Patient Restraint Allegations and the False Claims Act
By Stacey A. Tovino, J.D.
satovino@central.uh.edu
The Medicare Conditions of Participation for Hospitals (“COPs”) contain patient restraint
requirements that apply to hospitals that participate in the Medicare program.1 Very
generally, the civil False Claims Act makes a person or entity liable for knowingly
submitting false claims to a federal program or for making or using a false record or
statement to have a false claim paid.2 A recent settlement between Pennsylvania’s
Central Montgomery Medical Center (“Central Montgomery”) and the Department of
Justice (“DOJ”) shows how allegations of patient restraint violations can implicate the
False Claims Act.
The federal patient restraint requirements date back to July 2, 1999, when the Centers for
Medicare & Medicaid Services (“CMS”) adopted a final patients’ rights regulation as part
of CMS’ ongoing revisions to the COPs.3 Among other things, the patients’ rights
regulation addresses restraints for acute medical and surgical care4 and restraints for
behavior management.5 In the medical and surgical care context, patients have the right
to be free from restraints6 of any form that are not medically necessary or that are used as
a means of coercion, discipline, convenience or retaliation by staff.7 A hospital is
permitted to use a restraint in the medical or surgical context only if: (1) the restraint is
needed to improve the patient’s well-being, (2) less restrictive interventions are
ineffective, and (3) a physician or other licensed independent practitioner orders the
restraint in accordance with state law.8
In the behavior management context, patients have the right to be free from seclusion9
and restraints that are imposed as a means of coercion, discipline, convenience or
retaliation.10 A hospital is permitted to use seclusion or restraint in the behavior
management context only if: (1) the situation constitutes a behavioral emergency, (2) the
seclusion or restraint is needed to ensure the patient’s physical safety, (3) less restrictive
interventions are ineffective, and (4) a physician or other licensed independent
practitioner orders the seclusion or restraint in accordance with state law.11
On August 6, 2002, a 79-year-old woman with Alzheimer’s disease died at Central
Montgomery shortly after Central Montgomery personnel applied a Posey restraint, a
vest-like device designed to keep patients from falling or wandering from their beds.12
Although the county coroner ruled the death an accidental asphyxiation, the incident
prompted the federal government to investigate Central Montgomery’s use of physical
and chemical restraints.
The U.S. Attorney for the Eastern District of Pennsylvania issued a press release on July
25, 2005,13 announcing that the DOJ had reached a settlement agreement14 with Central
Montgomery based on allegations that, between February and October 2002, Central
Montgomer both (1) ordered and used physical and chemical restraints in violation of the
restraint requirements set forth in the COPs and (2) knowingly billed federal health care
programs for the care provided to the inappropriately restrained patients in violation of
the False Claims Act.15 Although it continues to deny both allegations, Central
Montgomery agreed to pay the federal government $200,000 and hire an independent
consultant to review the hospital’s restraint use policies.16 According to the settlement
agreement, Central Montgomery has drastically reduced its use of physical and chemical
restraints and now offers multiple less-restrictive alternatives to restraints.17
Although nursing homes have settled similar “quality of care” cases under the False
Claims Act, federal prosecutors say that Central Montgomery is the first hospital to do
so.18 However, Central Montgomery officials believe that the DOJ misapplied the False
Claims Act because “[the situation] had nothing to do with billing.”19 The settlement
between Central Montgomery and the DOJ thus continues the debate about the
appropriateness of using the False Claims Act to remedy violations of federal quality of
care requirements.20
1
42 C.F.R. § 482.13(e) and (f) (2005).
31 U.S.C. §§ 3729-3733 (2005).
3
64 Fed. Reg. 36088 (July 2, 1999) (codified at 42 C.F.R. § 482.13).
4
42 C.F.R. § 482.13(e) (2005).
5
Id. § 482.13(f).
6
Restraints include both physical restraints (“any manual method or physical or mechanical device,
material, or equipment attached or adjacent to the patient’s body that he or she cannot easily remove that
restricts freedom of movement or normal access to one’s body”) and drugs used as a restraint (“a
medication used to control behavior or to restrict the patient’s freedom of movement and that is not a
standard treatment for the patient’s medical or psychiatric condition”). Id. § 482.13(e)(1).
7
Id. § 482.13(e) and (f).
8
Id. § 482.13(e)(2), (3).
9
Seclusion is the “involuntary confinement of a person in a room or an area where the person is physically
prevented from leaving.” Id. § 482.13(f)(1).
10
Id. § 482.13(f)(1).
11
Id. § 482.13(f)(2), (3).
12
MaryClaire Dale, Montgomery Co. Hospital to Pay $200,000 after Restraint Death, LANCASTER
INTELLIGENCER JOURNAL, July 25, 2005, available at
Hhttp://ap.lancasteronline.com/4/pa_hospital_settlement.H
13
United States Attorney’s Office, News Release, U.S. Attorney’s Office Reaches Agreement with
Hospital to Resolve Failure of Care Allegations Stemming from Improper Use of Patient Restraints (July
25, 2005), available at Hhttp://www.usdoj.gov/usao/pae/News/Pr/2005/jul/CMMC.htmlH.
14
Settlement Agreement between the Department of Justice and Central Montgomery Medical Center,
available at
Hhttp://www.usdoj.gov/usao/pae/News/Pr/2005/jul/CMMC%20Settlement%20Agreement.pdfH.
15
Id. at 1, 5-6.
16
Id. at 3.
17
Id. at 2-3.
18
MaryClaire Dale, Montgomery Co. Hospital to Pay $200,000 after Restraint Death, PHILLYBURBS.COM,
July 25, 2005, available at Hhttp://www.phillyburbs.com/pb-dyn/news/103-07252005-518757.htmlH.
19
Id.
20
See Joan H. Krause, “Promises to Keep”: Health Care Providers and the Civil False Claims Act, 23
CARDOZO L. REV. 1363, 1399-1406 (2003) (discussing quality of care fraud cases).
2