positively one which grabs your consideration.

Last weekend in Denver, thieves broke right into a parked truck and stole a blue-and-white field labeled “exempt human specimen.” Turns out these specific specimens have been donated human heads.

While Denver police proceed their seek for the stolen property, many are left questioning how donated heads — and different physique elements — are sourced and used within the first place.

In this case, the field of heads was headed to an organization known as Science Care, primarily based in Phoenix, AZ. The firm payments itself because the world’s main physique donation authority, connecting donors and pharmaceutical corporations, medical machine makers, academic establishments, and well being care organizations. In this case, the stolen field was going again to Science Care after a medical coaching occasion.

“Science Care links donors who choose to donate their body to science with medical researchers and educators all over the world, leading to medical research and training that improves the quality of life for all of us,” says Tricia Hammett, CEO and program director on the firm. “As the first accredited non-transplant tissue bank in the world, we pride ourselves on compliance and safety in everything we do.”

It’s essential to grasp the distinction between this sort of donation program and the organ and tissue transplant business. The latter is ruled by the federal authorities and works to find and transport organs and tissues for the greater than 100,000 Americans on the nationwide transplant ready checklist. The former sort of program stays largely unregulated and isn’t concerned in transplantation.

Instead, non-transplant tissue donation can result in many various outcomes. One instance is taking cadaver tissue and utilizing it for medical and surgical functions. Think ACL restore, whereby a cadaver tendon replaces the dwelling broken ligament, giving the recipient a brand new lease on knee well being. Or harvesting cadaver veins to make use of in coronary heart bypass surgical procedures. Both are widespread and ship higher high quality of life.

Other makes use of for cadaver tissue embrace medical analysis and educating. Medical faculties depend upon these donations to teach their college students. Research establishments work with donated human tissues to advance therapies for a bunch of medical situations. These can embrace quite a lot of sorts of most cancers, coronary heart illness, orthopedics, and even psychological well being. By utilizing organ and body-part donations, medical surgical college students may also discover ways to carry out organ and tissue transplants, training their expertise on the donated elements earlier than advancing to the true, life-saving procedures.

Donated tissues may also play a job within the growth of medical and surgical units, even robotics for medical functions. This can result in much less invasive procedures, with quicker restoration instances, and might apply to a bunch of surgical procedures.

So about these stolen human heads, particularly — how would possibly they be helpful to science? Researchers would possibly use them to check human brains for the development of Alzheimer’s therapy, as an illustration. Or scientists might examine mind tissue to raised perceive how the mind regulates feelings or studying.

Thefts just like the one in Denver stay uncommon, and the investigation continues considerably beneath the radar as a consequence of its delicate nature. Hammett says the corporate is working intently with Denver authorities for a decision: “We are doing everything we can to locate the stolen tissue and protect the community.”

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Jan. 7, 2022 — The Biden administration mentioned this week it intends to problem insurance coverage firms to ship higher service to folks enrolled in Medicare, together with making use of reductions on medication lined by Part D extra on to their pharmacy prices.

The Centers for Medicare and Medicaid Services (CMS) on Thursday unveiled a 360-page proposed rule that seeks many modifications in how insurers handle their federal contracts. This proposed rule, for instance, additionally would require insurers to indicate that they’ve sufficient contracted medical professionals once they need to create new Medicare Advantage plans or to broaden present ones.

The rule additionally seeks extra accountability about how insurance coverage firms spend Medicare’s cash, together with larger transparency about spending on supplemental advantages equivalent to dental, imaginative and prescient, listening to, transportation, and meals.

With this proposed rule, CMS intends to ramp up oversight and stewardship of Medicare Advantage and use its authority to handle drug prices, says Tricia Neuman, ScD, government director of the Program on Medicare Policy on the nonprofit Kaiser Family Foundation.

In an e mail trade, Neuman mentioned the rule exhibits the Biden administration utilizing its authority to carry down drug prices, as it really works with Congress to attempt to cross the Build Back Better invoice “that includes a slew of policies to leverage lower drug prices.”

The proposed rule additionally addresses a key concern of the elevated position of personal insurers that deal with Medicare advantages. Much of Medicare is run by way of public-private partnerships, requiring CMS to maintain tabs on the well being plans that handle federal well being advantages for these ages 65 and older and folks with disabilities.

Insurer-run Advantage plans enrolled greater than 26 million folks, or 42% of Medicare’s whole inhabitants final yr, in response to an estimate from the Kaiser Family Foundation.

“Strengthening protections for seniors in Medicare Advantage plans is particularly important,” as a result of giant enrollment in these insurer-run applications, Neuman mentioned.

Part D Debates

Insurers additionally handle your complete Medicare Part D pharmacy profit, which covers about $100 billion in annual drug purchases. There’s been important bipartisan curiosity in altering the circulate of reductions negotiated throughout the Part D program to assist folks pay for medicines purchased at pharmacies.

In late 2018, for instance, the Trump administration sought feedback on a coverage that might require Part D plans to use all worth concessions they obtain from community pharmacies on the level of sale, which would scale back prices for folks enrolled in these plans.

There’s been rising concern lately about complicated negotiations throughout the drug provide chain, notably regarding the position of pharmacy profit managers (PBMs).

People enrolled in Part D who want medication, particularly costly medication, and house owners of small pharmacies miss out on direct financial savings from what are known as direct and oblique remuneration (DIR) charges. These embody rebates from drugmakers, administrative charges above honest market worth, worth concessions for administrative providers, authorized settlements affecting Part D drug prices, pharmacy worth concessions, drug prices associated to risk-sharing settlements, or different worth concessions or related advantages, CMS mentioned within the draft rule.

Insurers and pharmacy profit managers — who function as a sort of middlemen between drugmakers and insurance coverage firms — have argued that directing their financial savings on drug prices to well being plans ends in decrease premiums for these enrolled in Part D plans. But this method signifies that folks in Part D plans “end up paying a larger share of the actual cost of a drug” once they want medication, CMS mentioned within the rule.

The proposed rule would require Part D plans to use all worth concessions they obtain from community pharmacies to the purpose of sale. CMS desires to redefine the negotiated worth because the baseline, or lowest attainable, cost to a pharmacy, efficient Jan. 1, 2023. This coverage would scale back out-of-pocket prices for folks in Part D plans and enhance worth transparency and market competitors, CMS mentioned.

This proposal received swift approval from a Republican lawmaker who has been preventing for years for modifications to direct and oblique remuneration charges. In an announcement, Rep. Buddy Carter of Georgia, a pharmacist by coaching, mentioned he was inspired CMS is taking motion on this concern.

“The rule’s effectiveness remains to be seen and more must be done to protect consumers from harmful PBM practices. I hope this is the first of many steps to put patients before PBM’s profits,” he mentioned.

In Carter’s view, PBMs “are taking advantage of sick Americans to rake in higher profits.”

“Nowhere in America should a patient have to choose between life-saving medication and putting food on the table, yet that is the choice PBMs are forcing on them,” he mentioned.

In an announcement, the commerce group for pharmacy profit managers, the Pharmaceutical Care Management Association, defended the present method as being part of “value-based contracting in Medicare Part D.”

“We are currently reviewing the proposed rule,” affiliation CEO J.C. Scott mentioned in an announcement. “We look forward to working with CMS on ways to enhance the use of value-based contracting rather than limiting this important tool.”

Other key elements of the proposed rule embody:

• Greater oversight of third-party advertising organizations to stop misleading advertising techniques for Advantage and Part D plans.
• A clarification of necessities for plans throughout disasters and emergencies to make sure that beneficiaries have uninterrupted entry to wanted providers.

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