Hot Regulatory Topics Judi Lund Person, MPH NHPCO

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HOT REGULATORY TOPICS JUDI LUND PERSON, MPH NHPCO 1

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Hot Regulatory Topics Judi Lund Person, MPH NHPCO. Eligibility. Eligibility for Admission Medicare Hospice Benefit. § 418.20 Eligibility requirements. In order to be eligible to elect hospice care under Medicare, an individual must be-- ( a) Entitled to Part A of Medicare; and - PowerPoint PPT Presentation

Transcript of Hot Regulatory Topics Judi Lund Person, MPH NHPCO

Page 1: Hot Regulatory Topics Judi Lund Person, MPH NHPCO

HOT REGULATORY TOPICSJUDI LUND PERSON, MPH

NHPCO

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2 Eligibility

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Eligibility for Admission Medicare Hospice Benefit

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§ 418.20 Eligibility requirements. In order to be eligible to elect hospice

care under Medicare, an individual must be-- (a) Entitled to Part A of Medicare; and (b) Certified as being terminally ill in

accordance with Sec. 418.22.

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Compliance “Hot Spots” Eligibility of hospice patients

Initial Ongoing Physician narrative

Certain non-cancer diagnosis Dementia/ Alzheimer's Debility unspecified

Level of care documentation GIP

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MAC Compliance “Hot Spots”

Eligibility of hospice patients Ongoing Physician narrative

Certain non-cancer diagnosis – evidencing 6 month or less prognosis Dementia/ Alzheimer's Debility unspecified

Level of care documentation GIP – eligibility for all days billed at GIP

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Opportunities to document eligibility

Certification Verbal certification Written certification Physician narrative statement

Admission Comprehensive assessment

Ongoing hospice service Every note by the IDT Update to the comprehensive assessment

Recertification F2F encounter Physician narrative statement

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Eligibility assessment7

Definitely eligible

Probably eligible

Not eligible

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Eligibility - 1st 90-day period

Demonstration of eligibility at admission Information/ consultation between attending

physician and hospice physician

Procurement of medical history and recent clinical documentation For the clinical record For use in the certification process

Attending physician and hospice physician certify patient based on their medical judgment of the disease progression

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Eligibility - 1st 90-day period

Demonstration of eligibility at admission Physician narrative should concisely

describe why the patient is initially eligible for hospice

Comprehensive assessment documentation by IDG should evidence the details of the patient’s eligibility

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Eligibility – Continued and at Recertification Demonstration of eligibility at

recertification Physician narrative should concisely

describe why the patient is continues to be eligible for hospice

Clinical note from face-to-face visit demonstrates eligibility (if 3rd of subsequent benefit period)

Update to the comprehensive assessment documentation by IDG should evidence the details of the patient’s continued eligibility

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Certification/ Recertification11

NHPCO Certification/ recertification Process Maps available for purchase in NHPCO’s Marketplace

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Co-morbidities12

Chronic obstructive pulmonary disease

Congestive heart failure Ischemic heart disease Diabetes mellitus Neurologic disease (CVA,

ALS, MS, Parkinson’s)

Although not the primary hospice diagnosis, the presence of disease such as the following…should be considered in determining hospice eligibility

• Renal failure• Liver Disease• Neoplasia• Acquired immune

deficiency syndrome• Dementia

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Local Coverage Determination Policies (LCDs)

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GUIDELINES, not regulations: Developed by each MAC (CGS, NGS, NHIC,

Palmetto) Outline guidelines for condition-specific

determination of eligibility Discuss documentation of secondary

diagnoses and co morbid conditions to support terminal prognosis

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Local Coverage Determination Policies (LCDs)14

More emphasis on functional decline in the updated LCDs Must have details to document the

extent of decline Need to consider the impact of

disease on patient’s quality of life Be familiar with the LCDs that are

used in medical review for your region

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Documentation Using LCDs

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Documentation needs to address: Impairments in function & structure Activity limitations Participation restrictions Secondary diagnoses Co-morbid conditions

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Documentation Using LCDs

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Address the patient’s activity level, self care, communication, and mobility

Give a historical perspective of what the patient’s ability was in the previous time period and then document current status

BUT REMEMBER… Decline eligibility Decline necessary or sufficient

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Documentation Using LCDs17

Use specifics to show the extent of the symptoms and limitations

Use the term “as evidenced by” to qualify the problems

Include symptoms such as wt loss, decubitus ulcers, & edema

Co-morbid conditions such as CHF, COPD and diabetes affect prognosis

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The physician narrative

Components of a comprehensive and adequate physician narrative should include: Explanation of the clinical findings that

supports a life expectancy of 6 months or less

Reference to specific LCDs as appropriate

Reference to prognostic indicators or symptom management sales as appropriate

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The physician narrative

Components of a comprehensive and adequate physician narrative should include: Reference to functional status

PPS - Validated in palliative care ECOG - Cancer Karnofsky - Cancer FAST - Dementia

Being specific is the most important thing: don’t say that the patient has lost weight – state that there has been a 15 pound weight loss in the past 2 months and 45 pounds in the last 6

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The physician narrative

Components of a comprehensive and adequate physician narrative should include: Evidence of a decrease in anthropomorphic

measurements Recent hospitalizations Information about other significant complications in

addition to the LCD specific criteria appropriate for that particular diagnosis

Statement should be concise, but adequate Statement should contain prognostic

indicators

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21 Quality Reporting

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CY2013 QUALITY REPORTING

Measures for quality reporting:

NQF #0209 Pain Measure Structural Measure

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CY2013 QUALITY REPORTING

NQF #0209: Comfortable Dying (NHPCO)

Percentage of patients who were uncomfortable because of pain at the initial assessment (after admission to hospice services) whose pain was brought to a comfortable level within 48 hours.

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CY2013 QUALITY REPORTING

Structural Measure:

Participation in a QAPI program that includes at least 3 quality indicators related to patient care

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CY2013 QUALITY REPORTING

QAPI Structural MeasureSubmission = Indication if hospice has a QAPI program

that includes at least three indicators related to patient care; and

Measures are used during reporting period

Description of all quality indicators related to patient care.

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CY2013 QUALITY REPORTING

QAPI Structural Measure

No results are submitted -- only the patient care measure descriptions

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Hospice Quality Reporting

The data collection period is January 1 – December 26 of each year

Reporting is mandatory Data due April 1 of each year 2013 measures remain the same as

2012

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Miss the deadlines?

Mandatory reporting Measures required – no choice in

what measures should be reported Miss the 2013 reporting deadlines?

Deadlines HAVE NOT been extended

2% cut in hospital market basket increase (hospice reimbursement rate “inflation adjustment”) in FY2014

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CMS RESOURCES

CMS Hospice Quality Reporting web page Information posted on CMS web site as it becomes available

https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Hospice-Quality-Reporting/index.html

Download PowerPoint presentations and hospice quality questions and answers:

http://www.cms.gov/Hospice-Quality-Reporting/

Help Desk: [email protected] or by phone at 1.800.647.9670.

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NHPCO RESOURCES

Basic Information and Materials

www.nhpco.org/outcomemeasures

www.nhpco.org/qualityreporting

Questions – send email to:

[email protected]

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31 THE FUTURE OF HOSPICE QUALITY REPORTING

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Payment Year FY2015

NQF #0209: Percentage of patients who report being uncomfortable because of pain on the initial assessment (after admission to hospice services) who report pain was brought to a comfortable level within 48 hours

Structural measure: Participation in a Quality Assessment and Performance Improvement (QAPI) program that includes at least three quality indicators related to patient care. Hospices would report whether or not they have a QAPI program with at least three indicators related to patient care.

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Data Collection Period

Calendar year – January 1, 2013 through December 26, 2013

Hospices submit data in the fiscal year prior to the payment determination.

For FY2015 and beyond: Data submission deadline of April 1of each year.

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Payment Year FY2015

No additional measures Creation of a hospice patient-level data

item set Target date for implementation: CY2014

Data items included in standardized data set to support possible measures

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Patient level data collection

Mandatory data collection process being designed to collect data on individual hospice patients – demographics, diagnoses, symptoms

Used to collect data for future quality reporting

Expect to see a form and process in 2014 or 2015

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STANDARDIZED DATA ITEM SET

CMS developing standardized assessment instrument

Many items standardized and used by other providers

Some items developed specifically for hospice Developed to collect information for hospice-

appropriate quality measures Pilot testing with 9 hospices summer/fall 2012 Propose to implement hospice patient-level

data item set as early as CY 2014

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Payment Determinations beyond FY2015

Possible measures – implemented in future rulemaking 1617 Opioid with bowel regimen 1634 Pain screening 1637 Pain assessment 1638 Dyspnea treatment 1639 Dyspnea screening

0208 Family Evaluation of Hospice Care

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Experience of Care Survey

Similar to FEHC CAHPS survey being developed now

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VALUE BASED PURCHASING

Value based purchasing – pilot testing Utilize already implemented measures Implement pilot by January 1, 2016

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40 Part D and Hospice

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Part D and Hospice41

OIG report issued in 2012 Some Medicare hospice beneficiaries receiving

hospice care also had drugs paid for under Part D Scope of the problem:

198,543 hospice beneficiaries 677,022 prescription drugs through Part D Drugs should have been covered by the hospice? Part D paid pharmacies $33,638,137 Beneficiaries paid $3,835,557 in copayments

Expect additional scrutiny for Part D payments

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Recent Analysis

Analgesics only 2010 information

773,168 Medicare hospice beneficiaries enrolled in Part D

112,555 (14.6%) received 334,387 analgesic prescriptions through Part D during hospice enrollment

Gross costs -- $13,000,430 Examples of drugs: Fentanyl, oxycodone,

morphine, hydrocodone, hydromorphone….

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Recent Analysis

Location of patients? 63% in nursing facilities and assisted living 35% at home

Which hospices? 96.7% of hospices billed some analgesics to

Part D Which pharmacies?

40.9% of pharmacies

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CMS Draft 2014 Call Letter

Questions about eliminating Part D payments for Medicare hospice patients

Comments submitted March 1 2013 Proposing January 2014:

Part D sponsor who receives report that a beneficiary has elected the Medicare Hospice benefit

Sponsor place beneficiary-level prior authorization requirement for four categories of prescription drugs

Four categories: Analgesics antinauseants (antiemetics) Laxatives antianxiety

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45 Multiple Diagnoses on Claim Form

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Multiple diagnoses on claim form

Requirement is not new Clarification in FY 2013 Final Hospice

Wage Index Rule Analyses by CMS hospice contractor, showed

that 77.2% of hospice claims from 2010 only reported a principal diagnosis

CMS believes that hospice claims which only report a principal diagnosis are not providing an accurate description of the patients’ conditions

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Multiple diagnoses on claim form

Providers should code and report coexisting or additional diagnoses to more fully describe the Medicare patients they are treating CMS’ Hospice Claims Processing manual requires

that hospice claims include other diagnoses “as required by ICD-9-CM Coding Guidelines” (IOM 100-04, chapter 11, section 30.1, available at http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c11.pdf)

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Multiple diagnoses on claim form

CMS clarifies that all of a patient’s coexisting or additional diagnoses s should be reported on the hospice claim paper UB-04 claim allows for up to 17 additional

diagnoses electronic claim allows for 24 additional

diagnoses

Hospices should not report diagnoses which are unrelated to the terminal illness on their claims

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Mixed messages from CMS

CMS is asking for all coexisting diagnoses and comorbidities

Often significant and used to make the case in the narrative for 6 month life expectancy

Example: Patient with heart failure Significant COPD and Parkinson’s disease COPD and Parkinson’s contributing to decline “Unrelated” to the heart failure Previously instructed not to include these very

significant but unrelated diagnoses on claim form

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The issues Diagnoses definition inconsistency by

CMS Related Co-morbid Secondary

Many EMR software solutions do not allow more that one diagnosis (5010 allows 25 spaces)

Payment for non-related dx; concern of providers

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Corollary issues

If diagnosis on claim form…. Hospice responsible for paying for drugs, DME,

supplies related to diagnosis CMS will expect hospice to pay for all or nearly

all drugs, DME, supplies for broad diagnoses Debility Adult Failure to Thrive Others

Determining relatedness…..

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Joint task force – NHPCO & NAHC

Task force goals Refine diagnoses definitions and seek

clarification from CMS Develop a resource to assist hospice

providers to determine relatedness Diagnoses Medications Other supplies and services

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53 Illegal Aliens

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Provider responsibility

Medicare does not pay for medical items/services furnished to an alien beneficiary who was not lawfully present in the United States on the date of service that the items/services were furnished

Common Working File will indicate alien status for unlawfully present in the US

MAC will retroactively adjust previously paid claims

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55 2013 PEPPER report

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PEPPER Report

The Program for Evaluating Payment Patterns Electronic Report (PEPPER) second report

Available April 2013 FedEx to the hospice CEO Hospice-specific data statistics

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PEPPER Details

CMS sets PEPPER focus areas Services at risk for improper payments Three years of claims data Hospices can use the data to support internal

auditing and monitoring activities PEPPER compares a hospice’s Medicare billing

practices with other hospices in the: State Medicare Administrative Contractor (MAC)

jurisdiction US

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PEPPER Details

Time frame for claims: October 1, 2009 – September 30, 2012

Additional claims for period October 1, 2007 – September 30, 2009 included for episodes of service beginning prior to the reporting period

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PEPPER Details

Each hospice receives only its PEPPER Not available to the public Contractor provides Access database

with PEPPER data to MACs, Recovery Audit Contractors

Pay attention to any findings at or above the national 80th percentile

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Focus of PEPPER Report

Beneficiaries whose episode of service ends in the reporting year, either by live discharge or death.

Two focus areas: “Live Discharges” includes all episodes

where the beneficiary was discharged alive with a length of stay less than 25 days

“Long Length of Stay” counts beneficiary episodes of service that had a long length of stay -- greater than 180 days

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PEPPER Resources

www.pepperresources.org

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62 HIPAA Omnibus Rule

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The final omnibus rule

The final omnibus rule was published in the January 17, 2013 Federal Register http://www.gpo.gov/fdsys/pkg/FR-2013-01-25/pd

f/2013-01073.pdf Compliance with most of the new

requirements introduced in the Final Rule is required by September 23, 2013

An extended compliance period is provided for the modification of certain existing business associate agreements

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When is compliance required?

Effective date: This final rule is March 26, 2013

Compliance date: Covered entities and business associates must comply with the applicable requirements of this final rule by September 23, 2013

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New rule

Changes greatly enhance a patient's privacy rights and protections

Strengthens the ability of Office of Civil Rights to vigorously enforce the HIPAA privacy and security protections

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New Breach Standard

Substantial change to the definition of a “breach” of protected health information (PHI)

New standard defines any impermissible acquisition, access, use or disclosure of PHI under the Privacy Rule is a breach unless a covered entity or business associate can demonstrate that there is a low probability that the PHI has been compromised Entities determine whether there is a low probability

that PHI has been compromised by performing a risk assessment

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New Breach Standard

This modification to the definition of breach will make it more difficult for covered entities and business associates to justify a decision not to provide notification following a suspected breach incident

Following a breach, covered entities are still required to notify affected individuals, the Secretary of HHS, and the media (if a breach affects more than 500 residents of a State or jurisdiction) The current timing, content and methods for

notification also remain unchanged

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New Breach Standard

HHS intends to issue guidance to aid covered entities and business associates in performing risk assessments and to assist with the individual notification requirements at a future date

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Expanded Individual Rights

Individuals’ rights expanded with respect to their PHI in two important ways1. It provides them with the right to receive

certain PHI electronically2. It allows them to restrict certain

disclosures of PHI to their health plans Hospice providers will have to revise their

current policies and procedures and evaluate current system capabilities to ensure compliance with these new requirements

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Expanded Individual Rights

The Final Rule also provides individuals with the right to request that covered entities and business associates provide a copy of their PHI directly to a designated individual

This right applies to both paper and electronic information

Any such request must be in writing, signed by the individual, and must clearly identify the designated recipient and where the information should be sent

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Expanded Individual Rights

Restriction of certain disclosures of PHI to their health plans

Hospice providers will likely need to develop a method to flag or include a notation in the record of any individual who has exercised this right to restrict disclosures regarding services paid for out of pocket, in order to ensure that specific records are not sent or made accessible to health plans

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Modifications to Notices of Privacy Practices Required Privacy notices must include a statement

regarding the right of affected individuals to be notified following a data breach and must describe certain uses and disclosures of PHI that require patient authorization related to psychotherapy notes, marketing, and the sale of PHI

The Notice must also inform patients of their right to restrict certain disclosures of PHI to health plans where the individual pays out of pocket in full

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Direct Liability for Business Associates and Amendments to Business Associate Agreements

Business associates and business associate subcontractors will now be directly subject to applicable HIPAA rules including the HIPAA Security Rule and certain

provisions of the Privacy Rule HHS modified the definition of business

associates to specifically include several new entities, including subcontractors that create, receive or transmit PHI on behalf of business associates and entities that provide data transmission of PHI

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Direct Liability for Business Associates and Amendments to Business Associate Agreements

Data storage vendors that maintain PHI (both hardcopy and electronic), are business associates even if the vendor never actually views or accesses the PHI

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Business Associate Agreements

Business associate agreements will need to be modified to meet additional requirements

The Final Rule provides an extended transition period up to September 22, 2014 for amending existing business associate agreements only for an existing business associate agreement meeting the following conditions:

was in place prior to January 25, 2013 and complies with current HIPAA business associate agreement requirements; and

is not modified or renewed during the period from March 26, 2013 to September 23, 2013

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Business Associate Agreements

Business associate agreements not eligible for the extended transition period must be compliant with the Final Rule as of the September 23, 2013 compliance date

  HHS recently issued guidance on the

revised business associate agreement requirements and provided sample terms. This guidance is available at: http://

www.hhs.gov/ocr/privacy/hipaa/understanding/coveredentities/contractprov.html

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New Fundraising Requirements

Expansion of the type of information covered entities may use to target fundraising appeals to include the department of service, the treating physician and outcome information

Permits the use only of demographic information and dates of health care provided to the patient

Fundraising communications must provide recipients with a clear opportunity to opt-out and the method provided for the opt-out may not cause undue burden or more than nominal costs

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Decedent information

A covered entity only has an obligation to comply with the requirements of the Privacy Rule with respect to the PHI of a deceased individual for 50 years following the individual’s death

Rule permits covered entities to disclose PHI to a family member or other individual involved in a decedent’s care or payment for such care, unless such a disclosure is inconsistent with a prior expressed preference of the decedent

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New Enforcement Authority

Enforcement changes effective March 26, 2013

Civil and criminal penalties can now be applied directly to business associates

HHS must investigate any complaint and conduct compliance reviews in all cases where a preliminary review of the facts indicates a possible violation due to willful neglect

HHS must impose a civil money penalty for violations due to willful neglect

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New Enforcement Authority

HHS is not required to attempt to resolve cases of noncompliance due to willful neglect by informal means

The tiered penalty structure based on different levels of culpability has been finalized. Penalties now range from $100 to $50,000 per violation depending on the level of knowledge/willfulness with a $1.5 million cap per calendar year for multiple violations of identical provisions

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New Enforcement Authority

Covered entities and business associates can be subject to liability for a violation by their business associate agents and subcontractor business associate agents respectively

HHS may disclose PHI obtained in connection with a compliance review or investigation if permitted under the Privacy Act, thereby giving it the ability to share information with other law enforcement agencies (e.g., state attorneys general or the Federal Trade Commission)

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Other Important Changes

Expansion of Prohibited Marketing Activities HIPAA prohibits the use or disclosure of PHI for

marketing to individuals without obtaining an authorization, with certain important exceptions

Prohibition on the Sale of PHI Prohibits the receipt of direct or indirect remuneration

(including in-kind benefits) in exchange for PHI This new restriction includes several exceptions,

including disclosures to business associates, as required by law, and for treatment and payment purposes

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Other Important Changes

New Research Authorizations Permitted allows researchers to obtain authorizations to

use PHI for future research, provided that the future research is adequately described

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FY 2013 OIG Work Plan

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FY2013 OIG Work Plan

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Acute-Care Hospital Inpatient Transfers to Inpatient Hospice Care Review Medicare claims for inpatient stays when

beneficiary was transferred to hospice care and examine the relationship between the acute-care hospital and the hospice provider.

Hospice Marketing Practices and Financial Relationships with Nursing Facilities Review hospices’ marketing materials and practices and

their financial relationships with nursing facilities. Medicare Hospice General Inpatient Care

Use of GIP from 2005 to 2010. Assess appropriateness of GIP claims and beneficiary drug claims billed under Part D.

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FY2013 OIG Work Plan

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Medicaid: Hospice Services: Compliance With Reimbursement Requirements We will determine whether Medicaid

payments for hospice services complied with Federal reimbursement requirements.

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Regulatory and Compliance Team at NHPCO

Jennifer Kennedy, MA, BSN, RNRegulatory and Compliance Director

Judi Lund Person, MPHVice President, Compliance and

Regulatory Leadership

Email us at: [email protected]

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Q&A

NHPCO members enjoy unlimited access to Regulatory Assistance

Feel free to email questions to [email protected]