MSU and Nassar, FOIA responses

FOIA responses and other related materials

FOIA responses


PDFs were retitled to provide easier access.

Informed consent, scholastic athletes, minors and related topics

Informed Consent

A bedrock principle of medical practice is a patient should be treated only after granting informed consent. There are only a few exceptions (emergencies, mental health, drug overdose) when the patient is incapacitated or incapable.

Informed consent is sometimes more complicated than it may sound.

 Diligent compliance especially applies to minors and there is a significant body of law and best practices around these issues (informed consent tends to be based in state law, providers and school officials should be informed accordingly). In general, parents or guardians (“surrogates”) make medical decisions for minors, although older minors are sometimes subject to different state statutory rules.

Informed consent is not just about protecting the patient, it is also about protecting the physician and the organization.

The focus here is scholastic athletes, both in K-12 and college settings.

Implied Consent / Overt Consent

When an adult goes to the doctor there is often implied consent – the patient made an appointment, arrived at the appointed time, presented an I.D., signed a HIPAA form, followed the nurses’ instructions, let the physician do an examination and allowed testing.  Clearly the adult was consenting to this examination.

The consent, however, was not open ended. If the physician recommends surgery or an invasive procedure additional consent would be needed, preferably in writing.

When young athletes join middle school, high school and college sports teams there is at least an implied consent to athletic training and health monitoring, and often some sort of “permission to play”  and/or physical form involved which may constitute overt consent. There may even be a full-fledged consent to treatment form.

Permission to join the team by a parent or a college student deciding to join a team would seem to provide consent for basic athletic training, monitoring of health condition and emergent care.

The consent, however expressed, is not open ended. Especially in the case of minor.

Legal risk attaches to the provider and school entity, outcome risk attaches to the patient. All parties need to be aware of the risk and the general legal rules.

Providers must stay within the “scope of practice” attached to their license or certification by state law. School officials should be clear on which clinician can and should provide which services.

“Informed”

The definition of informed is part art and part law.  There is no absolute checklist.

The definition depends on context and the abilities of the patient or surrogate.

There is no requirement for “fully informed,” anyone who has tried to read a pharmacy drug insert will understand that. The patient will not be able to understand what is happening at the same level as the clinician.

Items  the patient must understand are  the 1) current or potential diagnosis, 2) the potential benefits of testing and/or treatment, 3) the potential risks (especially with surgery) and 4) and any viable alternatives (trying physical therapy before trying surgery).

In emergent situations there is no requirement for consent, but notice to parents or surrogates should be as quick as possible, and at some point the surrogate will be in a position to give or deny consent. Withholding information from parents should get a coach or clinician fired (“we won’t tell your parents, they might make you sit out!”)

The Team Physician

High school and college teams will normally have a team physician (or designated clinician) on the sidelines during the games.

It would seem reasonable that joining a team provides implied consent to be examined on the field by the team physician, as injuries would be considered potentially emergent.

When the team physician sees the athlete off the field in a non-emergent situation, rules of informed consent would seem to kick in.

Clubs and Camps and Community Sports

Not all sports activity is provided for enrolled students of a school or college.

Sports such as gymnastics are often club based, or the athlete may be trained and compete in club and school settings (and national gymnastics is currently immersed in a scandal of immense proportions). Youth baseball, flag football, swimming and other sport are offered through various community organization.

Many middle school and high school athletes attend summer camps, either sponsored by universities or by prominent coaching figures.

Again there are both implied consent and overt consent issues and notice to parent issues, and failure by the sponsor or clinician might trigger unwelcome liabilities.

How to protect a child away from home? Investigate the camp especially the regular chaperone system and the health care chaperone system.

Parents and Legal Surrogates

What is a parent to do?

Ask a lot of questions. And the higher the level, the rougher the sport, the higher the likelihood of significant injury, the more questions should be asked.

The horrific scandal in national gymnastics centered at Michigan State University was based on lack of informed consent and lack of parental information (and this  is not to blame the victims or parents).

Ask a lot of questions. And do not proceed without satisfactory answers.

Can an Athlete, Parent or Surrogate Say No to a Clinician?

Informed consent requires consent, and consent ultimately comes from the athlete, parent or the surrogate.

If a clinician seems to be rushing an athlete back to the field, or rushing the athlete into surgery, it is ok to say no. If a second opinion is required, it is ok to say no.

A parent or surrogate can also say no to a coach or athletic trainer who wants to put a child back on the field, perhaps too quickly.

It is ok to say NO!

Many sports injuries involve orthopaedic surgery, something I know a bit about. There are orthopaedists who fix knees, and orthos who specialize in fixing knees. I would pick the latter, who will probably not be found in a small town hospital, but in a major metro hospital.

Rub It in the Dirt and Play Ball

There is an ethos in sport of playing through pain and injury.

There is a difference in playing through dings and nicks treated at bump clinics versus serious  injuries needing more sophisticated medical treatment, which often mean missing games or meets.

The NFL and its’ alumni are now reaping a bitter harvest of this play-with-pain ethos.

Coaches should make the right decision, but parents should never count on that happening, even at the college level. Coaches live with pressures parents do not.

Responsible Officials

Like all executives and supervisors, school officials and other sports program sponsors are responsible for the design and operation of an appropriate risk management program. The program should be designed to protect the athletes and to protect the entity, using practices that accomplish both, but the athlete first.

It seems the answer to almost every question these days is “consult your lawyer.” A lawyer well versed in education law is a necessary member of the management team.

Any Good News?

Every year millions of young people have safe, healthy experiences with sports.

And remember….

Adults are supposed to protect young people. We all have responsibilities.

Arbitraging Grandma - HCR in Trouble

QCP, the REIT holding title to most of HCR Manorcare's real estate, served notice on the Securities and Exchange commission (8/18/17) of a pending receivership filing in a California state court.

HCR has been in default on rent payments and has failed to cure the default.

This is a huge story and developments will follow.

So Where Are We At?

The GOP is in chaos.

Congress is stuck in the mud.

The Democrats are impotent because they control nothing.

Obamacare is not imploding, but may suffer from benign neglect or intentional sabotage.

MACRA/MIPS is a huge expensive headache.

Long term planning is not possible.

Meanwhile, health care goes on - to an uncertain fate.

Published on Linkedin - Arbitraging Grandma

Arbitraging Grandma

Recent Media

Recent Media Dropbox link:

Dropbox link

Great Conference

Attended and spoke at the annual convocation of the American College of Health Care Administrators.     www.achca.org

For conference materials and updates please drop by Dropbox.  Dropbox Share

"Chaperone" Policy Template

There is a massive scandal raging at Michigan State University and widely across the national women's gymnastics program.

One physician, left largely unsupervised for decades, is alleged to have committed perhaps hundreds (or more) sexual assaults on innocent athletes, some of them minors.

We had policies for physician offices 25 years ago. Apparently not everyone was paying attention.

A draft chaperone policy can be found at our Dropbox link.
Updates will follow. 

This is NOT legal advice.

MGMA Dropbox Share Link

Ride the Tiger - Health Care Edition

President Harry S. Truman and country singer Buck Owens both used a familiar ancient idiom – when you grab hold of a tiger letting go is dangerous.

The Trump administration and the Republicans in Congress have learned the same lesson the hard way, they jumped on the health care tiger and now they do not know what to do.

Where are We At?

The Republicans in Congress have discovered some hard truths about health care.

U.S. health care is complicated.

The Affordable Care Act is complicated.

Health care economics is complicated.

Budget politics is complicated.

Writing new health care law is complicated.

Keeping promises is complicated.

Pleasing 325 million people, or even a slice of that population, is complicated.

So all of the chest thumping and hollering about “repeal and replace” has so far turned into hollow noise, because doing something of substance is a lot tougher than shouting slogans.

What They Don't Know

In six years I have not encountered a Republican, either face-to-face or through their media presence, who sounded as if they actually knew what is in Obamacare and why. I suppose such people exists.

It is all about the slogans.

“Death panels!” “Illegal mandates!” “Crushing tax burdens!”

The U.S. health care system was complicated before the Affordable Care Act, and the overwhelming complexity of ACA made it much worse. Add to this thousands of pages of Obama-era regulations and there is a lot to know about the current health care system.

This cannot be fixed with slogans.

The GOP Menu (maybe)

Conservative think tanks and the GOP have been circulating the same ideas for decades.

Health Savings Accounts – good for the affluent, not so good for anyone else

Interstate sales of health insurance – does absolutely nothing for consumers, except expose them to lousy insurance plans - but good for lousy insurance companies and salesmen

“Market based” consumer choices – as in buying oncology is like buying a cheeseburger

Dump ACA subsidies, replace with tax credits (subsidies!)

Special treatment for Big Pharma – yes, Congressmen are for sale (both parties)

Block grant Medicaid – give Medicaid policy to Sam Brownback and Paul Lepage - wow

Send poor people back to Emergency Departments (which hurts hospitals)

So What Am I Saying?

The GOP does not have a coherent plan to replace the Affordable Care Act and may never have such a plan. There will likely be a repeal, total or partial, but the replace will be difficult.

The GOP might eventually have a plan to make Rush Limbaugh, the Koch brothers, the Tea Party and Fox News happy, sort of. Even that may fail.

The GOP has been blaming ACA for higher consumer costs (higher deductibles and co-pays) , and may replace ACA with a plan with – you guessed it – higher deductibles and co-pays,, including for seniors.

Repeal and Replace, or Partial Repeal and Partial Replace, or Reform and Repair, or ?????

On Super Bowl Sunday President Trump told Fox News that “repeal and replace” could take up to a year. Huuuge!

A few days earlier Rep. Jim Jordan, on the far right wing of Congress, said the total and complete and quick repeal of ACA was the only viable strategy. Soon.

In the last ten days or so “repair” has become a popular word, often in a phrase such as “reform and repair.” This implies that not all of ACA would be repealed, some of it would be repealed and new features would be added as a repair.

Ask ten Republicans in Congress and get seven or eight different answers. There is also squabbling about whether health care should be done before tax reform. The House majority and the Senate majority have different ideas, and the Senate majority is pretty thin.

So, the GOP has painted itself into a corner. The GOP could recover, stranger things have happened in Washington, but as of early February consensus is not looking either quick or easy, which makes near term legislation unlikely.

Legislative strategy

IF, repeating IF the GOP can agree on a plan, the various pieces and parts must through the legislative process. Some parts could move through reconciliation, others through the standard legislative process. This could cause a problem in the Senate.

The Longer Term

House Speak Paul Ryan has promised to”fix” Medicare.

There are ways to fix Medicare, but Ryan apparently has no clue. There are serious reform efforts already in motion to move Medicare from the original fee-for-service model to a more sophisticated value-based model, the legislation passed by bipartisan votes.

His approach is to turn Medicare into a for-profit play pen for insurers and doing tremendous damage to senior citizens. Wow.

Believe It Or Not?!

President-elect Donald Trump has started inauguration week by promising to unveil a new replace plan for the GOP repeal-and-replace project.

Trump is now promising, or at least dancing around promising:

universal insurance coverage

better quality

lower premiums

lower deductibles

In other words, none of this is realistic in the slightest. Reality is no longer a concern.

The only way "inexpensive insurance” works is if it really “cheap insurance.” Also known as lousy insurance.

Reports have Congressional Republicans wondering where this came from and what it will look like. Not to mention, what it would cost? And how is it conservative?

Trump has at least one good idea, the Medicare and Medicaid programs should be able to negotiate fixed prices with Big Pharma. Problem is, Congressional Republicans are committed to protecting Big Pharma even if the taxpayers continue to be cheated.

Stay tuned.

Replace and Repeal

Obamacare is dead! Long live Obamacare.

The Republican Party will control all branches of government in January, and has a stated purpose to repeal and replace Obamacare (properly the Affordable Care Act). 

Repealing Obamacare may not be as easy as  it sounds, and replacing it has many risks and uncertainties.

Both parties agree the system needs reform. That is about all they agree on.

Repeal:

Obamacare care is much more than a piece of legislation, it is now six years of regulation and innovation, and is intertwined through the health care system. There is no unpeeling of an apple.

There has been much to like about the intentions of Obamacare, even if the design and  implementation were  often wretched. The latest regulations on Medicare physician payment run to 2171 pages of  complex and convoluted regulatory excess.

Obamacare gets a good grade on intentions, but not so good on design or operations. Still, a full operational repeal is not possible, too many changes are ingrained into the system for a full.

Replace:

Timing is everything. I just finished reading House Speaker Paul Ryan's  A Better Way plan including the health care section. Whether or not Ryan is popular with his own membership, his health plan lays out the key ingredients of any GOP or conservative health reform plan. I am not impressed.

Leading the list are Health Savings Accounts (HSAs) and the interstate sale of health insurance policies, neither of which are likely to provide the salvation promised. 

Health care markets do not work like the markets  for buying a shirt,  a car or a head of lettuce. The HSA idea may be overrated as a tool of salvation, but good for the affluent.

The interstate sale of insurance policies saves money only if the insurers under price their products, and that can only happen for a few years before something bad happens. This is much like several of the ACA exchanges. I fear interstate sales will empower 1-800-Lousy-Policy companies, a consumer nightmare in the making.

The replace program promises cost savings through consumer choice, a profound misreading of how consumer find and use health care.

Like most GOP initiatives, the plan works well for the affluent and not  so well for anyone else. And when the GOP talks about “protecting Medicare,”  I know we are in trouble. The pro-life GOP will find a way to punish Medicaid recipients, count on it (and punish hospitals in the process).

Curiously, the GOP plan for patient protection  includes many features – wait for it – of Obamacare, just without the details. Lots of buzzwords though.

Perhaps I am a bit too cynical, but I think not. The Trump administration will be a wild ride on many counts, and not the least of it will be health care.

This is Gonna Get Interesting

The Republican Party won all three branches of the federal government yesterday, which means the "repeal and replace" program for Obamacare will begin in earnest in January.

This is going to be interesting. What do we do now? Stay tuned.

Quick draw litigation

The American Health Care Association has filed suit again the federal government, challenging the prohibition of coerced arbitration agreements in long-term care admissions.  ( https://www.ahcancal.org/Pages/Default.aspx) 

The lawsuit challenges regulations published in the new long-term care regulatory package (https://s3.amazonaws.com/public-inspection.federalregister.gov/2016-23503.pdf).

Providers use the arbitration to protect themselves against malpractice and business practices litigation. Providers think the malpractice system is a holy mess (which it is).

Consumer advocates think arbitration is an attempt to deny due process to residents and families (which it is).

U.S. businesses have increased the use of arbitration to avoid the courthouse and to deny due process to customers, employees, patients, etc. The push back is coming from the federal government.

Regulators Gone Wild

Long-term care:

Two weeks ago DHHS-CMS issued long-awaited updates on nursing home regulations.

The package, 700+ pages, is largely updates and clarifications, plus the new compliance standards (which were due March 23, 2013).


https://s3.amazonaws.com/public-inspection.federalregister.gov/2016-23503.pdf

Physician Medicare Reimbursement:

Last week the new regulations on physician reimbursement dropped, all 2, 398 pages. Gasp.

The regulations begin a phase-in of the MACRA reimbursement system, replacing the failed SGR.  

In brief the system will evolve from a failed fee-for-service system to a value-based system. Essentially this is a good idea - if it can be implemented.

The feds have already admitted that small and rural physician practices are in a bad spot, and there are phase-in rules.

Much heavy lifting. Stay tuned.

https://qpp.cms.gov/docs/CMS-5517-FC.pdf

https://qpp.cms.gov/education

______

DHHS-CMS  = Department of Health and Human Services, Centers for Medicare and Medicaid Services

MACRA = Medicare Access and CHIP Reauthorization Act of 2015

SGR = sustainable growth rate

LTCF Mandatory Compliance

The Patient Protection and Affordable Care Act (PPACA or ACA or Obamacare) contained a requirement that long-term care facilities have a compliance program by October 23, 2013.

The regulations were not ready on time.

The regulations were finally dropped into the massive regulations package to be published on October 4, 2016. [Code of Federal Regulations 42.483.35]

If a facility does not have a compliance plan, it should not wait more than a year to comply. In a highly regulated environment enforced by numerous criminal laws and civil sanctions a compliance program has really been necessary all along.

The heart of a compliance program is billing integrity, when you ask the government for a check you certify the billing is accurate. Facilities are subject to the false claims act and the anti-kickback statute plus other civil and criminal penalties.

Billing integrity is not the end of a compliance program. 

Given the massive regulatory program facing LTCFs the program must be broader.

The regulations delineate a minimal standard as well as a standard for groups with five or more facilities. Facilities are free to exceed the minimum expectations and a more robust program is advised.

Is a compliance program more expense and work with no benefit? No, it should be much more. A compliance plan can prevent government sanctions and can also serve as a performance audit for numerous aspects of your operations. 

The “self-survey” used by many facilities are a preliminary approach to the state survey which is a type of performance audit that ties nicely to a compliance program.

Where to obtain guidance on a compliance program? The DHHS, Office of Inspector General offers direction for some, in the form of a series of guidance documents. [https://oig.hhs.gov/compliance/compliance-guidance/index.asp]

We can provide consulting and written direction on successful compliance programs.

Uncoordinated Care

My wife recently retired from a distinguished career as an RN, and I have been alleged to know a little bit about health care.

So, like the proverbial doctor at a cocktail party, we get asked about health care issues and health services. We gladly give the best advice and best referrals we can.

We are also are the recipients of a great deal of venting about problems in the health system. Lots of venting. And lots of venting about the failure of the system to be even a little coordinated.

Some of the venting is shocking. The lack of coordination in oncology care in some systems is almost scandalous. But oncology is not alone.

The era of hospital employed physicians is clearly causing some problems.

Patient: “When will I see my doctor, Dr. Smith?”

Nurse: “You won't see Dr. Smith until you are discharged, here you will see the hospital doctors.

Patient: Well, who is that?

Nurse: “ Dr. Jones will be your cardiologist, except on weekends when it will be Dr. Brown, but after 8:00 pm it will be the cardiologist on call. Dr. Clooney is your hematologist and Dr. Pitt is your gerontologist, except of course for after 8:00 pm and weekends and their day off.”

Patient (slowly): “Oh... my... God.”

And we wonder why patients are confused? Are we close to violating informed consent standards with this parade of physicians?

Surgery patients are a little luckier, at least they know who is in charge of the parade, usually.

And it can be worse after the discharge. Something even worse happens when patients are referred to physicians willy-nilly, and after the fact discover the physician is out of network. How do they find out, usually when a huge bill comes in the mail three weeks later.

So who is to blame for this? Everybody and nobody.

The health care system has been evolving rapidly since 2010, and most providers are trying to evolve and accommodate the change.

The September 2016 edition of the Annals of Internal Medicine gives us a grim report – the employment of physicians by hospitals has not improved care. The alleged benefits of better coordinated care, well, are not benefits so far.

The Feds "Help" Small Physician Practices

The Affordable Care Act (Obamacare) has been very bad for small practices and especially small rural practices, thus the mad rush to integrate with hospitals and networks.

The recent publication of the MACRA regulations, a massive and complex pile of over-regulation, has put small and small/rural practices in even greater jeopardy.

Apparently DHHS realizes this problem, because a new program spending $100 million over five years will attempt to fix mitigate the damages.

(Small is 15 clinicians or fewer, which presumably eliminates many practices in integrated settings.)

The most remarkable use of the money is “..... the funding would support small practices by helping them think ...” presumably about the mess created by ACA and MACRA and how to survive.

In order to survive small practices are going to need very very sophisticated management and very sophisticated EMR and data analytic capabilities. How will that happen?

Link to announcement:

DHHS Small Practice Announcement

MACRA Physician Office Regulations

962 pages, 4 1/2 inches thick


                                                                       

                                                                           

Brief Commentary of New Overtime Regulations

More detailed commentary to follow.

Brief Commentary on Overtime   (Dropbox link)

And do not forget, health care has some special rules, more on that later.

MMGMA Spring Conference Dropbox Link

Click on Link

MMGMA S2016 Dropbox Ealey

I will adding new spreadsheets over the next few weeks.

I will also be updating the MACRA memo and will probably add a piece on the new overtime rules.

Later this summer, likely a piece on physician compensation issues.

Enjoy! Comments welcome.