[Federal Register Volume 62, Number 126 (Tuesday, July 1, 1997)]
[Notices]
[Pages 35527-35529]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-17152]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 96-37]
Joseph M. Piacentile, M.D.; Revocation of Registration
On June 25, 1996, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration (DEA), issued an
Order to Show Cause to Joseph M. Piacentile, M.D., (Respondent) of
Yardley, Pennsylvania and Basking Ridge, New Jersey, notifying him of
an opportunity to show cause as to why DEA should not revoke his DEA
Certificates of Registration, BP1786853 and BP2526056, pursuant to 21
U.S.C. 824 (a)(4) and (a)(5), and deny any pending applications for
renewal of such registrations as a practitioner under 21 U.S.C. 823(f).
By letter dated July 15, 1996, Respondent, proceeding pro se, filed
a request for a hearing, and following prehearing procedures, a hearing
was held in New York, New York on November 20, 1996, before
Administrative Law Judge Gail A. Randall. At the hearing, the
Government called a witness to testify and introduced documentary
evidence. Respondent made a brief opening statement, but did not
testify under oath nor offer any documentary evidence. After the
hearing, Government counsel and Respondent submitted proposed findings
of fact, conclusions of law and argument. On March 26, 1997, Judge
Randall issued her Opinion and Recommended Ruling, recommending that
Respondent's DEA Certificates of Registration be revoked. Neither party
filed exceptions to her decision, and on May 5, 1997, Judge Randall
transmitted the record of these proceedings to the Acting Deputy
Administrator.
The Acting Deputy Administrator has considered the record in its
entirety, and pursuant to 21 CFR 1316.67, hereby issues his final order
based upon findings of fact and conclusions of law as hereinafter set
forth. The Acting Deputy Administrator adopts, in full, the Opinion and
Recommended Ruling of the Administrative Law Judge, and his adoption is
in no manner diminished by any recitation of facts, issues and
conclusions herein, or of any failure to mention a matter of fact or
law.
The Acting Deputy Administrator finds that Respondent is currently
registered with DEA in both Pennsylvania and New Jersey. In January
1985, the Department of Health and Human Services, Office of the
Inspector General initiated an investigation of Electro Therapeutics
(ETI) after receiving hundreds of complaints from Medicare patients
concerning medical equipment they had received from ETI. Respondent was
the President of ETI and was responsible for ETI's sales force.
ETI distributed transcutaneous electrical nerve stimulator units
(TENS units), TENS accessory kits, and lymphedema pumps. Both the TENS
unit and the lymphedema pump must be prescribed by a physician in order
for Medicare to pay for the equipment. Further, Medicare requires that
a physician assess a patient's use of a TENS unit for 30 days prior to
authorizing the purchase of the device. In addition, Medicare had very
specific diagnoses criteria. If a patient did not have a condition
covered by one of these criteria, Medicare would not authorize the
purchase of the unit. TENS accessory kits also required a prescription,
and were only authorized for distribution every three months.
Between 1984 and September 1987, ETI billed Medicare $49 million
for this equipment, $22 million of which was actually paid to ETI for
over 22,000 separate beneficiaries. In an attempt to verify the
validity of claims submitted by ETI to Medicare, agents interviewed a
number of the Medicare beneficiaries who had received equipment from
ETI and physicians whose signatures had served as authorization for the
distribution of the medical equipment. The investigation revealed that
ETI distributed these units by either sending out sales representatives
to ``health fairs'' held at supermarkets, senior citizen centers or
banks, or through arrangements with specific geriatric physicians
whereby the sales representatives would demonstrate the use of the
equipment at the physicians' offices. ETI would then obtain a
physicians's signature on a prescription, telling the physician that
the patient wanted the equipment.
However, the patients were told that the equipment was a free gift
from Medicare. After learning that Medicare was in fact billed for the
equipment, the patients complained because they stated that had they
known there would be a charge for the equipment, they would not have
accepted it. The investigation
[[Page 35528]]
further revealed that the patients were not assessed for 30 days by a
physician before ETI submitted a claim to Medicare for the purchase of
the equipment, but that ETI personnel were altering the dates on the
prescriptions. It was also determined that ETI personnel were giving
patients three to four TENS accessary kits at a time, and altering the
dates on the prescriptions that accompanied the Medicare claim forms.
Given the volume of claims, the agents were unable to investigate
the validity of each and every claim. It was determined however, that
$3.7 million of the $22 million that was reimbursed by Medicare were
false claims that had been altered by ETI personnel. It was the case
agent's opinion that 99% of the $22 million in claims were medically
unnecessary, as the equipment was provided to patients who did not have
a condition that would have caused reimbursement by Medicare.
Following the investigation, Respondent pled guilty in the United
States District Court for the Southern District of New York to one
count of conspiracy to make false statements in claims against
Medicare, in violation of 18 U.S.C. 371, and to one count of income tax
evasion, in violation of 26 U.S.C. 7201. As a result of his conviction,
by letter dated December 15, 1994, the Department of Health and Human
Services, Office of Inspector General, notified Respondent that he was
excluded from participating in the Medicare, Medicaid, Maternal and
Child Health Services Block Grant and Block Grants to States for Social
Services programs for a period of fifteen years pursuant to 42 U.S.C.
1320a-7(a). Subsequently, on May 28, 1996, Respondent and the Inspector
General of the Department of Health and Human Services entered into a
stipulation, whereby Respondent would be excluded, effective January 4,
1995, from participation in the Medicare and Medicaid programs for a
period of thirteen years, or until January 4, 2008. In addition, the
stipulation included a provision whereby Respondent agreed not to
further contest ``now or in the future'' his exclusion from the
Medicare and Medicaid programs.
On October 31, 1995, Respondent entered into a Consent Order with
the State of New Jersey, Department of Law and Public Safety, Division
of Consumer Affairs, State Board of Medical Examiners (New Jersey
Board). The new Jersey Board found that Respondent had engaged in
conduct which represented ``crimes of moral turpitude,'' and ordered
that Respondent's license to practice medicine and surgery in New
Jersey be suspended for 21 months, the first three months to be served
as an active suspension, and the remaining 18 months to be served as a
period of probation. On May 11, 1995, the Commonwealth of Pennsylvania,
Department of State, State Board of Medicine (Pennsylvania Board) and
Respondent entered into a Consent Agreement. The Pennsylvania Board
ordered, among other things, that Respondent's license to practice
medicine and surgery in Pennsylvania be suspended for a period of two
years, six months of which to be an active suspension, and the
remaining 18 months suspension to be stayed in favor of probation
subject to various conditions.
The Deputy Administrator may revoke or suspend a DEA Certificate of
Registration under 21 U.S.C. 824(a), upon a finding that the
registrant:
(1) Has materially falsified any application filed pursuant to or
required by this subchapter or subchapter II of this chapter;
(2) Has been convicted of a felony under this subchapter or
subchapter II of this chapter or any other law of the United States, or
of any State relating to any substance defined in this subchapter as a
controlled substance;
(3) Has had his State license or registration suspended, revoked,
or denied by competent State authority and is no longer authorized by
State law to engage in the manufacturing, distribution, or dispensing
of controlled substances or has had the suspension, revocation, or
denial of his registration recommended by competent State authority;
(4) Has committed such acts as would render his registration under
section 823 of this title inconsistent with the public interest as
determined under such section; or
(5) Has been excluded (or directed to be excluded) from
participation in a program pursuant to section 1320a-7(a) of Title 42.
As noted by Judge Randall, the Order to Show Cause and the
statement of the issue agreed to by the parties both alleged that
subsections (4) and (5) of 21 U.S.C. 824(a) provide the basis for the
revocation of Respondent's DEA Certificates of Registration. However,
the Government did not present any evidence nor argue in its post-
hearing filing that Respondent's continued registration would be
inconsistent with public interest pursuant to 21 U.S.C. 824(a)(4).
Therefore, the Acting Deputy Administrator agrees with Judge Randall's
conclusion ``that the Government has waived the position that a basis
for revocation exists under 21 U.S.C. Sec. 824(a)(4) in this matter.''
Consequently, subsection (5) of 21 U.S.C. 824(a) provides the sole
basis for the revocation of Respondent's DEA Certificates of
Registration.
Pursuant to 42 U.S.C. 1320a-7(a), Respondent has been excluded from
the Medicare and Medicaid programs for 13 years, or until January 4,
2008. The Government argues that based upon this exclusion,
Respondent's registrations should be revoked. Respondent did not
dispute that he has been excluded from the Medicare and Medicaid
programs. He did not offer any evidence into the record regarding why
his registration should not be revoked. Instead, Respondent argued that
the Government had failed to meet its burden of proof that Respondent's
continued registration would be inconsistent with the public interest.
As discussed above, the issue of whether Respondent's continued
registration would be inconsistent with the public interest was not
pursued by the Government as a basis for revocation. Instead, the
Government has presented evidence that Respondent has been excluded
from the Medicaid and Medicare programs pursuant to 42 U.S.C. 1320a-
7(a). Therefore, the Government has met its burden of proving that
grounds exist under 21 U.S.C. 824(a)(5) for revoking Respondent's DEA
Certificates of Registration. Respondent did not present any evidence
as to why his registrations should not be revoked based upon his
exclusion from such programs. Respondent did argue that ``DEA had
effectually suspended his prescribing privileges, by withholding his
renewal, without the benefit of a Court ruling, to the detriment of his
patients and their well-being. This constitutes punishment without due
process and should be considered by the Court.'' However, as Judge
Randall noted, ``the record contains no evidence, such as a denied
application for renewal, to support this factual assertion.''
Judge Randall stated that ``given the lack of rehabilitation
evidence, I conclude that circumstances do not exist to deviate from
the statutory purpose in this case,'' and recommended that Respondent's
DEA Certificates of Registration be revoked. The Acting Deputy
Administrator concludes that given the serious nature of the offenses
which led to Respondent's convictions, and ultimately to his exclusion
from the Medicare and Medicaid programs, and the lack of any evidence
of Respondent's rehabilitation or remorse,
[[Page 35529]]
Respondent's registrations should be revoked.
Accordingly, the Acting Deputy Administrator of the Drug
Enforcement Administration, pursuant to the authority vested in him by
21 U.S.C. 823 and 824 and 28 CFR 0.100(b) and 0.104, hereby orders that
DEA Certificates of Registration BP1786853 and BP2526056, issued to
Joseph M. Piacentile, M.D., be, and they hereby are, revoked. The
Acting Deputy Administrator further orders that any pending
applications for renewal of such registrations, be, and they hereby
are, denied. This order is effective July 31, 1997.
Dated: June 24, 1997.
James S. Milford,
Acting Deputy Administrator.
[FR Doc. 97-17152 Filed 6-30-97; 8:45 am]
BILLING CODE 4410-09-M