Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

Lindsey Faucette, D.O.!
(NPI: 1730313016),

Petitioner,
v.
Centers for Medicare & Medicaid Services.
Docket No. C-15-1091
Decision No. CR3992

Date: June 26, 2015

DECISION

Lindsey Faucette, D.O. (Petitioner), challenges a determination by the Centers for
Medicare & Medicaid Services (CMS), through its administrative contractor, Noridian
Healthcare Solutions (Noridian), that established the effective date of her Medicare
enrollment and billing privileges as August 21, 2014, with retrospective billing to July
22, 2014. Petitioner argues that Noridian should not have given her a new effective date
for Medicare enrollment because she was already enrolled in the Medicare program when
she moved from a medical practice in New York to one in California. Essentially,
Petitioner merely sought to reassign her Medicare benefits to the new practice in
California, called Pacific Central Coast Health Centers (Pacific Central Coast), rather
than to reenroll. CMS now moves for summary judgment, arguing that Petitioner was
required to submit a new enrollment application when she moved Medicare contractor
jurisdictions, and that the contractor undisputedly received that application on August 21,
2014. Petitioner cross-moves for summary judgment, arguing that CMS’s interpretive
guidelines in the Medicare Program Integrity Manual (MPIM) govern the effective dates

' This case was originally docketed in the Civil Remedies Division with Petitioner’s
name and title as Lindsey Faucette, M.D. I have amended the case caption to reflect
Petitioner’s status as an osteopathic physician.
for reassignments rather than the enrollment regulations that control the effective dates
for new enrollees in the Medicare program.

Because Petitioner was already an enrolled supplier in the Medicare program when she
began providing services with Pacific Central Coast on December 16, 2013, Petitioner
did not need to reenroll in the Medicare program and the effective date of reassignment
of Medicare benefits is controlled by the MPIM, rather than the enrollment regulations.
Therefore, I reverse CMS’s determination and order that Petitioner’s effective date for
the reassignment of benefits to Pacific Central Coast be December 16, 2013.

I. Background and Procedural History

Petitioner is a physician currently employed in California at Pacific Central Coast.
Petitioner was previously employed in New York and enrolled in the Medicare program
as a supplier.” Petitioner Exhibit (P. Ex.) 1 at 1. Petitioner asserts, and CMS does not
dispute, that she began providing services through Pacific Central Coast on December 16,
2013. CMS Exhibit (Ex.) 1 at 2. At that time, Pacific Central Coast was in the process of
changing its name from Marian Community Clinics and had submitted the necessary
applications to Palmetto GBA, another Medicare contractor. According to Petitioner,
Palmetto GBA approved the name change for Pacific Central Coast on September 3,
2013. CMS Ex. 6. Noridian ultimately approved the name change for Pacific Central
Coast on February 17, 2014. CMS Ex. 6.

On July 31, 2014, Petitioner filed with Noridian a Form CMS-855R application to
reassign her Medicare benefits to Pacific Central Coast. CMS Exs. 1, 2. On August 15,
2014, a provider enrollment representative with Noridian sent an e-mail to Pacific Central
Coast’s point of contact and directed Petitioner to file a completed CMS-855I enrollment
application. CMS Ex. 2 at 1. On August 21, 2014, Petitioner filed a CMS-8551 with
Noridian, as directed. See CMS Ex. 3. On September 11, 2014, Noridian issued a letter
that notified Petitioner her “initial Medicare enrollment application” was approved. CMS
Ex. 5 at 1. The letter included a table under the heading “Medicare Enrollment
Information,” which provided Petitioner’s “Participating status” as “Participating,” and
“Effective July 22, 2014.” CMS Ex. 5 at 1.

Pacific Central Coast, on behalf of Petitioner, requested reconsideration of the effective
date that Noridian stated in its September 11 letter. CMS Ex. 6. Pacific Central Coast
stated that changing its practice’s name took over seven months from when it submitted
its application to Noridian, and during that time Pacific Central Coast “held physician
enrollment and its account receivable for Medicare so as to not bill them under the
incorrect name.” CMS Ex. 6. Pacific Central Coast also said that it “had difficulty

> A “supplier” is a “physician or other practitioner, or an entity other than a provider, that
furnishes health care services under Medicare.” 42 C.F.R. § 400.202.
obtaining timely electronic signatures” through the Provider Enrollment, Chain, and
Ownership System (PECOS). CMS Ex. 6.

On November 10, 2014, Noridian issued a letter in response to the reconsideration
request and cited 42 C.F.R. § 424.520(d) as the basis for the effective date stated in the
September 11 letter. CMS Ex. 7. Noridian wrote that the “Carriers and Part A and Part
B Medicare Administrative Contractors (A/B MACs) will establish the effective date of
Medicare billing privileges (see 42 [C.F.R. §] 424.520(d)) for physicians ....” The letter
noted that the effective date of billing privileges is “the later of the date of filing or the
date [a supplier] first began furnishing services at a new practice location.” CMS Ex. 7
at 1. Finally, the letter stated that Petitioner’s “855R application” was received on
August 21, 2014.° Her effective date was made July 22, 2014, to reflect the “30 day [sic]
from receipt of application that [retrospective billing] is allowed.” CMS Ex. 7 at 2. The
letter concluded that “Pacific Central Coast Health Centers has not provided evidence to
definitely [sic] support an earlier effective date.” CMS Ex. 7 at 2.

On January 26, 2015, Petitioner filed her request for a hearing to challenge the effective
date of her Medicare enrollment and billing privileges that Noridian established.* The
case was assigned to me to hear and decide, and I issued an Acknowledgment and Pre-
hearing Order (Order) that directed the parties on presenting their evidence and argument.
CMS subsequently moved for summary judgment and filed a supporting brief (CMS Br.)
as well as eight proposed exhibits marked as CMS Exs. 1-8. Petitioner, through counsel,
opposed summary judgment in favor of CMS and filed a cross-motion for summary
judgment, supporting brief (P. Br.), and one proposed exhibit marked as P. Ex. 1.

> The contractor erroneously stated that the CMS-855R was received on August 21,
2014. The parties agree that Petitioner’s CMS-855R was submitted July 31, 2014, and
her CMS-855/ application was filed August 21, 2014, in response to Noridian’s August
15, 2014 e-mail request. See CMS Br. at 3; P. Br. at 2; see also CMS Ex. 2 at |
(acknowledging Noridian’s receipt of Petitioner’s CMS-855R on July 31, 2014).

* Pacific Central Coast initially attempted to file a single hearing request on behalf of
several suppliers that are part of its medical practice. Civil Remedies Division
management, however, contacted Pacific Central Coast and required each supplier to file
a separate hearing request because Noridian issued a separate determination for each
supplier. Petitioner’s hearing request was ultimately filed 12 days after the 60-day
deadline. See 42 C.F.R. § 498.40(a)(2). CMS did not move to dismiss Petitioner’s
hearing request as untimely, and there is no reason for me to exercise my discretion to do
so. See id. § 498.70(c). Pacific Central Coast’s first attempt to request a hearing on
behalf of Petitioner is good cause to accept the January 26 hearing request out of time.
See id. § 498.40(c)(2).
II. Issues

The issue in this case is whether Noridian, acting on behalf of CMS as the Medicare
administrative contractor, properly determined July 22, 2014, as the effective date of
Petitioner’s Medicare enrollment and billing privileges, and as Petitioner’s effective date
for reassignment of Medicare benefits to Pacific Central Coast.

III. Decision on the Written Record

Neither party objected to the admission of CMS Exs. 1-8 or P. Ex. 1; therefore, I admit
them into the record.

My Order advised the parties that they must submit written direct testimony for each
proposed witness, and that an in-person hearing would be necessary only if the opposing
party requested an opportunity to cross-examine a witness. Order §{j 8-10; CRDP

§§ 16(b), 19(b). Neither party submitted any written direct testimony. Therefore, a
hearing in this case is unnecessary and I issue this decision based on the written record.
Order ¥ 11; CRDP § 19(d).

IV. Findings of Fact, Conclusions of Law, and Analysis

The Social Security Act authorizes the Secretary of Health and Human Services
(Secretary) to promulgate regulations governing the enrollment process for providers and
suppliers in the Medicare program. 42 U.S.C. §§ 1302, 1395cc(j). The Secretary has set
forth enrollment requirements in 42 C.F.R. Part 424, Subpart P. Under the Secretary’s
regulations, a provider or supplier seeking billing privileges under the Medicare program
must “submit enrollment information on the applicable enrollment application. Once the
provider or supplier successfully completes the enrollment process .. .. CMS enrolls the
provider or supplier into the Medicare program.” 42 C.F.R. § 424.510(a). For suppliers,
CMS establishes the effective date for Medicare billing privileges pursuant to 42 C.F.R.
§ 424.520(d) and may permit limited retrospective billing under 42 C.F.R. § 424.521.

For Medicare Part B claims, a beneficiary may assign his or her benefits to an enrolled
physician or non-physician supplier providing services to that beneficiary. 42 U.S.C.

§ 1395u(b)(3)(B)(ii). By statute, a supplier is generally prohibited from reassigning his
or her Medicare benefits. 42 U.S.C. § 1395u(b)(6); see 42 C.F.R. § 424.80(a). There are
exceptions to this prohibition, including, among other things, when a supplier must
reassign his or her benefits to an employer as a condition of employment. 42 U.S.C.

§ 1395(u)(b)(6)(A)(i); see 42 C.F.R. § 424.80(b). For circumstances when reassignment
is allowed, a supplier must submit a Form CMS-855R. See 71 Fed. Reg. 20754, 20767
(Apr. 21, 2006) (final rule formally adopting the use of the CMS-855R). Although not
addressed by statute or regulation, CMS instructs its employees that reassignments of
benefits may only occur between enrolled suppliers and that “[t]he effective date of

reassignment is the date on which the individual began or will begin rendering services
with the reassignee.” MPIM § 15.5.20.

I. The regulation concerning the effective date of billing privileges, 42 C.F.R.
§ 424.520(d), does not apply to the reassignment of Petitioner’s Medicare
benefits to her new employer, Pacific Central Coast Health Centers.

After Petitioner filed a CMS-855R with Noridian on July 31, 2014, to reassign her
Medicare benefits to Pacific Central Coast, the contractor directed Petitioner to submit a
CMS-855I enrollment application. See CMS Ex. 2 at 1. Petitioner did so on August 21,
2014. See CMS Ex. 3. Noridian later determined that Petitioner was “participating” in
Medicare “effective July 22, 2014.” CMS Ex. 5 at 1. In its reconsidered determination,
the contractor specifically relied on 42 C.F.R. § 424.520(d) to affirm August 21, 2014, as
the effective date of Petitioner’s enrollment and billing privileges with retrospective
billing to July 22, 2014. CMS Ex. 6 at 1-2. CMS maintains before me that Petitioner had
to enroll with Noridian when she moved from New York to California because she was
relocating to a different Medicare administrative contractor’s jurisdiction. CMS Br. at 2-
3. That separate enrollment with Noridian, in turn, triggered the regulatory provision in
section 424.520(d) that establishes the effective date of billing privileges. CMS Br. at 3.

Under CMS’s theory, Petitioner could not reassign benefits to Pacific Central Coast prior
to the effective date of her enrollment with Noridian, which resulted in the effective date
of both her billing privileges and reassignment to Pacific Central Coast as July 22, 2014.
See CMS Br. at 2-3; CMS Ex. 2 at 1 (requiring submission of CMS-855I before
processing Petitioner’s CMS-855R). CMS has not argued that the reassignment of
Petitioner’s benefits alone triggered a new effective date for Petitioner’s Medicare billing
privileges. See CMS Br. at 2-3. Therefore, this case turns on whether Petitioner was
required to enroll with Noridian, the Medicare administrative contractor for California,
even though she was undisputedly already enrolled in Medicare as a supplier in New
York. See P. Ex. 1. Throughout this proceeding, however, CMS has not cited any
statutory or regulatory authority that requires a separate or new Medicare enrollment
when a supplier moves from one administrative contractor’s jurisdiction to another.
Below, I discuss separately each of the sources where such a requirement might be
located.

a. The enrollment regulations.

As stated above, Congress authorized the Secretary to establish the enrollment process,
which she has done in 42 C.F.R. Part 424, Subpart P. Any practitioner who wishes to
obtain payment for a Medicare covered item or service must first be “enrolled in the
Medicare program.” 42 C.F.R. § 424.505. The regulations define “enroll/enrollment” as:
the process that Medicare uses to establish eligibility to submit claims
for Medicare covered services and supplies. The process includes—

(1) Identification of a provider or supplier;

(2) Validation of the provider’s or supplier’s eligibility to provide
items or services to Medicare beneficiaries;

(3) Identification and confirmation of the provider or supplier’s
practice location(s) and owner(s); and

(4) Granting the provider or supplier Medicare billing privileges.

42 C.F.R. § 424.502. To enroll, a provider or supplier “must submit enrollment
information on the applicable enrollment application.” 42 C.F.R. § 424.510(a). After
successfully completing the enrollment process, “CMS enrolls the provider or supplier
into the Medicare program.” Jd.

The regulations provide that Medicare establishes eligibility to enroll and grants billing
privileges, but do not make specific reference to individual administrative contractor
jurisdictions with regard to enrollment generally. In addition, the regulations plainly state
that CMS, not each individual contractor, enrolls a provider or supplier into the Medicare
program. See 42 C.F.R. § 424.510(a). Indeed, each separate contractor works on behalf
of CMS and may therefore initially enroll a provider or supplier, but had the Secretary
intended to limit enrollment to each specific contractor, she would have said so, but did
not. The enrollment regulations make several references to Medicare contractors. See,
e.g., 42 C.F.R. §§ 424.510(d)(1) (directing the submission of an application to
“designated Medicare fee-for-service contractor”) and 424.516(d) (directing suppliers to
report changes to their “Medicare contractor”). But the Secretary established the
enrollment process in terms of “Medicare” generally, not its administrative contractors.
By including references to administrative contractors, the Secretary knew at the time of
promulgating the enrollment regulations that fee-for-service contractors would be part of
the enrollment process, but there is no regulatory language limiting enrollment to
anything other than Medicare generally. There is no regulatory provision in 42 C.F.R.
Part 424, Subpart P that requires a provider or supplier to enroll separately with each
administrative contractor. From this, I conclude that the Secretary did not intend to limit
enrollment to only one contractor at a time. Rather, “enrollment” is intended to be with
the Medicare program overall, not CMS’s administrative contractors.

b. The Medicare Program Integrity Manual.

The MPIM, which CMS has published as a guidance document for its administrative
contractors, defines “enrollment” as “the process that Medicare uses to grant Medicare
billing privileges.” MPIM, Ch. 15, § 15.1.1 (Rev. 404, 2012). Like the enrollment
regulations, the MPIM defines enrollment in terms of Medicare generally, not specific
contractors. See 42 C.F.R. § 424.502.

The MPIM indirectly refers to a requirement that a supplier must enroll with each
contractor rather than with Medicare generally, but there is no actual express requirement
to that effect in Chapter 15, which explains the enrollment process for contractors. When
discussing how contractors should process the CMS-855R, the MPIM explains that, in
“situations where an individual is reassigning benefits to a person/entity, both the
reassignor and the reassignee must be enrolled with the same contractor.” MPIM, Ch. 15,
§ 15.5.20(B). The phrase “enrolled with the same contractor” implies that “enrollment”
is tied to a specific contractor, not just Medicare overall. In addition, when discussing the
requirement that a provider or supplier list adverse actions in its enrollment application,
the MPIM says that if “the practitioner is submitting an initial enrollment application
(e.g., is moving to a new State and contractor jurisdiction) and did not report the adverse
action in section 3 of the CMS-855], the contractor shall deny the enrollment application
and establish a 3-year enrollment bar.” MPIM, Ch. 15 § 15.5.20(B) (emphasis added).
The example of a new contractor jurisdiction is parenthetical, yet it tends to support
CMS’s premise that an entirely new enrollment application is required for a change in
contractor jurisdictions. However, this parenthetical may also recognize that a supplier
will need to submit a CMS-855] to report a change of information, such as a change of
address.

The MPIM also discusses voluntary termination for suppliers and reminds CMS’s
contractors to determine whether the moving supplier needs to submit a “voluntary
termination.” MPIM, Ch. 15 § 15.7.5.1(B)(2). However, the term “enrollment” is not in
this section of the MPIM, and it is not clear whether termination of a prior practice
location in another state necessarily equates to a voluntary termination of enrollment,
requiring re-enrollment with a new contractor. Critically, there is no express or otherwise
unambiguous requirement that a supplier must enroll or re-enroll with Medicare when it
moves contractor jurisdictions.

c. The CMS-855I Medicare Enrollment Application.

The instructions of the CMS-8551, which CMS refers to in its brief, provide that a
supplier should use the CMS-8551 if he or she is “currently enrolled with a Medicare fee-
for-service contractor but need[s] to enroll in another fee-for-service contractor’s
jurisdiction... .” CMS Ex. 8 at 2; see CMS Br. at 5. The application’s instruction
recognizes an existing enrollment in the Medicare program, and then refers to a separate
enrollment, albeit through a different contractor. However, the application does not cite
any statutory or regulatory authority that supports the premise that a single supplier must
go through multiple enrollments in the Medicare program. Further, it is unclear whether
the word “enroll” in the application is intended to have the same meaning as that word is
defined in 42 C.F.R. § 424.502, or whether it simply means something similar to “register
with.”

Petitioner argues that enrollment in a new contractor jurisdiction is for the
“administrative convenience” of the contractor, and I agree. I find that the use of “enroll”
on the application instructions must be read to mean “register with” or some other similar
administrative meaning, because it would otherwise be contradictory to the Secretary’s
intent that the plain language of the regulation makes clear. The regulations only discuss
one enrollment with Medicare. 42 C.F.R. § 424.510(a). Therefore, I do not accept that
the ambiguous instruction in the CMS-855] establishes a legal requirement that a supplier
must actually “enroll” with each contractor — as that word is defined in the regulation — in
order to be enrolled in the Medicare program. If the Secretary meant that a supplier’s
movement from one CMS administrative contractor jurisdiction to another required
suppliers to enroll again in the Medicare program, the Secretary surely would have
indicated that in her regulations. Rather, the regulations establish only one Medicare
enrollment per provider or supplier. See 42 C.F.R. § 424.502.

Neither the statute nor regulations that discuss reassignment of a supplier’s Medicare
benefits address the effective date of that reassignment. See 42 U.S.C. § 1395u(b)(6);

42 C.F.R. § 424.80(b). CMS and its contractor applied the “effective date of billing
privileges” as the effective date of reassignment, but appear to have done so because they
required Petitioner to “enroll” separately with Noridian first. There is no language in the
regulation that permits the application of the enrollment effective date provision only to
the reassignment of benefits. The definition of “enroll/enrollment” in 42 C.F.R.

§ 424.502 states that “[g]ranting the . . . supplier Medicare billing privileges” is a
component of the enrollment process, not distinct from it. Regarding the “effective date
of billing privileges” for suppliers, the regulation states:

The effective date for billing privileges for physicians, nonphysician
practitioners, and physician and nonphysician practitioner organizations
is the later of the date of filing of a Medicare enrollment application that
was subsequently approved by a Medicare contractor or the date an
enrolled physician or nonphysician practitioner first began furnishing
services at a new practice location.

42 C.F.R. § 424.520(d). Because the granting of billing privileges is part of the overall
Medicare enrollment process, a supplier who is already enrolled cannot be granted new
billing privileges without first terminating enrollment and re-enrolling in the Medicare
program. As explained above, Petitioner was not required to enroll or re-enroll in the
Medicare program simply because she was changing from one contractor’s jurisdiction to
another. Therefore, because the “effective date of billing privileges” in 42 C.F.R.

§ 424.520(d) is part of the Medicare enrollment process and requires that a supplier
actually be enrolling in Medicare or re-enrolling, it also does not apply to the
reassignment of Petitioner’s Medicare benefits to Pacific Central Coast.

2. The effective date for Petitioner’s reassignment of Medicare benefits to
Pacific Central Coast is December 16, 2013, the date on which Petitioner
commenced providing services with Pacific Central Coast.

Petitioner did not enroll or re-enroll with Noridian when she moved to California. She
was already enrolled in Medicare through her prior employment in New York and never
voluntarily terminated that enrollment. See P. Ex. 1. Therefore, the effective date of her
Medicare billing privileges never changed from her initial enrollment in Medicare. The
only change in Petitioner’s status when she moved to California was the reassignment of
her benefits to Pacific Central Coast. The regulations do not address the effective date of
reassignment, only initial enrollment. See 42 C.F.R. § 424.520(d). The MPIM, however,
provides a written policy from CMS that the effective date of reassignment is “the date
on which the individual began or will begin rendering services with the reassignee.”
MPIM, Ch. 15, § 15.5.20(A). In this case, that date is December 16, 2013.> In light of
there being no alternative interpretations, CMS should have applied its written policy in
favor of Petitioner.

I recognize the likelihood that Petitioner was required to submit a CMS-855] in addition
to a CMS-855R because she moved contractor jurisdictions and presumably had changes
to her enrollment information.® See 42 C.F.R. § 424.516(d) (requiring physicians to
report changes in practice location within 30 days of the change). However, I do not
conclude that the submission of an enrollment application for a reason other than initial
enrollment or re-enrollment necessarily triggers the effective date regulation. While the
CMS-8551 is a “Medicare enrollment application,” see 42 C.F.R. § 424.520(d), it is also
used for purposes other than enrolling in the Medicare program for the first time.
Enrolled suppliers such as Petitioner use the CMS-855] to notify CMS about any changes

> CMS argues that Petitioner was not actually enrolled in the Medicare program until
February of 2014, meaning an effective date of billing privileges and reassignment is
only permissible later than that time. CMS Br. at 6 n.1. CMS offered no direct evidence
of this enrollment date. However, Petitioner has provided undisputed evidence that she
was, in fact, enrolled in the Medicare program as of July 8, 2012. P. Ex. | at 1.

° CMS points out in its brief that Petitioner failed to comply with the reporting
requirements in 42 C.F.R. § 424.516(d) by not notifying CMS of a change in address
within 30 days of moving to California. See CMS Br. at 6. If true, that would provide a
basis for revocation of billing privileges (42 C.F.R. § 424.535(a)(9)), but that is a
separate determination that Noridian did not make in this case. Therefore, whether
Petitioner complied with the reporting requirement is not at issue before me and has no
impact on the outcome of this case.

10

in information. CMS Ex. 8 at 2 (providing instruction on CMS-855] that says physicians
an “make a change in their enrollment information” using that application form).
Changing information to “maintain enrollment,” however, is not the same as
“enrollment,” and, therefore, does not result in new billing privileges. See 42 C.F.R.
§ 424.515 (requiring a supplier to revalidate enrollment information by using an
enrollment application, but not requiring the certifications necessary during initial
enrollment). Therefore, simply filing a CMS-8551I with CMS or its contractor for a
reason other than initial enrollment does not necessarily trigger the effective date of
billing privileges regulation in 42 C.F.R. § 424.520(d). See John Heverin, Ph.D., ALJ
Ruling 2013-6 at 7-8 (HHS 2013).

V. Conclusion and Order

For the reasons explained above, I reverse CMS’s determination and order that
Petitioner’s effective date of reassignment of Medicare benefits to Pacific Central Coast
be December 16, 2013.

/s/
Scott Anderson
Administrative Law Judge


Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

Thomas E. Dunaway, M.D.,
Petitioner,
v.
Centers for Medicare & Medicaid Services.
Docket No. C-15-1757
Decision No. CR3986

Date: June 26, 2015

DECISION

Noridian Healthcare Solutions (Noridian), an administrative contractor acting on behalf
of the Centers for Medicare & Medicaid Services (CMS), revoked the Medicare billing
privileges of Petitioner, Thomas E. Dunaway, M.D.., based on Petitioner’s termination
from the Medicaid program by the Ohio Department of Job and Family Services (Ohio
State Medicaid agency). Petitioner requested a hearing. For the reasons stated below, I
grant CMS’s Motion for Summary Judgment that CMS’s revocation of Petitioner’s
Medicare billing privileges was authorized.

I. Background and Procedural History

Petitioner is a physician who was licensed to practice medicine in the state of Ohio. On
April 9, 2010, the Ohio State Medicaid agency terminated Petitioner’s Medicaid provider
agreement because his license was inactive. CMS Ex. 1. Petitioner claims his license
was revoked “for failure to submit to an inpatient evaluation for alcohol abuse.” CMS
Ex. 5 at 14. Petitioner exhausted his appeal rights regarding this termination from the
Ohio Medicaid program. CMS Ex. 2 at 1. Petitioner moved to Wyoming and Wyoming
granted him a restricted medical license. CMS Ex. 4 at 4. Petitioner was granted an
unrestricted license when he completed Wyoming’s Professional Assistance Program.
CMS Ex. 3.

In July 2013, Petitioner submitted a CMS Form 855B to enroll a new clinic, Lander
Women’s Care, LLC. CMS Ex. 5. In its application the clinic disclosed the revocation
of Petitioner’s Ohio license as a final adverse legal action which the clinic stated was
resolved when Wyoming granted Petitioner an unrestricted license in 2012. CMS Ex. 5.
Noridian granted billing privileges to the clinic effective July 26, 2013. CMS Ex. 7.

In a letter dated August 18, 2014, Noridian revoked Petitioner’s Medicare billing
privileges effective September 17, 2014, pursuant to 42 C.F.R. § 424.535(a)(12). CMS
Ex. 2. On October 3, 2014, Petitioner requested reconsideration. Noridian issued its
reconsideration decision on January 29, 2015, and upheld its revocation. CMS Ex. 4.
Noridian also advised Petitioner that he was subject to a two-year enrollment bar. Jd.

Petitioner requested a hearing on March 9, 2015. CMS moved for Summary Judgment
on May 14, 2015, and filed eight exhibits (CMS Exs. 1-8). Petitioner responded on June
18, 2015, and filed two exhibits (P. Exs. 1-2).

IL. Issue

Whether CMS had a legitimate basis for revoking Petitioner’s Medicare billing privileges
under 42 C.F.R. § 424.535(a)(12).

III. Findings of Fact, Conclusions of Law, and Analysis’

Petitioner is a physician and, therefore, a supplier for purposes of the Medicare program.
See 42 U.S.C. § 1395x(d); 42 C.F.R. §§ 400.202 (definition of Supplier), 410.20(b)(1).
CMS may revoke the Medicare billing privileges of a supplier for any of the reasons
stated in 42 C.F.R. § 424.535.

I. On April 9, 2010, the Ohio State Medicaid agency terminated
Petitioner’s Medicaid participation and Petitioner has exhausted his
appeal rights.

' My findings of fact and conclusions of law are set forth in italics and bold font.
On April 9, 2010, the Ohio State Medicaid agency terminated Petitioner’s Medicaid
provider agreement and notified Petitioner that he could request administrative review of
the termination. CMS Ex. 1. Petitioner’s Medicaid termination became effective on
March 10, 2010. Ohio Medicaid confirmed that Petitioner’s appeal rights have been
exhausted with respect to the termination. CMS Ex. 2.

2. CMS had a legitimate basis for revoking Petitioner’s Medicare billing
privileges under 42 C.F.R. § 424.535(a)(12) because the Ohio State
Medicaid agency terminated Petitioner from the Medicaid program
and Petitioner has no appeal of the termination pending.

Based on the Ohio State Medicaid agency’s termination, CMS revoked Petitioner’s
Medicare billing privileges under 42 C.F.R. § 424.535(a)(12). CMS Ex. 2. That
regulation states that CMS may revoke billing privileges if:

(i) Medicaid billing privileges are terminated or revoked by a
State Medicaid Agency.

(ii) Medicare may not terminate unless and until a provider or
supplier has exhausted all applicable appeal rights.

Petitioner has not disputed that the Ohio State Medicaid agency is a state Medicaid
agency. Petitioner does not dispute that the Ohio State Medicaid agency terminated his
Medicaid participation. Petitioner does not dispute that he does not have an appeal of the
Ohio Medicaid termination pending.

The Secretary added section 424.535(a)(12) as a basis for revocation of Medicare billing
privileges so that it could “work in tandem” with the requirement in the Affordable Care
Act (ACA) § 6401 that each state must terminate the Medicaid billing privileges of a
provider or supplier who has been terminated from the Medicare program or another
state’s Medicaid program. 76 Fed. Reg. 5,861, 5,946 (Feb. 2, 2011). The reason that the
Secretary thought that coordination between Medicare and state Medicaid programs was
important was because “providers and suppliers whose enrollment has been terminated
by a State Medicaid program may pose an increased risk to the Medicare program.” Jd.

In his request for reconsideration Petitioner states that at the time his Ohio medical
icense was terminated he was in the process of moving to Wyoming, and he had already
applied for a Wyoming medical license. Petitioner states that he does not intend to
practice medicine in Ohio and does not wish to renew his Ohio medical license. CMS
Ex. 3. In his hearing request, Petitioner disputes only one fact: that his decision to

relocate to Wyoming occurred before any action by the Ohio State Board of Medicine.
Petitioner admits that his refusal to submit to an inpatient evaluation for alcohol abuse in
Ohio was based on the fact that he knew he would no longer be practicing medicine in
Ohio which he has learned carries long-lasting consequences.

The fact that Petitioner was granted a license to practice in Wyoming does not change the
operative facts of this case. CMS revoked Petitioner’s participation based on the adverse
action taken against Petitioner in Ohio. That action gave CMS the authority to act.
Petitioner has not shown that the Ohio adverse action was rescinded or overturned.

Petitioner provides me with two reference letters which state that he is now a valuable
asset to the Wyoming medical community and he provides needed services to patients
from an Indian reservation and the elderly. However, I am unable to consider his
reference letters because by the plain language of the regulation CMS was authorized to
revoke his participation in the Medicare program.

Petitioner’s billing privileges were terminated by the Ohio State Medicaid agency and

Petitioner has exhausted his appeal rights. As a result, Petitioner’s Medicaid termination
may serve as the basis for a Medicare revocation under section 424.535(a)(12).

IV. Conclusion

For the reasons explained above, | affirm CMS’s determination to revoke Petitioner’s
Medicare billing privileges.

/s/
Steven T. Kessel
Administrative Law Judge


Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

Randolph Cook, M.D.
(NPI: 1740254192),

Petitioner,
v.
Centers for Medicare & Medicaid Services.
Docket No. C-15-1037
Decision No. CR3985

Date: June 26, 2015

DECISION

Randolph Cook, M.D. (Petitioner), challenges a determination by the Centers for
Medicare & and Medicaid Services (CMS), through its administrative contractor,
Noridian Healthcare Solutions (Noridian), that established the effective date of his
Medicare enrollment and billing privileges as July 22, 2014, with retrospective billing to
June 22, 2014. Petitioner argues that Noridian should not have given him a new effective
date for Medicare enrollment because he was already enrolled in the Medicare program
when he moved from a medical practice in Virginia to one in California. Essentially,
Petitioner merely sought to reassign his Medicare benefits to the new practice in
California, called Pacific Central Coast Health Centers (Pacific Central Coast), rather
than to reenroll. CMS now moves for summary judgment, arguing that Petitioner was
required to submit a new enrollment application when he moved Medicare contractor
jurisdictions, and that the contractor undisputedly received that application on July 22,
2014. Petitioner cross-moves for summary judgment, arguing that CMS’s interpretive
guidelines in the Medicare Program Integrity Manual (MPIM) govern the effective dates
for reassignments rather than the enrollment regulations that control the effective dates
for new enrollees in the Medicare program.
Because Petitioner was already an enrolled supplier in the Medicare program when he
began providing services with Pacific Central Coast on August 23, 2013, Petitioner did
not need to reenroll in the Medicare program and the effective date of reassignment of
Medicare benefits is controlled by the MPIM, rather than the enrollment regulations.
Therefore, I reverse CMS’s determination and order that Petitioner’s effective date for
the reassignment of benefits to Pacific Central Coast be August 23, 2013.

I. Background and Procedural History

Petitioner is a physician currently employed in California at Pacific Central Coast.
Petitioner was previously employed in Virginia and enrolled in the Medicare program as
a supplier.’ Petitioner asserts, and CMS does not dispute, that he began providing
services through Pacific Central Coast on August 23, 2013. CMS Exhibit (Ex.) | at 2.

At that time, Pacific Central Coast was in the process of changing its name from Marian
Community Clinics and had submitted the necessary applications to Palmetto GBA,
another Medicare contractor. According to Petitioner, Palmetto GBA approved the name
change for Pacific Central Coast on September 3, 2013. CMS Ex. 5. Noridian ultimately
approved the name change for Pacific Central Coast on February 17, 2014. CMS Ex. 5.

On July 22, 2014, Petitioner filed with Noridian a CMS-855R application to reassign his
Medicare benefits to Pacific Central Coast. CMS Ex. 2. On July 24, 2014, a provider
enrollment representative with Noridian sent an e-mail to Pacific Central Coast’s point of
contact and directed Petitioner to file a CMS-855] “for initial enrollment with Medicare
Part B in California.” CMS Ex. 2 at 1. The Noridian representative wrote that “because
[Petitioner] is not currently enrolled with Medicare Part B in California the reassignment
cannot be processed until an initial enrollment application is submitted and approved.”
CMS Ex. 2 at 1. Petitioner subsequently filed a CMS-8551 with Noridian, as directed.
See CMS Ex. 7 at 1. On September 9, 2014, Noridian issued a letter that notified
Petitioner his “initial Medicare enrollment application” was approved. CMS Ex. 4 at 1.
The letter included a table under the heading “Medicare Enrollment Information,” which
provided Petitioner’s “Participating status” as “Participating,” and “Effective June 22,
2014.” CMS Ex. 4 at 1.

Pacific Central Coast, on behalf of Petitioner, requested reconsideration of the effective
date that Noridian stated in its September 9 letter. CMS Ex. 5. Pacific Central Coast
stated that changing its practice’s name took over seven months from when it submitted
its application to Noridian, and during that time Pacific Central Coast “held physician
enrollment and its account receivable for Medicare so as to not bill them under the
incorrect name.” CMS Ex. 5. Pacific Central Coast also said that it “had difficulty

' A “supplier” is a “physician or other practitioner, or an entity other than a provider, that
furnishes health care services under Medicare.” 42 C.F.R. § 400.202.
obtaining timely electronic signatures” through the Provider Enrollment, Chain, and
Ownership System (PECOS). CMS Ex. 5.

On November 10, 2014, Noridian issued a letter in response to the reconsideration
request and cited 42 C.F.R. § 424.520(d) as the basis for the effective date stated in the
September 9 letter. CMS Ex. 6. Noridian wrote that the “Carriers and Part A and Part B
Medicare Administrative Contractors (A/B MACs) will establish the effective date of
Medicare billing privileges (see 42 [C.F.R. §] 424.520(d)) for physicians ....” The letter
noted that the effective date of billing privileges is “the later of the date of filing or the
date [a supplier] first began furnishing services at a new practice location.” CMS Ex. 6
at 1. Finally, the letter stated that Petitioner’s CMS-855R was received on July 22, 2014.
His effective date was made June 22, 2014, to reflect the “30 day [sic] from receipt of
application that [retrospective billing] is allowed.” CMS Ex. 6 at 2. The letter concluded
that “Pacific Central Coast Health Centers has not provided evidence to definitely [sic]
support an earlier effective date.” CMS Ex. 6 at 2.

On January 21, 2015, Petitioner filed his request for a hearing to challenge the effective
date of his Medicare enrollment and billing privileges that Noridian established.’ The
case was assigned to me to hear and decide, and I issued an Acknowledgment and Pre-
hearing Order (Order) that directed the parties on presenting their evidence and argument.
CMS subsequently moved for summary judgment and filed a supporting brief (CMS Br.)
as well as eight proposed exhibits marked as CMS Exs. 1-8. Petitioner, through counsel,
opposed summary judgment in favor of CMS and filed a cross-motion for summary
judgment with supporting brief (P. Br.). Petitioner did not file any of his own exhibits,
but relied on the same documentary exhibits that CMS proposed.

IL. Issues

The issue in this case is whether Noridian, acting on behalf of CMS as the Medicare
administrative contractor, properly determined June 22, 2014, as the effective date of
Petitioner’s Medicare enrollment and billing privileges, and as Petitioner’s effective date
for reassignment of Medicare benefits to Pacific Central Coast.

> Pacific Central Coast initially attempted to file a single hearing request on behalf of
several suppliers that are part of its medical practice. Civil Remedies Division
management, however, contacted Pacific Central Coast and required each supplier to file
a separate hearing request because Noridian issued a separate determination for each
supplier. Petitioner’s hearing request was ultimately filed 7 days after the 60 day
deadline. See 42 C.F.R. § 498.40(a)(2). CMS did not move to dismiss Petitioner’s
hearing request as untimely, and there is no reason for me to exercise my discretion to do
so. See id. § 498.70(c). Pacific Central Coast’s first attempt to request a hearing on
behalf of Petitioner is good cause to accept the January 21 hearing request out of time.
See id. § 498.40(c)(2).
III. Decision on the Written Record

Petitioner did not object to the admission of CMS Exs. 1-8; therefore, I admit them into
the record.

My Order advised the parties that they must submit written direct testimony for each
proposed witness, and that an in-person hearing would be necessary only if the opposing
party requested an opportunity to cross-examine a witness. Order §{j 8-10; CRDP

§§ 16(b), 19(b). Neither party submitted any written direct testimony. Therefore, a
hearing in this case is unnecessary and I issue this decision based on the written record.
Order ¥ 11; CRDP § 19(d).

IV. Findings of Fact, Conclusions of Law, and Analysis

The Social Security Act authorizes the Secretary of Health and Human Services
(Secretary) to promulgate regulations governing the enrollment process for providers and
suppliers in the Medicare program. 42 U.S.C. §§ 1302, 1395cc(j). The Secretary has set
forth enrollment requirements in 42 C.F.R. Part 424, Subpart P. Under the Secretary’s
regulations, a provider or supplier seeking billing privileges under the Medicare program
must “submit enrollment information on the applicable enrollment application. Once the
provider or supplier successfully completes the enrollment process .. ... CMS enrolls the
provider or supplier into the Medicare program.” 42 C.F.R. § 424.510(a). For suppliers,
CMS establishes the effective date for Medicare billing privileges pursuant to 42 C.F.R.
§ 424.520(d) and may permit limited retrospective billing under 42 C.F.R. § 424.521.

For Medicare Part B claims, a beneficiary may assign his or her benefits to an enrolled
physician or non-physician supplier providing services to that beneficiary. 42 U.S.C.

§ 1395u(b)(3)(B)(ii). By statute, a supplier is generally prohibited from reassigning his
or her Medicare benefits. 42 U.S.C. § 1395u(b)(6); see 42 C.F.R. § 424.80(a). There are
exceptions to this prohibition, including, among other things, when a supplier must
reassign his or her benefits to an employer as a condition of employment. 42 U.S.C.

§ 1395(u)(b)(6)(A)(i); see 42 C.F.R. § 424.80(b). For circumstances when reassignment
is allowed, a supplier must submit a Form CMS-855R. See 71 Fed. Reg. 20754, 20767
(Apr. 21, 2006) (final rule formally adopting the use of the CMS-855R). Although not
addressed by statute or regulation, CMS instructs its employees that reassignments of
benefits may only occur between enrolled suppliers and that “[t]he effective date of
reassignment is the date on which the individual began or will begin rendering services
with the reassignee.” MPIM § 15.5.20.

I. The regulation concerning the effective date of billing privileges, 42 C.F.R.
§ 424.520(d), does not apply to the reassignment of Petitioner’s Medicare
benefits to his new employer, Pacific Central Coast Health Centers.

After Petitioner filed a CMS-855R with Noridian on July 22, 2014, to reassign his
Medicare benefits to Pacific Central Coast, the contractor directed Petitioner to submit a
CMS-855I because he was not “currently enrolled” with “Medicare Part B in California.”
See CMS Ex. 2 at 1. Noridian later determined that Petitioner was “participating” in
Medicare “effective June 22, 2014.” CMS Ex. 3 at 1. In its reconsidered determination,
the contractor specifically relied on 42 C.F.R. § 424.520(d) to affirm July 22, 2014 as the
effective date of Petitioner’s enrollment and billing privileges with retrospective billing
to June 22, 2014. CMS Ex. 6 at 1-2. CMS maintains before me that Petitioner had to
enroll with Noridian when he moved from Virginia to California because he was
relocating to a different Medicare administrative contractor’s jurisdiction. CMS Br. at 2-
3. That separate enrollment with Noridian, in turn, triggered the regulatory provision in
section 424.520(d) that establishes the effective date of billing privileges. CMS Br. at 3.

Under CMS’s theory, Petitioner could not reassign benefits to Pacific Central Coast prior
to the effective date of his enrollment with Noridian, which resulted in the effective date
of both his billing privileges and reassignment to Pacific Central Coast as June 22, 2014.
See CMS Br. at 2-3; CMS Ex. 2 at 1 (“[B]ecause you are not currently enrolled with
Medicare Part B in California the reassignment cannot be processed . . . .”). CMS has not
argued that the reassignment of Petitioner’s benefits alone triggered a new effective date
for Petitioner’s Medicare billing privileges. See CMS Br. at 2-3. Therefore, this case
turns on whether Petitioner was required to enroll with Noridian, the Medicare
administrative contractor for California, even though he was undisputedly already
enrolled in Medicare as a supplier in Virginia. See CMS Br. at 5; P. Br. at 4. Throughout
this proceeding, however, CMS has not cited any statutory or regulatory authority that
requires a separate or new Medicare enrollment when a supplier moves from one
administrative contractor’s jurisdiction to another. Below, I discuss separately each of
the sources where such a requirement might be located.

a. The enrollment regulations.

As stated above, Congress authorized the Secretary to establish the enrollment process,
which she has done in 42 C.F.R. Part 424, Subpart P. Any practitioner who wishes to
obtain payment for a Medicare covered item or service must first be “enrolled in the
Medicare program.” 42 C.F.R. § 424.505. The regulations define “enroll/enrollment” as:

the process that Medicare uses to establish eligibility to submit claims
for Medicare covered services and supplies. The process includes—
(1) Identification of a provider or supplier;

(2) Validation of the provider’s or supplier’s eligibility to provide
items or services to Medicare beneficiaries;

(3) Identification and confirmation of the provider or supplier’s
practice location(s) and owner(s); and

(4) Granting the provider or supplier Medicare billing privileges.

42 C.F.R. § 424.502. To enroll, a provider or supplier “must submit enrollment
information on the applicable enrollment application.” 42 C.F.R. § 424.510(a). After
successfully completing the enrollment process, “CMS enrolls the provider or supplier
into the Medicare program.” Jd.

The regulations provide that Medicare establishes eligibility to enroll and grants billing
privileges, but do not make specific reference to individual administrative contractor
jurisdictions with regard to enrollment generally. In addition, the regulations plainly state
that CMS, not each individual contractor, enrolls a provider or supplier into the Medicare
program. See 42 C.F.R. § 424.510(a). Indeed, each separate contractor works on behalf
of CMS and may therefore initially enroll a provider or supplier, but had the Secretary
intended to limit enrollment to each specific contractor, she would have said so, but did
not. The enrollment regulations make several references to Medicare contractors. See,
e.g., 42 C.F.R. §§ 424.510(d)(1) (directing the submission of an application to
“designated Medicare fee-for-service contractor”) and 424.516(d) (directing suppliers to
report changes to their “Medicare contractor”). But the Secretary established the
enrollment process in terms of “Medicare” generally, not its administrative contractors.
By including references to administrative contractors, the Secretary knew at the time of
promulgating the enrollment regulations that fee-for-service contractors would be part of
the enrollment process, but there is no regulatory language limiting enrollment to
anything other than Medicare generally. There is no regulatory provision in 42 C.F.R.
Part 424, Subpart P that requires a provider or supplier to enroll separately with each
administrative contractor. From this, I conclude that the Secretary did not intend to limit
enrollment to only one contractor at a time. Rather, “enrollment” is intended to be with
the Medicare program overall, not CMS’s administrative contractors.

b. The Medicare Program Integrity Manual.

The MPIM, which CMS has published as a guidance document for its administrative
contractors, defines “enrollment” as “the process that Medicare uses to grant Medicare
billing privileges.” MPIM, Ch. 15, § 15.1.1 (Rev. 404, 2012). Like the enrollment
regulations, the MPIM defines enrollment in terms of Medicare generally, not specific
contractors. See 42 C.F.R. § 424.502.
The MPIM indirectly refers to a requirement that a supplier must enroll with each
contractor rather than with Medicare generally, but there is no actual express requirement
to that effect in Chapter 15, which explains the enrollment process for contractors. When
discussing how contractors should process the CMS-855R, the MPIM explains that, in
“situations where an individual is reassigning benefits to a person/entity, both the
reassignor and the reassignee must be enrolled with the same contractor.” MPIM, Ch. 15,
§ 15.5.20(B). The phrase “enrolled with the same contractor” implies that “enrollment”
is tied to a specific contractor, not just Medicare overall. In addition, when discussing the
requirement that a provider or supplier list adverse actions in its enrollment application,
the MPIM says that if “the practitioner is submitting an initial enrollment application
(e.g., is moving to a new State and contractor jurisdiction) and did not report the adverse
action in section 3 of the CMS-855], the contractor shall deny the enrollment application
and establish a 3-year enrollment bar.” MPIM, Ch. 15 § 15.5.20(B) (emphasis added).
The example of a new contractor jurisdiction is parenthetical, yet it tends to support
CMS’s premise that an entirely new enrollment application is required for a change in
contractor jurisdictions. However, this parenthetical may also recognize that a supplier
will need to submit a CMS-855] to report a change of information, such as a change of
address.

The MPIM also discusses voluntary termination for suppliers and reminds CMS’s
contractors to determine whether the moving supplier needs to submit a “voluntary
termination.” MPIM, Ch. 15 § 15.7.5.1(B)(2). However, the term “enrollment” is not in
this section of the MPIM, and it is not clear whether termination of a prior practice
location in another state necessarily equates to a voluntary termination of enrollment,
requiring re-enrollment with a new contractor. Critically, there is no express or otherwise
unambiguous requirement that a supplier must enroll or re-enroll with Medicare when it
moves contractor jurisdictions.

c. The CMS-855I Medicare Enrollment Application.

The instructions of the CMS-8551, which CMS refers to in its brief, provide that a
supplier should use the CMS-8551 if he or she is “currently enrolled with a Medicare fee-
for-service contractor but need[s] to enroll in another fee-for-service contractor’s
jurisdiction... .” CMS Ex. 8 at 2; see CMS Br. at 5. The application’s instruction
recognizes an existing enrollment in the Medicare program, and then refers to a separate
enrollment, albeit through a different contractor. However, the application does not cite
any statutory or regulatory authority that supports the premise that a single supplier must
go through multiple enrollments in the Medicare program. Further, it is unclear whether
the word “enroll” in the application is intended to have the same meaning as that word is
defined in 42 C.F.R. § 424.502, or whether it simply means something similar to “register
with.”
Petitioner argues that enrollment in a new contractor jurisdiction is for the
“administrative convenience” of the contractor, and I agree. I find that the use of “enroll”
on the application instructions must be read to mean “register with” or some other similar
administrative meaning, because it would otherwise be contradictory to the Secretary’s
intent that the plain language of the regulation makes clear. The regulations only discuss
one enrollment with Medicare. 42 C.F.R. § 424.510(a). Therefore, I do not accept that
the ambiguous instruction in the CMS-855] establishes a legal requirement that a supplier
must actually “enroll” with each contractor — as that word is defined in the regulation — in
order to be enrolled in the Medicare program. If the Secretary meant that a supplier’s
movement from one CMS administrative contractor jurisdiction to another required
suppliers to enroll again in the Medicare program, the Secretary surely would have
indicated that in her regulations. Rather, the regulations establish only one Medicare
enrollment per provider or supplier. See 42 C.F.R. § 424.502.

Neither the statute nor regulations that discuss reassignment of a supplier’s Medicare
benefits address the effective date of that reassignment. See 42 U.S.C. § 1395u(b)(6);

42 C.F.R. § 424.80(b). CMS and its contractor applied the “effective date of billing
privileges” as the effective date of reassignment, but appear to have done so because they
required Petitioner to “enroll” separately with Noridian first. There is no language in the
regulation that permits the application of the enrollment effective date provision only to
the reassignment of benefits. The definition of “enroll/enrollment” in 42 C.F.R.

§ 424.502 states that “[g]ranting the . . . supplier Medicare billing privileges” is a
component of the enrollment process, not distinct from it. Regarding the “effective date
of billing privileges” for suppliers, the regulation states:

The effective date for billing privileges for physicians, nonphysician
practitioners, and physician and nonphysician practitioner organizations
is the later of the date of filing of a Medicare enrollment application that
was subsequently approved by a Medicare contractor or the date an
enrolled physician or nonphysician practitioner first began furnishing
services at a new practice location.

42 C.F.R. § 424.520(d). Because the granting of billing privileges is part of the overall
Medicare enrollment process, a supplier who is already enrolled cannot be granted new
billing privileges without first terminating enrollment and re-enrolling in the Medicare
program. As explained above, Petitioner was not required to enroll or re-enroll in the
Medicare program simply because he was changing from one contractor’s jurisdiction to
another. Therefore, because the “effective date of billing privileges” in 42 C.F.R.

§ 424.520(d) is part of the Medicare enrollment process and requires that a supplier
actually be enrolling in Medicare or re-enrolling, it also does not apply to the
reassignment of Petitioner’s Medicare benefits to Pacific Central Coast.
2. The effective date for Petitioner’s reassignment of Medicare benefits to
Pacific Central Coast is August 23, 2013, the date on which Petitioner
commenced providing services with Pacific Central Coast.

Petitioner did not enroll or re-enroll with Noridian when he moved to California. He was
already enrolled in Medicare through his prior employment in Virginia and never
voluntarily terminated that enrollment. Therefore, the effective date of his Medicare
billing privileges never changed from his initial enrollment in Medicare. The only
change in Petitioner’s status when he moved to California was the reassignment of his
benefits to Pacific Central Coast. The regulations do not address the effective date of
reassignment, only initial enrollment. See 42 C.F.R. § 424.520(d). The MPIM, however,
provides a written policy from CMS that the effective date of reassignment is “the date
on which the individual began or will begin rendering services with the reassignee.”
MPIM, Ch. 15, § 15.5.20(A). In this case, that date is August 23, 2013. In light of there
being no alternative interpretations, CMS should have applied its written policy in favor
of Petitioner.

I recognize the likelihood that Petitioner was required to submit a CMS-855] in addition
to a CMS-855R because he moved contractor jurisdictions and presumably had changes
to his enrollment information.’ See 42 C.F.R. § 424.516(d) (requiring physicians to
report changes in practice location within 30 days of the change). However, I do not
conclude that the submission of an enrollment application for a reason other than initial
enrollment or re-enrollment necessarily triggers the effective date regulation. While the
CMS-8551 is a “Medicare enrollment application,” see 42 C.F.R. § 424.520(d), it is also
used for purposes other than enrolling in the Medicare program for the first time.
Enrolled suppliers such as Petitioner use the CMS-855] to notify CMS about any changes
in information. CMS Ex. 8 at 2 (providing instruction on CMS-855] that says physicians
an “make a change in their enrollment information” using that application form).
Changing information to “maintain enrollment,” however, is not the same as
“enrollment,” and, therefore, does not result in new billing privileges. See 42 C.F.R.
§ 424.515 (requiring a supplier to revalidate enrollment information by using an
enrollment application, but not requiring the certifications necessary during initial
enrollment). Therefore, simply filing a CMS-8551I with CMS or its contractor for a
reason other than initial enrollment does not necessarily trigger the effective date of

> CMS noted in its brief that Petitioner failed to comply with the reporting requirements
in 42 C.F.R. § 424.516(d) by not notifying CMS of a change in address within 30 days of
moving to California. See CMS Br. at 5 n.1. If true, that would provide a basis for
revocation of billing privileges (42 C.F.R. § 424.535(a)(9)), but that is a separate
determination that Noridian did not make in this case. Therefore, whether Petitioner
complied with the reporting requirement is not at issue before me and has no impact on
the outcome of this case.
10

billing privileges regulation in 42 C.F.R. § 424.520(d). See John Heverin, Ph.D., ALJ
Ruling 2013-6 at 7-8 (HHS 2013).

V. Conclusion and Order

For the reasons explained above, I reverse CMS’s determination and order that
Petitioner’s effective date of reassignment of Medicare benefits to Pacific Central Coast
be August 23, 2013.

/s/
Scott Anderson
Administrative Law Judge


Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division
Wingate at Beacon,
(CCN: 33-5828),
Petitioner,
v.
Centers for Medicare & Medicaid Services
Docket No. C-13-160
Decision No. CR3979

Date: June 22, 2015

DECISION

In this case, I consider a facility’s responsibility for assuring that it provides proper
treatment and care to residents who have gastronomy tubes (G-tubes)! or tracheostomies
(trachs).?

Petitioner, Wingate at Beacon, is a long-term care facility located in Beacon, New York,
that participates in the Medicare program. Based on the facility’s annual survey,
completed August 20, 2012, the Centers for Medicare & Medicaid Services (CMS)
determined that, from August 17 through October 1, 2012, the facility was not in
substantial compliance with Medicare program requirements and that, from August 17
through 22, 2012, its deficiencies posed immediate jeopardy to resident health and safety.

' A gastronomy tube is inserted through the skin and stomach wall directly into the
stomach. See CMS Ex. 18 at 4 (McWeeney Decl. § 11); CMS Ex. 19 at 4 (Moran Decl.

411).

> A tracheostomy is a surgically-created opening in the neck, which provides a direct
airway into the trachea. The term also refers to the surgical procedure by which the
opening is created. See CMS Ex. 19 at 7 (Moran Decl. § 24).
CMS imposed civil money penalties (CMPs) of $5,650 per day for six days of immediate
jeopardy and $150 per day for 40 days of substantial noncompliance that was not
immediate jeopardy.

Petitioner admits that it was not in substantial compliance but challenges the deficiencies
cited at the immediate jeopardy level and the immediate jeopardy determination itself.
The parties have filed cross-motions for summary judgment.

The undisputed evidence establishes that: 1) from August 17 through October 1, 2012,
the facility was not in substantial compliance with either the quality-of-care requirements
governing G-tube and trach care (42 C.F.R. §§ 483.25(g)(2), 483.25(k)) or with the
requirements for administration (42 C.F.R. §§ 483.75, 483.75(d)(1) — (2), 483.75(4)); and
2) from August 17 through 22, 2012, these deficiencies posed immediate jeopardy to
resident health and safety. I therefore grant CMS’s motion for summary judgment and
deny Petitioner’s.

Background

The Social Security Act (Act) sets forth requirements for nursing facility participation in
the Medicare program and authorizes the Secretary of Health and Human Services to
promulgate regulations implementing those statutory provisions. Act § 1819. The
Secretary’s regulations are found at 42 C.F.R. Part 483. To participate in the Medicare
program, a nursing facility must maintain substantial compliance with program
requirements. To be in substantial compliance, a facility’s deficiencies may pose no
greater risk to resident health and safety than “the potential for causing minimal harm.”
42 CFR. § 488.301.

The Secretary contracts with state survey agencies to conduct periodic surveys to
determine whether skilled nursing facilities are in substantial compliance. Act § 1864(a);
42 C.F.R. § 488.20. The regulations require that each facility be surveyed annually, with
no more than fifteen months elapsing between surveys. 42 C.F.R. § 488.308(a).
Facilities must be surveyed more often, if necessary, to ensure that identified deficiencies
are corrected. Act § 1819(g)(2)(A); 42 C.F.R. § 488.20(a).

Here, on August 20, 2012, surveyors from the New York State Department of Health
(state agency) completed a standard survey of the facility. Based on the survey findings,
CMS determined that the facility was not in substantial compliance with multiple
program requirements:

e 42C.F.R. § 483.10(b) (Tag F156 — notice of rights and services) at scope and
severity level D (isolated instance of noncompliance that causes no actual harm
with the potential for more than minimal harm);
© 42 C.F.R. § 483.15(a) (Tag F241 — quality of life: dignity) at scope and severity

level D;

© 42 C.F.R. § 483.15(e)(1) (Tag F246 — quality of life: accommodation of needs) at
scope and severity level E (pattern of noncompliance that causes no actual harm
with the potential for more than minimal harm);

© 42 C.F.R. § 483.15(h)(2) (Tag F253 — quality of life: environment) at scope and

severity leve

E;

© 42C.F.R. § 483.20(g) — (j) (Tag F278 — accuracy of resident assessments) at scope

and severity

© 42CER.§§

level D;

483.20(d) and 483.20(k)(1) (Tag F279 — use of resident assessments

and development of comprehensive care plans) at scope and severity level E;

© 42 C.F.R. § 483.20(k)(3)(ii) (Tag F282 — comprehensive care plans: services

provided) at

scope and severity level D;

e 42C.F.R. § 483.25 (Tag F309 — quality of care) at scope and severity level E;

© 42C.F.R. § 483.25(c) (Tag F314 — quality of care: pressure sores) at scope and

severity leve

D;

© 42 C.F.R. § 483.25(d) (Tag F315 — quality of care: urinary incontinence) at scope

and severity

level D;

© 42 C.F.R. § 483.25(e)(2) (Tag F318 — quality of care: range of motion) at scope

and severity

level D;

e 42 C.E.R. § 483.25(g)(2) (Tag F322) — quality of care: naso-gastric tubes) at
scope and severity level K (pattern of immediate jeopardy);

e 42 C.F.R. § 483.25(h) (Tag F323 — quality of care: accident prevention) at scope

and severity

level D;

e 42 C.F.R. § 483.25(k) (Tag F328 — quality of care: special needs) at scope and
severity level K;

> Petitioner has not
those that are the su

appealed most of the deficiencies cited. This list highlights, in bold,
ibject of this appeal.
© 42 C.F.R. § 483.25(n) (Tag F334 — quality of care: immunizations) at scope and
severity level D;

e 42C.F.R. § 483.35(i) (Tag F371 — dietary services/sanitary conditions) at scope
and severity level E;

e 42C.F.R. § 483.65 (Tag F441 — infection control) at scope and severity level E;
e 42 C.F.R. § 483.75 (Tag F490 — administration) at scope and severity level K;

e 42 C.F.R. § 483.75(d)(1) — (2) (Tag F493 - administration: governing body) at
scope and severity level K;

e 42 C.F.R. § 483.75(i) (Tag F501 — administration: medical director) at scope
and severity level K; and

e 42C.F.R. § 483.75 (I)(1) (Tag F514 — administration: clinical records) at scope
and severity level E.

CMS Exs. 1, 2. Thereafter, CMS determined that the facility removed the immediate
jeopardy effective August 23, 2012, and returned to substantial compliance on October 2,
2012. CMS has imposed CMPs of $5,650 per day for six days of immediate jeopardy
($33,900) and $150 per day for the remaining 40 days of substantial noncompliance
($6,000), for a total penalty of $39,900. CMS Exs. 2, 9.

Petitioner timely requested review, challenging the quality-of-care deficiencies cited at
the immediate jeopardy level — 42 C.F.R. §§ 483.25(g) and 483.25(k) — and CMS’s
conclusion that the facility’s deficiencies posed immediate jeopardy to resident health
and safety. Hearing Request. In its brief, Petitioner added challenges to the deficiencies
cited under the regulation governing administration (42 C.F.R. §§ 483.75, 483.75(d)(1) —
(2), and 483.75(i)), which derive from the quality-of-care deficiencies and are also cited
at the immediate jeopardy level. P. Br. at 19.

The parties have filed cross-motions for summary judgment. With its motion and brief
(CMS Br.), CMS submitted 19 exhibits (CMS Exs. 1-19). With its motion and brief
(P. Br.), Petitioner submitted 14 exhibits (P. Exs. 1-14).

Issues

Based on the uncontested issues, the facility was not in substantial compliance with
Medicare program requirements from August 17 through October 1, 2012.
The remaining issues are: 1) Was the facility in substantial compliance with 42 C.F.R.
§§ 483.25(g)(2), 483.25(k), 483.75, 483.75(d)(1) — (2), and 483.75(i); and 2) if not, did
those deficiencies pose immediate jeopardy to resident health and safety.

Except to argue that its deficiencies did not pose immediate jeopardy, Petitioner has not
challenged the amount of the CMP.

Discussion

Summary judgment. Summary judgment is appropriate if a case presents no genuine
issue of material fact, and the moving party is entitled to judgment as a matter of law.
Illinois Knights Templar Home, DAB No. 2274 at 3-4 (2009), and cases cited therein.

The moving party may show the absence of a genuine factual dispute by presenting
evidence so one-sided that it must prevail as a matter of law, or by showing that the non-
moving party has presented no evidence “sufficient to establish the existence of an
element essential to [that party’s] case, and on which [that party] will bear the burden of
proof at trial.” Livingston Care Ctr. v. Dep’t of Health & Human Servs., 388 F.3d 168,
173 (6th Cir. 2004) (quoting Celotex Corp. v. Catrett, 477 U.S. 317, 323-24 (1986)). To
avoid summary judgment, the non-moving party must then act affirmatively by tendering
evidence of specific facts showing that a dispute exists. Matsushita Elec. Indus. Co. v.
Zenith Radio Corp., 475 U.S. 574, 586 n.11 (1986); see also Vandalia Park, DAB No.
1939 (2004); Lebanon Nursing & Rehab. Ctr., DAB No. 1918 (2004).

In examining the evidence for purposes of determining the appropriateness of summary
judgment, I must draw all reasonable inferences in the light most favorable to the non-
moving party. Brightview Care Ctr., DAB No. 2132 at 2, 9 (2007); Livingston Care Ctr.,
388 F.3d at 172; Guardian Health Care Ctr., DAB No. 1943 at 8 (2004); but see,
Brightview, DAB No. 2132 at 10 (entry of summary judgment upheld where inferences
and views of non-moving party are not reasonable). However, drawing factual inferences
in the light most favorable to the non-moving party does not require that I accept the non-
moving party’s legal conclusions. Cf Guardian Health Care Center, DAB No. 1943 at
11 (“A dispute over the conclusion to be drawn from applying relevant legal criteria to
undisputed facts does not preclude summary judgment if the record is sufficiently
developed and there is only one reasonable conclusion that can be drawn from those
facts.”).

1. CMS is entitled to summary judgment, because the undisputed evidence
establishes that facility staff could not and did not provide appropriate treatment
and services to its residents with G-tubes and did not provide proper trach
treatment and care; the facility therefore did not comply substantially with
42 C.F.R. §§ 483.25(g)(2) , 483.25(k), 483.75, 483.75(d)(1) — (2), and 483.75(i).*

Program requirements. Under the statute and quality-of-care regulation, each resident
must receive, and the facility must provide, the necessary care and services to allow a
resident to attain or maintain the highest practicable physical, mental, and psychosocial
well-being, in accordance with the resident’s comprehensive assessment and plan of care.
Act § 1819(b); 42 C.F.R. § 483.25. To this end, among other requirements, the facility
must ensure that a resident who is fed by a G-tube receives appropriate treatment and
services, in accordance with his comprehensive assessment, to prevent aspiration
pneumonia, diarrhea, vomiting, dehydration, metabolic abnormalities, and nasal-
pharyngeal ulcers and to restore, if possible, normal eating skills. 42 C.F.R.

§ 483.25(g)(2).

The facility must also ensure that residents receive proper trach treatment and care.
42 CFR. § 483.25(k).

In Petitioner’s view, a facility is not out of substantial compliance simply because it lacks
policies and procedures for G-tube or trach care or because it fails to ensure that its
nurses are competent to provide that care. Disregarding the factual underpinnings of this
case, Petitioner argues that no authority requires it to: 1) have in place written policies
and procedures for changing G-tubes or providing trach care; or 2) assure that its nurses
are adequately trained and competent to reinsert G-tubes and care for its residents with
trachs. In Petitioner’s view, the facility has no responsibility except to hire licensed
nurses and hope for the best.

Petitioner begins with the remarkable claim that CMS’s “own guidance documents . . .
make clear that there are no current requirements for [G-tube] policies or training.” P.
Br. at 2. According to Petitioner, the requirements for G-tubes — including the
requirements that the facility have in place “policies, practice, and training” — stems from
a September 7, 2011 CMS transmittal, which CMS retracted and did not replace until
September 27, 2012, after the time of this survey. P. Br. at 2; P. Exs. 1, 2.

This is nonsense. The transmittals in question — which are sent to the state survey
agencies to guide them in conducting their surveys — made no substantive changes. They
simply combined two F tags, eliminating Tag F321 and adding its provisions to Tag
F322. In any event, while CMS’s Survey and Certification Transmittals provide useful

+ My findings of fact/conclusions of law are set forth, in italics and bold, in the
discussion captions of this decision.
guidance to the state survey agencies, and may even include CMS’s interpretations of
applicable law, they do not constitute enforceable, substantive rules. Beverly Health &
Rehab. Servs. v. Thompson, 223 F. Supp. 2d 73, at 99-106 (D.D.C. 2002); Oakwood
Cmty. Ctr., DAB No. 2214 at 16 (2008); Aase Haugen Homes, Inc., DAB No. 2013 at 15
(2006). The regulations, on the other hand, constitute enforceable rules, and I am bound
to follow them. Here, the regulations did not change. Since their inception, Medicare
regulations have required facilities to have in place written policies and procedures for
resident care and to ensure that nursing staff are trained and competent to provide needed
services. Petitioner’s view is incompatible with the basic regulatory scheme and with
widely-accepted professional standards of quality.

The requirements in sections 483.25(g)(2) and 483.25(k) are part of a facility’s “overall
obligation under section 483.25 to provide each resident with ‘the necessary care and
services to attain or maintain the highest practicable physical, mental, and psychosocial
well-being, in accordance with the [resident’s] comprehensive assessment and plan of
care.’” Autumn Ridge Rehab. Ctr., DAB No. 2467 at 3 (2012). Inherent in all quality-of-
care requirements is the notion that the services provided meet professional standards of
quality and be provided by qualified persons. 42 C.F.R. § 483.20(k)(3).° And a facility
cannot assure that its staff are providing appropriate G-tube and trach care and services
unless it: 1) defines for them what that care entails (hence, the need for written policies
and procedures), particularly with respect to the individual needs of each resident (hence,
the need for individualized care plan instructions); 2) trains them to provide that level of
care; and 3) monitors them to assure that they have, in fact, provided that appropriate
treatment and care.°

5 Although CMS cited deficiencies under 42 C.F.R. § 483.20(k)(1) and (k)(3)(ii), it did
not base those citations on the facility’s failures with respect to its care for residents with
G-tubes and trachs. The facility’s failures with respect to G-tube and trach care likely put
it out of substantial compliance with numerous regulations that were not cited for that
purpose. But CMS is not required to cite every regulatory violation, and, while it might
have cited the more general “professional standards” regulation, the fact that it did not do
so does not preclude it from citing deficiencies under the more particular substantive
provisions relating to G-tube and trach care. See Premier Living & Rehab. Ctr., DAB
No. 2146 at 18-19 (2008).

® | agree with Petitioner that facilities have flexibility in deciding how they will provide
appropriate care. See P. Br. at 8-10. For example, a facility may decide that only
specially-trained nurses will be authorized to perform some procedures. This is perfectly
acceptable but must be spelled out in the facility policies so that all staff understand their
responsibilities and their limitations.
Policies and procedures. The parties agree that the facility did not have in place written
policies and procedures for providing G-tube and trach services, although the facility
possessed a nursing manual, which staff were free to consult. CMS Ex. 18 at 3-4, 5,6
(McWeeney Decl. ff 10, 18, 22); CMS Ex. 19 at 5, 8-9 (Moran Decl. ¥§ 15, 31, 32, 33);
P. Ex. 6 at 2 (Boulay Decl. § 8).

According to CMS, the surveyors could not find the manual on any of the facility’s four
nursing units, and they discovered that the facility possessed only one copy. CMS Ex. 18
at 5 (McWeeney Decl. 4 18); CMS Ex. 19 at 6 (Moran Decl. { 20). Petitioner disputes
that assertion and claims that the facility maintained a copy of the manual at each of the
four unit manager’s offices and kept an additional copy at the Administrative Director’s
office. P. Ex. 6 at 3 (Boulay Decl. § 9). For purposes of summary judgment, I accept
Petitioner’s claim but find it not material. A nursing manual is simply no substitute for
written policies and procedures, particularly when no written policy directs staff to it or
explains which sections apply. Moreover, a general nursing manual is not institution-
specific. It will not assign responsibilities among the facility staff, indicate who is
authorized to perform necessary procedures, nor specify the individuals within the facility
to whom staff must report problems. See CMS Ex. | at 78; CMS Ex. 18 at 5 (McWeeney
Decl. 19).

Staff training and competencies. The undisputed evidence also establishes that the
facility had not provided its nursing staff with any formal training in trach or G-tube care
in more than one year and that the facility had no safeguards in place to assure that
nursing staff were competent to provide G-tube and trach care. See P. Br. at 16 (“[I]t is
undisputed that the facility did not possess or administer competencies to its nursing staff
regarding the management of tracheostomy tubes. . . .”).

According to CMS, during an interview with Surveyor Roberta Moran, R.N., the
facility’s then director of nursing (DON), Marie Boulay, conceded that she was not aware
that the facility had provided any formal G-tube or trach training to its nursing staff nor
that the facility had a system in place to evaluate nurse competencies in reinserting G-
tubes or providing trach care. CMS Ex. 19 at 5, 12 (Moran Decl. {ff 15, 47); see CMS Br.
at 9, 13-14; CMS Ex. | at 40-41, 49; CMS Ex. 18 at 2, 6 (McWeeney Decl. {ff 3, 4, 22).

DON Boulay denies telling Surveyor Moran that she was not aware of any formal
training relating to G-tube insertions or trachs. She claims that, with respect to G-tube
training, she was unable to locate documentation of the training but believed that nurses
had been trained. P. Ex. 6 at 2 (Boulay Decl. § 6). She also claims that she produced
evidence that the facility had provided trach training. P. Ex. 6 at 3 (Boulay Decl. § 11).
The facility has produced evidence that, on March 31, 2011, it provided approximately
one hour of in-service training in trach care to at least some of its nurses. P. Ex. 3.
Petitioner also produces what appears to be a list of nurses and the dates of their in-
service training in trach and (for some) G-tube care. Although Petitioner does not
explain the list, and DON Boulay does not refer to it at all, it seems to indicate the dates
on which each nurse attended training or was tested, and the duration of that training
(generally an hour) and testing (half an hour). The list shows that, for the most part,
nurses attended the G-tube in-service and were tested in March 2011. In June and July
2011, five LPNs and one RN attended an in-service on tube feeding/medication orders.
P. Ex. 4 at 3. No one was trained or tested after August 5, 2011. P. Ex. 4. For purposes
of summary judgment, I draw all reasonable inferences in Petitioner’s favor and infer
from its submissions that the facility provided its nurses with in-service training as
indicated in P. Ex. 4.

But, even assuming that the facility’s nursing staff did not change between March 2011
and August 2012, and that all of the facility’s nurses attended the 2011 in-service
training, I find the training simply too remote in time to establish that staff were capable
of providing appropriate G-tube and trach care. Moreover, even if the training had been
more recent, one hour of in-service training, with or without some testing, does not
establish that facility staff are competent to provide the necessary care. The facility must
also take steps to insure that the training has been effective.

Here, not only was the facility unable to show that its staff were capable of providing
adequate care to its residents with G-tubes and trachs, the undisputed facts establish that,
in fact, its staff did not provide adequate care.

First, two staff nurses (an R.N. and an LPN) told Surveyor Moran that they did not know
what to do if a resident’s trach became dislodged, but would ask their supervisor.
However, DON Boulay admitted that the supervisor had not been trained to replace a
trach tube. CMS Ex. 19 at 9 (Moran Decl. §] 33); see P. Ex. 6 (Boulay Decl.) (in which
DON Boulay does not deny making that statement or claim that the supervisor in
question had any training).

Even more disturbing, patient care reflected this absence of policies and procedures and
the staff’s incompetence:

Resident 8 (R8). R8 was a 90-year-old woman, admitted to the facility in November
2011, suffering from multiple ailments, including the effects of a stroke, dementia, and
dysphagia (swallowing difficulties). CMS Ex. 16 at 1. Even though she had a G-tube in
place to supplement her caloric and protein intake, her care plan included no instructions
for changing that tube or for providing any other G-tube-related treatment and services.
CMS Ex. 16 at 7. No physician order directed staff regarding when and how to change
the tube. CMS Ex. 18 at 4 (McWeeney Decl. § 13). Notwithstanding this complete
absence of instructions, an August 7, 2012 nursing note establishes that one of the facility
nurses changed R8’s G-tube. Initially, the nurse tried to replace the tube with one of the

10

same size. But the resident complained of pain upon insertion, and the nurse could not
complete the procedure, nor did she recognize the potentially serious complications
associated with complaints of pain when a G-tube is inserted. See CMS Ex. 18 at 5
(McWeeney Decl. § 14).

On her own — without the physician’s knowledge or consent — the nurse replaced R8’s G-
tube with a smaller one.’ Even worse, she admitted to Surveyor McWeeney that she had
not been trained to reinsert a G-tube. Nor did the surveyors find any indication that this
nurse — or anyone else — notified R8’s physician of the incident or the resident’s
complaints of pain. CMS Ex. 18 at 4-5 (McWeeney Decl. §§ 13, 14, 15, 16); see CMS
Ex. 12 at 4; CMS Ex. 16.

The problems here — any one of which would put the facility out of substantial
compliance with program requirements — are numerous and deeply disturbing. Failing to
include G-tube care in the resident’s comprehensive care plan virtually assures that she
will not receive appropriate treatment and services, in accordance with her assessment.*
The absence of a physician’s order compounds that problem. An untrained and thus
unqualified individual was simply left to her own devices do determine when and how to
change the resident’s G-tube. I cannot overstate the seriousness of allowing an untrained
person to change a G-tube, especially without a care plan or physician’s order. See, e.g.,
Rosewood Care Ctr. of Rockford, DAB No. 2466 at 13, 17-18 (finding the facility
noncompliant with section 483.25(g)(2) where, without consulting the physician, a nurse
practitioner replaced the resident’s G-tube with one of a different size); see P. Ex. 7 at 2
(explaining that an improperly-placed tube can cause, among other complications,
nausea, vomiting, bowel obstruction, or peritonitis).

I also agree with Surveyor Joan McWeeney, R.N., and CMS: standard nursing practices
dictate that staff notify the physician if a G-tube needs to be reinserted, and the nurse
violated standard nursing practice and federal regulations when she reinserted the tube

7 Tube diameters are measured in “French units” (Fr). One Fr = 0.33mm. Here, the
nurse replaced a #20 Fr G-tube with a #14 Fr G-tube. CMS Ex. 18 at 4 (McWeeney
Decl. § 13).

® Each resident must have in place a comprehensive plan of care, with measurable
objectives and time tables, that describes the services the facility will provide so that the
resident will attain or maintain his/her highest practicable physical, mental, and psycho-
social well-being. 42 C.F. R. § 483.20(k). Based on other findings, CMS cited a lower-
level deficiency under section 483.20(k), but did not include in that citation the facility’s
failure to include in R8’s care plan instructions regarding her G-tube. It nevertheless
seems plain that a resident’s comprehensive care plan must include G-tube care, if the
resident has a G-tube, and that omission from R8’s plan put the facility out of substantial
compliance with both section 483.20(k) and section 483.25(g)(2).

11

without a physician’s order. That she changed the size of the tube without consulting the
resident’s physician compounded the violation. Further, the resident’s complaints of pain
should have been reported to the physician. See CMS Ex. 18 at 4-6 (McWeeney Decl.

49 14, 19, 21)?

Petitioner dismisses the dangers inherent in allowing untrained and unqualified
individuals to re-insert G-tubes. According to Petitioner, “facility nurses have at their
constant disposal the ability and corresponding responsibility to contact the resident’s
physician for guidance on how to respond to [clinical complications].” P. Br. at 6.
Putting aside the immediate harm that can occur when an unqualified person attempts the
procedure, R8’s situation highlights the weaknesses in Petitioner’s argument. For
reasons that have not been explained, the nurse simply did not contact R8’s physician to
request a physician order, report the G-tube change, the resident’s pain, or her decision to
insert a significantly smaller G-tube.

Resident 5 (R5). R5 was a 56-year-old woman admitted to the facility in November 2011
with diagnoses that included respiratory failure, anoxic brain damage, and status post
cardiac arrest. She was in a vegetative state and required a tracheostomy in order to
breathe and a G-tube for nourishment. CMS Ex. 14 at 1, 29. Her care plan directed staff
to “change tube as ordered.” CMS Ex. 14 at 34. A physician’s order directed staff to
change her G-tube “per policy.” CMS Ex. 14 at 53, 62; CMS Ex. 19 at 5 (Moran Decl.

4 15). Thus, in order to comply with the care plan instruction and the physician order,
staff needed to consult the facility’s policies. But the facility had no such policies. CMS
Ex. 19 at 5 (Moran Decl. § 15); P. Ex. 6 at 2 (Boulay Decl. { 8).

R5’s trach also required care. Her physician ordered staff to change it monthly. CMS
Ex. 14 at 78. Surveyor Moran reviewed R5’s respiratory assessment forms, which
showed that her trach had last been changed almost three months earlier — on May 21,
2012. CMS Ex. 14 at 128, 142; CMS Ex. 19 at 9 (Moran Decl. § 34). The DON did not
claim that the trach had been changed since May and could not explain why it had not
been changed. CMS Ex. 19 at 9 (Moran Decl. § 35). Following the interview, R5’s
physician issued another order directing staff to “please change trach monthly” and “may
change tomorrow.” CMS Ex. 14 at 7.

R5’s physician ordered staff to maintain RS’s oxygen saturation levels (SpO:2) at 92% or
above, with humidified oxygen (O2) supplied via nasal canula at 30%. CMS Ex. 14 at 1,
66. But facility staff rarely followed the physician order. Instead they supplied R5 with
28% humidified O,. CMS Ex. 14 at 101-120. One of the nurses caring for R5 told

° A facility must immediately consult the resident’s physician of any significant change
in the resident’s physical, mental, or psychosocial status or a need to alter treatment
significantly. 42 C.F.R. § 483.10(b)(11). Arguably, the facility violated this
requirement, although CMS did not cite a deficiency under section 483.10 (b)(11).
12

Surveyor Moran that the “night nurse set it that way because she felt that it was all the
resident needed and a lot of steam was coming from the tube and the physician order said
to titrate the O, to keep above 92%.” CMS Ex. 19 at 8 (Moran Decl. § 28). No one
informed R5’s physician that the nursing staff had effectively changed his order. CMS
Ex. 19 at 8 (Moran Decl. {ff 28, 29).

Resident 12 (R12). R12 was a 60-year-old man, admitted to the facility in April 2012.
He suffered from chronic respiratory failure and was in a persistent vegetative state
caused by encephalopathy (brain damage due to lack of oxygen). CMS Ex. 15 at 1, 13.
He was fed through a G-tube and had a tracheostomy in place to assist with his breathing.
CMS Ex. 15 at 113, 114, 115, 124, 144; See CMS Ex. 19 at 5 (Moran Decl. § 16).

The surveyors reviewed his history, care plan, progress notes, physician orders, physician
notes and nurses notes, but could not find any indication as to the appropriate size of his
G-tube nor instructions as to when to change the G-tube. CMS Ex. 15 at 142; CMS Ex.
19 at 5-6 (Moran Decl. § 18). DON Boulay did not know that R12 had no order that
addressed when to change the G-tube. CMS Ex. 19 at 6 (Moran Decl. § 19). Following
that interview, R12’s physician ordered a G-tube change that day, every three months
thereafter, and as needed. CMS Ex. 15 at 5.

With respect to R12’s trach, on May 21, 2012, the facility’s consultant respiratory
therapist reported that an RN asked her to change R12’s trach, which was “#8 Portex
cuff,” but the facility had no replacements. The respiratory therapist instructed the DON
to order a replacement trach and reminded her that the facility should keep one at the
resident’s bedside. CMS Ex. 15 at 19; see CMS Ex. 19 at 14 (Moran Decl. § 54). On
May 30, the respiratory therapist changed the trach. CMS Ex. 15 at 18. In an order dated
the following day — May 31, 2012 — R12’s physician ordered a size “#8 Portex cuffed
trach,” and directed that it be changed monthly. CMS Ex. 15 at 56. But Surveyor Moran
found no evidence that the trach was changed after May 31. CMS Ex. 19 at 11 (Moran
Decl. § 40). Again, the facility’s DON was not aware that the trach had not been
changed. CMS Ex. 19 at 11 (Moran Decl. ¢ 41).

Nor did staff follow physician orders regarding the amount of oxygen supplied to R12.
His physician ordered 30% humidified O, via his trach collar to maintain SpO; levels
above 92%. CMS Ex. 15 at 2,56. But nurses notes show that the staff regularly
disregarded this order, usually providing 45% humidified O, and, on one occasion,
providing 28% humidified O). CMS Ex. 15 at 116-124; CMS Ex. 19 at 11 (Moran Decl.
4 42).

Petitioner dismisses these significant facts, characterizing CMS’s position as “‘a factual
recitation on whether doctors’ orders were followed in a few cases.” P. Br. at 6 n.4.
Because CMS did not specifically cite the facility for failing to follow a doctor’s order,
Petitioner claims that CMS’s arguments regarding staff’s failure to follow physician

13

orders “should be ignored.” P. Br. at 14n.7. But in order to provide “appropriate” or
“proper” care and treatment, nursing staff must follow physician orders, and their failing
to do so puts the facility out of substantial compliance with 42 C.F.R. §§ 483.25(g)(2)
and 483.25(k), as well as multiple other regulations, which CMS did not cite.'°

Administration. The facility must be governed in a manner that enables it to use its
resources effectively and efficiently to attain or maintain the highest practicable physical,
mental, and psychosocial well-being of each resident. 42 C.F.R. § 483.75. Among other
requirements, it must have in place a governing body that is legally responsible for
establishing and implementing policies regarding the management and operation of the
facility. 42 C.F.R. § 483.75(d)(1). The governing body appoints the administrator, who
is responsible for managing the facility. 42 C.F.R. § 483.75(d)(2). The governing body
must also designate a physician to serve as medical director who is responsible for
implementing resident care policies and coordinating medical care in the facility.

42 CFR. § 483.75(i).

A deficiency citation alleging noncompliance with section 483.75 (administration) may
be derived from findings of noncompliance with other participation requirements.

[W]here a facility has been shown to be so out of compliance
with program requirements that its residents have been placed
in immediate jeopardy, the facility was not administered in a
manner that used its resources effectively to attain the highest
practicable physical, mental, and psychosocial well-being of
each resident.

Asbury Ctr. at Johnson City, DAB No. 1815 at 11 (2002); see also Woodland Oaks
Healthcare Facility, DAB No. 2355 at 17 (2010); Stone Cnty. Nursing & Rehab. Ctr.,
DAB No. 2276 at 15-16 (2009); Odd Fellow & Rebekah Health Care Facility, DAB No.
1839 at 7 (2002). As discussed below, I find that the facility’s deficiencies posed
immediate jeopardy to resident health and safety, which, by itself, justifies the finding
that the facility was not in substantial compliance with 42 C.F.R. § 483.75.

Moreover, the facility’s shortcomings here were directly attributable to administrative
failures. The facility’s administration — including its governing body, administrator, and
medical director — is responsible for having written policies in place. The administration
is responsible for training and supervising staff. Because it had no policies and
procedures in place for providing essential care and treatment to its residents; because its
medical director was not even aware that the facility lacked those policies; because

'° Moreover, failing to follow a physician’s order means that staff do not meet
professional standards of quality, which puts it out of substantial compliance with
42 CFR. § 483.20(k)(3)(i). See footnote 5.
14

administration did not assure that staff were capable of providing necessary care, the
facility was not in substantial compliance with 42 C.F.R. §§ 483.75, 483.75(d)(1) - (2), or
483.75(i).

2. CMS’s determination that the facility’s deficiencies posed immediate jeopardy to
resident health and safety is not clearly erroneous.

Immediate jeopardy. Immediate jeopardy exists if a facility’s noncompliance has caused
or is likely to cause “serious injury, harm, impairment, or death to a resident.” 42 C.F.R.
§ 488.301. CMS’s determination as to the level of a facility’s noncompliance (which
would include an immediate jeopardy finding) must be upheld unless it is “clearly
erroneous.” 42 C.F.R. § 498.60(c). The Board has observed repeatedly that the “clearly
erroneous” standard imposes on facilities a “heavy burden” to show no immediate
jeopardy, and has sustained determinations of immediate jeopardy where CMS presented
evidence “from which ‘[o]ne could reasonably conclude’ that immediate jeopardy
exists.” Barbourville Nursing Home, DAB No. 1931 at 27-28 (2004) (citing Koester
Pavilion, DAB No. 1750 (2000)); Daughters of Miriam Ctr., DAB No. 2067 at 7, 9
(2007).

I need not find that the facility’s noncompliance actually caused serious harm or injury to
aresident.'' So long as the deficiencies are likely to cause serious injury or harm, they
pose immediate jeopardy.

As discussed above, I cannot overstate the seriousness of allowing an untrained person to
reinsert a G-tube or to attempt trach care, especially in the absence of written instructions,
a physician’s order, or in contravention of a physician’s order. Residents requiring G-
tubes are vulnerable. An untrained person inserting a G-tube can perforate the stomach,
causing bleeding and peritonitis. CMS Ex. 19 at 12-13 (Moran Decl. ¥ 49); P. Ex. 7 at 2.
Replacing a G-tube with one of a different size, particularly without the physician’s order
or knowledge, is dangerous. As Surveyor McWeeney explained, if the tube is too large,
it can be painful; if too small, it might leave a dangerous open space, allowing the acidic
gastric contents of the stomach to leak out, causing pain and skin breakdown. CMS Ex.
18 at 6 (McWeeney Decl. § 21).

Residents with trachs are even more vulnerable.’* They rely on the trachs to breathe.
Trachs must be suctioned regularly, replaced periodically, and monitored to ensure that

'' CMS did not press the point, but, when she attempted to change R8’s G-tube, the
untrained nurse inflicted pain, which is actual harm.

"2 Because R5 and R12 had both G-tubes and trachs, and because they were comatose,
they were especially fragile. As the above discussion shows, the care they received did
not reflect that staff recognized that fragility.
15

they are working properly. Complications are serious and include infection, hemorrhage,
tracheal esophageal fistula, and interference with swallowing. P. Ex. 5, file
M2U00077.MPG at 4:38. Furthermore, cuffed trachs, such as R12’s (CMS Ex. 15 at 1),
present their own potential hazards, including the esophageal wall tissue dying. In fact,
during the 2011 trach training, the facility recommended that cuffed trachs be changed to
uncuffed trachs. P. Ex. 5, file M2U00077.MPG at 5:09 - 6:10. But multiple residents did
not receive the care their physicians had ordered. Trach tubes, which should have been
changed monthly, were left in place months after they should have been replaced.

Notwithstanding the importance of providing appropriate treatment and services, staff
regularly disregarded physician orders. They did not change trach tubes as ordered, but
left them in place for months after they should have been changed. They simply refused
to follow orders for oxygen, substituting their own judgment for that of the physician,
without the physician’s knowledge or consent.

Because the facility’s deficiencies were likely to cause serious harm to vulnerable facility
residents, CMS’s determination that the deficiencies posed immediate jeopardy to
resident health and safety is not clearly erroneous.

Conclusion

Petitioner has conceded that, from August 17 through October 1, 2012, the facility was
not in substantial compliance with Medicare program requirements. For the reasons set
forth above, I find that, during this period, the facility was not in substantial compliance
with 42 C.F.R. §§ 483.25(g)(2), 483.25(k), 483.75, 483.75(d)(1) - (2), and 483.75(i) and
that, from August 17 through 22, 2012, these deficiencies posed immediate jeopardy to
resident health and safety. I therefore grant CMS’s motion for summary judgment and
deny Petitioner’s.

/s/
Carolyn Cozad Hughes
Administrative Law Judge