United States of America et al v. Kinetic Concepts, Inc.

Filing 383

STIPULATED PROTECTIVE ORDER FOR PRODUCTION BY NON-PARTIES THE CENTERS FOR MEDICARE & MEDICAID SERVICES; NORIDIAN HEALTHCARE SOLUTIONS, LLC; AND CGS ADMINISTRATORS, LLC by Magistrate Judge Alicia G. Rosenberg. re Stipulation for Protective Order, 381 . (See Order for Further Details) (kl)

Case 2:08-cv-06403-CAS-AGR Document 383 Filed 08/16/21 Page 1 of 24 Page ID #:5979

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UNITED STATES DISTRICT COURT

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CENTRAL DISTRICT OF CALIFORNIA

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WESTERN DIVISION

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UNITED STATES OF AMERICA,
ex rel. GERALDINE GODECKE,
Plaintiff,
v.
KINETIC CONCEPTS, INC. and
KCI USA, INC.,
Defendants.

NO.: 2:08-cv-06403-CAS-AGR
[PROPOSED] STIPULATED
PROTECTIVE ORDER FOR
PRODUCTION BY NON-PARTIES
THE CENTERS FOR MEDICARE &
MEDICAID SERVICES; NORIDIAN
HEALTHCARE SOLUTIONS, LLC;
AND CGS ADMINISTRATORS, LLC
Hon. Christina A. Snyder
Judge:
Courtroom: 8D

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STIPULATED PROTECTIVE ORDER FOR PRODUCTION BY CMS AND DME MACS

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[PROPOSED] STIPULATED PROTECTIVE ORDER FOR PRODUCTION
BY NON-PARTIES THE CENTERS FOR MEDICARE & MEDICAID
SERVICES (“CMS”); NORIDIAN HEALTHCARE SOLUTIONS, LLC
(“NORIDIAN”); AND CGS ADMINISTRATORS, LLC (“CGS”)

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Relator Geraldine Godecke (“Relator”) and defendants Kinetic Concepts, Inc.
and KCI USA, Inc. (collectively defendants are “KCI”) (Relator and KCI are the
“Parties” and each is a “Party”) file this Stipulated Protective Order and Exhibits for
Production by non-party the Department of Health & Human Services (“HHS”),
Centers for Medicare & Medicaid Services (“CMS”; HHS and CMS are agencies of
the United States), and on CMS’s Durable Medical Equipment Medicare
Administrative Contractors (“DME MACs”), Noridian Healthcare Solutions, LLC
(“Noridian”) and CGS Administrators, LLC (“CGS”) (the “Protective Order”) to
preserve the confidentiality of Protected Health Information (“PHI”), privileged, and
financial, commercial, and trade secret information that may be produced in discovery
in this action. The Parties agree that a protective order concerning such information
is necessary to protect the confidentiality and integrity of the information, waiver of
privilege, and to prevent injury (including without limitation financial and competitive
injury) that the Producing Party or the person who is the subject of the information
might incur from public disclosure.

All headings and subheadings used in this

Protective Order are used for convenience only and are not to be considered in
construing or interpreting this Protective Order. The Parties have agreed to the
following terms of confidentiality, and the court has found that good cause exists for
issuance of an appropriately-tailored Protective Order governing all phases of this
action. It is therefore ORDERED:
1.

Definitions. As used in this Protective Order,

(a) “Commercially Sensitive Information” means information that the
Producing Party believes would result in competitive, commercial, or
financial harm, including pricing information, reimbursement rates, rebate
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terms, minimum guarantee payments, sales reports, sales margins, and

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contracts or agreements between pharmaceutical companies and pharmacy

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benefit managers.

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(b) “Conclusion” means the end time for any records retention requirement and
statute of limitations applicable to a Party or a Party’s counsel.
(c) “Covered Entity or Entities” means “covered entity” as defined in 45 C.F.R.
§ 160.103.
(d) “Discovery Material” is intended to be comprehensive and includes any and
all

CMS/Noridian/CGS

produced

materials,

including

documents,

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information, electronically-stored information (“ESI”) and tangible things in

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the broadest sense contemplated under Federal Rules of Civil Procedure 34,

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and includes all written, oral, recorded, electronic, or graphic material,

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however produced or reproduced, including, but not limited to all written or

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printed matter of any kind, computer data of any kind, graphic or manual

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records or representations of any kind, and electronic, mechanical, or electric

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records furnished in the course of discovery under this Protective Order by

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the signatories to this Protective Order, and other persons or entities subject

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to this Protective Order, including deposition testimony and exhibits,

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answers to interrogatories, and responses to discovery requests and

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subpoenas issued under this Protective Order.

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(e) “Litigation” or “this case” means the case entitled United States ex rel.

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Geraldine Godecke v. Kinetic Concepts, Inc. and KCI USA, Inc., Central

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District of California no. 2:08-cv-06403-CAS-AGR as well as all related

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appellate proceedings.

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(f) “Parties” means Relator Geraldine Godecke and defendants Kinetic
Concepts, Inc. and KCI USA, Inc., and each is a “Party.”
(g) “Producing Party” means CMS or any CMS contractor or CMS agent that
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produces Discovery Material pursuant to this Protective Order (specifically

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including Noridian and CGS).

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(h) “Proprietary Information” means trade secret or other confidential research,

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development, or commercial information entitled to protection under Federal

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Rules of Civil Procedure 26(c)(1)(G).

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(i) “Protected Health Information” or “PHI” means “protected health

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information” as defined in 45 C.F.R. § 160.103.

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(j) “Service Providers” means any court reporter service, videographer service,

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translation service, photocopy service, document management service,

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records management service, graphics service, or other such litigation

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service designated by a Party or a Party’s legal counsel in this case.

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2.

CONFIDENTIAL

Information.

Information

designated

as

13 “CONFIDENTIAL” pursuant to this Protective Order (hereinafter “CONFIDENTIAL
14 Information”) means Discovery Material that contains PHI and any Discovery
15 Material that would be protected by the Privacy Act of 1974, 5 U.S.C. § 552a, and/or
16 45 C.F.R. Part 5b in the hands of CMS.
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3.

HIGHLY CONFIDENTIAL Information. Information designated as

18 “HIGHLY CONFIDENTIAL” pursuant to this Protective Order (hereinafter
19 “HIGHLY CONFIDENTIAL Information”) means Discovery Material that contains
20 Proprietary Information or Commercially Sensitive Information.

“HIGHLY

21 CONFIDENTIAL” information is also documents that are marked as Deliberative
22 Process Privileged (“DPP”) but produced under the separate STIPULATED
23 PROTECTIVE ORDER GOVERNING NON-WAIVER OF UNITED STATES OF
24 AMERICA’S PRIVILEGE AND PROTECTED MATERIAL that is attached as
25 Exhibit A to this Protective Order.
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4.

Designation of Material as CONFIDENTIAL.

Upon producing

27 Discovery Material to the Parties pursuant to a subpoena or other lawful process, the
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1 Producing Party should designate the Discovery Material as “CONFIDENTIAL.” The
2 Producing Party shall, if practical, designate “CONFIDENTIAL” on every page of the
3 Discovery Material in the same manner in which every page is Bates stamped. If it is
4 not practical to designate “CONFIDENTIAL” on the Discovery Material, then the
5 Producing Party shall designate the Discovery Material as “CONFIDENTIAL” in
6 correspondence or in some other manner reasonably giving notice of the designation,
7 including (but not limited to) affixing a label marked “CONFIDENTIAL” on the cover
8 of or surface of any electronic media. It is practical to designate “CONFIDENTIAL”
9 on every page of the Discovery Material if it is produced with a Bates stamp on every
10 page. It is not practical to designate “CONFIDENTIAL” on every page of the
11 Discovery Material if it is a spreadsheet or presentation file produced in native format
12 (e.g., Microsoft Excel, PowerPoint, or Access).
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5.

Designation of Material as HIGHLY CONFIDENTIAL.

Upon

14 producing Discovery Material containing Proprietary Information or Commercially
15 Sensitive Information to the Parties pursuant to a subpoena or other lawful process,
16 the Producing Party should designate the Discovery Material as “HIGHLY
17 CONFIDENTIAL.” The Producing Party shall, if practical, designate “HIGHLY
18 CONFIDENTIAL” on every page of the Discovery Material in the same manner in
19 which every page is Bates stamped. If it is not practical to designate “HIGHLY
20 CONFIDENTIAL” on the Discovery Material, then the Producing Party shall
21 designate the Discovery Material as “HIGHLY CONFIDENTIAL” in correspondence
22 or in some other manner reasonably giving notice of the designation, including (but
23 not limited to) affixing a label marked “HIGHLY CONFIDENTIAL” on the cover of
24 or surface of any electronic media.

It is practical to designate “HIGHLY

25 CONFIDENTIAL” on every page of the Discovery Material if it is produced with a
26 Bates stamp on every page.

It is not practical to designate “HIGHLY

27 CONFIDENTIAL” on every page of the Discovery Material if it is a spreadsheet or
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1 presentation file produced in native format (e.g., Microsoft Excel, PowerPoint, or
2 Access). Moreover, as noted above, “HIGHLY CONFIDENTIAL” information is
3 also documents that are marked as Deliberative Process Privileged (“DPP”) but
4 produced under the separate STIPULATED PROTECTIVE ORDER GOVERNING
5 NON-WAIVER OF UNITED STATES OF AMERICA’S PRIVILEGE AND
6 PROTECTED MATERIAL that is attached as Exhibit A to this Protective Order.
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6.

Access to CONFIDENTIAL Information. As needed to pursue the

8 Litigation, and subject to paragraph 8, the Parties shall permit only the following
9 persons to have access to CONFIDENTIAL Information:
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(a) The Parties’ outside legal counsel and their employees and agents;

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(b) The Parties’ in-house legal counsel, employees, and agents;

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(c) Any Service Providers,;

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(d) The Parties' experts and consultants and their employees and agents;

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(e) Individuals who any Party or Party’s legal counsel interviews or deposes;

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(f) The court and court-related personnel; and

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(g) Such other persons if this court so orders.

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7.

Access to HIGHLY CONFIDENTIAL Information. As needed to

18 pursue the Litigation, and subject to paragraph 8, the Parties shall permit only the
19 following persons to have access to HIGHLY CONFIDENTIAL Information:
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(a) The Parties’ outside legal counsel, and outside legal counsel’s employees

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and agents;

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(b) Any Service Providers;

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(c) The Parties’ experts and consultants and their employees and agents;

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(d) Individuals who any Party or Party’s legal counsel interviews or deposes;

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(e) The court and court-related personnel; and

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(f) Such other persons if this court so orders.

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8.

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Except for the individuals designated under paragraphs 6(f) and 7(e).
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1 Except for the individuals designated under paragraphs 6(f) and 7(e), the Parties shall
2 ensure that each individual designated in paragraphs 6 and 7 who reviews or is given
3 access to Discovery Materials reads, agrees to, and signs a copy of the attached
4 Acknowledgement of Protective Order (attached at Exhibit B), except that entry of this
5 Protective Order by the court will constitute Acknowledgement by the Parties and their
6 legal counsel. Where an entity is designated in paragraphs 6 and 7, an officer or
7 manager of the entity may sign the Acknowledgement of Protective Order on behalf
8 of the entire entity. Each Party’s legal counsel shall maintain the copy of the
9 Acknowledgement of Protective Order as signed by each individual or entity
10 designated in paragraphs 6 and 7 and shall permit the opposing Party’s legal counsel
11 and U.S. Department of Health and Human Services (HHS) Office of the General
12 Counsel, CMS Division to inspect said copy or copies upon request. Individuals and
13 entities designated in paragraphs 6 and 7, except for the individuals designated under
14 paragraphs 6(f) and 7(e), who do not sign the attached Acknowledgement of Protective
15 Order must not be given access to Discovery Materials.
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9.

Destruction of CONFIDENTIAL Information and HIGHLY

17 CONFIDENTIAL Information at the Conclusion of the Litigation. No later than
18 90 days following the Conclusion of the Litigation, the Parties and the individuals and
19 entities designated in paragraphs 6 and 7 shall destroy all CONFIDENTIAL
20 Information and HIGHLY CONFIDENTIAL Information (including all copies made).
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All counsel of record shall certify compliance with paragraph 9 on behalf

22 of themselves, the Parties they represent, and the Parties’ employees and agents
23 (including, but not limited to, the individuals and entities designated in paragraphs 6
24 and 7, as applicable) and shall deliver this certification to HHS Office of the General
25 Counsel, CMS Division not more than 90 days after the Conclusion of the Litigation.
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10.

Use

of

CONFIDENTIAL

Information

or

HIGHLY

27 CONFIDENTIAL Information in documents filed with the court. In the event any
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1 Party wishes to use CONFIDENTIAL Information or HIGHLY CONFIDENTIAL
2 Information in any affidavits, briefs, memoranda, exhibits, motions, or other papers
3 filed in court in this action, such Party shall take appropriate steps to safeguard
4 CONFIDENTIAL Information or HIGHLY CONFIDENTIAL Information, including
5 ensuring compliance with all applicable local rules and district court rules. Where the
6 papers

to

be

filed

contain

CONFIDENTIAL

Information

or

HIGHLY

7 CONFIDENTIAL Information not pertinent to the issue before the court, the Parties
8 should redact such CONFIDENTIAL Information or HIGHLY CONFIDENTIAL
9 Information. Where the filing Party wishes the court to review the CONFIDENTIAL
10 Information or HIGHLY CONFIDENTIAL Information filed with the court, and all
11 portions of pleadings, motions or other papers filed with the court that disclose such
12 CONFIDENTIAL Information or HIGHLY CONFIDENTIAL Information, the filing
13 Party must make the filing under seal with the clerk of the court and the filing should
14 remain under seal until further order of the court. The Parties will use their best efforts
15 to minimize such sealing.
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11.

Exercise of Restraint and Care in Designating Material for

17 Protection. The Producing Party will take care to limit any such CONFIDENTIAL
18 or HIGHLY CONFIDENTIAL designation to specific material that qualifies under the
19 appropriate standards. The Producing Party must designate for protection only those
20 parts of material, documents, items, or oral or written communications that qualify –
21 so that other portions of the material, documents, items, or communications for which
22 protection is not warranted are not swept unjustifiably within the ambit of this
23 Protective Order.
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Mass, indiscriminate, or routinized designations are prohibited. If it

25 comes to the Producing Party’s attention that information or items that it designated
26 for CONFIDENTIAL or HIGHLY CONFIDENTIAL protection do not qualify for
27 protection, the Producing Party must promptly notify all Parties that it is withdrawing
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1 the mistaken designation.
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The Parties recognize that the Local Rules of the Central District of

3 California and controlling case law require that the party or nonparty who seeks to
4 designate material as confidential bears the burden of showing why such documents
5 are confidential and require filing under seal. Civil Local Rule 79 sets forth the
6 procedures that must be followed and the standards that will be applied when a party
7 seeks permission from the court to file material under seal.
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Should any Party seek, or contemplate, filing with the Court a document

9 designated as privileged or otherwise protectable under the law, that Party should
10 notify the Producing Party five-business days in advance of such filing. If the
11 Producing Party still desires that the document be filed under seal, it shall be so filed
12 pursuant to applicable rules and a Court determination, based on the Parties’ legal
13 burdens, of any claim of privilege or other protection.
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12.

Filing Protected Material. Without written permission from the

15 Producing Party or a court order secured after appropriate notice to all interested
16 persons, a Party may not file in the public Court record any CONFIDENTIAL or
17 HIGHLY CONFIDENTIAL material. And a Party seeking to file under seal any
18 CONFIDENTIAL or HIGHLY CONFIDENTIAL material must comply with
19 applicable Civil Local Rules including Local Rule 79. CONFIDENTIAL or HIGHLY
20 CONFIDENTIAL material may only be filed under seal pursuant to a court order
21 authorizing

the

sealing

of

the

specific

CONFIDENTIAL

or

HIGHLY

22 CONFIDENTIAL material at issue with the Party seeking such under seal filing
23 bearing the burden as to why the sealing of such documents should be authorized or
24 continue. Pursuant to Civil Local Rule 79 a sealing order will issue only upon a
25 request establishing that the CONFIDENTIAL or HIGHLY CONFIDENTIAL
26 material at issue is privileged, protectable as a trade secret, or otherwise entitled to
27 protection under the law. The Parties shall also give notice to the Producing Party of
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1 any requests to file CONFIDENTIAL or HIGHLY CONFIDENTIAL materials under
2 seal, and of any oppositions to such requests, so that the Producing Party may assert
3 any interest it has in keeping the CONFIDENTIAL or HIGHLY CONFIDENTIAL
4 material under seal.

If a Party's request to file CONFIDENTIAL or HIGHLY

5 CONFIDENTIAL material under seal pursuant to Civil Local Rule 79 is denied by the
6 court, then the Party may file the information.
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Paragraphs 13–16—Terms Specific to PHI.
13.

Pursuant to 45 C.F.R. § 164.512(e)(1) and for purposes of compliance

9 with the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), the
10 Parties’ legal counsel in this Litigation, the employees and agents of each Party, and
11 all non-Party Covered Entities are expressly and specifically authorized to use or
12 disclose PHI in accordance with this order to:
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(a) Respond to interrogatories, requests for admission, or requests for

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production of documents, including ESI, served pursuant to the Federal

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Rules of Civil Procedure in this case seeking PHI;

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(b) Request interviews or depositions and interview, depose, or respond in

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interviews or depositions in which PHI might be disclosed;
(c) Prepare briefs and other materials for the court so long as such materials are

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treated in accordance with paragraph 10 of this Protective Order; and
(d) Disclose PHI to a Party’s expert regardless of whether the expert is a

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consulting or testifying expert.
14.

Pursuant to 45 C.F.R. § 164.512(e)(1) and for purposes of HIPAA

23 compliance, each deponent noticed for deposition in this case, including but not
24 limited to a Party, a fact witness, a records custodian, an expert, or a Covered Entity
25 of any type, is expressly and specifically authorized to use or to disclose to the Parties’
26 legal counsel in this case and the employees and agents of each Party and each Party’s
27 legal counsel in this case, the PHI that is responsive to deposition questions or a valid
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1 subpoena duces tecum.
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15.

Pursuant to 45 C.F.R. § 164.512(e)(1) and for purposes of HIPAA

3 compliance, any person or entity authorized or ordered under paragraphs 11 or 12
4 above to use or disclose PHI is expressly and specifically authorized to do so with, to,
5 or before any Service Providers designated by a Party or a Party’s legal counsel in this
6 case. The protections and requirements of paragraphs 16 and 19 of this Protective
7 Order must be imposed on Service Providers as a condition of any Service Provider’s
8 receipt of PHI. Each Party or the Party’s legal counsel is charged with obtaining
9 advance consent of such Service Provider to comply with this paragraph. Upon such
10 consent, the Service Provider will be deemed to have voluntarily submitted to this
11 court’s jurisdiction during the pendency of this case for purposes of enforcement of
12 this paragraph, including but not limited to the imposition of such sanctions as may be
13 appropriate for any non-compliance.
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16.

The intent of this Protective Order is to authorize the use and disclosure

15 of PHI in accordance with 45 C.F.R. § 164.512(e) and the terms of this Protective
16 Order. To the extent that the uses and disclosures of PHI authorized under this
17 Protective Order may be permitted under other provisions of the HIPAA Privacy Rule,
18 such uses and disclosures are made pursuant to and in accordance with 45 C.F.R. §
19 164.512(e). This paragraph does not apply to uses and disclosures of PHI that are not
20 authorized under this Protective Order.
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17.

Terms Specific to Proprietary Information and Commercially

22 Sensitive Information. For Discovery Materials containing Proprietary Information
23 or Commercially Sensitive Information designated as HIGHLY CONFIDENTIAL,
24 the Producing Party’s production of HIGHLY CONFIDENTIAL Information in this
25 case is not to be construed as waiving or diminishing the Producing Party’s interests
26 in and rights to the confidentiality of Proprietary Information or Commercially
27 Sensitive Information, unless otherwise ordered by the court.
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18.

Discovery Material may not be disclosed or used by any Party or any

2 individual or entity designated in paragraphs 6 or 7 for any purpose other than the
3 Litigation.
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19.

Subject to paragraph 19, all CONFIDENTIAL Information and HIGHLY

5 CONFIDENTIAL Information produced, transmitted, or otherwise received
6 electronically must be maintained in a reasonably secure manner and guarded against
7 re-disclosure for the life of the record.
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20.

Inadvertent production by the Producing Party. If at any time prior

9 to the trial of this action, the Producing Party realizes that:
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(a) Some portion(s) of Discovery Material was produced without a designation

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of CONFIDENTIAL or HIGHLY CONFIDENTIAL, the Producing Party

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may add either designation to those Discovery Materials without limitation

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by apprising the Parties in writing of such designation. Such Discovery

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Material will thereafter be treated as CONFIDENTIAL Information or

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HIGHLY CONFIDENTIAL Information under the terms of this Protective

16

Order. Any failure of the Producing Party to designate Discovery Material

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as CONFIDENTIAL or HIGHLY CONFIDENTIAL does not constitute a

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waiver of any claim of privilege or work product protection with respect to

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the Discovery Material.

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(b) If Discovery Materials subject to a claim of attorney-client privilege or

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attorney work product protection (“Inadvertently Disclosed Information”)

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were inadvertently produced, the Producing Party will be entitled to

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“clawback” this Inadvertently Disclosed Information and to have all copies

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of it either returned to the Producing Party or destroyed. If the Producing

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Party seeks to clawback Inadvertently Disclosed Information, it is entitled to

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do so, regardless of the Producing Party’s diligence in initially attempting to

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prevent such an inadvertent disclosure. To the extent possible, the Producing

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Party will clawback only the portions of Discovery Materials containing

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information subject to a claim of attorney-client privilege or attorney work

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product protection. Any Inadvertent Disclosure by the Producing Party does

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not constitute and shall not be deemed a waiver or forfeiture of any claim of

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privilege or work product protection with respect to the Inadvertently

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Disclosed Information itself and/or its subject matter with respect to this

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Litigation or in any other federal, state, or local proceeding, regardless of the

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Producing Party’s diligence in initially attempting to prevent such

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disclosure. If the Producing Party makes a claim of inadvertent disclosure,

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the Parties shall, within five business days, return or destroy all copies of the

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Inadvertently Disclosed Information, and provide a certification of counsel

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that all such information has been returned or destroyed. Within five

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business days of the notification that such Inadvertently Disclosed

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Information has been returned or destroyed, the Producing Party shall

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produce a privilege log with respect to the Inadvertently Disclosed

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Information. The Parties may move the court for an order compelling

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production of the Inadvertently Disclosed Information. The motion must be

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filed under seal, and may not assert as a ground for entering such an order

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the fact or circumstances of the inadvertent production. The Producing Party

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retains the burden of establishing the privileged or protected nature of any

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Inadvertently Disclosed Information contained in Discovery Materials.

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Nothing in this Protective Order limits the right of any Party to request an in

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camera review of the Inadvertently Disclosed Information.

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21.

Inadvertent production or re-disclosure by a Party or an individual

25 or entity designated in paragraphs 6 or 7. If a Party or an individual or entity
26 designated in paragraphs 6 or 7 (the “Responsible Party”) produces or discloses
27 Discovery Material designated as CONFIDENTIAL Information or HIGHLY
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1 CONFIDENTIAL Information to a person or entity not authorized to receive such
2 disclosure under this Protective Order, such Responsible Party shall, upon becoming
3 aware of such disclosure, immediately inform the Producing Party. The Responsible
4 Party also shall take all reasonable measures to cure the improper disclosure and to
5 promptly ensure that no further or greater unauthorized disclosure of the Discovery
6 Material designated as CONFIDENTIAL Information or HIGHLY CONFIDENTIAL
7 Information.
8
9

Miscellaneous Provisions
22.

Any and all Medicare Part D Prescription Drug Event (PDE) data

10 produced by the Producing Party in this action is considered CONFIDENTIAL
11 Information and/or HIGHLY CONFIDENTIAL Information (depending on which
12 data fields are included or excluded) as that term is used throughout this Protective
13 Order.
14

23.

Pursuant to 5 U.S.C. § 552a(b)(11), this Protective Order authorizes CMS

15 to release Privacy Act-protected information covered by this Protective Order, without
16 the consent of the subject individual.
17

24.

The production of any Discovery Material by CMS in the course of this

18 action, pursuant to and in compliance with the terms of this Protective Order, which
19 might otherwise be prohibited by the Trade Secrets Act, 18 U.S.C. § 1905, constitutes
20 a disclosure “authorized by law” under the terms of the Act.
21

25.

Should any Party bound by this Protective Order receive a subpoena, civil

22 investigative demand, or other process from a third Party seeking, requesting, or
23 requiring disclosure of Discovery Materials produced in this Litigation designated as
24 CONFIDENTIAL Information or HIGHLY CONFIDENTIAL Information, such
25 person shall give notice to HHS Office of the General Counsel, CMS Division so that
26 CMS may seek appropriate relief, if any. Notice must be made by the sooner date of
27 ten days from the date the Party received the request for production or seven days prior
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1 to the deadline for responding to the request for production, and must be in writing.
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26.

Notwithstanding any provisions of this Protective Order to the contrary,

3 in accordance with any applicable federal, state, or local laws that afford heightened
4 protection to certain categories of confidential health information, including but not
5 limited to, records or diagnosis or treatment for alcohol or substance abuse, certain
6 sexually transmitted diseases such as HIV/AIDS, mental health, and research
7 pertaining to genetic testing, the Party in receipt of such information shall comply with
8 the applicable federal, state, or local law that affords heightened protection to such
9 information.
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27.

Nothing in this Protective Order affects the rights of the Parties,

11 Producing Party, or third-Parties to object to discovery on grounds other than those
12 related to the protection of CONFIDENTIAL Information or HIGHLY
13 CONFIDENTIAL Information, nor does it preclude any Party or third-Party from
14 seeking further relief or protective orders from this court as may be appropriate under
15 the Federal Rules of Civil Procedure.
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Any

person

requiring

further

protection

of

CONFIDENTIAL

17 Information or HIGHLY CONFIDENTIAL Information may petition this court for a
18 separate order governing the disclosure of its information.
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29.

The provisions of this Protective Order survive the Conclusion of this

20 Litigation.
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This court retains jurisdiction over all persons subject to this Protective

22 Order to the extent necessary to enforce any obligations arising hereunder or to impose
23 sanctions for any contempt therefore.
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31.

This Protective Order does not dictate the use of CONFIDENTIAL

25 Information or HIGHLY CONFIDENTIAL designated information by a Party at trial.
26 Such use must be determined by appropriate order of the court upon noticed motion.
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32.

To the extent that inconsistences exist between this Protective Order and
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1 any CMS Data Use Agreement executed by the Party in receipt of applicable
2 Discovery Materials, the provisions of this Protective Order control.
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33.

This Protective Order may be amended for good cause shown.

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34.

This Protective Order for Production by non-Party CMS (including its

5 DME MACs Noridian and CGS) is intended solely to supplement any existing
6 Protective Order in the case. It governs only Discovery Materials produced by the
7 Producing Party as defined in this Protective Order.
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1 IT IS SO STIPULATED, THROUGH COUNSEL OF RECORD.
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DATED: August 3, 2021
By: /s/Mark I. Labaton
MARK I. LABATON
[e-mail]
Glancy Prongay & Murray LLP
1925 Century Park East, Suite 2100
Los Angeles, CA 90067
Telephone: [phone]
Facsimile: [phone]
MICHAEL A. HIRST
[e-mail]
HIRST LAW GROUP, P.C.
200 B Street, Suite A
Davis, CA 95616
Telephone: [phone]
Facsimile: [phone]
PATRICK J. O’CONNELL
(pro hac vice)
[e-mail]
2525 Wallingwood Dr., Bldg. 14
Austin, TX 78746
Telephone: [phone]
Attorneys for Relator

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DATED: August 3, 2021
By: /s/Matthew E. Sloan
MATTHEW E. SLOAN (SBN 165165)
[e-mail]
ALYSSA E. MUSANTE (SBN 320821)
[e-mail]
SKADDEN, ARPS, SLATE, MEAGHER & FLOM LLP
300 South Grand Avenue
Los Angeles, California 90071-3144
Telephone: [phone]
Facsimile: [phone]

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GREGORY M. LUCE (pro hac vice)
[e-mail]
BRADLEY A. KLEIN (pro hac vice)
[e-mail]
PAUL A. SOLOMON (pro hac vice)
[e-mail]
JOHN A.J. BARKMEYER (pro hac vice)
[e-mail]
SKADDEN, ARPS, SLATE, MEAGHER & FROM LLP
1440 New York Ave., N.W.
Washington, D.C. 20005
Telephone: [phone]
Facsimile: [phone]

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Attorneys for Kinetic Concepts, Inc. & KCI, USA, Inc.

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17 FOR GOOD CAUSE SHOWN, IT IS SO ORDERED.
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19 DATED: ________________________
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____________________________________
Honorable
United States
Judge

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EXHIBIT A

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STIPULATED PROTECTIVE ORDER GOVERNING NON-WAIVER OF
UNITED STATES OF AMERICA’S PRIVILEGE AND PROTECTED
MATERIAL

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Good Cause Statement
This Action is a qui tam False Claims Act case. The United States of America
declined to intervene in this Action in April 2011.
Defendants Kinetic Concepts, Inc. and KCI USA, Inc. (collectively “KCI” or
defendants), and relator Geraldine Godecke (“Relator”) have each served Rule 45
subpoenas on non-parties (1) the Department of Health & Human Services (“HHS”),
Centers for Medicare & Medicaid Services (“CMS”; HHS and CMS are agencies of
the United States), and on CMS’s Durable Medical Equipment Medicare
Administrative Contractors (“DME MACs”), (2) Noridian Healthcare Solutions, LLC
(“Noridian”) and (3) CGS Administrators, LLC (“CGS”).
CMS, Noridian, and CGS contend that CMS may claim the deliberative process
privilege for documents in the possession of Noridian and CGS (as well as for CMS’
own documents).
KCI disputes that CMS may claim the deliberative process privilege for
Medicare records in the possession of Noridian and CGS; and further contends that
even if it does apply to such documents in the possession of Noridian, CGS, and CMS,
the privilege is a qualified one that may be overridden in appropriate circumstances,
which KCI contends exist in this case.
CMS, Noridian, and CGS wish to produce responsive documents to KCI and
Relator as soon as reasonably possible.
In order to potentially avoid litigating the issue of deliberative process privilege,
KCI, Relator, and CMS/Noridian/CGS desire that discovery proceed in an expeditious
and efficient manner without waiver of any potential privilege or protection afforded
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1 to the CMS, Noridian, and CGS materials.
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Good cause existing for entry of this Protective Order, it is, pursuant to the

3 Court’s authority and with the consent of KCI, Relator, CMS, Noridian, and CGS,
4 ORDERED as follows:
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Terms:

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1. Documents produced by CMS, Noridian, and CGS to KCI and Relator in this

7

Action will be held not to have waived any applicable protections or privileges,

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including the deliberative process privilege. The production of materials by

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CMS, Noridian, and CGS to KCI and Relator does not constitute a waiver of

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any privilege or protection in this Action or any other federal or state

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proceeding. This Order shall be interpreted to provide the maximum protection

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allowed by Rule 502(d) of the Federal Rules of Evidence.

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2. KCI and Relator retain their rights to later challenge the applicability of any

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privilege or protection to the produced documents, including any challenges to

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the applicability of the deliberative process privilege.

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3. CMS, Noridian, and/or CGS retain their rights to later assert any privilege or

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protection applicable to the produced documents, including the deliberative

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process privilege.

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4. Experts for KCI and Relator may review any material produced by CMS,

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Noridian, and CGS; but experts shall be bound by this Order to the same extent

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as KCI and Relator.

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5. Nothing in this Order prohibits CMS, Noridian, or CGS from withholding from

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production any material covered by any privilege or other protection properly

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claimed, including any deliberative process privileged materials (for instance,

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including, but not limited to: (a) draft LCDs, LMRPs, articles and related

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communications; and (b) draft proposed and final rules and related

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communications). As noted, KCI and Relator retain their rights to challenge

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any such assertions of privilege or protection.

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6. KCI, Relator, CMS, Noridian, or CGS may seek modification of this Order for

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good cause – including but not limited to any circumstance created or

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exacerbated by the terms of this Order that may result in an unreasonable burden

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being imposed on KCI, Relator, CMS, Noridian, or CGS – at any time; but the

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provisions of this Order shall continue to be binding after the termination of this

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Action, whether by settlement, judgment, or other disposition or conclusion and

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all appeals therefrom, unless otherwise ordered. KCI, Relator, CMS, Noridian,

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and CGS agree to promptly meet and discuss joint modification of this Order

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should any specific provision become overly burdensome upon implementation.

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IT IS SO STIPULATED, THROUGH COUNSEL.

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DATED: August 3, 2021
By: /s/Mark I. Labaton
MARK I. LABATON
[e-mail]
Glancy Prongay & Murray LLP
1925 Century Park East, Suite 2100
Los Angeles, CA 90067
Telephone: [phone]
Facsimile: [phone]
MICHAEL A. HIRST
[e-mail]
HIRST LAW GROUP, P.C.
200 B Street, Suite A
Davis, CA 95616
Telephone: [phone]
Facsimile: [phone]
PATRICK J. O’CONNELL
(pro hac vice)
[e-mail]
2525 Wallingwood Dr., Bldg. 14
Austin, TX 78746
Telephone: [phone]
Attorneys for Relator
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DATED: August 3, 2021
By: /s/Matthew E. Sloan
MATTHEW E. SLOAN (SBN 165165)
[e-mail]
ALYSSA E. MUSANTE (SBN 320821)
[e-mail]
SKADDEN, ARPS, SLATE, MEAGHER & FLOM LLP
300 South Grand Avenue
Los Angeles, California 90071-3144
Telephone: [phone]
Facsimile: [phone]

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GREGORY M. LUCE (pro hac vice)
[e-mail]
BRADLEY A. KLEIN (pro hac vice)
[e-mail]
PAUL A. SOLOMON (pro hac vice)
[e-mail]
JOHN A.J. BARKMEYER (pro hac vice)
[e-mail]
SKADDEN, ARPS, SLATE, MEAGHER & FROM LLP
1440 New York Ave., N.W.
Washington, D.C. 20005
Telephone: [phone]
Facsimile: [phone]

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Attorneys for Kinetic Concepts, Inc. & KCI, USA, Inc.

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FOR GOOD CAUSE SHOWN, IT IS SO ORDERED.

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19 DATED: ________________________
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_____________________________________
Honorable Alicia G. Rosenberg
United States Magistrate Judge

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EXHIBIT B

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ACKNOWLEDGEMENT OF PROTECTIVE ORDER

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I, ________________________, [in my individual capacity] OR [as

5 _______________ (title) of _______________ (entity name), on behalf of
6 _______________ (entity name)], acknowledge that I have read, understand and agree
7 to be bound by the Stipulated Protective Order for Production by Non-Parties the
8 Centers for Medicare & Medicaid Services (“CMS”); Noridian Healthcare Solutions,
9 LLC (“Noridian”); and CGS Administrators, LLC (“CGS”), including CMS’s Durable
10 Medical Equipment Medicare Administrative Contractors (“DME MACs”), Noridian
11 and CGS (the “Protective Order”) in this action governing the non-disclosure of those
12 portions of Discovery Material that have been designated as CONFIDENTIAL
13 Information and/or HIGHLY CONFIDENTIAL Information. I agree that I will
14 disclose such CONFIDENTIAL Information or HIGHLY CONFIDENTIAL
15 Information only as expressly permitted by this Protective Order and only for purposes
16 of the Litigation (as defined in the Protective Order), that I will not use, or cause to be
17 used, the CONFIDENTIAL Information or HIGHLY CONFIDENTIAL Information
18 for the commercial or competitive benefit of any Party or competitor to any Party in
19 this Litigation, and that I will take all reasonable measures to protect the confidentiality
20 of all such Discovery Material. No later than 90 days following the Conclusion of the
21 Litigation, I will destroy or return to HHS Office of the General Counsel, CMS
22 Division all CONFIDENTIAL Information and HIGHLY CONFIDENTIAL
23 Information in my possession (including all copies made). If I am counsel of record
24 in the Litigation, I will certify compliance with paragraph 9 of the Protective Order
25 and deliver this certification to HHS Office of the General Counsel, CMS Division not
26 more than 90 days after the Conclusion of the Litigation.
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By acknowledging these obligations under the Protective Order, I understand
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1 that I am submitting myself to the jurisdiction of the United States District Court for
2 the ____ District of __________ for the purpose of any issue or dispute arising
3 hereunder and that my willful violation of any term of the Protective Order could
4 subject me to punishment for contempt of court.
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6 Date: ______________________________________
7 City and State where sworn and signed: _________________________________
8 Printed name: _______________________________
9 Signature: __________________________________
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