DATE: August 12, 2002
TO: NORD Member Organizations
CC: NORD Board of Directors & Vice Presidents
FROM: Abbey S. Meyers, President
RE: UPDATES: MEDICAL PRIVACY & MEDICARE OUTPATIENT DRUGS
Two very important regulatory events occurred recently, and both may have
a profound impact on people with rare disorders:
Medical Privacy:
On August 9, 2002 the Bush administration published the final federal rule
for medical privacy, rolling back the Clinton administration's promise
that medical records could not be released without a person's permission. It
has taken five years to finalize the privacy rules, and they will become
effective on April 14, 2003.
The basis of the Clinton rule was a requirement that health care providers
must obtain a person's written consent before medical records could be
released. Under the Bush regulation, health care providers must notify
patients and make a "good-faith effort to obtain acknowledgement of
receipt of the notice." Thus medical records can be released to other health care
providers, insurers, etc., without a person's permission.
Opposition to this change is from consumer organizations and particularly
from psychiatrists who oppose the release of psychiatric records without a
person's permission. Consumer organizations point out that some people
prefer to pay for pregnancy or genetic tests privately so their insurer
will not be able to learn the results of such tests. Under the Bush rule,
insurers, hospitals, and other health care providers can access any
notation in a person's medical file.
Defenders of the Bush rule say health care workers and insurers need to
share information without requiring people to sign permission forms. The
hospital and the insurance industries have opposed the Clinton privacy
regulations, and have lobbied for these changes.
The Clinton privacy rule would have allowed release of certain medical
information for the purpose of marketing, and consumer organizations
lobbied to tie up this loophole. The revised Bush regulations have closed some of
the marketing loopholes, particularly with a prohibition against
pharmacies selling personal information to drug companies and other businesses that
want to sell products or services to patients. However, drug companies
will still be allowed to pay a pharmacy to act as its agent so the pharmacy can
do the marketing directly to the patient. The definition of "marketing"
in the new rules excludes communications to a patient by a health care
provider (i.e., pharmacist) who is promoting goods and services offered by the
provider itself.
The President of the American Psychiatric Association said the new rule
would abolish the control a patient should have over their own medical
records and will "discourage patients from revealing information to their
physicians that's necessary for their treatment."
Supporters of the new rule say the regulation retains most of the
provisions of the old rule including: medical records cannot be disclosed to an
employer; patients can review their records and request changes to correct
errors; researchers can use medical records for epidemiological research
if all personal identifiers are stripped from the records.
The Bush administration's federal rules establish "minimum" privacy
protections, and states can (and often do) have more stringent rules.
When state laws are stronger, the state privacy rules will override the federal
rules.
Medicare Outpatient Drugs:
Medicare pays for injectable and intravenous (IV) outpatient drugs
administered in a clinic or doctor's office. The Center for Medicare and
Medicaid Services (CMS) pays very little for such drugs (e.g., $150 under
the Ambulatory Payment code), which includes the cost of the drug, doctor
services, infusion supplies, hospital bed, nursing, etc. Several years
ago NORD was instrumental in getting an exception for orphan drugs since they
are usually very expensive, and outpatient clinics will not stock them if
they will be reimbursed les than the drug costs.
The orphan drug exception (called a "pass-through") will expire at the end
of this year, and NORD is working with patient organizations and orphan
drug manufacturers to obtain a permanent pass-through exemption for out-patient
orphan drugs.
Last week CMS issued a "Notice of Proposed Rulemaking" (NPRM), which will
extend the exemption until the end of 2003 while CMS further studies the
payment system. Blood and blood products would be affected by the
one-year extension, as well as orphan drugs; but only three orphan drugs are named
in the NPRM: Ceredase for Gaucher's disease, Mylotarg for Acute Myeloid
Leukaemia (AML), and Prolastin for Alpha-1-antitrypsin Deficiency. NORD
will continue to work for a permanent pass-through for all injectable and
IV orphan drugs. If you wish to be involved in this effort, please contact
Diane Dorman: Phone: (202) 496-1296, ext 3014; email: ddorman@rarediseases.org.
Check here to read about events on Capitol Hill, funding for rare-disease research, and other topics of interest from NORD's office in Washington, DC.