CMS UPDATE AHFSA Conference September 2014

Objectives O After reviewing the presentation, the

audience will be able to describe one update from each of the four CMS Survey and Certification divisions.

Division of Laboratory Services Judith Yost, Director Karen Dyer, Deputy Director

Topics O Basic Training O Interpretive Guidance O State Operations Manual O Individualized Quality Control Plan (IQCP) O Blood Glucose Monitors

CLIA Basic Training O Planning is in progress O It will be a modular, interactive webinar • Students may attend at their convenience • Use information as a resource after training

O Students must have successfully completed

orientation program in advance O Training experts are assisting DLS O RO/CO folks will be SMEs O More info in 2015

CLIA Interpretive Guidelines (IGs) O Totally revamped document in clearance (400 O O O O

pp.) Most changes are updates, clarifications, corrections, not major Includes everything but IQCP IQCP will be added at the end of the Education & Transition period (1/2016); EQC removed Webinar training on key IG information will be provided to SA/RO

CLIA Interpretive Guidelines (IGs) O New items that IGs will also include: O Additional Patient Access rule guidance O PT referral guidance from the TEST Act &

Burden rules O Fecal Occult Blood guidance (if rule is published)

O IGs should be published late 2014-early

2015

State Operations Manual (SOM) Updates O DLS, in conjunction w/ RO SMEs, will begin

updating all CLIA sections of the SOM in 2015 • To add any outstanding S & C letters • To clarify/correct policies & procedures • To add new information

O More to follow on this project

IQCP Update O Education & Transition period underway O Continuing with communication, education

tools development & policy clarifications O Refresher training webinar will be provided near the end of the E & T period for all surveyors O SA/RO have assisted with local presentations, using standard power point slides

Blood Glucose Monitors (BGM) O FDA limitation on these devices recently noted O Not following manufacturer’s instructions can O O O O

cause risk of harm to patients Labs must become high complexity per existing regulations/policy, if using device inappropriately Causes consternation in waived facilities due to added burdens CMS/CLIA providing guidance/education and Collaborating w/ FDA

Division of Nursing Home Updates Karen Tritz, Director Evan Shulman, Deputy Director

Overview O Survey Process • QIS • QAPI • Life Safety Code • Hospice Services

O Enforcement O Dementia Care O MDS / RAI Activities O CMP Grants O Nursing Home Compare 12

Survey Process -QIS Interpretive Guidance -Survey Process Hospice, Dialysis O 10.1.7 Updates • Print all reports – print everything from survey • Updated management views in ACO/ARO • Updated kitchen pathway and screen • Automatically populate electronic Plan of Correction text (for applicable SAs) • Fixed error message when entering DOB • Added capability to store individual surveyor notes • Added save functionality for Stage 2 documentation • Date & time stamp can be added to any notes field • Added ability to add resident # to Stage 2 notes field O Resident Interview videos http://www.ucdenver.edu/academics/colleges/medicalschool/departmen 13 ts/medicine/hcpr/qis/qis-training-info/Pages/QISuTubeVideo.aspx

QAPI O Completion of Nursing Home Quality Improvement

questionnaire and QAPI Demonstration (17 NHs)

O 6/07/13 – Phase 1 – Introductory Materials posted

to the CMS QAPI webpage (http://www.cms.gov/Medicare/Provider-Enrollmentand-Certification/QAPI/nhqapi.html)

O Winter 2014 – Phase 2 – Additional QAPI

Tools/Resources posted on web

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QAPI O Release of training materials on principles of

QAPI

• Leadership • Direct-Care Staff • Consumers (Residents, Families, Advocates)

O Plan of Correction Guidance – incorporating

QAPI Principles O Surveyor Training – Basic QAPI Principles O Adverse Events (AEs)

• Call to Action: Raising Awareness for Reducing Adverse Events in

NHs – 9/23/14 • Development of surveyor protocol and tool for identifying AEs • Coming soon - Focused surveys to test protocol/tool

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Life Safety Code O

Sprinkler Deadline (August 13, 2013) • S&C 13-55 – Survey and Enforcement Activities • Time Extension Rule Finalized May 12, 2014 •

S&C 14-29 – Information for Applications to Extend Due Date to Install Sprinklers

O Emergency Preparedness Rule: NPRM • Comment period closed March 31, 2014 • Comments being evaluated currently

O

2012 Life Safety Code Adoption Rule: NPRM • Comment period closed June 16, 2014 16

Hospice Services Requirements for LTC Facilities F-309 Provide Care and Services Highest Well Being O O O O

Outcome tag Symptom management Quality and consistency of care Coordinated plan of care that guides both providers

F-525 Written Agreement

O Process tag O Roles and Responsibilities of each entity

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Hospice Services Solicited a second round of stakeholder comments on interpretive guidance

(advocates, nursing home, hospice providers, AMDA, and SA’s) O AHFSA comments supported development of surveyor

interpretive guidance for hospice services in a nursing home

NEXT STEPS:

O Internal CMS clearance including OGC O Development of training, job aide(laminate), S&C letter,

SOM

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Enforcement Enforcement Action Plan New Chapter 7 revisions • • •

Facility closure language New SFF Section Other

CMP Tool Revised and Distributed to ROs Special Focus Facility Program • •

Restart SFF program – S&C letter Pilot different approaches 19

Use of CMP funds O Final SNF PPS Rule – effective Oct 1, 2014 O Use of CMP funds – Reasonable costs to O O O O O

manage CMPS projects Prior approval Approved plan Transparency Emergency reserve Authority to withhold future disbursements

O Additional guidance forthcoming

Dementia Care We have seen a 17.1% reduction in the use of antipsychotic medications!

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Dementia Care

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MDS / RAI Activities O Identify opportunities to enhance accuracy

of assessing residents’ needs and driving care O Continued focus on training for providers and State RAI Coordinators to ensure consistency O Enhance Q & A process to decrease response time and improve clarity O Seek input and strengthen relationships with stakeholders

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CMP Grants O First CMP grant opportunity - ‘Reinvestment of

Civil Money Penalties to Benefit Nursing Home Residents’ •

•

Grant will utilize Civil Money Penalty funds to support and expand the National Partnership to Improve Dementia Care Expect award(s) to be made in September

O Next CMP grant opportunity – Coming Soon 24

Nursing Home Compare O QMs and QM ratings are analyzed quarterly • Use 3 quarters to determine average (currently 3rd qtr. 2013 – 1st qtr. 2014) • Very low/high rating can change overall NH rating

Rating determined by 3 last standard surveys and 3 years of complaint deficiencies O Last 3 years of imposed CMPs & DPNAs are listed; amounts of CMPs are listed O Enforcement data not used in Five-Star Quality rating system O Proposed Changes O

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Targeted Surveys

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Targeted Surveys

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QIO 11th Statement of Work Outreach to State Survey Agency within first 60 days O Inform SSA’s of QIO/NH activities and work to align efforts O Refer homes for engagement in NNHQCC O Letter of Agreement outlining joint effort

National Nursing Home Quality Care Collaborative: O Goals:

Recruit 75% of state CMS-Certified homes Recruit 75% One - Star homes in each state O Framework: QAPI principles, QI methodology, learn data! O Outcome: Improve systems to improve care.

Division of Continuing Care Providers Director: Martin Kennedy Deputy: Peggye Wilkerson

End Stage Renal Disease (ESRD) SCG Leads: Judith Kari/Je’Annine O’Malley: O Core Survey Update: O SOM Revisions : O STAR Core Survey Roll Out: O CMS/SCG ESRD Website: O §494.100 Condition: Care at Home • (Initial Certification )

Rehabilitation Agencies SCG Lead: Jim Cowher O SOM Guidance for In-House Pools (OPT) O Revision of IPPS Self-Attestation (CMS 437)

Hospice SCG Lead: Annette Snyder O Training to Web-Based Medium (CY 2015) O Quality Measures O Focused Survey Development O Recent Articles- Action Plan • # Agencies Over 6.5 Years Survey Interval • Decreasing the Survey Interval • Criteria for Targeting • Collaboration

Home Health SCG Leads: Pat Sevast /Sarah Fahrendorf O Focused Survey Pilot O Alternative Sanctions O HHA Moratoria O OASIS C1

CMHC SCG Leads: Don Howard /Peter Ajuonuma O New Regulations Effective this Fall O Demographics O Cleaning Up ASPEN O Basic Training Classes O Prioritizing the Survey Schedule O The 40% Rule

PRTF SCG Leads: Don Howard/Peter Ajuonuma O Web-Based Training O Demographics O New SOM Section

Psychiatric Hospitals SCG Leads: Peter Ajuonuma/Don Howard O Web-Based Training O Demographics

ICF/IID SCG Lead: Melissa Rice O Average Survey Time/Focused Survey Process: O Interpretive Guidance: O Web-Based Training: Thank Your Staff for

Completing Post Survey Scenarios O Quality Assurance Project: • W 369 Review Completed • Findings and Webinar

SCG/QIO Coordination SCG Leads: Grace Zaczek/Sandra Phelps O Collaboration with QIG on QIO 11th Scope of

Work Phase II Projects

O Development of a QIO/SSA Collaboration Project O National Partnership Calls with Selected States O Facilitation of Quality of Care in the Territories

(Islands)

Background Check Program O Currently 25 States and Territories have received Grants O Grants are being extended up to 5 years to assure

adequate time for implementation

O The OIG will issue an interim report on the program this

fall. The OIG has begun examining state implementation of background checks to assure patient safety.

O Systems developed through the grant program are

reducing costs and improving the efficiency of background check programs nationally.

Division of Acute Care Services Marilyn Dahl, Director Pat Chmielewski, Deputy Director

Recent Reg Changes O FQHC PPS & RHC, effective 7/1/14 O “Burden Reduction #2”, effective 7/11/14 O Affected DACS providers/suppliers: 1. 2. 3. 4. 5.

Hospitals Critical Access Hospitals (CAH) Ambulatory Surgical Centers (ASC) Rural Health Clinics (RHC) Federally Qualified Health Centers (FQHC)

Hospital Reg Changes O Governing Body – consultation with medical

staff leadership, instead of mandatory medical staff membership on Governing Body

O Medical staff O “Unified” medical staff permitted for systems O Membership v privileges for non-physician

practitioners

Hospital Reg Changes, con’t. O Qualified dieticians/nutritional professionals

may order patient diets

O Nuclear medicine – no more “direct”

supervision for prep of radiopharmaceuticals

O Orders for outpatient services – reg confirms

policy previously identified in S&C 12-17

Hospital Reg Changes, con’t. O Swing bed rule renumbered to §482.58,

moved to Subpart D, Optional Services, from Subpart E, Specialty Hospitals O Practical significance: AOs now required to

include swing bed services in their hospital accreditation programs; separate SA surveys for deemed hospitals not required

CAH Reg Changes O Removed requirement for outside person to

participate in P&P development/review

O MD/DO Responsibilities: O Must periodically review sample of outpatient

records of patients cared for by non-physician practitioners only to the extent required under State law O Rule reorganized to make clearer when outpatient

record review required O Removed requirement to review sample every 2 weeks

CAH Reg Changes, con’t. O

MD/DO Responsibilities con’t.:

O No longer requires MD/DO to be present at

least every 2 weeks; instead, for “sufficient periods of time” O

For CAHs providing larger volume and/or more complex services, likely to be more often than once every 2 weeks

O

For very small, very rural CAHs, telemedicine can greatly reduce need for MD/DO to be onsite, so long as mid-levels are present

ASC Reg Changes O Radiologic Services • Removed requirement for supervision of

radiologic services by radiologist • Governing Body must appoint qualified individual responsible for assuring all radiologic services provided in accordance with selected requirements under Hospital CoP • Still may only provide radiologic services integral to surgical procedure

RHC/FQHC Reg Changes O Both RHCs & FHQCs:

O Definition of “Physician” expanded,

but only MD/DO fulfills medical direction requirements

O MD/DO no longer required on-site at least

every 2 weeks – but still must have either mid-level or physician on-site when open

RHCs Only O Mid-levels must be in RHC at least 50% of

the time

O Permits using contracted NPs or PAs, so long

as at least one NP or PA is an RHC employee

ASPEN Changes O Reg changes, including changes in tags,

expected to be deployed in ASPEN soon, if not already accomplished

O Note in several cases the IG field says

“under development”

IG Updates to Reflect Reg Changes O 3 separate memo’s, each moving through

internal clearance:

O Hospital Governing Body & Medical staff O Remaining Hospital, ASC, & RHC/FQHC changes O CAH reg changes and comprehensive update of

CAH Provision of Services CoP (also includes FY 14 IPPS rule change re: inpatient services)

LTCH Moratorium O S&C 14-26, 5/9/14, explained statutory

moratorium on adding new LTCHs, LTCH satellites & LTCH beds

O Regulations implementing moratorium

published 8/22/14 & effective October 1st

O S&C memo describing implementation in

clearance

Other S&C Memos O Advanced stage of development: O Immediate Use Steam Sterilization (formerly

known as “flash sterilization”) O Power strip use in patient care areas O RHC location determinations O CAH location requirements refined

IG Revisions - Longer Term O Emergency Preparedness, after final rule

published

O Other O Hospitals – Compounded Sterile Preparations O Hospitals – Radiologic Services & Nuclear

Medicine O Rest of CAH Appendix W O RHC Appendix G

Hospital Surveyor Training Vision: O on-line basic:

O 2-part course O Surveyors ready to survey after Part 1, for Part 1

topics O Must complete Parts 1 & 2 within one year O Replaces annual face-to-face basic

O Use webinars & maybe shorter face-to-face

course for advanced and new/changing areas

On-line Hospital Basic O Beta testing Part 1 completed mid-August O Responses being evaluated; early indications

positive O Further changes to be made and Part 1 finalized by end of CY 2014 O Beta testing Part 2 to start 2/2015

Hospital Patient Safety Initiative O What’s changed: O Pilot ends September 30 O Starting October 1: tools to be used for

regular full and complaint surveys, with regular citation practices

Hospital Patient Safety Initiative O If funds are available, will continue selecting

(smaller) sample for 3-tool surveys

O Selection method based on SA & AO survey

citation history

O Applies to all hospital types O Encourage you to include LTCHs, rehab, psych

O Citations of deficiencies will be made

Surveying Hospitals w EHRs O 2 webinars offered to date O Encourage you & staff who could not

participate to view archived webinars

O Next webinar to focus on survey process –

this is a work in progress!

O Need your feedback as issues arise, to better

inform ourselves and develop policies

AO Validation Program O No changes for FY 2014 O Next report to Congress using FY 13

validation surveys to be published later this year as part of FY 14 CMS Financial Report

Training Staff ?, Director

Plans for the Upcoming Year O New director O Continuing move to fewer trainings that

require travel O And more resources available online

Plans for the coming year O More web-based training available O To be continued: O Basic ICF/IID O Basic Home Health O Basic ASC

O New additions: O Basic Hospital O Basic Hospice O Investigative Skills

Plans for coming year O IACET accreditation for web-based classes O Preceptor manual O Addition of LTC O Possible expansion in already published

sections

Plans for coming year O IACET accreditation for web-based classes O Preceptor manual O Addition of LTC O Possible expansion in already published

sections

Questions

See you next year in

Baltimore