Operationalizing the OIG’s Supplemental Corporate Compliance Guidance for … · 2012-04-24 · Operationalizing the OIG’s Supplemental Corporate Compliance Guidance for NFs The

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Operationalizing the OIG’s Supplemental Corporate Compliance Guidance for NFs

The Industry’s Response, The Opportunities

and the Challenges Presented

These materials have been prepared by Poyner Spruill LLP for informational purposes only and are not legal advice. This information is not intended to create, and receipt of it does not constitute, a lawyer-client relationship.

ACKNOWLEDGEMENTS

• The American Health Care Association

– Dianne DeLeMare

• Howard Solllins

– Ober, Kaler, Grimes & Shriver

• The Office of Inspector General

– Joann Francis, Robin Schneider

• Cheree Batee

– Fundamentals Healthcare

• Susan Whittle

– The Skilled Network


Our Goals Today:

• Explain the industry’s response to the OIG Supplemental

Guidance

– The AHCA original compliance guidance and ongoing revisions

• Highlight some of the challenges in operationalizing the

Supplemental Guidance

• Offer some thoughts on how you carry out that task

– Revisiting your existing compliance program

– Exploring how you revise and update it

– Using what you already have

– Tackling how to explain in a written program some of the new or

enhanced risk areas you just heard about

What We Can’t Do

• Give you a take-away, updated compliance program

• Why?

– Still in development (the AHCA project)

– Some of the enhanced/new risk areas are broad goal statements

• Better care plans that ensure “highest practicable” resident status

– Some of them recommend specific policies

• How do you policy-ize “Resident Safety?”

• “No one size fits all” per the OIG

• Some providers already have these and some may not realize it


The Industry’s Response to the Supplemental Guidance

• Need to tell you where we’ve been to discuss where we

hope to go

• So, a little history

A Little History

• 2000—OIG 1st compliance guidance for NFs

• “Earlier that same year”-AHCA published the “Redbook,”industry’s first compliance guidance, published before OIG published its guidance

• Based on compliance guidance for other industries like

hospitals and clinical labs

• Addressed:

– Mechanical aspects of compliance programs

– And sample policies explaining applicable laws

– Employee Standards and Codes of Conduct

• “Readers’ Digest” of laws applicable to NFs


A Little History (cont.)

• NF industry was the first in the country to develop

compliance guidance before the OIG published guidance for the industry

• Opportunities to impact the published guidance

• Challenges

– Not everyone thought this was such a great idea

• OIG applauded the industry for being proactive

• And we did impact the guidance

• AHCA “Redbook” was updated in 2002 to reflect OIG’sstatements on various practices and risk areas

Now, 8 Years Later, Where Are We?

• Eight years of actual experience with these programs

• What have we learned?

– The biggest obstacle to effective compliance programs is

programs that are overly-complex, hard to develop, manage,

teach and revise as law and practices change

– Or as new risk areas present themselves

– We also know more about NF operations and have lots of new

data and tools to help measure the industry’s performance

• The reasons for revising the “Redbook” now

– OIG’s Supplemental Guidance

– Our own experiences as an industry

– Hopefully address the “complexity” problem


External Pressures to Update Compliance Programs

• Providers with vibrant programs tell us they help

• Perception that the industry has not fully embraced compliance

– The “dusty notebook on the shelf” perception

• Or has given superficial attention to it in some cases

• OIG statements of interest in requiring compliance

programs for all special focus facilities

• State legislatures considering requiring for all NFs

• Will Congress someday soon require them anyway?

So, Here’s The Plan

• We’re revising the Redbook and teaching it as we go

• Via monthly webinars and postings to the AHCA website

• Our firm, compliance officers, & OIG technical assistance

• We began November 2008 with background and some “how to get started” steps, and moved next to building the

mechanics of an “effective” compliance program

• To continue through November 2009

– The laws you must follow restated in summaries, employee codes

of conduct/standards and some practical pointers on how you

develop those, teach them, and monitor your compliance

• Including new / enhanced OIG risk areas


We Have Three Major Goals

• Give the original compliance guidance fresh paint

– Reorganize it, make it simpler, make it easier to use

– Reflect the industry’s shared experience since 2000 guidance

• Renovate the original AHCA guidance

– To reflect OIG statements since the original 2008 NF guidance,

industry practices, and the OIG’s 2008 supplemental guidance

• Hopefully address the complexity and “dusty shelf” issues:

– Make it more understandable

– More user-friendly

– Help you teach compliance in your company

Out On A Limb

• Supplemental Guidance does not say much new about the mechanics of compliance programs

– Compliance officers and committees, reporting mechanics for

suspected violations, filing systems for compliance materials,

Employee Standards & Codes of Conduct

– All re-emphasized from original guidance

– Remember, this is “supplemental” not replacement guidance

• One exception – employee training and education

– What’s new?

• Additional risk areas that should be part of that training

• Even here, the stress on training on “applicable laws” is same


What’s New? The Risk Areas

• They’ve been described already

• But it helps to think of them in groups

• In terms of does your program already address them

• Or are they addressed in existing policies that may not be

technically “in” your compliance program but can be

referenced?

• And, if not, how do you include them?

– Recurring theme – how do you operationalize some of the risk

areas?

– Policies and procedures challenges

Creating a Roadmap to Updating Your Plan

• THE RISK AREA GROUPINGS


A. Quality of Care

• Supplemental Guidance has been described by many as

all about “Quality of Care, Quality of Care, Quality of Care”

• Discussion begins with broad statements

– “Compliance with applicable standards and regulations is essential

for the lawful behavior and success of nursing facilities”

– Comply with 42 CFR Part 483

• Fondly known as “OBRA” regulations

• CoPs for Medicaid and Medicare

– “Targeted training for providers, employees, owners & directors

• OIG: the additional risk areas in other categories are intertwined with quality of care specific risk areas

• Hence, the description “Quality, Quality, Quality”

Quality of Care (cont.) -- Subcategories

• Sufficient staffing

• Comprehensive resident care plans

• Medication management

• Appropriate use of psychotropic medications

• Resident safety – 3 sub-sub-categories

– Promoting resident safety (the resident being cared for)

– Resident interactions (resident-to-resident safety issues)

– Staff screening

• AHCA just completed an entire webinar session in checking the exclusion status of employees and contractors


B. Submission of Accurate Claims

• Subcategories:

– Proper reporting of resident case-mix by SNFs

– Therapy services

– Screening for excluded individuals and entities

– Restorative and personal care services

• Theme in these sections:

– Are you providing the services

– Are they necessary (medically appropriate)

– Are they “quality” services deserving of payment

– Are you properly documenting those facts

– Are you properly billing for them

C. The Federal Anti-Kickback Statute

• This section:

– Explains again this criminal statute

– Talks about “intent” and how the OIG discerns it in some cases

– Suggests a list of questions providers should ask to ensure they

don’t run afoul of this statute

– Discusses the “safe harbors” under the statute

• Strict compliance for guaranteed protection

• Or take your chances otherwise

– References OIG’s advisory opinions and fraud alerts

– And the advisory opinion process


The Federal Anti-Kickback Statute - Subcategories

• Free goods and services

• Services contracts (sub-subcategories)

– Non-physician services (vendors, suppliers, contractors)

– Big focus on pharmacy contracts and services

• Physician services

– Medical director contracts

– Quality assurance contracts and services

– “Other” physician services

– Potential for physicians to refer patients to NF in exchange for

upcoding MDS or ordering items separately billable by the NF

The Federal Anti-Kickback Statute - Subcategories

• Discounts (sub-subcategories)

– Price reductions (properly disclosing discounts on cost reports)

– Swapping (Lower Part A charges for Part B business)

• Hospices

– Payment to the NF and services provided by the NF or hospice

• Reserved bed payments

– Is the arrangement a “sham” since NF it’s already occupied

– Is payment more than NF stands to lose on empty bed

– Is the bed really needed by hospital


D. Other Risk Areas

• Physician self-referrals

– NFs that bill Part B for lab services, PT, OT or other “designated

health services” are covered entities subject to these laws

– OIG suggests list of questions for evaluating arrangements with

doctors who are ordering and/or referring these services

• Anti-Supplementation (limited to Medicaid and Medicare

rates for covered services

• Medicare Part D –Steering residents to pharmacies

because you own it or for “inducements”

E. HIPAA Privacy and Security Rules

• OIG’s focus:

– Ensuring NFs understand the requirements of these rules

– Properly use and disclose and secure “protected health

information” of residents

– Have in place the security safeguards to accomplish the privacy

obligations


Okay, So Why This Simplistic Roadmap?

• These new/enhanced “risk areas” in tandem with those in

the original OIG guidance are enormous

• In short, they say “comply with all applicable laws”

• But, you have to put that in a written compliance program

• That is useable by your compliance officer and committee

and every single employee

• Conventional wisdom:

– The detailed compliance program is for the compliance officer and

committee

– The Employee Standards and Code of Conduct is given to all

employees

Okay, So Why This Simplistic Roadmap?

• But, the bigger written plan drives the Readers’ Digest you give employees

• And it drives ALL your periodic training

• So, back to the question we started with:

– HOW DO I OPERATIONALIZE IN WRITTEN FORM THE VERY

BROAD COMPLIANCE MANDATE FOR ALL AFFECTED FROM

OWNERS AND DIRECTORS TO EMPLOYEES?


What We’re Hearing Out There

• This is impossible

• How do I write a policy that covers “have better and more appropriate care plans?

• Or “sufficient staffing?”

• Or better “medication management?”

• Do I just say “It is the policy of Ken’s NF to provide appropriate medications to residents based on their

medical needs as directed by the attending physician and

per a periodic review by our consulting pharmacist?”

• Or do I need a 50-page medication policy with formularies, danger signs of over-medication, etc.?

If You Have The Answer, Please See Me After This Lecture

• The reality:

– The OIG has set out some very broad goal statements for sure

– But has also given specific examples of the issues it is concerned

about

– Some risk areas have more OIG specifics than others

• So, maybe we need a combination of:

– Broad policy goals (care plans consistent with applicable laws)

– And specifics from the Supplemental Guidance

• Interdisciplinary care planning teams

• That are not perfunctory

• That start on time and are substantive

• That include the medical director and attending physician


Operationalizing the Supplemental Guidance

• No one can give you a policy book or compliance

guidance this is “approved” by the OIG

• We can suggest some ways to get started

• Start with breaking down the Supplemental Guidance into

sections, like we’ve done here or in your own way

• Then ask who best in my organization can assimilate the

risk areas as described by OIG and commit them to policy

• Then, are there other related “risk areas” from our own

experience (complaints, surveys, QI scores, QA process)

• Then what blend of broad statements and detail works for us

Breaking the Guidance Into Manageable Portions

• Helps with the “I’m overwhelmed” factor

• Brings into the compliance process those most affected

– Which OIG has ALWAYS said is the standard

• Invests your staff and management in the process

– Which the OIG has ALWAYS said is the standard

• Helps you vet what will work and what will not

• In our AHCA project, we’ve done exactly that and found an amazing variety of approaches, best practices, things that

were tried and failed, and things that worked better than

the lawyers or consultants dreamed up

• Find out what you already have to incorporate / revise


Use The Supplemental Guidance

• Begin with the specifics OIG has identified

– Use the questions OIG poses as helpful on specific issues

– Then, again, ask if there are other specifics from your operations

• With the broader goal statements in the Supplemental

Guidance, ask “is a general statement of commitment to

abide by, for example, the federal care planning

regulations sufficient or do we need more

• Remember a policy is not the same thing as a training

manual

– Use training documents to supplement your policies

– Failure to follow your own policies problems

Conclusion

• If you hoped to leave with a complete, revised compliance program, my apologies

• But I hope we’ve given you a way of thinking about how to tackle the Supplemental Guidance

• And updating and revising your compliance program

• I recommend to you the AHCA “work in progress” revision

• And invite you to participate in that

• Final thought – per the OIG, there is no “one size fits all”

• If we don’t make a good faith effort to handle this challenge, it may soon not be an option, but a requirement

Documents

Operationalizing the OIG’s Supplemental Corporate Compliance Guidance for … · 2012-04-24 · Operationalizing the OIG’s Supplemental Corporate Compliance Guidance for NFs The