From the Statehouse
From the Legal Counsel
Important Dates
2010 Annual
Meeting
April 17, 2010
The Westin Princeton
2011 Annual
Meeting
April 16, 2011
The Westin Princeton
More details to
come!
From the Statehouse...Beverly
J. Lynch
"PATIENT SAFETY" BILL AMENDED TO REMOVE PHYSICIAN REFERENCE ...
AND MOVES TO GOVERNOR'S DESK
A bill which would require the Department of Health and Senior
Services (DHSS) to publicly report certain preventable patient
safety errors at New Jersey's hospitals was approved by the
Assembly on May 18 by a vote of 76-1. The Senate, which had
previously approved a slightly different version, concurred with
the Assembly amendments and sent the bill to the Governor for
consideration and signature.
As reported previously to the physician community, this measure
would have prohibited physicians from billing patients if they
admitted causing one of a list of hospital-acquired conditions.
The bill, however, was amended significantly in the Assembly
Health Committee, and led by Chairman Herb Conaway, Jr., MD, the
physician section was deleted completely.
In its current form, the bill (S-2471) would require DHSS to
include in the annual New Jersey Hospital Performance Report
certain patient safety indicators and preventable medical errors
on a hospital-by-hospital basis. DHSS would be required to
report information on 14 pre-established patient safety
indicators, including: foreign body left after medical
procedure; postoperative hemorrhage or hematoma; postoperative
sepsis; accidental puncture or laceration; or surgery performed
on the wrong side, wrong body part, or wrong patient. The
patient safety indicators listed in the bill were developed by
the federal Agency for Healthcare Research and Quality or are
listed by the Centers for Medicare and Medicaid Services (CMS)
as "never" events that are not eligible for payment under
Medicare or Medicaid.
The information would be available to the public to allow them
to make more informed decisions about their health care, and
would put pressure on poor performing hospitals to do more to
ensure patient safety in New Jersey.
The bill would also prohibit hospitals from charging a patient
or third-party payer for certain medical errors or
hospital-acquired conditions which are ineligible for
reimbursement under the CMS-established medical error
guidelines. The sponsors noted that asking a patient to pay for
treatment of a preventable medical error is unfair, particularly
since many health insurers, including Medicaid and Medicare, do
not cover treatment for preventable medical errors.
Kudos to Chairman Conaway for his leadership on this important
initiative.
CDS Prescription Measure Advances
On May 18, the Assembly unanimously approved A-3799, which
authorizes a physician to issue multiple prescriptions for a
Schedule II controlled dangerous substance, such as
Ritalin, under certain circumstances. Specifically, the bill
permits a physician to issue up to three prescriptions
authorizing the patient to receive a total of up to a 90-day
supply of a Schedule II substance, if:
-
each separate
prescription is issued for a legitimate medical purpose by
the physician acting in the usual course of professional
practice;
-
the physician
provides written instructions on each prescription (other
than the first prescription if it is to be filled
immediately) indicating the earliest date on which a
pharmacy may fill each prescription;
-
the physician
determines that providing the patient with multiple
prescriptions in this manner does not create an undue risk
of diversion or abuse; and
-
the physician
complies with all other applicable State and federal laws
and regulations.
This bill is intended to relieve the burden on patients who
require the use of maintenance Schedule II controlled dangerous
substances, and who must now typically obtain a new prescription
every 30 days, if the prescribing physician determines that
there is not an undue risk of diversion or abuse.
The provisions of the bill are not intended to require or
encourage physicians to issue multiple prescriptions, or to see
their patients only once every 90 days when prescribing Schedule
II controlled dangerous substances. Individual practitioners
must determine on their own, based on sound medical judgment and
in accordance with established medical standards, whether it is
appropriate to issue multiple prescriptions and how often to see
their patients when doing so.
An
identical Senate measure (S-2550) is awaiting consideration by
the full Senate before it moves to the Governor's desk.
Another
interesting piece of legislation....
Coming on the heels of the media surrounding Tom Cruise and his
personal use of an ultrasound machine to monitor the pregnancy
of his wife, Katie Holmes, the New Jersey Assembly has approved
A-3477, which prohibits the sale, lease, or distribution
of an obstetric-gynecologic ultrasonic imager in the
State to any person other than the following:
1. a
licensed health care professional;
2. a licensed health care facility;
3. a dealer, distributor, manufacturer's
representative, or sales agent that purchases an
obstetric-gynecologic ultrasonic imager for the sole purpose
of selling, leasing, or otherwise distributing the equipment
to a person pursuant to this act;
4. a bank, leasing company, or financial institution
that purchases an obstetric-gynecologic ultrasonic imager
from a manufacturer or other person for the sole purpose of
leasing the system to a person pursuant to this act; or
5. an educational or research facility that purchases
an obstetric-gynecologic ultrasonic imager for training or
research purposes.
A
person violating the provisions of this bill is subject to a
civil penalty of not less than $500 and not more than $1,000 for
each offense.
For more information on these or any legislative or regulatory
issue, please contact Beverly J. Lynch, B. Lynch Associates, at
blynch@blynchassociates.com or 609-392-7553.
Legal Report...Kern
Augustine Conroy & Schoppmann, P.C.
Red Flags Rule Enforcement Delayed Again
The Federal Trade Commission (FTC) has announced that it will
further delay enforcement of the Red Flags Rule until August 1,
2009. As previously reported in Statlaw, the Red Flags Rule
requires covered entities to implement an identity theft
prevention program. Despite efforts of the AMA and others to
reason with the FTC that the Rule should not apply to medical
practices, the agency refused to yield until the day before
covered entities were required to comply with the first delayed
enforcement date of May 1, 2009. The FTC conveyed that this
second delay would give covered entities additional time to
comply with the regulations and allow the agency to consider
altering the rules to allow low risk businesses to maintain less
cumbersome policies. While a relief for some practices, this
delay comes as a slap in the face to the many physicians across
the country who have spent an estimated 50 to 100 million
dollars to implement the Red Flags Rule in their practices and
train their staffs. We applaud the practitioners who took
advantage of our Red Flags Rule resources and instituted a
conforming program. The only solace physicians may take is that,
even if the FTC changes its mandate, plans that have already
been established to conform to existing requirements should not
need modification. See the KACS website at
www.drlaw.com for the latest
information on the Red Flags Rule.
NJ & Medical Device Maker Enter into "Model" Settlement
Agreement
New Jersey has entered into a settlement agreement with medical
device maker Synthes, Inc., resolving allegations Synthes failed
to disclose financial conflicts-of-interest among doctors who
conducted clinical testing on its products. Under the agreement,
Synthes will disclose on its website any future payments made by
the company to physicians conducting clinical trials on its
devices and any investments held by the physicians in devices
they test, and agrees to stop paying clinical trial physicians
with company stock or stock options. Synthes will also make such
disclosures to the research institutions serving as clinical
trial locations and to the FDA. The NJ Attorney General
criticized the FDA for granting pre-market approval for Synthes'
device ProDisc, even though its application revealed potential
conflicts-of-interest. Synthes will also commit to paying
clinical investigators fair market value compensation for their
clinical trial work, as well as any other consulting services
they provide to the company. In announcing the settlement, the
Attorney General stated that the Synthes settlement should serve
as a template for the entire medical device industry and the
same day issued subpoenas to five major medical device
manufacturers seeking information about their business
practices.
DOBI Proposes Certain High/Low Malpractice Payments Not Be
Reported to SBME
The NJ Dept of Banking & Insurance (DOBI) has proposed that
insurers do not have to report to the Medical Board's Review
Panel payments made pursuant to a so-called "high/low agreement"
where there is a verdict in favor of the defendant physician (no
liability). In high/low agreements, the insurer agrees to pay
the claimant a specified maximum or minimum amount on behalf of
the insured, irrespective of the verdict or the damage award.
Where a "no liability" verdict is returned, the insurer
nevertheless would make a payment to the claimant under the
"low" provision of the agreement. The Medical Board advised DOBI
that the inclusion of such payments on the physician's profile
maintained by the Medical Board could be misleading. Insurers
would still be required to report the payments to DOBI. Comments
on the proposal are due to DOBI by June 19, 2009.
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