Elder Law, Drug and Device Laws and Insurance Laws

This blog is written by Mr. Steven C. Schurr, Esq. and focuses on health care law matters that pertain to food and drug law, regulatory compliance, privacy rights, insurance coverage, state and federal disability coverage, patient advocacy issues, and mental health coverage and treatment.

Sunday, April 30, 2017

MacArthur Amendment to the Federal Healthcare Law

Below is the congressional link to the recent proposed Amendment related to healthcare reform.  It is only a draft document at the present.  There has been no official action on the bill.

docs.house.gov/billsthisweek/20170424/MacArthur Amendment.pdf

Amendment to H.R. 1628 Offered by Mr. MacArthur

The eight page amendment would allow a particular state to request waivers to 1.) charge the elderly more for premiums, 2.) to consider pre-existing conditions when offering plans, and 3.) to offer plans that do not cover all of the Affordable Care Act's Essential Benefits.  The Essential Health Benefits are:
Essential Health Benefits. A qualified health plan must provide the following: ambulatory (“one-day”) patient services, emergency services, hospitalization, maternity and newborn care, “mental health and substance use disorder services, including behavioral health treatment”, prescription drugs, rehabilitative and habilitative services and devices, laboratory services, preventive and wellness and chronic disease management, and pediatric services including oral and vision care. 
A state's application for a waiver would be approved by default if, among other things, it declares:
"(B) The application specifies how the approval of such application will provide for one 2 or more of the following: 
(i) Reducing average premiums for 4 health insurance coverage in the State.
(ii) Increasing enrollment in health 6 insurance coverage in the State. 
(iii) Stabilizing the market for health 8 insurance coverage in the State.
(iv) Stabilizing premiums for individuals with pre-existing conditions.
(v) Increasing the choice of health plans in the State."
On major problem that I see is that any specification in the application for the waiver as to how the granting of the waiver would accomplish any of the above five goals would be pure conjecture and would not be evidence based.  Hence I view the above requirements for approval of the waiver as merely an ostensible (stating or appearing to be true, but not necessarily so) justification for its application.  In practical effect, if a state requests a waiver, they will receive it, at least under the current administration.

Thursday, April 6, 2017

Answers to FAQs Re: Obamacare, Prepared for Congressional Staff

Below is a link to FAQ regarding the Affordable Care Act.  35 pages. "This report provides resources to help congressional staff respond to constituents' frequently asked questions about the law. The report lists selected resources regarding consumers, employers, and other stakeholders, with a focus on federal sources. It also lists CRS reports that summarize the ACA's provisions."
Patient Protection and Affordable Care Act
(ACA): Resources for Frequently Asked
Questions by Angela Napili, Senior Research Librarian, Congressional Research Service

Wednesday, February 15, 2017

Would Selling Health Insurance Across State Lines Reduce Our Health Insurance Premiums?

Health insurance and insurance in general has traditionally been regulated by the individual states.  Companies are licensed by the state to sell insurance, and insurance laws and requirements are different in each state. 

Republicans, including Donald Trump, have often advocated allowing insurance to be sold nationwide, i.e., across state lines, to increase competition and therefore reduce rates, as part of their efforts to replace the Affordable Care Act (ACA).  Would this have the desired effect?

Currently, 21% of enrollees in states using the federal exchange have only one participating insurer for 2017.  This is hardly a competitive marketplace and is viewed by many as one of the failures of the Affordable Care Act (ACA).

Insurance rates are determined by actuaries.  An actuary is a business professional who deals with the measurement and management of risk and uncertainty.  The American Academy of Actuaries has released a February 2017 Issue Brief to address the issue of selling health insurance across state lines.  As you are about to find out, selling health insurance across state lines is not as simple as it sounds.  In their brief, the actuaries arrive at three key points:

1.       Allowing insurers to sell coverage across state lines has limited potential for premium savings, as premiums would continue to reflect local health care costs.”  An individual living in a high-cost area would not necessarily enjoy lower premiums by purchasing coverage from an insurer licensed in a low-cost state.  Per the actuaries, premiums will reflect local health costs, regardless of where the coverage is purchased.

2.       “Out-of-state insurers would have difficulty developing provider networks and negotiating provider or payment discounts.”  In order for insurers to sell across state lines, they would first have to develop provider networks via reimbursement agreements with local hospitals and physicians, or buy into an existing network.  Unless the out-of-state insurers were able to accomplish large enrollment, they would have little leverage in negotiating with providers.  Health Maintenance Organizations (HMOs), who limit out-of-network coverage, would have even more difficulty operating in other states.

3.       Unintended consequences could result if states are given more flexibility regarding benefit requirements or issue and rating rules.  Adverse selection would occur, threatening the viability of insurers licensed in states with more restrictive requirements.  The ability of high risk individuals to obtain coverage could be compromised as a result.”  The actuaries say that the establishment and regulation of state-level consumer protection laws is often ignored during discussions of selling insurance across state lines.  These laws vary from state to state as to whether they require minimal network adequacy or, for example, if they require an appeal processes for denied services.  Not only would this be terribly confusing, it would be difficult for state regulators to regulate out-of-state provider networks.

For a health insurance market to be sustainable, competing insurers must all operate under the same rules, according to the actuaries.  Allowing an insurer licensed in their home state to sell insurance in another state under their home state rules would violate that principal.  Per the actuaries, “The ACA harmonized many of the rules applying to the individual and small group markets.  Although states have mandated benefits to varying degrees, the ACA’s essential health benefit requirements narrowed the differences in covered benefits across states.”  Also, the actuarial requirements for the platinum, gold, silver and bronze tiers of the ACA set a “floor” for plan coverage.

Finally, the ACA harmonized issue and rating rules, which previously varied from state to state.  Medical underwriting is now prohibited by the ACA, which means insurers can no longer deny coverage or charge higher premiums to individuals based upon their health.  The ACA also limited the extent that premiums could be adjusted due to an applicant’s age. 

If the ACA is repealed but not replaced, or these rules are abolished or relaxed, and as a result the states are allowed more flexibility, insurers licensed to operate in a state that permits less generous coverage would attract the healthier residents of other states.  Premiums for insurance licensed in states with more comprehensive benefit requirements would increase as a result, and individuals with health problems could find it more difficult to obtain coverage.

In conclusion, if rules governing insurance are consistent across state lines (like they are now with the ACA) premium reductions would be minimal because they would continue to reflect local health care costs, no matter where the insurer is located.  If rules governing insurance vary from state to state, insurers based in states with more restrictive requirements would be at a disadvantage compared to insurers based in states with less restrictive requirements.  Regardless, regulatory authority and consumer protection laws would need to be very clearly defined.
Here is a link to the American Academy of Actuaries' brief, entitled, "Selling Insurance Across State Lines":  http://www.actuary.org/content/selling-insurance-across-state-lines-0

Senators Propose Importation of Less Expensive Pharmaceuticals from Canada If US Prices Rise

Several Senators call for the allowance of importation of expensive medications from Canada under certain circumstances.  This has been expressed in a letter to the new Secretary of Health and Human Services, Tom Price.  Attached is the letter from Senators Chuck Grassley (R-IA), John McCain (R-AZ) and Amy Klobuchar (D-MN):  http://www.grassley.senate.gov/sites/default/files/constituents/20170214%20Secretary%20Price%20reimportation%20letter.pdf
"Those circumstances are: If a drug is off patent or no longer marketed in the US by the innovator company that initially developed that drug; if there are “significant and unexplained increases in price”; if no direct competitor drug is currently marketed and the introduction of such a competitor will lower prices for taxpayers and consumers; or if the drug is produced in another country by a brand name manufacturer or by a “well-known generic manufacturer that commonly sells pharmaceutical products in the US.”  - Zachary Brennan, Regulatory Affairs Professionals Society
The unknown receipt of counterfeit drugs from illegitimate destinations can be a problem if ordered from a Canadian Pharmacy but this can be avoided by proper screening and vetting of the approved pharmacies.  I am in favor of this policy if it can be implemented properly.
See the attached newsletter from the Regulatory Affairs Professionals Society (RAPs):


Friday, January 27, 2017

What is the Current Legal Status of the Affordable Care Act?

This linked article explains, without the hype, what the true legal status of the Affordable Care Act is right now:

"A popular meme suggests that the Senate voted to eliminate virtually all of the provisions of the ACA, including the ability to obtain insurance in spite of pre-existing conditions, the requirement to cover adult children up to the age of 26, etc. This is not the case.
It is clear that President Trump, and the majority of Republicans in Congress, want to pass some sort of repeal of the ACA as quickly as possible. However, neither the resolution passed by Congress nor the Executive Order makes any changes in current law. Many of the provisions of the ACA would be difficult or impossible for Republicans to repeal without Democratic support. And with only a narrow majority in the Senate, it is not even clear that the votes are there for repeal before a replacement plan can be developed. Thus, for now, employers should continue to assume that they will need to comply with the ACA mandates"


Friday, January 20, 2017


My answer is a resounding “NO!”  Prior to this recent fall 2016 local and presidential election, I was one of those na├»ve idealists who actually believed that everyone in America deserved health care.   I had three reasons: 

1.)  First, it is necessary to maintain your health, which falls under our inalienable right to “life, liberty and the pursuit of happiness” guaranteed to us in the Declaration of Independence;

2.)  Second, it is in everyone’s economic best interest to have broad health care coverage, both from a micro and macro viewpoint; and

3.) Third, we are the richest county in the world, and if other much poorer countries like Cuba can afford to provide health care to all its citizens, we certainly should be able to as well, if we make it a priority.


The phrase “if we make it a priority” is the caveat that changed my mind about the answer to the question above.  You can tell from the results of the recent election that receiving good health care and possessing good health insurance for ourselves, our families and our fellow Americans is not a priority for the majority of Americans.  Most Americans put one or more other issues way ahead of having access to health care.  I can’t cite and don’t even know all of the issues that were given a higher priority, but examples are issues such as fear of a transgender in the restroom (even though they have been there for years and we just haven’t known it), fear of a gay married couple living next door, fear of having their guns taken away (which was never going to happen), the importance of making a protest vote or no vote at all to prove a political point, zealous concern about the environment, change for change’s sake without a clue as to whether the alternative would be better, dislike of a particular candidate, dislike of President Obama and anything even remotely associated with him, hatred of minorities and foreigners,  fear of big government in general, not to mention just an overall apathy or too little concern to bother to vote.   All of these non-healthcare issues seem trivial to me when compared to the threat to the physical and financial welfare of an individual and his/her family that result from having an accident or becoming ill without health insurance. Obviously, most Americans do not agree with me.  About the only issue that veers close to the importance of insurance coverage in its immediate effect on the health and quality of life of us and our loved ones is the fear of a terrorist attack.  The terrorist threat is frightening and is very real, but it is much less likely statistically to afflict any one individual versus the chances of becoming ill from any variety of diseases or accidents.  Another competitive possible threat is harm due to crime such as in the more violent neighborhoods in Chicago.  But even the survivor of a terrorist attack or a random crime will need good medical care and mental health care after the attack.  Let's remember how we let down our first responders to 911 who later became ill as a result of their heroic efforts.  Let's also remember the many domestic shootings that have occurred because the shooter could not get adequate mental health care.  And let us also not forget that we will all get old and frail if we are lucky, no matter what we do or believe.


Is it necessary to maintain your personal health and the health of your friends and loved ones to achieve “life, liberty and the pursuit of happiness”?  I think everyone would agree that maintaining your personal health is necessary to maintain one’s life.  While the sick are often happy (God bless them), it is easier to be cheerful when one has good health.  I’ve never met anyone who has ever said they would rather be sick than healthy.  It is also easier to pursue other personal and professional goals if you are in good health versus battling a physical or mental affliction.

So, in the United States, is it necessary to have health care insurance to maintain this good health?  In America, I would say “yes” due to the way our health care system is structured and financed.  Some people may argue that you can get free care at the emergency room if you don’t have insurance, so why pay premiums?  This has been true in the past but the health care received in the ER is more like a bandage than a fix.  There are provisions in the Affordable Care Act designed to encourage hospitals to perform post-discharge follow-up for hospitalized patients and to financially punish hospitals when they fail to do so.  A person needs routine medical evaluations, preventive medicine, pharmaceuticals and diagnostic procedures to remain healthy.  And don’t forget about hip and knee replacements!  You won’t die without these, our ancestors lived without them, but they certainly can improve your quality of life.

The real reason that I think health insurance is necessary in America to maintain good health is that EVEN THE RICHEST AMERICANS POSSESS HEALTH INSURANCE.  (On my trips to the Mayo or Cleveland Clinic I often see rich foreign leaders staying at the hotels and paying out of pocket for their US care.)  Yet the wealthy in the US buy health insurance even though they could easily afford to pay for their own. They purchase it because it helps them maintain financial stability and shifts the financial risk to the insurance companies.  If it were such a trivial matter, the wealthy would not bother.  Wealthy individuals have the extra benefit that if they do not like the treatment offered to them by the insurance company, they can buy their own if necessary.  This is why we don’t see Congress giving up their health care.  We pay for their health care while they take ours away.

If I were to ask you, do you accept the premise that we have an inalienable right to “life, liberty and the pursuit of happiness” as stated in the Declaration of Independence, most Americans would answer “yes” without even giving it a thought.   An argument can be made that all Americans are entitled to health insurance because they need health insurance to have access to health care, and they need access to health care to remain healthy.  An “inalienable” right is a right which cannot be taken away or given away by the possessor.  Ironically, that is exactly what the repeal of the Affordable Care Act will do, take away an inalienable right from many Americans, most of whom knew they were taking that risk when they made their votes in the 2016 election.


Prior to the Affordable Care Act, many talented company employees with a pre-existing condition, such as a cancer diagnosis within the past five years, or a chronic incurable condition such as diabetes, were afraid and/or unable to move to a better job because they were dependent on their current employer for their insurance.  If they jumped to a better job, their new employer’s insurer could declare their pre-existing condition uninsurable.  As a result they would be without insurance, and quite frankly, it just wasn’t worth it.  This holds back the economy on a micro level.  Likewise, those employees that were thinking of striking out on their own and starting their own business found it difficult, if not impossible, due to the availability of insurance and its cost.  How often has a politician told you it is the small businesses that drive the economy? This economic benefit on a personal level is not a priority to most Americans, as I have stated above.

At a macro level, uninsured people increase overall health care costs because they wait until they are seriously ill to get treatment and go to the Emergency Room to get their care, which is much more expensive than a routine visit to a neighborhood clinic.  A healthy citizen is more likely to be a productive citizen.  Addicts who cannot receive treatment will remain addicts.  In addition, health care costs gobble up a large portion of our Gross Domestic Product compared to other countries.  On a macroeconomics level, this is a complex issue that few understand.  But I can guarantee you there will always be a market and a demand for health care because it is not a luxury item.  It will not go away, and it will always be the elephant in the room when analyzing the competitiveness of our economy.


This argument is raised the most frequently, and its rejection is the most puzzling to me.  It is the strongest evidence I have that we, individually and collectively, as Americans, do not value and/or prioritize access to health care.  I think of a Latin phrase I learned in law school, “res ipsa loquitur”, which means "The thing speaks for itself”.  The mere fact that we are the richest country in the world yet many of our citizens are not covered is really all you need to know.  And the recent fact that many citizens voted against the recent enhancement of health insurance coverage in the 2016 election, even when it may have been against their own personal interest to do so, confirms my point.


I used to believe in health care for everyone.  Now I no longer do because this recent vote was a repudiation of expanded health care coverage.  Politicians were very clear during the election where they stood in regards to the upcoming repeal of the Affordable Care Act.  I hope the people that are complaining at the personal level, and on social and traditional media, voted in this past election to keep America insured.  If so, I feel sorry for you and I wish you the best.  If you did not vote to retain expanded coverage, but now complain, shame on you. You are getting what you deserve, which very well may be nothing.

Monday, January 16, 2017

Is it Safe to Use Imported Drugs from Canada?

The Senate recently voted against an Amendment that would have allowed " the importation of safe and affordable prescription drugs by American pharmacists, wholesalers, and individuals with a valid prescription from a provider licensed to practice in the United States".  The amendment was proposed because the same, exact chemical medications purchased from outside the country can be far less expensive than their identical counterparts sold in the US.  In many instances, the comparative drugs are even made at the same FDA-approved facility, which may or may not be in the United States. 

While this Amendment sounds like a good idea and sounds very simple (we all know that pharmaceutical prices are way too high in the US), it is not that straightforward to guarantee that medications you may purchase from a Canadian pharmacy, for example, are exactly the same, just as safe, and just as effective, as their US-purchased counterparts.  In addition, even if they are, there are certain legal issues that arise.  Just because you purchase a medication from a Canadian pharmacy, that does not guarantee that the drug is authentic or of the same quality as its US-purchased counterpart.  Such  imported drugs that appear to be from Canada may actually have been manufactured in places like India or Turkey.  There have been instances where individuals have been criminally convicted for importing drugs into the US, including cancer drugs, that have been counterfeit and/or dangerous in their own right. 

Furthermore, even if an imported drug is chemically identical to its US counterpart, the imported drug's product labeling, which includes directions for use and important warnings about side effects, would be different from the current product labeling that is approved for use by the FDA.  Such labeling may not even be in the same language, may not even be readable to the US purchaser, and may not include the FDA's latest warnings or instructions. 

Finally, even if the US-sold and the imported drug are chemically the same, yet the labelling of the imported drug is not the FDA-approved version, the imported drug is considered "misbranded" under US drug law, which means its importation is technically illegal, except for very narrow exceptions.  To ensure these imported medications are "safe" is not that easy, and to declare their importation as legal, is not that simple.