                                                                                           04/29/2020
                 IN THE SUPREME COURT OF TENNESSEE
                            AT NASHVILLE
                                  May 30, 2019 Session

 MELISSA MARTIN, ET AL. v. ROLLING HILLS HOSPITAL, LLC, ET AL.

                   Appeal by Permission from the Court of Appeals
                        Circuit Court for Williamson County
                        No. 2016-8 Michael Binkley, Judge
                      ___________________________________

                            No. M2016-02214-SC-R11-CV
                       ___________________________________


We granted permission to appeal to clarify the role of prejudice in a court’s determination
of whether a plaintiff in a health care liability action substantially complied with the
statutory pre-suit notice requirements of Tennessee Code Annotated section 29-26-121
(Supp. 2019) (“Section 121”) and to clarify the burdens each party bears when seeking to
establish, or to challenge, compliance with Section 121. We hold that prejudice is
relevant to the determination of whether a plaintiff substantially complied with Section
121, but it is not a separate and independent analytical element. We also hold that a
plaintiff bears the initial burden of either attaching documents to her health care liability
complaint demonstrating compliance with Section 121 or of alleging facts in the
complaint demonstrating extraordinary cause sufficient to excuse any noncompliance
with Section 121. A defendant seeking to challenge a plaintiff’s compliance with Section
121 must file a Tennessee Rule of Civil Procedure 12.02(6) motion to dismiss for failure
to state a claim. See Myers v. AMISUB (SFH), Inc., 382 S.W.3d 300, 307 (Tenn. 2012).
A defendant’s Rule 12.02(6) motion must include allegations that identify the plaintiff’s
noncompliance and explain “the extent and significance of the plaintiff’s errors and
omissions and whether the defendant was prejudiced by the plaintiff’s noncompliance.”
Stevens ex rel. Stevens v. Hickman Cmty. Health Care Servs., Inc., 418 S.W.3d 547, 556
(Tenn. 2013). One means of satisfying this burden is to allege that a plaintiff’s Section
121(a)(2)(E) medical authorization lacks one or more of the six core elements federal law
requires for compliance with the Health Insurance Portability and Accountability Act of
1996 (“HIPAA”). See Pub. L. No. 104-191, 110 Stat. 1936 (1996) (codified as amended
in scattered sections of 18, 26, 29, and 42 of the United States Code). Once a defendant
files a Rule 12.02 motion that satisfies this prima facie showing, the burden then shifts to
the plaintiff either to establish substantial compliance with Section 121—which includes
the burden of demonstrating that the noncompliance did not prejudice the defense—or to
demonstrate extraordinary cause that excuses any noncompliance. In this case, the
defendants met their burden by showing that the plaintiffs’ medical authorizations lacked
three of the six core elements federal law requires for HIPAA compliance. This showing
shifted the burden to the plaintiffs, and they failed to establish either substantial
compliance or extraordinary cause to excuse their noncompliance. As a result of this
noncompliance with Section 121(a)(2)(E), the plaintiffs were not entitled to the 120-day
extension of the statute of limitations. Therefore, their first lawsuit, filed after the one-
year statute of limitations expired, was not “commenced within the time limited by a rule
or statute of limitation,” Tenn. Code Ann. § 28-1-105(a) (2017), so the plaintiffs cannot
rely on the one-year savings statute to establish the timeliness of this lawsuit.
Accordingly, we reverse the judgment of the Court of Appeals and reinstate the trial
court’s judgment dismissing the plaintiffs’ health care liability action as time-barred.


   Tenn. R. App. P. 11 Appeal by Permission; Judgment of the Court of Appeals
               Vacated; Judgment of the Circuit Court Reinstated


CORNELIA A. CLARK, J., delivered the opinion of the Court, in which JEFFREY S. BIVINS,
C.J., and SHARON G. LEE, and ROGER A. PAGE, JJ., joined. HOLLY KIRBY, J., filed an
opinion concurring in part and dissenting in part.

Edward A. Hadley, Linda A. Nathanson, and Matthew J. Buchbinder, Nashville,
Tennessee, for the appellant, Matthew Karl, M.D.

Ashley D. Cleek and Brandon J. Stout, Jackson, Tennessee, for the appellants, Rolling
Hills Hospital, LLC, and Universal Health Services, Inc.

Trudy Bloodworth, Nashville, Tennessee; and Dawn M. Smith, Dallas, Texas (pro hac
vice), for the appellees, Melissa Martin, on behalf of herself and minor children C.H.,
A.H., Jr., wrongful death beneficiaries of Chelsey Elizabeth Kay Helwig, deceased, and
James Harrison.

W. Bryan Smith, Memphis, Tennessee; John Vail, Washington, D.C.; and Brian G.
Brooks, Greenbriar, Arkansas, for Amicus Curiae Tennessee Trial Lawyers Association.

Christopher A. Vrettos, Nashville, Tennessee, for Amicus Curiae Tennessee Defense
Lawyers Association.




                                            -2-
                                              OPINION

                            I. Factual and Procedural Background1

       On June 25, 2013, twenty-three-year-old Chelsey Elizabeth Kay Helwig (“Ms.
Helwig” or “decedent”) presented to Skyline Medical Center complaining of suicidal
ideation and depressive disorder. After an examination, she was transferred to Rolling
Hills Hospital, LLC (“Rolling Hills”), a mental health facility. On June 26, 2013, she
was admitted to Rolling Hills for specialized in-patient psychiatric care for suicidal
ideation and detoxification from opiates, benzodiazepines, alcohol, and cocaine. Dr.
Matthew Karl (“Dr. Karl”), who specialized in psychiatric medicine and provided care
and treatment to patients at Rolling Hills, evaluated Ms. Helwig and prescribed
medications for her. On the morning of June 28, 2013, Rolling Hills’ staff discovered
Ms. Helwig unresponsive in her hospital room. They began CPR and called 9-1-1.
Emergency personnel arrived a short time later and transferred her to Williamson
Medical Center. Subsequently, Ms. Helwig was transferred to Vanderbilt Medical
Center, where she died later that day.

       On October 17, 2014, the decedent’s mother, Melissa Martin, and her father,
James Harrison, filed a health care liability action. They sued in their individual
capacities, and the decedent’s mother also sued on behalf of the decedent’s estate and the
decedent’s two minor children (collectively “the Plaintiffs”). The Plaintiffs named as
defendants Rolling Hills, Dr. Karl, and Universal Health Services, Inc. (“UHS”), the
parent company that owned, managed, controlled, and/or operated Rolling Hills
(collectively “the Defendants”). The Plaintiffs alleged that the Defendants were
negligent in their evaluation, treatment, monitoring, and care of the decedent and that
their negligence caused her death.

        As with any health care liability lawsuit, the Plaintiffs were required to provide the
Defendants with written pre-suit notice at least sixty days before filing their health care
liability action. See Tenn. Code Ann. § 29-26-121(a)(1). On October 4, 2013,
approximately a year before they filed their complaint, the Plaintiffs attempted to comply
with Section 121 by sending a letter to both Rolling Hills and UHS (collectively, “the
Hospital Defendants”) notifying them of their intent to file suit. Along with each letter,
the Plaintiffs included a separate document purporting to list “all providers being sent a


        1
          Because this matter was dismissed on defense motions, this factual summary is taken from the
complaint and other pleadings in the record on appeal. Citations and quotations in this opinion are to the
current version of statutes because the relevant statutory text remains the same as it was when this matter
began in the trial court.



                                                   -3-
notice[,]” but this document listed only Rolling Hills. The Plaintiffs also included two
medical authorizations with each letter, but the Plaintiffs failed to list on any of these four
authorizations the name and address of the provider authorized to release medical
records. They also left blank the space on the medical authorizations designated for an
expiration or event date. Finally, while the decedent’s mother signed the medical
authorizations in her representative capacity, she failed to provide a description or
documentation of her authority to act for the decedent.

       The Plaintiffs first attempted to provide Dr. Karl with pre-suit notice several
months later, on June 20, 2014. As with the Hospital Defendants, the Plaintiffs sent Dr.
Karl a letter notifying him of their intent to file suit and included a separate document
purporting to list “all providers being sent a notice[,]” but this document listed only Dr.
Karl and Rolling Hills. Dr. Karl’s letter included two medical authorizations, but, like
the medical authorizations sent to the Hospital Defendants, the Plaintiffs failed to list the
name and address of the provider authorized to release medical records to Dr. Karl. The
Plaintiffs also left blank the space on the medical authorizations designated for an
expiration or event date. Finally, while the decedent’s mother signed the medical
authorizations in her representative capacity, she failed to provide a description or
documentation of her authority to act for the decedent.

        As already noted, the document the Plaintiffs included with their October 2013
pre-suit notice letters to the Hospital Defendants did not list Dr. Karl as a provider who
would be named as a defendant. Additionally, prior to filing the lawsuit, the Plaintiffs
never informed the Hospital Defendants that they had sent Dr. Karl a pre-suit notice
letter. Nor did the Plaintiffs ever send the Hospital Defendants a medical authorization
permitting them to obtain the decedent’s medical records from Dr. Karl.

        After the Plaintiffs filed their lawsuit in October 2014, the Defendants objected
that the Plaintiffs had failed to provide pre-suit notice in compliance with Section 121.2
However, before the trial court ruled on the matter, the Plaintiffs voluntarily nonsuited
their lawsuit. Tenn. R. Civ. P. 41.01.3 On January 27, 2015, the trial court entered an
order dismissing the lawsuit without prejudice.


        2
           The record in this appeal does not indicate the manner in which the Defendants objected to the
Plaintiffs’ pre-suit notice, but it is undisputed that the Defendants raised the issue before the Plaintiffs
voluntarily nonsuited the action.

        3
            Rule 41.01 states in pertinent part:

                 (1) Subject to the provisions of Rule 23.05, Rule 23.06, or Rule 66 or of any
        statute, and except when a motion for summary judgment made by an adverse party is
        pending, the plaintiff shall have the right to take a voluntary nonsuit to dismiss an action
                                                     -4-
       Less than a year later, on January 7, 2016, the Plaintiffs filed a second lawsuit
alleging the same health care liability claims against the Defendants. To establish the
timeliness of this second lawsuit, the Plaintiffs relied on the savings statute, which
provides:

        If the [original] action is commenced within the time limited by a rule or
        statute of limitation, but the judgment or decree is rendered against the
        plaintiff upon any ground not concluding the plaintiff’s right of action, or
        where the judgment or decree is rendered in favor of the plaintiff, and is
        arrested, or reversed on appeal, the plaintiff, or the plaintiff’s
        representatives and privies, as the case may be, may, from time to time,
        commence a new action within one (1) year after the reversal or arrest.

Tenn. Code Ann. § 28-1-105(a).

        On January 28, 2016, the Hospital Defendants filed a joint motion to dismiss the
second lawsuit as time-barred. The Hospital Defendants acknowledged that the Plaintiffs
filed the first lawsuit within 120 days of the expiration of the statute of limitations and
that the first lawsuit would have been timely had the Plaintiffs provided pre-suit notice
substantially compliant with Section 121. See Tenn. Code Ann. § 29-26-121(c) (“When
notice is given to a provider as provided in this section, the applicable statutes of
limitations and repose shall be extended for a period of one hundred twenty (120)
days . . . .”). The Hospital Defendants contended, however, that the Plaintiffs’ pre-suit
notice was not substantially compliant with Section 121.4 In particular, the Hospital
Defendants asserted that: (1) the Plaintiffs failed to mail the pre-suit notice letter to the
Hospital Defendants’ registered agents for service of process, as required by Section
121(a)(3)(B)(ii); (2) the Plaintiffs’ medical authorizations lacked three core elements
mandated by federal law and were therefore not HIPAA compliant as required by Section
121(a)(2)(E); and (3) the Plaintiffs failed to notify the Hospital Defendants that Dr. Karl

        without prejudice by filing a written notice of dismissal at any time before the trial of a
        cause and serving a copy of the notice upon all parties . . . .

                ....

                 (3) A voluntary nonsuit to dismiss an action without prejudice must be followed
        by an order of voluntary dismissal signed by the court and entered by the clerk. The date
        of entry of the order will govern the running of pertinent time periods.
        4
            It is undisputed that the Plaintiffs provided timely and fully compliant pre-suit notice to the
Defendants before filing their second lawsuit. This appeal pertains only to the pre-suit notice the
Plaintiffs provided before filing their first lawsuit.



                                                   -5-
was a potential defendant as required by Section 121(a)(2)(D). Because the Plaintiffs’
pre-suit notice was not substantially compliant with Section 121, the Hospital Defendants
asserted that the Plaintiffs were not entitled to the 120-day extension of the statute of
limitations, so their first lawsuit was not timely filed. As a result, the Hospital
Defendants asserted that the Plaintiffs could not rely on the one-year savings statute to
establish the timeliness of their second lawsuit.

        In March 2016, Dr. Karl filed his own motion to dismiss in which he joined the
Hospital Defendants’ motion to dismiss and adopted their arguments.5 In addition, Dr.
Karl asserted that he had attempted to use the medical authorization the Plaintiffs
provided “to obtain [Rolling Hills’] records pertaining to the decedent[,]” but “[t]he
hospital [had] declined to produce the records because of the defective authorization.”
Dr. Karl argued that the Plaintiffs’ noncompliance thus deprived him of “the opportunity
to evaluate the medical records and the merits of the [Plaintiffs’] claim prior to suit being
filed.”

        In separate responses to the motions to dismiss, the Plaintiffs argued that they had
substantially complied with the pre-suit notice requirements of Section 121 and that any
noncompliance had not prejudiced the Defendants. The Plaintiffs did not rely upon or
attempt to establish that extraordinary cause excused their noncompliance. As to
prejudice, the Plaintiffs did not submit affidavits but merely argued in their responses to
the motions that they had engaged in settlement negotiations with the Hospital
Defendants from April to June 2014, and that these negotiations “equipped [the Hospital
Defendants] with the means to evaluate the substantive merits of [the Plaintiffs’] claims
by early discovery and early access to [the decedent’s] medical records.” The Plaintiffs
stated that the Hospital Defendants called Dr. Karl’s conduct into question during the
settlement negotiations, so the Hospital Defendants clearly were aware that Dr. Karl was
a potential defendant. The Plaintiffs also argued without relying upon any affidavit or
defense admission that the Hospital Defendants were not prejudiced by any deficiencies
in the pre-suit notice relating to Dr. Karl because he was an employee or agent of Rolling
Hills and had no relevant medical records aside from those the Hospital Defendants
already had in their possession.

      On August 4, 2016, the trial court held a hearing on the Defendants’ motions to
dismiss. By a written order entered on September 19, 2016, the trial court granted the
Defendants’ motions and dismissed the lawsuit. The trial court based its decision solely


       5
          For reasons that are not apparent, the record contains two identical motions to dismiss by Dr.
Karl, one filed on March 4 and another filed on March 16, 2016.



                                                 -6-
on the Plaintiffs’ failure to provide the Defendants with HIPAA-compliant medical
authorizations as required by Section 121(a)(2)(E).6 The trial court pointed out that the
medical authorizations “failed to indicate the providers that were authorized to make
required disclosures, failed to list an expiration date, and left blank section B on the []
authorization form.” When rejecting the Plaintiffs’ argument that the Defendants were
not prejudiced by the defective authorizations, the trial court quoted an earlier decision of
the Court of Appeals stating, “defendants were prejudiced by the fact that they were
unable to obtain the patient’s medical records due to some flaw in the medical
authorization.” Hughes v. Henry Cnty. Med. Ctr., No. W2014-01973-COA-R3-CV, 2015
WL 3562733, at *4 (Tenn. Ct. App. June 9, 2015). The trial court also rejected the
Plaintiffs’ argument that the Defendants were not prejudiced “because they already had
possession of the relevant documents.” The trial court explained that the “omissions” on
the medical authorizations “were significant because without this information, even if
[the] Defendants were already in possession of certain documentations, the authorizations
were useless” and “would not have allowed Defendants to request or obtain records from
any of the other providers.” The trial court also pointed out that the Plaintiffs had failed
to respond with any showing of extraordinary cause to excuse the noncompliance. See
Tenn. Code Ann. § 29-26-121(b) (“The court has discretion to excuse compliance with
this section only for extraordinary cause shown.”). Based on these findings, the trial
court ruled: “Due to their substantial non-compliance [with Section 121(a)(2)(E)],
Plaintiffs were not originally entitled to the 120-day extension of the statute of limitations
under . . . Section 29-26-121(c). Without the 120-day extension, Plaintiffs’ initial filing
was time-barred, and as such, the current matter must be dismissed.” The Plaintiffs
appealed.

        The Court of Appeals reversed. Martin v. Rolling Hills Hosp., LLC, No. M2016-
02214-COA-R3-CV, 2018 WL 3097231, at *9 (Tenn. Ct. App. June 22, 2018), perm.
app. granted (Tenn. Nov. 16, 2018). The intermediate appellate court commented that the
trial court “[had] not explain[ed] its conclusion that the authorizations were ‘useless’ or
reach[ed] the question of whether Defendants were prejudiced by Plaintiffs’ errors.” Id.
at *8. Addressing Dr. Karl’s “attempt[] to use the authorizations to obtain records,” id. at


        6
          The trial court also determined that the Defendants were not prejudiced by the Plaintiffs’ failure
to include in their pre-suit notice the names and addresses of all providers sent pre-suit notice, as required
by Section 121(a)(2)(D) or by the Plaintiffs’ failure to mail pre-suit notice letters to Defendants’
registered agents for service of process as required by Section 121(a)(3)(B)(ii). We need not address these
determinations because our holding that the Plaintiffs failed to substantially comply with Section
121(a)(2)(E) is dispositive.




                                                    -7-
*8, the Court of Appeals observed that the letters exchanged between counsel for Dr.
Karl and Rolling Hills did not “reflect a good faith attempt on the part of Defendants to
secure the records,” but instead showed “an effort by their counsel to establish a record
upon which to present this argument[,]” id. at *8 n.7. The Court of Appeals determined
that the Defendants had not shown prejudice because Dr. Karl was an “employee and/or
ostensible agent” of Rolling Hills, and UHS was “merely a corporate entity (not
Provider/Health Plan) and obviously had no treatment records regarding Ms. Helwig.”
Id. at *9. Based on its conclusions that the Plaintiffs had substantially complied with
Section 121(a)(2) and that the Defendants had failed to show prejudice from the
Plaintiffs’ noncompliance, the Court of Appeals concluded that the Plaintiffs’ first
lawsuit was timely filed and that the savings statute applied to their second lawsuit. Id.
Accordingly, the Court of Appeals reversed the trial court’s decision and remanded the
case for further proceedings. Id.

       This Court granted the Defendants’ applications for permission to appeal and
directed the parties to address:

       1) the proper role of prejudice in the substantial compliance analysis and
       determination; and

       2) the proper burden of production and/or proof with respect to the presence
       or absence of prejudice for purposes of the substantial compliance analysis
       and determination, including whether or not the Court should consider the
       adoption of a rebuttable presumption of prejudice where the pre-suit notice
       is not accompanied by a medical authorization which is facially compliant
       with HIPAA.

Martin v. Rolling Hills Hospital, No. M2016-02214-SC-R11-CV (Tenn. Nov. 16, 2018)
(Order) (granting applications for permission to appeal).

                                 II. Standard of Review

        The Defendants filed motions to dismiss under Rule 12.02(6) of the Tennessee
Rules of Civil Procedure, arguing that the lawsuit is time-barred by the one-year statute
of limitations because the savings statute does not apply. A Rule 12.02(6) motion is an
appropriate means of invoking the statute of limitations as a ground for dismissing a
complaint. Redwing v. Catholic Bishop for Diocese of Memphis, 363 S.W.3d 436, 455
n.11 (Tenn. 2012). The Defendants’ statute of limitations argument is also premised on
the assertion that the Plaintiffs’ first lawsuit was not timely filed because the Plaintiffs
failed to provide pre-suit notice substantially compliant with Section 121. Rule 12.02(6)
is the proper vehicle for challenging a plaintiff’s compliance with the pre-suit notice
requirements of Section 121. Myers, 382 S.W.3d at 307. However, because the
                                            -8-
Defendants submitted matters outside the pleadings in support of their 12.02(6) motions,
the motions “shall be treated as [motions] for summary judgment . . . .” Tenn. R. Civ. P.
12.02; see Runions v. Jackson-Madison Cnty. Gen. Hosp. Dist., 549 S.W.3d 77, 81 n.5
(Tenn. 2018). Summary judgment is appropriate when “the pleadings, depositions,
answers to interrogatories, and admissions on file, together with the affidavits, if any,
show that there is no genuine issue as to any material fact and that the moving party is
entitled to a judgment as a matter of law.” Tenn. R. Civ. P. 56.04. We review a trial
court’s decision on a motion for summary judgment de novo without a presumption of
correctness. Rye v. Women’s Care Ctr. of Memphis, MPLLC, 477 S.W.3d 235, 250
(Tenn. 2015) (citing Bain v. Wells, 936 S.W.2d 618, 622 (Tenn. 1997)).

       “[W]hether [Plaintiffs] ha[ve] demonstrated extraordinary cause that would excuse
compliance with [Section 121] is a mixed question of law and fact, and our review of that
determination is de novo with a presumption of correctness applying only to the trial
court’s findings of fact and not to the legal effect of those findings.” Myers, 382 S.W.3d
at 307. Additionally, issues of statutory construction are questions of law, to which
de novo review applies, with no presumption of correctness afforded to lower court
decisions. Thurmond v. Mid-Cumberland Infectious Disease Consultants, PLC, 433
S.W.3d 512, 516-17 (Tenn. 2014) (citing Baker v. State, 417 S.W.3d 428, 433 (Tenn.
2013)). Thus, de novo review applies to the issues presented in this appeal.

                                        III. Analysis

        At least sixty days before filing a complaint alleging a health care liability claim, a
plaintiff in Tennessee must give written notice of the claim to each health care provider
that will be named as a defendant in the lawsuit. Tenn. Code Ann. § 29-26-121(a)(1)
(“Any person, or that person’s authorized agent, asserting a potential claim for health
care liability shall give written notice of the potential claim to each health care provider
that will be a named defendant at least sixty (60) days before the filing of a complaint
based upon health care liability in any court of this state.”). This statutory requirement of
timely, written pre-suit notice is mandatory and may be satisfied only by strict
compliance; substantial compliance is inadequate. Myers, 382 S.W.3d at 309; see also
Runions, 549 S.W.3d at 86.

       Section 121(a)(2) defines the information—the content—that a plaintiff must
include in the pre-suit notice:

              The notice shall include:

                     (A) The full name and date of birth of the patient
                     whose treatment is at issue;


                                             -9-
                     (B) The name and address of the claimant authorizing
                     the notice and the relationship to the patient, if the
                     notice is not sent by the patient;
                     (C) The name and address of the attorney sending the
                     notice, if applicable;
                     (D) A list of the name[s] and address[es] of all
                     providers being sent a notice; and
                     (E) A HIPAA compliant medical authorization
                     permitting the provider receiving the notice to obtain
                     complete medical records from each other provider
                     being sent a notice.

Tenn. Code Ann. § 29-26-121(a)(2); John A. Day, Med Mal Makeover 2009 Act
Improves on ’08: The New New Medical Malpractice Notice & Certificate of Good Faith
Statutes, 45 Tenn. B.J. 14, 14-16 (July 2009) (discussing Section 121(a)(2) and the pre-
suit notice content requirements). These statutory content requirements are directory and
may be satisfied by substantial compliance. Stevens, 418 S.W.3d at 555 (evaluating
whether a plaintiff substantially complied with Section 121(a)(2)(E)); see also Arden v.
Kozawa, 466 S.W.3d 758, 762-64 (Tenn. 2015) (holding that the requirements of Section
121(a)(3)(B) and (a)(4) may be satisfied through substantial compliance); Thurmond, 433
S.W.3d at 520 (holding that the affidavit requirement of Section 121(a)(3)(B) and (a)(4)
may be satisfied by substantial compliance).

        This Court has explained the distinct but interdependent purposes Section 121
serves, stating that it “ensures that a plaintiff give[s] timely notice to a potential
defendant of a health care liability claim so it can investigate the merits of the claim and
pursue settlement negotiations before the start of the litigation.” Runions, 549 S.W.3d at
86 (citing Foster v. Chiles, 467 S.W.3d 911, 915 (Tenn. 2015)). “Pre-suit notice benefits
the parties by promoting early resolution of claims, which also serves the interest of
judicial economy.” Id. (citing Foster, 467 S.W.3d at 915). The first three content
requirements of Section 121(a)(2) “facilitate early resolution of healthcare liability claims
by requiring plaintiffs to advise defendants who the plaintiff is, how to reach him or her,
and how to contact his or her attorney.” Stevens, 418 S.W.3d at 554. The last two
requirements “serve an investigatory function, equipping defendants with the actual
means to evaluate the substantive merits of a plaintiff’s claim by enabling early discovery
of potential co-defendants and early access to a plaintiff’s medical records.” Id.

        With these principles in mind, we return to the dispositive issue in this appeal:
whether the Plaintiffs substantially complied with Section 121(a)(2) before filing their
first lawsuit. Stevens ex rel. Stevens v. Hickman Community Health Care Services, Inc.,
provides the framework for our analysis of this issue. In Stevens, the plaintiff failed to
provide a “‘HIPAA compliant medical authorization permitting the provider receiving the
                                            - 10 -
notice to obtain complete medical records from each other provider being sent a notice.’”
Id. at 555 (quoting Tenn. Code Ann. § 29-26-121(a)(2)(E)). We pointed out that HIPAA
generally “prohibits medical providers from using or disclosing a plaintiff’s medical
records without a fully compliant authorization form.” Id. We therefore declared that “it
is a threshold requirement of [Section 121] that the plaintiff’s medical authorization must
be sufficient to enable defendants to obtain and review a plaintiff’s relevant medical
records.” Id. And we emphasized that “[f]ederal regulations” mandate the following six
“core” elements for a HIPAA compliant medical authorization:

                 (i) A description of the information to be used or disclosed that
         identifies the information in a specific and meaningful fashion.
                 (ii) The name or other specific identification of the person(s),
         or class of persons, authorized to make the requested use or
         disclosure.
                 (iii) The name or other specific identification of the person(s),
         or class of persons, to whom the covered entity may make the
         requested use or disclosure.
                 (iv) A description of each purpose of the requested use or
         disclosure . . . .
                 (v) An expiration date or an expiration event that relates to the
         individual or the purpose of the use or disclosure . . . .
                 (vi) Signature of the individual and date. If the authorization is
         signed by a personal representative of the individual, a description of
         such representative’s authority to act for the individual must also be
         provided.

Id. at 555-56 (quoting 45 C.F.R. § 164.508(c)(1) (2013)). We noted that omitting any of
these core elements may render a medical authorization noncompliant with HIPAA and
ineffective “to enable defendants to obtain and review a plaintiff’s relevant medical
records.” Id. at 555 (citing 45 C.F.R. § 164.508(a)(1)). We also emphasized that “[t]he
penalties imposed upon covered entities that wrongfully disclose or obtain private health
information in violation of HIPAA are . . . extremely severe, with such entities facing
punishment of up to $50,000 per offense and/or imprisonment of up to one year for non-
compliance.” Stevens, 418 S.W.3d at 555 n.6 (citing 42 U.S.C.A. § 1320d-6). We ruled
that, when determining whether a plaintiff “has substantially complied with [Section
121(a)(2)(E),] a reviewing court should consider the extent and significance of the
plaintiff’s errors and omissions and whether the defendant was prejudiced by the
plaintiff’s noncompliance.” Id. at 556.




                                           - 11 -
       Applying that analysis, we noted that the plaintiff in Stevens had conceded that her
medical authorization provided “‘very little benefit’” to the defendants and failed to
comply with HIPAA. Id. This Court agreed and pointed out that the plaintiff’s medical
authorization failed to satisfy at least three of the six core elements mandated by federal
law for HIPAA compliance. Id. In particular, the medical authorization:

       lacked a description of the medical information to be disclosed, 45 C.F.R. §
       164.508(c)(1)(i); failed to state the individuals or organizations authorized
       to disclose the . . . medical records, 45 C.F.R. § 164.508(c)(1)(ii); and
       failed to specify the type of information authorized to be used or disclosed,
       45 C.F.R. § 164.508(c)(1)(iv).

Id. We thus concluded that the medical authorization the Stevens plaintiff provided “was
woefully deficient,” had “numerous and significant” errors and omissions, and that,
because of these deficiencies, the “[d]efendants were not authorized to receive any of the
Plaintiff’s records.” Id. Nevertheless, we cautioned that “[a] plaintiff’s less-than-perfect
compliance with [Section 121(a)(2)(E)]” will not always “derail a healthcare liability
claim” because “[n]on-substantive errors and omissions will not always prejudice
defendants by preventing them from obtaining a plaintiff’s relevant medical records.”7
Id. at 555. But we concluded that, “[a]s a result of multiple errors,” the Stevens plaintiff
“failed to substantially comply with the requirements of [Section 121(a)(2)(E)].” Id. at
556.

       Tennessee courts have now applied Stevens for more than six years, yet
“Tennessee law is less than settled concerning the question of substantial compliance[,]”
particularly with respect to Section 121(a)(2)(E). Rush v. Jackson Surgical Assocs. PA,
No. W2016-01289-COA-R3-CV, 2017 WL 564887, at *4-5 (Tenn. Ct. App. Feb. 13,
2017). For example, in some cases, prejudice has been treated as a separate independent
element of analysis, in addition to substantial compliance. See, e.g., Buckman v.
Mountain States Health Alliance, 570 S.W.3d 229, 238-39 (Tenn. Ct. App. 2018)
(concluding that the plaintiff failed to substantially comply with subsection (a)(2)(E) and
also concluding “that the defendants were prejudiced” by the plaintiff’s noncompliance),
perm. app. denied (Tenn. Nov. 15, 2018). In other cases, prejudice has been treated as a
consideration relevant to the determination of whether a plaintiff has substantially
complied with Section 121(a)(2)(E), and not as a separate and independent analytical
element. See, e.g., Lawson v. Knoxville Dermatology Grp., P.C., 544 S.W.3d 704, 713
(Tenn. Ct. App. 2017) (concluding that the plaintiff failed to substantially comply with


       7
         For an example of an imperfect but substantially compliant medical authorization form, consult
Hamilton v. Abercrombie Radiological Consultants, Inc., E2014-003433-COA-R3-CV, 2014 WL
7117802 (Tenn. Ct. App. Dec. 15, 2014), perm. app. denied (Tenn. May 15, 2015).

                                                - 12 -
Section 121(a)(2)(E) where errors in the authorization prejudiced defendants), perm. app.
denied (Tenn. Nov. 16, 2017); Hunt v. Nair, No. E2014-01261-COA-R9-CV, 2015 WL
5657083, at *10-12 (Tenn. Ct. App. Sept. 25, 2015) (concluding that plaintiffs
substantially complied with Section 121(a)(2)(E) where non-substantive errors in the
HIPAA authorizations did not prejudice the defendants), perm. app. denied (Tenn. Jan.
21, 2015).

       We take this opportunity to clarify the role of prejudice in a court’s determination
of whether a plaintiff in a health care liability action has substantially complied with
Section 121. We reaffirm Stevens and hold that prejudice is not a separate and
independent analytical element; rather, as Stevens explained, prejudice is a consideration
relevant to determining whether a plaintiff has substantially complied. Stevens, 418
S.W.3d at 556 (stating that whether a plaintiff “has substantially complied with a
statutory [content] requirement, a reviewing court should consider the extent and
significance of the plaintiff’s errors and omissions and whether the defendant was
prejudiced by the plaintiff’s noncompliance”). Prejudice, or the absence of prejudice, is
especially relevant to evaluating the extent and significance of the plaintiff’s
noncompliance. If a plaintiff’s noncompliance with Section 121 frustrates or interferes
with the purposes of Section 121 or prevents the defendant from receiving a benefit
Section 121 confers, then the plaintiff likely has not substantially complied with Section
121. See id. at 563 (noting that the focus should be “on the extent of the shortcomings
and whether those shortcomings have frustrated the purpose of the statute or caused
prejudice to the adversary party”). On the other hand, if the plaintiff’s noncompliance
neither frustrates or interferes with the purposes of Section 121 nor prevents a defendant
from receiving a benefit the statute confers, then a court is more likely to determine that
the plaintiff has substantially complied.

        We also take this opportunity to clarify the burdens each party bears when seeking
to establish, or to challenge, compliance with Section 121. We adopt and apply the
burden-shifting approach articulated in Myers v. AMISUB (SFH), Inc., 382 S.W.3d at
307. By statute, a health care liability plaintiff bears the initial burden of establishing
compliance with Section 121 by stating in the pleadings and providing “the
documentation specified in subdivision (a)(2),” or of alleging “extraordinary cause” for
any noncompliance. Tenn. Code Ann. § 29-26-121(b). A defendant wishing to challenge
a plaintiff’s compliance with Section 121(a)(2) must file a 12.02(6) motion to dismiss for
failure to state a claim.8 Myers, 382 S.W.3d at 307. The defense motion must describe


        8
           If proof outside the pleadings is submitted and considered by the trial court, the motion must be
treated as a motion for summary judgment. See Tenn. R. Civ. P. 12.02.



                                                   - 13 -
“how the plaintiff has failed to comply with [Section 121] by referencing specific
omissions,” id., and by explaining “the extent and significance of the plaintiff’s errors
and omissions and whether the defendant was prejudiced by the plaintiff’s
noncompliance,” Stevens, 418 S.W.3d at 556. A defendant may demonstrate that the
noncompliance resulted in prejudice by explaining—for example—how the
noncompliance frustrated or interfered with the purposes of Section 121 or deprived the
defendant of a benefit Section 121 confers. One means of satisfying this burden is by
alleging that the plaintiff’s Section 121(a)(2)(E) medical authorization lacks one or more
of the six core elements required by federal law for HIPAA compliance. Under federal
law, a medical authorization is not HIPAA compliant if “[t]he authorization has not been
filled out completely, with respect to” a core element. 45 C.F.R. § 164.508(b)(2)(ii).
Without a HIPAA compliant medical authorization, a defendant would ordinarily be
deprived of a benefit Section 121 confers, as it declares that “[a]ll parties . . . shall be
entitled to obtain complete copies of the claimant’s medical records from any other
provider receiving notice.” Tenn. Code Ann. § 29-26-121(d)(1). Although defendants
must explain how they were prejudiced by noncompliance, defendants need not “test”
incomplete and facially noncompliant medical authorizations. As we recognized in
Stevens, obtaining medical records with a HIPAA noncompliant medical authorization
would violate federal regulations and could result in the imposition of severe penalties.
Stevens, 418 S.W.3d at 565 n.6; see also Woodruff ex rel. Cockrell v. Walker, 542
S.W.3d 486, 499 (Tenn. Ct. App. 2017) (“Because the penalties imposed on entities that
wrongfully disclose or obtain private health information in violation of HIPAA are
severe, the sufficiency of the plaintiffs’ medical authorizations is imperative.”), perm.
app. denied (Tenn. Oct. 6, 2017); J.A.C. ex rel. Carter v. Methodist Healthcare Memphis
Hosps., 542 S.W.3d 502, 514-15 (Tenn. Ct. App. 2016) (stating that a health care liability
defendant has no duty to assist a plaintiff to achieve compliance with Section 121 or to
test the validity of a medical authorization that is facially lacking a core element required
for HIPAA compliance); Dolman v. Donovan, No. W2015-00392-COA-R3-CV, 2015
WL 9315565, at *5 (Tenn. Ct. App. Dec. 23, 2015) (rejecting the plaintiffs’ argument
that the medical providers could not have been prejudiced because they never attempted
to obtain medical records with the deficient medical authorization provided), perm. app.
denied (Tenn. May 6, 2016). As we emphasized in Stevens, plaintiffs, not defendants,
are “responsible for complying with the requirements of [Section 121].” Stevens, 418
S.W.3d at 559.

       Once a defendant files a motion that satisfies the foregoing prima facie showing,
the plaintiff then bears the burden of establishing substantial compliance with Section
121, which includes the burden of demonstrating that the noncompliance did not
prejudice the defense. Rye, 477 S.W.3d at 264-65; see also Moreno v. City of
Clarksville, 479 S.W.3d 795, 802 (Tenn. 2015) (citations omitted) (stating that once the
City established a prima facie statute of limitations defense, the plaintiff bore the burden
of establishing an exception to the defense); Benton v. Snyder, 825 S.W.2d 409, 414
                                            - 14 -
(Tenn. 1992) (citations omitted) (same). The plaintiff “may not rest upon the mere
allegations or denials of [its] pleading,” but must respond, and by affidavits or another
means provided in Tennessee Rule 56, “set forth specific facts” demonstrating that the
noncompliance did not prejudice the defense. Rye, 477 S.W.3d at 265. Defendants have
no obligation to aid plaintiffs in meeting this burden, and defendants need not notify
plaintiffs that a medical authorization lacks one or more of the six core elements federal
law requires for HIPAA compliance. See Stevens, 418 S.W.3d at 559 (rejecting the
argument that the defendant should have notified the plaintiff of the noncompliance with
Section 121 so that the plaintiff could have remedied the problem).9

       Applying this analysis to the undisputed facts in the record on appeal, we conclude
that the Plaintiffs failed to substantially comply with Section 121(a)(2)(E). Like the
medical authorization in Stevens, the Plaintiffs’ medical authorizations lacked three of
the core elements required by federal law for HIPAA compliance. The Plaintiffs’
medical authorizations failed to include: (1)“[t]he name or other specific identification of
the person(s), or class of persons authorized to make the requested use or disclosure[s,]”
see 45 C.F.R. § 164.508(c)(1)(ii); (2) “[a]n expiration date or an expiration event that
relates to the individual or the purpose of the use or disclosure[,]” see 45 C.F.R. §
164.508(c)(1)(v); and (3) “[i]f the authorization is signed by a personal representative of
the individual, a description of such representative’s authority to act for the individual
must also be provided[,]” see 45 C.F.R. § 164.508(c)(1)(vi). Given these omissions, the
trial court correctly found that the medical authorizations were “useless” to the
Defendants. 45 C.F.R § 164.508(b)(2)(ii) (stating that a medical authorization lacking a
core element is not valid).

       The Plaintiffs failed to respond to the Defendants’ prima facie showing and
instead rested on the allegations and arguments in their pleadings, specifically, that the
Defendants were not prejudiced by the noncompliance because the Plaintiffs and the
Hospital Defendants had engaged in settlement negotiations several months before the
Plaintiffs filed the lawsuit and that the Hospital Defendants already had all of the
decedent’s relevant medical records. The Hospital Defendants have never conceded that
they were not prejudiced by the Plaintiffs’ failure to comply with Section 121(a)(2)(E), as


        9
            As one commentator cautioned not long after Section 121(a)(2) was adopted:

                 There is no penalty for giving more information than required by statute in the
        notice letter. However, those who fail to give the information required by the statute are
        at risk for an assertion that the notice is defective and does not operate to extend the
        statute of limitations. Thus, counsel may wish to use a checklist to ensure that each letter
        sent to a health care provider complies with the notice statute.

Day, supra, at 15 (emphasis added).

                                                   - 15 -
the hospital did in the case on which the Plaintiffs rely to support their argument. See
Hughes, 2015 WL 3562733. To the contrary, the Hospital Defendants have consistently
argued that they were prejudiced because, without an authorization allowing them to
request records from Dr. Karl, they were unable to fully investigate the case during the
pre-suit notice period. In any event, settlement negotiations are not a substitute for a
HIPAA compliant medical authorization as required by Section 121(a)(2)(E). Cf. Foster,
467 S.W.3d at 916 (holding that plaintiffs must provide pre-suit notice each time a
complaint is filed and that the pre-suit notice filed before the first complaint was not
sufficient when the plaintiff filed a second complaint pursuant to the savings statute). As
to Dr. Karl, the Plaintiffs have asserted that he had access to all the decedent’s medical
records because he was either an employee or ostensible agent of Rolling Hills. Again,
Dr. Karl has not admitted these allegations, and he introduced correspondence showing
that he attempted to use the Plaintiffs’ noncompliant medical authorization without
success. The Plaintiffs simply have failed to point to specific facts in the record to satisfy
their burden of showing that the Defendants were not prejudiced by their noncompliance.
The record on appeal instead supports the Defendants’ arguments that the Plaintiffs’
noncompliance precluded them from receiving the benefits Section 121(a)(2)(E) and (d)
were intended to confer by preventing them from obtaining the decedent’s medical
records from all other providers named as defendants. See Parks v. Walker, 585 S.W.3d
895, 900 (Tenn. Ct. App. 2018) (holding that a medical authorization lacking core
elements required by federal law for HIPAA compliance was not substantially compliant
with Section 121(a)(2)(E)), perm. app. denied (Tenn. Mar. 27, 2019); Buckman, 570
S.W.3d at 239 (same); J.A.C., 542 S.W.3d at 513 (same).

        The trial court here also noted that the Plaintiffs failed to make any showing of
extraordinary cause to excuse their noncompliance with Section 121(a)(2)(E). The trial
court addressed this issue, even though the Plaintiffs did not assert extraordinary cause at
all in their responses to the Defendants’ motions to dismiss. Rather, the Plaintiffs resisted
the Defendants’ motions by asserting that they had substantially complied with Section
121. The Plaintiffs have raised extraordinary cause in passing in their briefs in the Court
of Appeals and in this Court; but, as a general rule, “issues raised for the first time on
appeal are waived.” State v. Rowland, 520 S.W.3d 542, 545 (Tenn. 2017) (citing Fayne
v. Vincent, 301 S.W.3d 162, 171 (Tenn. 2009)). This general rule of waiver applies here
to the Plaintiffs’ assertion that extraordinary cause excused their noncompliance.

        Accordingly, we conclude that the pre-suit notice the Plaintiffs provided before
filing their first lawsuit failed to substantially comply with Section 121(a)(2)(E).
Therefore, the Plaintiffs were not entitled to the 120-day extension of the statute of
limitations and their first lawsuit was untimely filed. Because their first lawsuit was not
timely filed, the Plaintiffs were not entitled to rely on the savings statute to establish the
timeliness of this second lawsuit. Accordingly, the trial court correctly held that the
Plaintiffs’ lawsuit is time-barred.
                                            - 16 -
                         IV.     Waived Issue and Separate Opinion

        In their brief to this Court, the Plaintiffs also assert that, even if they failed to
substantially comply with Section 121(a)(2), they were still entitled to the 120-day
extension of the statute of limitations provided in Section 121(c) because that extension is
contingent upon a plaintiff’s compliance with Section 121(a)(2)(B) not upon a plaintiff’s
compliance with Section 121(a)(2). The Plaintiffs recognize that this argument is
inconsistent with several prior appellate court decisions, citing Stevens, 418 S.W.3d at
560; J.A.C., 542 S.W.3d at 512; Dolman, 2015 WL 9315565, at *3; and Roberts v. Prill,
E2013-02202-COA-R3-CV, 2014 WL 2921930, at *1 (Tenn. Ct. App. June 26, 2014),
but the Plaintiffs assert that these decisions failed to analyze properly the language of
Section 121(c). The Plaintiffs failed to raise this issue in either the trial court or the Court
of Appeals. “Issues not raised in the trial court or in the intermediate appellate courts
may be deemed waived when presented to this Court.” Hodge v. Craig, 382 S.W.3d 325,
334 n.3 (Tenn. 2012) (citing Brown v. Roland, 357 S.W.3d 614, 620 (Tenn. 2012); In re
Adoption of E.N.R., 42 S.W.3d 26, 32 (Tenn. 2001); Alexander v. Armentrout, 24
S.W.3d 267, 273 (Tenn. 2000)); see also Harmon v. Hickman Cmty. Healthcare Servs.,
Inc., 594 S.W.3d 297, 300-301 (Tenn. 2020) (deeming waived several issues raised for
the first time in this Court). We conclude that the Plaintiffs have waived this issue.

        Inexplicably, Justice Kirby refuses to deem the Plaintiffs’ new issue waived in her
separate concurring in part and dissenting in part opinion and instead declares that the
Defendants waived the defense of waiver. In Justice Kirby’s circular analysis, the
Defendants are at fault for not asserting waiver when the Plaintiffs raised an issue for the
first time in their brief to this Court. Of course, the Plaintiffs have not argued that the
Defendants waived the waiver defense (which presumably would mean, under Justice
Kirby’s analysis, that the Plaintiffs waived the argument that the Defendants waived the
waiver defense).       Nevertheless, Justice Kirby makes that declaration—that the
Defendants waived the waiver defense—and then proceeds to address the merits of the
issue the Plaintiffs have plainly waived. Conspicuous by its absence is any citation to
authority supporting Justice Kirby’s declaration that the Defendants waived the waiver
defense. More importantly, Justice Kirby acknowledges that this Court’s authority and
discretion to deem an issue waived exists independent of a litigant’s assertion of the
defense. We exercise that authority without hesitation here, where the record on appeal is
a textbook example of waiver. This record leaves no doubt that the Plaintiffs failed to
preserve and raise in the courts below the issue Justice Kirby addresses on the merits and
shows that the Plaintiffs first raised it in this Court. Moreover, only three months ago
Justice Kirby authored an opinion that applied waiver in almost identical circumstances.
See Harmon, 594 S.W.3d at 300-301 (“In Plaintiffs’ brief to this Court, they seek to raise
several additional issues. Most of these arguments were not made to either the trial court
or the Court of Appeals. We deem these issues waived. ‘Issues not raised in the trial


                                             - 17 -
court or in the intermediate appellate courts may be deemed waived when presented to
this Court.’” (quoting Hodge, 382 S.W.3d at 334)).

        In any event, notwithstanding the fundamental principle of waiver, Justice Kirby
addresses the issue on the merits, faults the Court of Appeals (and presumably this Court
as well as it denied applications seeking review of many of the intermediate appellate
court decisions she now deems erroneous), and asserts that the Court of Appeals has
frustrated the General Assembly’s intent by construing Section 121 as requiring plaintiffs
to comply strictly with Section 121(a)(1) and substantially comply with Section 121(a)(2)
to obtain a 120-day extension of the statute of limitations. Because the issue is waived,
we need not expressly rebut each of Justice Kirby’s assertions. We are, however,
constrained to make three observations.

        First, Justice Kirby’s statutory analysis renders Section 121(a)(2) meaningless and
is inconsistent with the understanding of the statute’s meaning by persons who were
familiar with the 2009 amendments. See, e.g., Day, supra, at 15 (“There is no penalty for
giving more information than required by statute in the notice letter. However, those who
fail to give the information required by the statute are at risk for an assertion that the
notice is defective and does not operate to extend the statute of limitations.”).

        Second, Justice Kirby mischaracterizes in footnote 7 this Court’s decision in
Stevens. This Court in Stevens dismissed the lawsuit without prejudice and did not
decide whether the dismissal without prejudice would, as a practical matter, mean the
plaintiff’s claim was time-barred because “the trial court did not reach this issue.”
Stevens, 418 S.W.3d at 560.

        Third, and finally, Justice Kirby’s assertion that courts have misconstrued Section
121 and frustrated the General Assembly’s intent is refuted by the fact that in the eleven
years since its enactment the General Assembly has not amended the statute to abrogate
these allegedly erroneous judicial decisions. Coffee Cnty. Bd. of Ed. v. City of
Tullahoma, 574 S.W.3d 832, 847 (Tenn. 2019) (“[L]egislative inaction following a
contemporaneous and practical interpretation of a statute is considered persuasive
evidence of the Legislature’s intent to adopt that interpretation.” (Citations omitted));
Freeman Indus. v. Eastman Chem. Co., 172 S.W.3d 512, 519 (Tenn. 2005) (“[T]he
legislature’s failure to express disapproval of a judicial construction of a statute is
persuasive evidence of legislative adoption of the judicial construction.” (Internal
quotation marks and citations omitted)).




                                           - 18 -
                                     V. Conclusion

       For the reasons stated herein, we reverse the judgment of the Court of Appeals and
reinstate the judgment of the trial court dismissing this lawsuit as time-barred. Costs on
appeal are taxed to the Plaintiffs for which execution may issue if necessary.



                                                   _________________________________
                                                   CORNELIA A. CLARK, JUSTICE




                                          - 19 -
