Tag Archives: alzheimer’s

Aduhelm: Case Study on Paying for Health

In July, I wrote an article that criticized the newly authorized Alzheimer’s drug Aduhelm. Six months later, the market response is heartening and, in my opinion, a case study in what it will take to fix the way that we pay for healthcare in America. 

A review of the problem

The FDA approved the first new drug to treat Alzheimer’s in June. Of 11 scientists who reviewed the research and science behind the new treatment for the FDA, 10 voted against approval, and one was undecided. The FDA approved Aduhelm despite the lack of evidence that it either cures or slows the progression of the Alzheimer’s and has given the company nine years to conduct a confirmatory trial. Three of the scientists resigned as a result. The head of the FDA also took the very unusual step of asking for an investigation into unusual/informal contacts between the manufacturer and people at the FDA.

The drug price is set at a whopping $56,000 per year, and the real price tag is more like $100,000 when you include the cost of performing the infusion in a provider’s office, testing to monitor for brain bleeds, etc. With 6 million Alzheimer’s patients in America today, having just one in six get a prescription would drive costs of around $100 billion into the system. Total outpatient Medicare drug spending with pharmacy prescriptions was $136 billion for 2019.

A review of the last six months

Biogen and other analysts projected sales of $103 million this year, about $1 billion in 2022 and $5 billion-plus in 2023. However, the market has responded in a very encouraging way. Sales have just totaled $2 million thus far.

What happened? The Veterans Administration, several Blue Cross Blue Shield companies and most notably Medicare are not yet paying for the treatment. Highly respected medical institutions like Cleveland Clinic and NY City’s Mount Sinai have also chosen not to administer the drug. So have many well-managed, large employer health plans. All are waiting for real evidence the drug is effective in either slowing the development of or in curing Alzheimer’s disease. 

See also: How Synthetic Data Aids in Healthcare

How we will make real progress

The free market is the only viable solution — if we can get to one in the way that we pay for healthcare.

I am often asked when we will see real progress in our insurance payment model. I typically laugh and say, “As soon as lobbying is no longer effective.” But that is not the end of the story. I more seriously share that we are seeing the problem get solved one employer at a time (another way of saying it will be solved by the free market). When employers build a health plan with a consultant that provides transparency around the actual cost of care and then build their plan to reward good consumption, it is amazing how quickly they can get to a place, where costs go down and quality goes up. 

For change that will affect the system more broadly, we need government to ensure that we have rules in place that require transparency. Until that happens, we will be stuck handling the problem one employer at a time.

Aduhelm – and What’s Wrong in Healthcare

The FDA approved the first new drug to treat Alzheimer’s in nearly 20 years in recent weeks, and it is a prime example of why our spending on healthcare is so unnecessarily high and not slowing down anytime soon. The new drug is Aduhelm, an infusion therapy developed by Biogen.

A panel of 11 scientists reviewed the research and science for the FDA, and 10 voted against approval of the new treatment, while one was undecided. In fact, three of the scientists have resigned over the approval. The FDA moved to approve Aduhelm despite the lack of evidence that it either cures or slows the progression of the Alzheimer’s and has given the company nine years to conduct a confirmatory trial.

What is the actual cost of this treatment? The drug price is set at a whopping $56,000/year, and the overall costs will be much higher. According to the Kaiser Family Foundation, when related costs are included (the testing to monitor for brain bleeds and other possible side effects, outpatient facilities and staff, etc.) the real price tag will be more like $100,000/year. 

What is the cost to the individual? Copays will be as much as $11,500 – nearly 40% of the average income for a Medicare, enrollee according to the Kaiser Family Foundation.

How will this affect Medicare Part B premiums? As an infusion given in a provider’s office, administering Aduhelm will be covered by Medicare Part B. The current average premium for this coverage is just under $150/month. This will almost certainly have to be increased, so the impact will be widespread across Medicare enrollees.

See also: Are Your Healthcare Vendor’s Claims Valid?

What are the potential impacts to our overall healthcare spending? Biogen estimates that 1 million to 2 million Alzheimer’s patients match the patients studied in the clinical trials. Overall, we have approximately 6 million people who have Alzheimer’s in the U.S., and most are enrolled in Medicare. Interestingly, the FDA has approved the medication widely not just for those who are in the early stages of the disease with mild symptoms like those in the trial. If 1 million people are given this treatment, it could cost Medicare $56 billion annually. Medicare Part B spent $37 billion in total on drugs in 2019. Total outpatient Medicare drug spending with pharmacy prescriptions was $136 billion for 2019.

Biogen’s estimates of future sales are seemingly conservative. The company and other analysts are expecting $103 million in sales this year, about $1 billion in 2022 and $5 billion-plus in 2023. 

When you factor in the incentives paid to prescribing physicians by Medicare ($3,360 for each prescription in this case), it seems we have a real problem on our hands.  

The Centers for Medicare and Medicaid Services could decide not to cover Aduhelm, but if the past is any indicator this is not likely. Private insurers that provide Part B benefits could also place some limitations on the drug’s use. But, all things considered, It is clearly time for us to take a serious look at how we have allowed a fifth of our economy to get to this point.

Workers' Compensation No Longer the Exclusive Remedy: RICO on the Radar, Part 2

Understandably, Part 1 of this article series has been met with some controversy and skepticism. The article is not designed to scare employers, as might have been suggested. Its intention is to educate employers about the many issues facing them when an employee becomes injured, that transcend the State Workers’ Compensation System and a workable solution to overcoming the challenges. Employers can no longer afford to bury their heads and rely on the exclusive remedy position. Yes, it may be here to stay, but it is becoming a bit frayed around the edges.

Coincidently, when Part 1 of this article was published, The National Football League (NFL) announced that it had reached a 765 million dollar settlement with players and their families for the settlement and consolidation of approximately 4,500 concussion claims. The players alleged that the NFL hid or ignored the facts that concussions caused brain injuries. Under the settlement, the NFL will pay 675 million dollars to retired players who demonstrate medical evidence of brain injury. Payouts of up to 5 million dollars each could go to players found to have Alzheimer's or Parkinson's diseases or other concussion-related conditions, or to their families. The settlement came just prior to the start of football season and will put an end to the mounting litigation that threatened the multi-billion dollar league.

United States District Presiding Judge Anita B. Brody appointed Judge Phillips to oversee the negotiations. Judge Philips said, “This is a historic agreement, one that will make sure that former NFL players who need and deserve compensation will receive it, and that will promote safety for players at all levels of football.”

 “This agreement lets us help those who need it most and continue our work to make the game safer for current and future players. Commissioner Goodell and every owner gave the legal team the same direction: do the right thing for the game and for the men who played it,” said NFL Executive Vice President Jeffrey Pash. “We thought it was critical to get more help to players and families who deserve it, rather than spend many years and millions of dollars on litigation. This is an important step that builds on the significant changes we’ve made in recent years to make the game safer, and we will continue our work to better the long-term health and well-being of NFL players.”

Once final documentation is completed, the settlement will be filed with Judge Brody, who will then schedule a hearing to consider whether or not to grant preliminary approval to the agreement. The retired players will then have the ability to file objections to the settlement.

One may ask what this has to do with Part 1 of this article.  An important component of this settlement is baseline testing. According to the settlement, baseline medical exams will be provided, the cost of which will be capped at $75 million. This will be a key element in ascertaining the conditions of current and retired players, gauging  the progression of any injuries they may have and having documentation of the medical status. This key component is the subject of Part 1 of this article. Baseline testing is not simply a self-promotion for the EFA-STM, but is a major part of helping injured workers, no matter what their occupations may be.

These cases are just the beginning, and it appears that the exclusive remedy provision for workers' compensation will no longer serve to prevent costly civil litigation as evidenced by the NFL settlement. An employer, insurance carrier/TPA and physician can take several steps to protect themselves. First, evidence-based medicine should always prevail. Objective medical evidence can help protect against claims for fraudulent denials of work-related injuries. Also, employers should accept only claims that arise out of the course and scope of employment (AOECOE). If an employer can objectively document AOECOE issues, fraudulent claims and fraudulent denials can be avoided and most importantly, correct treatment can be prevail.

A good approach to determining AOECOE claims is baseline testing, as it can identify injuries that arise out of the course and scope of employment. When a work-related claim is not AOECOE, as proved by objective medical evidence, such as pre and post assessments, then not only is there no workers’ compensation claim, there is no OSHA recordable claim, and no mandatory reporting issue. Conversely, if there is an injury, the injured worker can get the best site specific treatment and prevent inappropriate treatment and unnecessary progression of the underlying conditions.

The NFL recognized the importance of baseline testing with its recent settlement, and it is only the beginning. MSD for NFL players is also a significant problem. Why not baseline all football players, or, for that matter, all professional athletes, to address any injuries that may occur while playing and return them to the field sooner? This would promote better health and performance and might extend their careers. Professional athletes tend to play through their injuries, potentially causing more harm. An objective baseline test can assist all parties by providing objective medical evidence of an injury and outlining appropriate care. This truly is a win-win situation.

A proven example of a baseline test for musculoskeletal disorders (MSD) cases is the EFA-STM program. EFA-STM program begins by providing baseline injury testing for existing employees and new hires. The data is interpreted only when and if there is a soft tissue claim.  After a claim, the injured worker is required to undergo the post-loss testing. The subsequent comparison objectively demonstrates whether or not an acute injury exists. If there is a change from the baseline, site specific treatment recommendations are made for the AOECOE condition, giving the doctors more information and helping to ensure the injured worker receives the best care possible.

The case of the NFL settlement may not be a RICO claim, but, certainly, it tries the boundaries of the exclusive remedy provision of workers compensation. Baseline tests like the EFA-STM are a proven way to providing better work-related care. It is time for change and to think outside of the box to provide the answers so that we can become proactive, not reactive.

What Features Of Long-Term Care Policies Should I Focus On?

Where May Care Occur?
The best policies pay for care in a nursing home, assisted living facility, or at home. Benefits are typically expressed in daily amounts, with a lifetime maximum. Some policies pay half as much per day for at-home care as for nursing home care. Others pay the same amount, or have a “pool of benefits” that can be used as needed.

Under What Conditions Will The Policy Begin Paying Benefits?
The policy should state the various conditions that must be met.

  • The inability to perform two or three specific “activities of daily living” without help. These include bathing, dressing, eating, toileting and “transferring” or being able to move from place to place or between a bed and a chair.
  • Cognitive impairment. Most policies cover stroke and Alzheimer’s and Parkinson’s disease, but other forms of mental incapacity may be excluded.
  • Medical necessity, or certification by a doctor that long-term care is necessary.

What Events Must Occur Before The Policy Begins Paying Benefits?

  • Some older policies require a hospital stay of at least three days before benefits can be paid. This requirement is very restrictive — you should avoid it.
  • Most policies have a “waiting period” or “elimination” period. This is a period that begins when you first need long-term care and lasts as long as the policy provides. During the waiting period, the policy will not pay benefits. If you recover before the waiting period ends, the policy doesn’t pay for expenses you incur during the waiting period. The policy pays only for expenses that occur after the waiting period is over, if you continue to need care. In general, the longer the waiting period, the lower the premium for the long-term care policy.

How Long Will Benefits Last?
A benefit period may range from two years to lifetime. You can keep premiums down by electing coverage for three to four years — longer than the average nursing home stay — instead of lifetime.

Indemnity vs. Reimbursement
Most long-term care policies pay on a reimbursement (or expense-incurred) basis, up to the policy limits. In other words, if you have a $150 per day benefit but spend only $130 per day for a home long-term care provider, the policy will pay only $130. The “extra” $20 each day will, in some policies, go into a “pool” of unused funds that can be used to extend the length of time for which the policy will pay benefits. Other policies pay on an indemnity basis. Using the same example as above, an indemnity policy would pay $150 per day as long as the insured needs and receives long-term care services, regardless of the actual outlay.

Inflation Protection
Inflation protection is an important feature, especially if you are under 65, when you buy benefits that you may not use for 20 years or more. A good inflation provision compounds benefits at 5 percent a year. Without inflation protection, even 3 percent annual inflation will, over 24 years, reduce the purchasing power of a $150 daily benefit to the equivalent of $75.

Six Other Important Policy Provisions

  1. 1=7 Elimination period. Under some policies, if the insured has qualifying long-term care expenses on one day during a seven-day period, he or she will be credited with having satisfied seven days toward the elimination period. This type of provision reflects the way home care is often delivered — some days by professionals and some days by family members.
  2. Guaranteed renewable policies must be renewed by the insurance company, although premiums can go up if they are increased for an entire class of policyholders.
  3. Waiver of premium, so that no further premiums are due once you start to receive benefits.
  4. Third-party notification, so that a relative, friend or professional adviser will be notified if you forget to pay a premium.
  5. Nonforfeiture benefits keep a lesser amount of insurance in force if you let the policy lapse. This provision is required by some states.
  6. Restoration of benefits, which ensures that maximum benefits are put back in place if you receive benefits for a time, then recover and go for a specified period (typically six months) without receiving benefits.

There Are No Rules For Dealing With Those Who Suffer From Some Type Of Dementia

Let me begin by saying: There are no rules for dealing with this. That is, there is no firm set of steps to take, no one size fits all plan.

Sometime over the last few years, the baby boomers started to retire. This has created a complex double-edged sword for professionals. While these people are typically in need of legal and financial help, they are also more likely to suffer from some type of dementia. This problem is compounded by the fact that people typically wait until later in their life to perform complex transactions.

As an attorney who practices in the area of asset protection, captive insurance and estate planning, it’s a situation I run into with more and more regularity. In addition, I have a parent who has Alzheimer’s, so I’m familiar with this situation from the other side of the equation.

Below are some tips for dealing with this situation. In my next piece, I’ll discuss my situation in general to give you an idea of the solution that has worked for my family.

Let me begin by saying: There are no rules for dealing with this. That is, there is no firm set of steps to take, no one size fits all plan. For all of us, this is a matter of figuring it out as we go; every fact pattern is a different situation. So, if you’ve run into this situation and you’re looking for a plan, realize there isn’t one.

All professionals who deal with older clients are struggling with this just as much as you are. I realize this offers little comfort, but that’s more or less where we are.

That being said, consider these points:

Don’t be willfully blind.

The older people get, the more likely they are to suffer from some type of dementia. When you meet someone who is 60 years or older, be vigilant.

Assume there’s a problem.

And look for reason to prove there isn’t a problem. Look for the following signs:

  • repetition of conversation topics
  • inability to understand simple concepts
  • reaching for words they should know
  • overall general confusion

You don’t have to be a doctor to let common sense inform your observations on these points. If it seems like there is something wrong, there probably is.

Meet older clients multiple times.

People who suffer from Alzheimer’s and dementia can have good and bad days. On a good day, everything may seem fine over a short period of time, but problems will present themselves over a longer period of time. On bad days, they have pronounced problems.

Commit to see older prospects at least three times and for longer than a few minutes — meet with them for at least an hour.

In addition, meet with them at different times throughout the day. There is a condition called sundowning, meaning that as the day progresses, people get worse. Meeting someone later in the day can highlight a developing problem.

The older the client, the more conservative the recommendation.

There are a number of cases involving family limited partnerships that were sold to the deceased within years — if not weeks — of death. The various courts overturned the deductions claimed because the partnerships were obviously formed purely for tax reasons. In short, none of these plans should have been sold to the parties in the first place.

The same is true in all fields, be it legal, accounting or financial. Put more directly, don’t sell Grammy junk bonds.

Document everything.

For an older existing client, have an agenda for each meeting and send it to them beforehand, asking them to add their own topics of discussion. Document the meeting as soon as they leave. For prospects, develop a set of detailed questions that not only allow you to comply with “know your customer” rules, but also help to gain some insight into their respective mental condition.

It’s important to ask prospects for an explanation of their previous service providers.

For example, if a 65 year old who is financially well off comes into your office and says, “I want to create an estate plan,” begin by asking them if they already have a will written. The point is, a prosperous older person probably has existing relationships with various professionals. Why are they looking to change?

And again, keep the above points to look out for in mind: repetition, confusion, reaching for words etc…

Don’t be afraid to turn away business.

Here’s a real life example from my practice. An older gentleman (roughly late 60s) wanted to write a new estate plan. We met for lunch and toward the end of the meal, he just seemed a little “off.” I scheduled another meeting about one week later in the late afternoon (4 pm) and he was definitely worse off. More importantly, he already had an estate plan drawn by another attorney (who’s very good).

After the meeting, I sent him a letter thanking him for considering me, but stating I didn’t think he would benefit from my services. My suspicions (completely unproven by the facts) were that he and the other attorney had an argument or falling out and that I’d be walking into a powder keg if I took him on as a client.

Please share your own ideas, experiences and observations in the comments section below so that others may benefit from your experience.