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.

Saturday, November 15, 2008

Enrollment for Medicare Drug Plan Begins November 15, 2008

Starting today, seniors can enroll in a new or different Medicare drug plan for 2009.

Even if you are already enrolled, please review your options since several popular plans are raising monthly premiums or changing benefits. Do not assume that your plan will be the same in the following year. By now, you should have received an "annual notice of change" package of materials telling you the changes in your plan that go into effect in the next year.

To be on safe side, the Medicare Rights Center advises seniors to call their plans and check if their medications are covered. Be sure to make a list of all your drugs and the dosages prescribed in advance.

Also, you'll want to ask about drug co-payments, the pharmacies in the plan network, and if the plan has placed any restrictions on the medications you use.

For an overview of the Medicare drug benefit, the different types of plans available and questions you might want to consider, go to You can compare how your plan stacks up against others by going to the Medicare Drug Plan finder at or calling 1-800-Medicare (1-800-633-4227).

Remember, if you don't have much money, you might qualify for financial subsidies from the government to cover drug expenses.

Please contact me if I can help or if you have any questions.


Thursday, October 23, 2008

Update on Enforcement of HIPAA Privacy Rule

CCH has published a summary of enforcement data for privacy violations under HIPAA since enforcement of the law began in April 2003:

There is no individual private cause of action for HIPAA violations. A complaint must be filed with the Office of Civil Rights in the case of an alleged violation.


New Mental Health Parity Law

At least one good thing came out of the recent financial troubles that our country has been experiencing. After more than 10 years of trying, Congress has passed a law that requires employer-sponsored health care plans to treat mental health disorders to the same level and degree as they do physical ailments.

The new requirements are included in the Emergency Economic Stabilization Act (H.R. 1424), which is the "economic bailout" bill that President Bush signed into law on October 3, 2008. For years, plans have generally been less generous in their coverage of treatment for mental illness. The new law becomes effective in 2010 and generally applies to employers with more than 50 workers, with certain exceptions.

Under the new law, plan participants cannot be required to pay more in deductibles, copayments, coinsurance and out-of-pocket expenses for mental health and substance use disorder benefits than they are required to pay for the plan's most common or frequent types of medical/surgical benefit.

The new law prevents plans from limiting the frequency of treatment, the number of visits, the days of coverage, etc. for mental health/substance use treatment moreso than they do for medical/surgical benefits.

In addition, "out-of-network" mental health services must be covered under the law if they are covered for medical/surgical benefits.

A plan must provide a legally acceptable definition of "mental health" and "substance use disorder" and is permitted to use utilization review and/or pre-authorization to determine medical necessity and appropriateness. The plan administrator must disclose any medical necessity determination criteria to any participant upon request. Also, the reason for any denial of reimbursement or payment also must be provided.

The law provides a penalty of up to $100/day for non-compliance and allows plan participants to file civil lawsuits to obtain inappropriately denied benefits.


Thursday, August 28, 2008

Importation of Medicines via the Internet

Is it legal to order prescription pharmaceuticals over the internet? If not, your shipment could be seized at the border by US Customs and you could receive an alarming letter.

In the United States, the FDA has given guidelines for review of the personal importation of pharmacuetical products. They will generally be allowed on a doctor's prescription being for personal use only and no more than a 3 months supply.

FDA personnel are responsible for monitoring mail importations. If a customs officer examines a parcel, he/she is to set is aside if it appears to contain a drug, biologic, or device that the FDA has specifically requested to be held.

Additional issues arise when the pharmaceutical in question is a controlled substance, such as Valium, and falls under the jurisdiction of the US Drug Enforcement Administration.

Can an individual legally order drugs using the internet without seeing a doctor? No.

Federal law requires that "A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice" (21 CFR 1306.04(a)). In other words, there must be a bona fide doctor/patient relationship.

Four elements indicate a legitimate doctor/patient relationship: 1.) patient has a medical complaint; 2.) medical history has been taken; 3.) physical examination has been performed; and 4.) some logical connection exists between the medical complaint, the medical history, the physical examination and the drug prescribed.

A patient completing a questionnaire that is then reviewed by a physician hired by or working on behalf of an internet pharmacy does not establish a doctor/patient relationship.

In addition, providing false material information to obtain controlled substances could be considered obtaining a controlled substance by fraud and deceit, which is subject to Federal and State penalties. Illegal importation of controlled substances is a felony that may result in imprisonment and fines (21 U.S.C. 960).

Steve to Participate in MEDI Conference

I will be attending a round table at the MEDI medical device conference at the Marriott in Hartford, CT on September 9, 2008. I was asked to review what I consider to be the 10 most important documents for the conduct of a successful investigational medical device clinical trial.

My topics will include the clinical trial agreement, investigator agreement/FDA form 1572, indemnification, reimbursement for adverse events, the informed consent form, delegation of responsibilities, etc. The presentation will be useful to clinical monitors, sponsor and site management, and clinical trial vendors.

For more information, go to



Monday, August 25, 2008

Increase in personal medical costs

There was an article in the Washington Post last week reporting that more than 2 in 5 adults in the 19-64 age group reported problems paying medical bills or had accumulated medical debt in 2007, compared to 1 in 3 in 2005. We all know about the plight of the uninsured. What is alarming about this new statistic is that 61% of those with medical debt or bill problems in this survey had health insurance.

I've recently seen an increase in the rise of individuals coming to me with problems having their insurance cover major medical bills that, IMO, are unquestionable as to the medical necessity. This is occurring among clients who are insured by the most reputable insurance companies. It is difficult to pay health insurance premiums AND out of pocket expenses at the same time.

You can review this survey at The survey defines four problems with access to health care due to money or poor coverage: 1.) failure to fill a prescription, 2.) not seeing a specialist when needed, 3.) skipping a medical test, treatment or follow-up, and/or 4.) refraining from seeing a practitioner when a problem exists.

These problems are no longer relegated to the poor and the uninsured. The percentage of people with the above problems has approximately doubled among those with middle income ($40.000-59,999/year) and those with incomes of more than 60K per year.


Thursday, May 8, 2008

Welcome to my health care blog

Greetings, everyone. I will be posting information soon regarding the plight of the uninsured and the legal problems associated with purchasing prescription pharmaceuticals on line.