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.

Wednesday, April 1, 2020

Hospitals Participating in Drug Trial for COVID-19 Across the US

Here is the official government website for a nationwide trial to evaluate the safety and efficacy of various novel therapeutic agents in hospitalized adults with COVID-19:


Here are the study site locations across the us:
United States, Alabama
University of Alabama at Birmingham School of Medicine - Infectious Disease Recruiting
Birmingham, Alabama, United States, 35233
United States, California
University of California San Diego Health - Jacobs Medical Center Recruiting
La Jolla, California, United States, 29037
University of California Los Angeles Medical Center - Westwood Clinic Recruiting
Los Angeles, California, United States, 90095
University of California Irvine Medical Center - Infectious Disease Recruiting
Orange, California, United States, 92868-3298
VA Palo Alto Health Care System - Infectious Diseases Recruiting
Palo Alto, California, United States, 94304-1207
Stanford University - Stanford Hospital and Clinics - Pediatrics - Infectious Diseases Recruiting
Palo Alto, California, United States, 94304-1503
University of California Davis Medical Center - Internal Medicine - Infectious Disease Recruiting
Sacramento, California, United States, 95817-1460
Naval Medical Center San Diego - Infectious Disease Clinic Not yet recruiting
San Diego, California, United States, 92314
University of California San Francisco - Zuckerberg San Francisco General Hospital - Division of Human Immunodeficiency Virus, Infectious Disease, and Global Medicine Recruiting
San Francisco, California, United States, 94110-2859
United States, Colorado
Denver Health Division of Hospital Medicine - Main Campus Recruiting
Denver, Colorado, United States, 80204
United States, Georgia
Emory Vaccine Center - The Hope Clinic Recruiting
Decatur, Georgia, United States, 30030-1705
United States, Illinois
Northwestern Hospital - Infectious Disease Recruiting
Chicago, Illinois, United States, 60611-2908
University of Illinois at Chicago College of Medicine - Division of Infectious Diseases Not yet recruiting
Chicago, Illinois, United States, 60612
United States, Maryland
University of Maryland School of Medicine - Center for Vaccine Development - Baltimore Not yet recruiting
Annapolis, Maryland, United States, 21401-1527
Johns Hopkins Hospital - Medicine - Infectious Diseases Not yet recruiting
Baltimore, Maryland, United States, 21287-0005
National Institutes of Health - Clinical Center, National Institute of Allergy and Infectious Diseases Laboratory Of Immunoregulation, Clinical Research Section Recruiting
Bethesda, Maryland, United States, 20892-1504
Walter Reed Army Institute of Research - Clinical Trials Center Not yet recruiting
Silver Spring, Maryland, United States, 20910-7500
United States, Massachusetts
Massachusetts General Hospital - Infectious Diseases Recruiting
Boston, Massachusetts, United States, 02114-2621
United States, Minnesota
University of Minnesota Medical Center, Fairview - Infectious Diseases and International Medicine Recruiting
Minneapolis, Minnesota, United States, 55455-0341
United States, Missouri
Saint Louis University - Center for Vaccine Development Recruiting
Saint Louis, Missouri, United States, 63104-1015
United States, Nebraska
University of Nebraska Medical Center - Infectious Diseases Recruiting
Omaha, Nebraska, United States, 68198-5400
United States, New York
Montefiore Medical Center - Infectious Diseases Recruiting
Bronx, New York, United States, 10467-2401
New York University School of Medicine - Langone Medical Center - Microbiology - Parasitology Not yet recruiting
New York, New York, United States, 10016-6402
University of Rochester Medical Center - Vaccine Research Unit Not yet recruiting
Rochester, New York, United States, 14642
United States, North Carolina
Duke Human Vaccine Institute - Duke Vaccine and Trials Unit Recruiting
Durham, North Carolina, United States, 27704
United States, Pennsylvania
Hospital of the University of Pennsylvania - Infectious Diseases Recruiting
Philadelphia, Pennsylvania, United States, 19104-4238
United States, Tennessee
Vanderbilt University Medical Center - Infectious Diseases Recruiting
Nashville, Tennessee, United States, 37232-0011
United States, Texas
Brooke Army Medical Center Not yet recruiting
Fort Sam Houston, Texas, United States, 78234
University of Texas Medical Branch - Division of Infectious Disease Recruiting
Galveston, Texas, United States, 77555-0435
Baylor College of Medicine - Molecular Virology and Microbiology Recruiting
Houston, Texas, United States, 77030-3411
University of Texas Health Science Center at San Antonio - Infectious Diseases Not yet recruiting
San Antonio, Texas, United States, 78229-3901
United States, Virginia
Naval Medical Center Portsmouth - Infectious Disease Division Not yet recruiting
Portsmouth, Virginia, United States, 23708
United States, Washington
EvergreenHealth Infectious Disease Service Recruiting
Kirkland, Washington, United States, 98034
The University of Washington - Virology Research Clinic Recruiting
Seattle, Washington, United States, 98104-2433
Providence Sacred Heart Medical Center Recruiting
Spokane, Washington, United States, 99204
Madigan Army Medical Center - Infectious Disease Clinic Not yet recruiting
Tacoma, Washington, United States, 98431
National Center for Global Health and Medicine Hospital - Disease Control and Prevention Center Recruiting
Tokyo, Japan, 162-8655
Korea, Republic of
Seoul National University Bundang Hospital - Division of Infectious Diseases Recruiting
Bundang-gu Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
Seoul National University Hospital Recruiting
Seoul, Jongno-gu, Korea, Republic of, 03080
National Centre for Infectious Diseases (NCID) Recruiting

Monday, March 23, 2020

COVID-19 Stay At Home Order - State of Illinois

Under the order, dry cleaners, laundromats, any business that sells equipment/materials needed to work at home, computer stores, law offices, payroll services, hardware stores, cabbies, Uber, and of course grocers, pharmacies and carry-out/delivery restaurants may stay open.

If you keep your office open, for example, you must provide 1.) six foot distances, 2.) hand sanitizer and disenfectant, 3.) separate operating hours for vulnerable populations, and 4.) posting online... if you are open and how best to reach the facility and contact by phone or remotely.

Individuals can go outside for:

Health and safety: seeking emergency services, obtaining medical supplies or medication or visiting a health care professional

For necessary supplies and services: obtaining groceries and food, household consumer products, supplies they need to work from home, and products necessary to maintain the safety, sanitation and essential operation of residences

For outdoor activity: walking, hiking, running or biking – including going to public parks and open outdoor recreation areas, except for playgrounds

For certain types of work: Providing essential products and services at Essential Businesses or Operations or otherwise carrying out activities specifically permitted in the order, including

Minimum Basic Operations
To take care of others: Caring for or transporting a family member, friend or pet in another household

Saturday, December 15, 2018

What Is the Effect of the Recent Court Decision in Texas That Ruled the Entire Affordable Care Act is Unconsitutional?

There is no immediate effect to yesterday's court ruling.  You can still enroll in health care plans on the exchange through the end of today and any plan that you enroll in will be in effect for all of next year.  But there could be long term effects and the decision once again throws uncertainty into the health care insurance industry, which is an industry that does not fare well under, or appreciate, uncertainly.
Technically, that court ruling only effects the federal district in Texas where the court resides and the judge did not order cessation of the law even in that district.  However, the case will be appealed first to the appeals court and then almost certainly to the Supreme Court of the United States where there is a possibility that the Supreme Court could uphold the ruling and invalidate the entire law nationwide.
Such a ruling would be devastating because it would invalidate unrelated portions of the law that have nothing to do with the insurance mandate, such as the expansion of Medicaid and Medicare reforms, and remove protections for pre-existing conditions.
There are two prongs to the court's ruling.  First, the judge ruled that the law can no longer be upheld as a constitutional tax because Republicans removed the tax penalty in 2017.  In 2012, the Supreme Court upheld the law as an acceptable use of Congress's power to tax.
Second the judge ruled that if the insurance mandate part of the law is unconstitutional, the entire law must be unconstitutional because the insurance mandate is a critical component of the law.
However, the entire law is so massive and comprehensive I do not agree that the individual mandate is critical to many of the unrelated provisions of the law which have little to do with insurance coverage.  In addition, there are other parts of the law that do pertain to health care coverage, such as the expansion of Medicaid for the states, that are not affected by the individual mandate.   I do not agree that the entire law should be declared unconstitutional.
Regardless, if the individual mandate is ultimately declared unconstitutional nationwide, this will cause all sorts of problems for the insurance industry and many people will lose their coverage either under their insurance plans or Medicaid.
The bottom line as usual is that you get what you vote for.  If you live in one of these states and ultimately lose you health care as a result of this decision, you have your government to thank: Plaintiffs are the States of Alabama, Arizona, Arkansas, Florida, Georgia, Indiana, Kansas, Louisiana, Mississippi, Missouri, Nebraska, North Dakota, South Carolina, South Dakota, Tennessee, Texas, Utah, West Virginia, Wisconsin, Governor Paul LePage of Maine (the “State Plaintiffs”), and individuals Neill Hurley and John Nantz (the “Individual Plaintiffs” and, collectively with the State Plaintiffs, “Plaintiffs”).  If you live in one of these states, your Republican Attorney General filed this suit specifically in an attempt to achieve this result.
Also, if you voted for a Republican congressman or senator and they voted to repeal the tax penalty of the Affordable Care Act, this was an intended consequence.
The chances of a Democrat Congress, a Republican Senate and the President agreeing upon a fix to this problem is very slim indeed.
Below is some of the critical text of the decision:
Texas District Court: Repeal of Penalty Renders Individual Mandate Unconstitutional -- Entire ACA Ruled Invalid (PDF)
55 pages. "Plaintiffs allege that, following passage of the Tax Cuts and Jobs Act of 2017 (TCJA), the Individual Mandate in the [ACA] is unconstitutional. They say it is no longer fairly readable as an exercise of Congress's Tax Power.... The Supreme Court's reasoning in [NFIB v. Sebelius] ... compels the conclusion that the Individual Mandate may no longer be upheld under the Tax Power. And because the Individual Mandate continues to mandate the purchase of health insurance, it remains unsustainable under the Interstate Commerce Clause -- as the Supreme Court already held....
"Congress stated many times unequivocally -- through enacted text signed by the President -- that the Individual Mandate is 'essential' to the ACA.... All nine Justices to review the ACA acknowledged this text and Congress's manifest intent to establish the Individual Mandate as the ACA's 'essential' provision.... Because rewriting the ACA without its 'essential' feature is beyond the power of an Article III court, the Court thus adheres to Congress's textually expressed intent and binding Supreme Court precedent to find the Individual Mandate is inseverable from the ACA's remaining provisions....
"Under the law as it now stands, the Individual Mandate no longer 'triggers a tax' beginning in 2019. So long as the shared-responsibility payment is zero, the saving construction articulated in NFIB is inapplicable and the Individual Mandate cannot be upheld under Congress's Tax Power....
"The Court today finds the Individual Mandate is no longer fairly readable as an exercise of Congress's Tax Power and continues to be unsustainable under Congress's Interstate Commerce Power. The Court therefore finds the Individual Mandate, unmoored from a tax, is unconstitutional and GRANTS Plaintiffs' claim for declaratory relief ...
"All told, Congress stated three separate times that the Individual Mandate is essential to the ACA. That is once, twice, three times and plainly. It also stated the absence of the Individual Mandate would 'undercut' its 'regulation of the health insurance market.' Thirteen different times, Congress explained how the Individual Mandate stood as the keystone of the ACA. And six times, Congress explained it was not just the Individual Mandate, but the Individual Mandate 'together with the other provisions' that allowed the ACA to function as Congress intended....On the unambiguous enacted text alone, the Court finds the Individual Mandate is inseverable from the Act to which it is essential....
"For the reasons stated above, the Court grants Plaintiffs partial summary judgment and declares the Individual Mandate, 26 U.S.C. Section 5000A(a), UNCONSTITUTIONAL. Further, the Court declares the remaining provisions of the ACA, Pub. L. 111-148, are INSEVERABLE and therefore INVALID. The Court GRANTS Plaintiffs' claim for declaratory relief[.]"
[Texas v. U.S., No. 18-167 (N.D. Tex. Dec. 14, 2018)]

Saturday, November 3, 2018

How To Vote If You are In a Health Care Facility During Election Time

Can you still vote if you are stuck in a hospital or a health care facility around election time?  In Illinois and Indiana, yes.

 In Illinois, the following instructions are given by the state board of elections:


1. Voter must obtain an Application for Ballot for Qualified Voter Admitted to Hospital, Nursing Home or Rehabilitation Center . The application can be obtained from the election authority (county clerk or board of election commissioners, depending on where the voter is registered to vote).

2. Voter must complete his/her application and his/her physician must complete and sign the Ce rtificate of Attending Physician section of the application.

 3. After the form is completed and signed by the voter and his/her physician, a registered voter from the voter’s precinct or any legal relative can then hand deliver the application to the election authority’s office.

4. After signing an affidavit, the precinct voter or legal relative may personally hand deliver the ballot to the voter at the health care facility he/she has been admitted to.

5. Once the voter receives the ballot, he/she will vote the ballot in secret and complete the certification on the ballot return envelope.

 6. After depositing his/her voted ballot in the return envelope, the voter will securely seal the envelope, and give the envelope to the precinct voter or to the legal relative.  The ballot must be delivered back to the election authority before 7:00 p.m. on Election Day.

Assistance is the actual casting of votes for a voter in accordance with the voter’s wishes. Assistance can be given by a friend or relative, but cannot be given by an officer or agent of the voter’s employer or the voter’s union.  A candidate whose name appears on the ballot is also prohibited from assisting a physically incapacitated voter unless the candidate is the spouse, parent, child, brother, or sister of the incapacitated voter.  This would prohibit precinct committeemen from giving assistance in a primary election.  If assistance is given, the name and address of the person giving assistance must be provided on the certification envelope.



You may vote by absentee ballot In Indiana if:
  • You have a specific, reasonable expectation that you will be absent from the county on Election Day during the entire 12 hours that the polls are open (6:00 a.m. until 6:00 p.m.).
  • You have a disability.
  • You are at least 65 years of age.
  • You will have official election duties outside of your voting precinct.
  • You are scheduled to work at your regular place of employment during the entire 12 hours that the polls are open.
  • You are prevented from voting due to the unavailability of transportation to the polls.
  • You will be confined due to illness or injury or you will be caring for an individual confined due to illness or injury during the entire 12 hours that the polls are open.
  • You are prevented from voting because of a religious discipline or religious holiday during the entire 12 hours that the polls are open.
  • You are a participant in the state’s address confidentiality program.
  • You are a serious sex offender as defined in Indiana Code 35-42-4-14(a).
  • You are a member of the military or a public safety officer.
Per Indiana law, a disabled person or one who is unable to read or write English may request assistance in the voting booth:

"Sec. 2 . (a) A voter who:
(1) is a voter with disabilities;  or
(2) is unable to read or write English;
may request assistance in voting before entering the voting booth and designate a person (other than the voter's employer, an officer of the voter's union, or an agent of the voter's employer or union) to assist the voter in voting at an election, as required by 52 U.S.C. 10508 .
(b) The person designated must execute a sworn affidavit on a form provided by the absentee voter board or the precinct election board stating that, to the best of the designated person's knowledge, the voter:
(1) is a voter with disabilities or is unable to read or write English;  and
(2) has requested the designated person to assist the voter in voting under this section.
(c) The person designated may then accompany the voter into the voting booth and assist the voter in marking the voter's paper ballot or ballot card or in registering the voter's vote on the electronic voting system.  IC 3-11-9-2.


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