just when you thought it was safe to go outside…

©2009 Meade & Roach, LLP 1

Just When You Thought it was Safe to Go Outside….

October 19, 2009

HCCA Research Compliance Conference

Minneapolis, Minnesota

Ryan Meade

312.498.7004

[email protected]

Presentation

• Just when you thought it was safe to go outside of your office…

…your job just got harder.



Disclaimer:

This presentation may be hazardous to your sleeping

patterns


Goals

• Discuss Hot Topics:

– The “state of things” in research compliance

– Research billing issues

– Human subject protection challenges

– What to do in the current environment?




Starting at the end

• Despite the state of things, there are 2 messages to take away from this presentation:



Message 1

You are not alone,


Message 1

You are not alone,

but your risks may be unique to you




Message 2

• When the world is swirling around you and you can’t figure out what to do and where to begin…

…stick to the compliance basics


Message 2-A

• The compliance basics:

–Develop a research compliance program with the basic 7 elements and continually strengthen and improve each element



The State of Things in Research Compliance

• Increasing regulations

• No clear regulatory priorities from the government

• Tougher enforcement across more laws

• Enforcement appears to be relying heavily on whistleblowers

• Adds up to: Risks are random


Theme to Research Compliance Risks?


Theme to Research Compliance Risks?

• There is no theme

• Risks and enforcement are unique to you


Theme to Research Compliance Risks



• Challenge 1: Communicate to senior leadership that there is no template model to manage research compliance risk


Theme to Research Compliance Risks



• Challenge 2: Communicate to senior leadership that “something” is more likely to happen than not happen


Not all chaos

• Nevertheless, there are issues to prioritize


Research Billing

• Confronting the reality of differences between Medicare Contractors

• Drug administration during a research study

• Medicare Part C & research billing

• Relevant parts of the OIG Workplan


Medicare & Medicaid Numbers

• Medicare Program FY2010:

– $453 billion

• Medicaid Program FY201:

– $508 billion (approximate)

• $290 billion (Federal)

• $218 billion (approximate from States)

• Total: $961 billion (annual)


Operations, not just concepts

• Applying Q0/Q1 modifiers (and V-code) is becoming increasingly important

• Operational processes for managing research billing is critical

– It’s not enough anymore just to be sure Medicare is not billed for services paid for by the sponsor or promised free


CMS quote from 2000

• “Payment will include costs associated with providing items and services that would otherwise be covered by Medicare if they were not provided in the context of a clinical trial.”


Getting on the same page

• Medicare is a federal program administered by private contractors:

– Part A & B: Single Medicare Administrative Contractor (MAC) per region (conversion in process)

– Part C: Multiple Medicare Advantage Plans in a region that compete for enrollment

– Part D: Multiple Prescription Drug Plans in a region that compete for enrollment

• Medicare pays for items and services that are “reasonable and necessary to diagnose or treat illness or injury”


Getting on the same page

• If there is no national rule or a rule is ambiguous, the local Medicare Contractor is allowed to interpret what is “reasonable and necessary”

– Significantly, Medicare Contractors are allowed to disagree with each other

• Significance for Research:

– Medicare coverage during a research study can differ around the country

– Budgeting in multi-site studies must be aware of local Medicare rules


Example of Regional Differences: Cyberknife

• Example: Cyberknife

– No national uniform policy; regional decision

– “Geography Has Role in Medicare Cancer Coverage,”New York Times, December 16, 2008

• “[G]eography may play as big a role as medicine in determining which men diagnosed with prostate cancer are eligible for CyberKnife. As it turns out, Medicare pays for the treatments in 33 states — but not in 17 others.”

• “Our guidance to them is that if there’s no evidence it works, they shouldn’t pay for it,” said Dr. Steve Phurrough, Medicare’s coverage director in Washington. “The CyberKnife is a good example of a technology where you can review the evidence and come to different conclusions.”


Example of Regional Differences: Phase I Drug Studies

• AAMC Letter to CMS (March 12, 2009):

– “An informal survey of our members has revealed that some Medicare contractors cover the routine costs of beneficiaries enrolled in Phase I clinical trials, and others do not.”


Drug Administration

• Medicare will pay for drug administration separately from the drug, if the drug is not usually self-administered.

• There are three groups of drug administration CPT codes:

– Hydration

– Non-chemotherapy drugs

– Chemotherapy drugs


Drug Administration

• “Chemotherapy drugs” is more than chemo

– The category includes antineoplastic drugs that a local Medicare Contractor considers “qualifying” (can be for cancer or non-cancer conditions)

• Contractors differ on what they consider to be a “qualifying drug”

• See Transmittal/Change Request 3631


OIG Report: Drug Administration

• June 2009:

– OIG Report on Chemotherapy Administration

• Audited drug administration when no drug was also charged – could not reach findings; too many variations on why no drug would be charged

• OIG recommends MACs conduct audits when no drug is charged along with administration code

• Vague, but appears to recognize that claims with clinical trial modifiers and no drug charge assumes a study drug is provided free and that’s why it is not on the claim


Practical aspects of billing drug administration

• Contractors differ on how to bill administration codes during clinical trials

• Medicare Claims Processing Manual, Ch. 32, Sec. 67.2 addresses billing for “no cost items”

– Generally speaking, institutional providers should not have to report the usage of a no cost item. However, for some claims (e.g., hospital Outpatient Prospective Payment System (OPPS) claims), providers may be required to bill a no cost item due toclaims processing edits that require an item (even if received at no cost) to be billed along with an associated service (e.g.,a specified device must be reported along with a specified implantation procedure).

– For OPPS claims, providers must report a token charge of less than $1.01 for the item in the covered charge field….


Medicare Part C

• Medicare Claims Processing Manual, Ch. 16, Sec. 69.9

• Clinical trial services are not billed to the Medicare Advantage plan, but billed to the Part A/B MAC

– Deductible is waived

– Co-insurance (co-pay) is not waived


Medicare Part C

• In theory…

– If a provider sends a claim to a Medicare Advantage Plan and it contains a v-code or Q0/Q1 modifier, the Plan should reject the claim

• In practice…

– Some Plans are accepting and paying when they shouldn’t


Medicare Part C

• “[F]or beneficiaries enrolled in a managed care plan, institutional providers must not bill outpatient clinical trial services non-clinical trial services on the same claims. If covered outpatient services unrelated to the clinical trial are rendered during the same day/stay, the provider must split-bill so that ONLY the clinical trial services are contained on a single claim and billed as fee-for service…Any outpatient services unrelated to the clinical trial should be billed to the managed care plan.”


Medicare Part C

• “Any outpatient services unrelated to the clinical trial should be billed to the managed care plan.”

• What does “unrelated to the clinical trial” mean?


OIG Workplan Risks

• Payments for Off-Label Anticancer Pharmaceuticals and Biologicals

• The Food and Drug Administration’s Oversight of Investigational New Drug Applications

• Use of Data and Safety Monitoring Boards in Clinical Trials

• Financial Interests Held by Institutions Receiving National

Institutes of Health Research Grants

• Recovery Act Reviews



Human Subjects Protection

• February 2009 list of risks

• October 2009 oversight procedures

• 2009 determination Letters


Human Subject Protections

• OHRPs Compliance Oversight Procedures for Evaluating Institutions (October 14, 2009)

– For cause investigations

– Not-for-cause investigations


OHRP Investigations

• For-cause Investigations:

– Heavily reliant on whistleblowers and “complainants”

– Allows anonymous reporting

– Sets out 10 step process once a complaint is received


OHRP Investigations

• Not-for-cause Investigations:

– OHRP sets out variety of factors:

• Volume of studies

• Low level of reporting to OHRP

• Evaluation of corrective actions

• Geographic location

• Accreditation status

• Reviews by other agencies


Non-compliance Risks

• OHRP released list of human subjects protection non-compliance risks: February 4, 2009

• 51 Risks (9 categories):

– Initial and Compliance Review

– Expedited Review

– Reporting to OHRP

– Protocol Changes

– Exemptions

– Informed Consent

– IRB Structure

– IRB Documentation and Procedures

– Other


2009 Determination Letters

• 1 – 3 pages

• 2 – 2 pages

• 3 – 5 pages

• 4 – 5 pages

• 5 – 5 pages

• 6 – 5 pages

• 7 – 2 pages

• 8 – 5 pages

• 9 – 2 pages

• 10 – 2 pages

• 11 – 2 pages

• 12 – 5 pages

• 13 – 7 pages

• 14 – 4 pages

• 15 – 12 pages

• 16 – 2 pages

• 17 – 3 pages

• 18 – 2 pages

• 19 – 3 pages

• 20 – 8 pages

• 21 – 3 pages

• 22 – 26 pages

• 23 – 7 pages

• 24 – 2 pages

• 25 – 6 pages

• 26 – 19 pages

• 27 – 5 pages

• 28 – 5 pages


2009 Determination Letters

• 1 – 3 pages

• 2 – 2 pages

• 3 – 5 pages

• 4 – 5 pages

• 5 – 5 pages

• 6 – 5 pages

• 7 – 2 pages

• 8 – 5 pages

• 9 – 2 pages

• 10 – 2 pages

• 11 – 2 pages

• 12 – 5 pages

• 13 – 7 pages

• 14 – 4 pages

• 15 – 12 pages

• 16 – 2 pages

• 17 – 3 pages

• 18 – 2 pages

• 19 – 3 pages

• 20 – 8 pages

• 21 – 3 pages

• 22 – 26 pages

• 23 – 7 pages

• 24 – 2 pages

• 25 – 6 pages

• 26 – 19 pages

• 27 – 5 pages

• 28 – 5 pages


Determination Letter:Carle Foundation Hospital/Carle Clinical Association

• CFH – hospital with IRB

• CCA – large physician group that had appointed hospital’s IRB as the IRB of record

• Significant points from Determination Letter:

– Entities demonstrated that they evolved to a research compliance program model, including internal auditing plan of the IRB reviews and processes



What to do?

• Get back to basics

• Develop a research compliance program

• Formalize your research compliance activities into a clear component of your compliance program

• Document activities


The 7 Elements of a Compliance Program

1. Compliance officer

2. Policies and procedures

3. Education and training

4. Hotline/means of communication

5. Demonstrate quick response to reported non-compliance

6. Discipline for non-compliance

7. Auditing and monitoring


The 7 Elements of a Compliance Program

1. Compliance officer

2. Policies and procedures

3. Education and training

4. Hotline/means of communication

5. Demonstrate quick response to reported non-compliance

6. Discipline for non-compliance

7. Auditing and monitoring


Research Auditing & Monitoring

• Identify risks unique to your organization

• What is high volume? (numbers & dollars)

• Who are high volume investigators?

• IRB auditing

• Billing auditing

• Keep an eye on Recovery Act funds


• Questions?

Ryan Meade

[email protected]

312-498-7004


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