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.

Monday, November 23, 2009

Drug and Device Info on the Internet

On November 12 and 13 the US Food and Drug Administration (FDA) held a "Public Hearing on Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools." If you would like to view a video of the public meeting on this topic, you may do so at the following link:

Tony Blank of Boston Scientific speaks on behalf of AdvaMed in the first morning session of the first day. Jeffrey Francer speaks on behalf of PhRMA during this same session. In addition, representatives from Eli Lilly, sanofi-aventis, Johnson and Johnson and Pifzer also give short presentations on behalf of manufacturers.

Comments on the hearing are due by February 28, 2010.

Some of the issues that arise seem to be: 1.) how to distinguish between reliable FDA- approved information and unreliable information on the web, 2.) what should, if anything, a manufacturer do if someone posts inaccurate information about their product on the internet; should they police this and respond?; if so, are they assuming responsibility for all the content of the blog that they are responding to? and 3.) what are the responsibilities of a manufacturer if they post reliable information and a third-party modifies it. Some problems that I have experienced: What do you do when study patients or clinical investigators communicate on a blog and mention potential adverse events that have not been reported on the study case report forms? Should someone at the sponsor be monitoring these blogs?


Medicare Part D - Prescription Drug Plans - Enrollment and Health Care Reform

Once again, it is the open enrollment period for the Medicare prescription drug plan known as Medicare Part D. The enrollment period runs from November 15, 2009 to December 31, 2009. It is time to evaulate your current plan to see if it best meets your needs. Did you purchase enough medications this year so that you reached the "donut hole", that is, the part of the plan that requires you to pay 100% of your costs for medication? If so, can you afford to buy insurance coverage for drug costs within the donut hole? Are you already purchasing insurance to cover the donut hole costs, but your drug expenditures were so few that you probably do not need the coverage? Does you current plan allow you to purchase the medications that you truly need?

While I am on the topic, I would like to comment on the effect on Medicare Part D of the two proposed health care plans. The plan proposed by the House of Representatives (HR 3962)promptly reduces the amount of the donut hole by $500 and then requires gradual phase-out of the donut hole over the next several years. The plan proposed by the Senate (The Patient Protection Affordable Care Act) promptly reduces the donut hole by $500 but proposes no further reductions.

This would suggest that the final bill, if passed, would include some sort of relief, either short-term or long-term, in regards to this infamous donut hole.


Thursday, November 19, 2009

Health Care Reform

When I first heard that the proposed health care bill from Congress (HR 3962) essentially would not take effect until 2013, I became discouraged, because many people will suffer from now until then due to lack of health insurance. However, there are some provisions in the proposed bill that would take effect immediately on passage, as explained below by the Speaker of the House:


1. BEGINS TO CLOSE THE MEDICARE PART D DONUT HOLE — Reduces the donut hole by $500 and institutes a 50%discount on brand-name drugs, effective January 1, 2010.

2. IMMEDIATE HELP FOR THE UNINSURED UNTIL EXCHANGE IS AVAILABLE (INTERIM HIGH-RISK POOL) — Creates atemporary insurance program until the Exchange is available for individuals who have been uninsured for severalmonths or have been denied a policy because of pre-existing conditions.

3. BANS LIFETIME LIMITS ON COVERAGE—Prohibits health insurance companies from placing lifetime caps on coverage.

4. ENDS RESCISSIONS—Prohibits insurers from nullifying or rescinding a patient’s policy when they file a claim forbenefits, except in the case of fraud.

5. EXTENDS COVERAGE FOR YOUNG PEOPLE UP TO 27TH BIRTHDAY THROUGH PARENTS’ INSURANCE— Requires healthplans to allow young people through age 26 to remain on their parents’ insurance policy, at the parents’ choice.

6. ELIMINATES COST-SHARING FOR PREVENTIVE SERVICES IN MEDICARE—Eliminates co-payments for preventiveservices and exempts preventive services from deductibles under the Medicare program.

7. IMPROVES HELP FOR LOW-INCOME MEDICARE BENEFICIARIES—Improves the low-income protection programs inMedicare to assure more individuals are able to access this vital help.

8. PROVIDES NEW CONSUMER PROTECTIONS IN MEDICARE ADVANTAGE— Prohibits Medicare Advantage plans fromcharging enrollees higher cost-sharing for services in their private plan than what is charged in traditional Medicare.

9. IMMEDIATE SUNSHINE ON PRICE GOUGING—Discourages excessive price increases by insurance companies throughreview and disclosure of insurance rate increases.

10. CONTINUITY FOR DISPLACED WORKERS—Allows Americans to keep their COBRA coverage until the Exchange is inplace and they can access affordable coverage.

11. CREATES NEW, VOLUNTARY, PUBLIC LONG-TERM CARE INSURANCE PROGRAM—Creates a long-term care insuranceprogram to be financed by voluntary payroll deductions to provide benefits to adults who become functionally disabled.

12. HELP FOR EARLY RETIREES—Creates a $10 billon fund to finance a temporary reinsurance program to help offset thecosts of expensive health claims for employers that provide health benefits for retirees age 55-64.

13. COMMUNITY HEALTH CENTERS—Increases funding for Community Health Centers to allow for a doubling of thenumber of patients seen by the centers over the next 5 years.

14. INCREASING NUMBER OF PRIMARY CARE DOCTORS — Provides new investment in training programs to increase thenumber of primary care doctors, nurses, and public health professionals.