1. Heightened Scrutiny Training for States
Division of Long-Term Services and Supports
Disabled and Elderly Health Programs Group
Centers for Medicaid and CHIP Services

2. Objectives for Today’s Session
Provide a brief overview of the Frequently Asked Questions (FAQs) Guidance on Heightened Scrutiny (HS) issued on March 22, 2019, including a summary of what the guidance has accomplished and the characteristics of a setting that isolates (See Resource Slide #2 for the link to this guidance);
Identify the process for the review of HS packages that has evolved from CMS’ work with the HS pilot states;
Provide clarifying guidance on specific issues where the HS FAQs were not clear;
Share promising practices initiated by states as they work through the HS process.

3. FAQs: Guidance on Heightened Scrutiny
The regulations describe three categories of residential or non-residential settings that are presumed to have the qualities of an institution to which the HS process applies:
Settings that are located in a building that is also a publicly or privately operated facility that provides inpatient institutional treatment;
Settings that are in a building located on the grounds of, or immediately adjacent to, a public institution; and
Any other settings that have the effect of isolating individuals receiving Medicaid home and community-based services (HCBS) from the broader community of individuals not receiving Medicaid HCBS.

4. What is a Setting that Isolates? (1 of 3)
CMS will take the following factors into account in determining whether a setting may isolate Medicaid HCBS beneficiaries from the broader community:
Due to the design or model of service provision in the setting, individuals have limited, if any, opportunities* for interaction in and with the broader community, including individuals not receiving Medicaid-funded HCBS;
The setting restricts a beneficiary’s choice to receive services or to engage in activities outside of the setting; or

5. What is a Setting that Isolates? (2 of 3)
The setting is located separate and apart from the broader community without facilitating beneficiary opportunity to access the broader community and participate in community services, consistent with a beneficiary’s person-centered plan.
*Opportunities, as well as identified supports, that provide access to and participation in the broader community, should be reflected in both the individuals’ person-centered plans and the policies and practices of the setting in accordance with the regulations.

6. What is a Setting that Isolates? (3 of 3)
This new guidance in the FAQs completely replaces prior guidance published on this criteria which was originally found at:
The new guidance eliminates specific examples of settings that isolate.

7. How Can States Bring Settings that Isolate into Compliance without a HS Review and Timeframes?
March 17, 2022: The end of the transition period for all settings to come into compliance with the settings rule.
For settings that isolate idividuals from their broader community: The state can work with these settings to initiate remediation and to come into compliance by July 1, 2020.
If the setting complies with the settings rule to the state’s satisfaction by July 1, 2020, then there is no need to submit those settings for a HS review.
These settings should be identified in a state’s STP for public comment and/or identified in information disseminated separate from the STP for public comment.

8. What if a Setting that Isolates Cannot Complete Remediation by July 1, 2020?
If a state determines that an isolating setting can implement remediation before March 17, 2022
And
Also determines that the isolating setting can achieve compliance with the settings criteria,
Then
The state should submit to CMS a list of those isolating settings that have not completed remediation by July 1, 2020.
The list of settings will need to be in to CMS by October 2020 from which CMS will request a sample of settings for which the state will submit evidence packages for review.

9. Promising Practices to Remediate Settings that Isolate to Ensure Compliance
Promising practices that states and providers might consider:
Increase technical assistance to assist states to fully implement person-centered thinking, planning and practices.
Increase engagement with the broader community through partnerships with generic community entities or by establishing a community-based advisory group.

10. Promising Practices to Remediate Settings that Isolate to Ensure Compliance (cont.)
Implement a broad range of services and supports, programming, and multiple daily activities to facilitate access to the broader community so individuals can select an array of options and control their own schedule.
Implement organizational changes.
Expand strategies for increasing beneficiary access to transportation through existing means.

11. HIPAA Related Privacy Concerns and Settings that Isolate
For those settings that have the effect of isolating individuals, the FAQs identified HIPAA related privacy concerns, including restrictions placed on State Medicaid Agencies and identified providers, preventing the public disclosure of protected health information (PHI);
Provided CMS guidance on how to disclose information to adhere to federal and state privacy laws and regulations; and

12. HIPAA Related Privacy Concerns and Settings that Isolate (cont.)
Described the extent to which stakeholders may receive notice and provide comment on these settings.
Note: Question 7 of the FAQs replaces prior guidance to account for HIPAA implications.
Contact your state HIPAA compliance officer for guidance specific to your state or local rules who will make the final determination of what information can be disclosed.

13. Guidance Pertaining to All Presumptively Institutional Settings
What information the state should provide during the public comment period on settings that the state has considered for heightened scrutiny review;
Note: Question 8 of the FAQs replaces prior guidance given on presumptively institutional settings as states are no longer encouraged to identify the number of individuals receiving services at each setting.
How CMS will review requests for HS of settings the state believes will overcome the institutional presumption;
Note: Question 9 of the FAQs supplements prior guidance, including the use of sampling.

14. Guidance Pertaining to All Presumptively Institutional Settings (cont
What information the state should submit to CMS for a HS review of a setting selected for the review sample;
Note: Question 10 of the FAQs replaces prior guidance to streamline the suggested content of information submitted for a heightened scrutiny review.
How CMS will monitor settings identified as presumptively institutional to ensure adherence to the rule by the end of the transition period.

15. Information Sharing (1 of 5)
All states that have already submitted settings that isolate individuals receiving Medicaid HCBS from the broader community of individuals not receiving Medicaid HCBS, prior to the March 22, 2019 guidance have received communication from CMS with a request to consider the following:
States should go back and assess the setting based on the new guidance to determine if it has the characteristics of a setting that isolates.
If the state determines that the setting does not isolate individuals, then the state may rescind the submission of these settings as they would no longer require a heightened scrutiny review.

16. Information Sharing (2 of 5)
For those settings originally submitted that the state believes do still possess one or more of the characteristics that isolate beneficiaries from their broader community as outlined in the updated guidance, the state does have the option of working with the settings to see if they can overcome their isolating characteristics and fully comply by July 2020.
Any settings that the state can attest have come into full compliance with the rule by that date would not be required to be submitted for a heightened scrutiny review.

17. Information Sharing (3 of 5)
Please keep in mind that these settings for which a remediation plan has been implemented to bring the setting into compliance will need to be disseminated for public comment prior to July 2020, in accordance with the guidance outlined in the March 22, 2019 FAQs.
All settings that have the characteristics of settings that isolate beneficiaries from their broader community that are not remediated into compliance by July 2020 will need to be disseminated for public notice and submitted to CMS for heightened scrutiny review.
States are strongly encouraged to submit a list of such settings to CMS by October 31, 2020.

18. Information Sharing (4 of 5)
CMS has requested the state to review all settings that have been submitted thus far as isolating and provide the following information to CMS within 30 days:
A list of any of the settings that the state believes are no longer isolating because they do not meet one or more of the isolating characteristics listed in the new sub-regulatory guidance;

19. Information Sharing (5 of 5)
A list of any settings that the state would like to pull from its original submission so as to work with the settings to see if they can overcome their isolating characteristics and comply fully with the HCBS settings criteria by July 2020;
A list of any settings originally submitted that the state would like CMS to move forward at this time in reviewing.

20. Heightened Scrutiny Pilot Project
CMS provided review and feedback to 6 states on the HS evidentiary packages submitted for residential settings that are located in a publicly or privately operated facility that provides inpatient institutional treatment; or that are in a building located on the grounds of, or immediately adjacent to, a public institution.
Lessons learned produced a more efficient process for the review of all HS packages submitted by the state including settings that isolate.

21. Heightened Scrutiny Pilot Project (cont.)
The revised process resulted in a Summary of Findings which includes the support submitted by the state to demonstrate a setting’s progress in overcoming the institutional presumption, an initial determination of compliance by CMS, a link between the requirements and the regulations, and identification of additional information requested by CMS to confirm compliance with the settings criteria and that the setting has overcome any institutional presumption.

22. The Heightened Scrutiny Review Process (1 of 3)
The state submits the numbered list of settings identified for each category of presumptively institutional settings;
CMS will use the list to compile a random sample of settings to review, including any setting the state requests CMS to review and any setting that generated significant public comment in opposition to the state’s assessment;
CMS will notify the state as to which settings should have evidentiary packages submitted. This should include the remediation plan for the setting if applicable and the public comments received;

23. The Heightened Scrutiny Review Process (2 of 3)
The state will receive an initial determination letter that will indicate CMS’ preliminary decision regarding whether or not the state has demonstrated that the setting overcomes its institutional presumption;
The state will also receive a Summary of Findings for each setting submitted by the state that includes:
A brief description of the setting;
The support submitted by the state to demonstrate the setting’s progress in overcoming the institutional presumption;

24. The Heightened Scrutiny Review Process (3 of 3)
The areas found to demonstrate compliance according to the information received;
The areas where additional information will be needed to clearly articulate that the setting meets the HCBS criteria and has overcome any institutional presumption.
In the pilot, the state responded directly in the Summary of Findings’ document to all questions posed by CMS.

25. The Heightened Scrutiny Review Process (cont.)
The final determination letter and the Summary of Findings, including the interactive communications between CMS and the state, will be posted at
The state will receive notification before these documents are posted to the website.

26. What Should the State Submit to CMS for a HS Review of a Setting Selected for the Review Sample?
For all presumptively institutional settings that have been selected for the review sample, states should provide:
Evidence of how the state has determined that a setting overcame the institutional presumption;
Information on the qualities of the setting; how the setting is integrated in and supports access to the broader community via the organization’s policies and practices and how the setting supports individuals consistent with their person-centered service plans.
The exploratory questions available in CMS’ Toolkit can also help determine the type of information that should be included.

27. Clarifying the FAQs Guidance
Issue re: Isolating Settings: States want to know whether they will be held accountable for getting HS evidentiary packages for any setting in the sample into CMS by October of 2020 or whether they would only have to submit their list of HS settings by that date. Answer: States should have the list of isolating settings requiring HS review ready to submit to CMS by October CMS will communicate to the state what settings they need to submit evidentiary packages for and states then submit the packages within 30 days of that communication.

28. Clarifying the FAQs Guidance (cont.)
Issue re: Settings located in a publicly or privately operated facility that provides inpatient institutional treatment or that are in a building located on the grounds of, or immediately adjacent to, a public institution: States are also looking for clarification that CMS expects states to submit these settings ASAP and prior to July Answer: In addition to securing final approval of their STPs by the end of the calendar year, CMS is strongly encouraging states to submit the evidentiary packages for these settings ASAP within this calendar year and no later than July 2020.

29. Promising Practices
Promising practices are beginning to emerge as states work through the heightened scrutiny review process. We will continue to share these methods and techniques with you as we learn about them. MN and KY are two states that are engaging stakeholders in the HS process. OH and WI provided a nicely organized, easy to read format for the submission of their HS pilot project materials that may prove helpful to other states.

30. Resources (1 of 6)
CMS Central Office Contact—Division of Long-Term Services and Supports:
HCBS Statewide Transition Plan Website:

31. Resources (2 of 6)
Frequently Asked Questions (FAQs): HCBS Settings Regulation Implementation Heightened Scrutiny Review of Presumptively Institutional Settings, issued by CMS on March 22, 2019:
Question 1 of the FAQs totally replaces prior guidance. See:

32. Resources (3 of 6)
Question 7 of the FAQs replaces prior guidance given on this topic, to account for HIPAA implications. See question 8 on page 7 of
Question 8 of the FAQs replaces prior guidance given on presumptively institutional settings as states are no longer encouraged to identify the number of individuals receiving services at each setting. See the third bullet of question 8 at the above website.

33. Resources (4 of 6)
Question 9 of the FAQs supplements prior guidance given on this topic, to refine the process by which CMS will review settings presumed to be institutions, including through the use of sampling. See question 10 at
Question 10 of the FAQs replaces prior guidance to streamline the suggested content of information submitted for a heightened scrutiny review. See question 3 at the above website.
HS Initial Determination Letters and Summary of Findings:

34. Resources (5 of 6)
CMS’ Toolkit, including CMS Exploratory Questions for Assessment of Residential and Non-Residential HCBS Settings. See
MN: Information re Department of Human Services HCBS Settings Review Panel. See
KY: Information re Department of Medicaid Services Stakeholder Engagement Methods. See

35. Resources (6 of 6)
OH:

36. Questions & Answers

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