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Compliance and
Privacy Update
© Copyright 2015-2016, PWW Media, Inc. All Rights Reserved.
All Use Subject to Attendee License Agreement.
2015-2016 Program Materials
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Con Ed CreditNAAC
• Certificates at NAAC booth after the conference
• Must attend entire conference to earn full 12 credits
• CACs: Log into your NAAC account enter your CEUs
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Publications and Products
Available Today!
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Ambulance Service Guide to HIPAA Compliance – 4th Ed.
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Includes:
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Forms
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Training
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COMPLIANCE UPDATE
abc360 General Sessions
Our 2 Goals Today
1. Provide you with the latest about compliance and government enforcement
2. Give you the strategies you need to combat the risks you face
First, What’s the Government Doing?
NEW Regulations on the ACA’s 60 Day
Overpayment Rule
Two Provisions in the ACA1. Providers and suppliers must report
and return identified overpayments from Medicare and Medicaid within 60 days
2. Retaining an overpayment after the deadline constitutes a violation of the Federal False Claims Act (FCA)
Your Duty…
• Since March 23, 2010 ambulance services have been under a duty to report and return Medicare andMedicaid overpayments 60 days after identification
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The New Regulations
• Published February 12, 2016
Effective:March 14, 2016
Regulations Apply to…
• Medicare overpayments • CMS said it will issue other rules for
Medicaid overpayments Even without Medicaid-specific rules, you
still have a duty under ACA to return Medicaid overpayments within 60 days of identification
Definition of “Overpayment”
• Any funds a provider has received or retained from Medicare to which the provider is not entitled
Clarifications About Overpayments from CMS
It’s An Overpayment - Even if It is Medicare’s Fault!
• Examples: CMS system error classifying a Medicare
beneficiary as FFS when the beneficiary was enrolled in a MA Plan MAC pays for a non-covered service due
to a contractor system edit problem MAC inadvertently pays a non-emergency
claim at the emergency rate
Overpayments Can be Partial
• Example: Provider paid $400 for a claim when it should have received $300 - the overpayment is $100
• A claim inadvertently coded and paid at a higher level of service does not mean the entire claim must be refunded - if coverage criteria for lower level of service is met
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Overpayments May Include the Entire Claim
• Where payment is made for a service not payable under the Medicare e.g., claims resulting from Anti-Kickback Statute
violations or intentional upcoding (fraudulent claims)
• Overpayments are the entire amount paid in these situations
Meaning of “Identified”
The Regulation
• A provider has identified an overpayment if the provider has, or should have through the exercise of reasonable diligence Determined that an overpayment has been
received, and Quantified the amount of the overpayment
42 CFR § 401.305(a)(2)
The Regulation
• A provider should have determined that it received an overpayment and quantified the amount of the overpayment if the provider fails to exercise reasonable diligence and in fact received an overpayment.
42 CFR § 401.305(a)(2)
Here’s the Way it WorksYou determined
you’ve received an overpayment and
quantified it
You exercise “reasonable diligence”
You fail to exercise “reasonable diligence”
You have “identified” and overpayment
The overpayment is “identified” once you’ve determined
you’ve received it and you’ve quantified it
The overpayment is likely “identified”
when it was received
CMS Examples - When an Overpayment Has Been Identified
A provider reviews billing or payment records and learns that it incorrectly coded certain services, resulting in increased reimbursement
A provider learns that services were provided by an unlicensed or excluded individual on its behalf
A provider performs an internal audit and discovers that overpayments exist.
A provider is informed by a government agency of an audit that discovered a potential overpayment, and the provider or supplier fails to make a reasonable inquiry.
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Identified By Whom?• Generally anyone in the organization• CMS said an overpayment does NOT
have to be confirmed by management or “senior official”
Exercise Reasonable Diligence!• If you exercise reasonable diligence, you
get time to investigate and quantify the overpayment
• If you don’t exercise reasonable diligence, you don’t get the benefit of time to investigate and quantify
What is “Reasonable Diligence?” Reasonable Diligence is Proactive
• Proactive compliance activities conducted in good faith by qualified individuals to monitor for the receipt of overpayments
Proactive Compliance Activities
Track and Compare Medicare Revenue
• Should be part of your compliance monitoring activities
• Significant changes without an obvious cause such should be investigated
Potential Causes
More ALS than last year?
More BLS NE?
Higher average charges?
Higher mileage claims
New contract?
New billing company?
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Compare to National Data
• Use of “Cadillac codes” ALS1-NE (2%) ALS2 (1%) SCT (1%)
• ALS vs. BLS utilization rates
Use Billing Edits
A0427HN = STOP
Perform 100% Audits of High Risk Areas
• Dialysis• High mileage trips (especially urban
providers)• Emergency trips going to nonhospital
destination
Reasonable Diligence is Reactive
Investigations conducted in good faith and in a timely manner by qualified individuals in response to obtaining “credible information” of a potential overpayment
Examples of “Credible Information” of a
Potential Overpayment
Learning About a Coding Error
Example: ABC Ambulance’s billing software has a default in the ambulance certification questions which automatically populates “Yes” to a question about whether the transport was medical necessity.
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Unlicensed or Excluded Provider
• Example: ABC Ambulance learns from another provider that an EMT’s certification may have been revoked
• Example: ABC Ambulance finds out that one of the physicians signing its PCS forms was on the OIG’s List of Excluded Entities and Individuals
You Learn About A Potential Issue Though an Audit
Example: During a quarterly claims audit, ABC Ambulance discovers that one of its billers billed 2 claims as A0427 – ALS Emergency on trips where there was no ALS assessment or ALS intervention performed.
A Single Overpaid Claim
• CMS says that after finding a single overpaid claim it is appropriate to determine whether there are more overpayments on the same issue
Hotline Complaints• Repeated hotline calls regarding the
same issue• One detailed hotline compliant
Unexplained Increase in Revenue
CMS said an “unexplained increase in Medicare revenue” could be enough to trigger an investigation to determine if an overpayment exists
How Much Time to “Identify” an Overpayment?
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CMS on Time to Investigate
• When investigations are necessary as part of “reasonable diligence,” CMS says that the investigation should take at most 6 months from the receipt of the credible information except in extraordinary circumstances
Given 6 Months to Investigate…
8 months would be an outer limit from the start of the investigation to reporting and returning
6 months maximum to investigate + 60 days to refund the overpayment
May Depend on the Circumstances
• Clear cut cases - the ambulance service determines it was paid for 10 additional miles on a claim during an audit No further investigation needed 60 days likely begins from the date it was
discovered in the audit
May Depend on the Circumstances
• Less clear cut- ABC Ambulance realizes one of its paramedics may have lapsed in his CPR certification because another coworker reported it through the compliance hotline Need time to investigate and potentially consult
with legal counsel about the implications 60 days likely begins once ABC Ambulance confirms
the certification had lapsed and legal counsel determines coverage criteria were not met
Best Practices - Investigation
• Where little or no investigation is required – report and return 60 days from date you discovered the issue
• If you need to investigate: Proceed with “reasonable diligence” Don’t take longer than 6 months to investigate Don’t take more than 8 months from discovery to
repay
If You Don’t Exercise Reasonable Diligence
• 60 day time period begins when the provider received credible information of a potential overpayment but failed to conduct reasonable diligence
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OIG Self-Disclosure• Use of OIG Self-Disclosure Protocol
(SDP) tolls the 60 day requirement• If reasonable diligence determines that
use of the SDP is the proper action only the initiation of the protocol needs to take place within 60 days, not the actual repayment
Quantifying the Overpayment
If Actual Amount Readily Determined
• Refund the actual amount• Remember, only the difference between
the amount you got paid and the amount you should have been paid needs to be refunded
In More Complicated Cases
• Often a 2-step process Probe sample Extrapolation
Cases where:
• Large or indeterminate number of claims involved
• Long term issue
• Cannot determine with 100% certainty the exact amount
In More Complicated Cases• “It is not appropriate…to only return a
subset of claims identified as overpayments and not extrapolate the full amount of the overpayment.”
• “The supplier should not report and return overpayments on specific claims form the probe sample until the full overpayment is identified.”
• 81 Federal Register 7664 (February 12, 2016)
In More Complicated Cases• This entire process (probe sampling +
extrapolation) must all be completed within the 6-month outer limit for investigating potential overpayments
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The “Lookback” Period CMS Went With 6 Years Instead of 10
• Overpayments must be refunded only if provider identifies the overpayment within 6 years of the date the overpayment was received
• When investigating potential overpayments – may need to go back 6 years!
Amending Reopening Rules
• CMS is amending the reopening rules to have a reopening period that accommodates the 6-year lookback period
• Currently: 48 months (4 years)
Reporting Overpayments
• HHS will likely develop a standardized form in the future for repayments
• Currently, most MACs have an Overpayment Refund Form
• Requesting an offset instead of submitting an actual refund is acceptable
Financial Hardship
• Providers may request an “Extended Repayment Schedule” when true financial hardship can be demonstrated
Ambulance Overpayment Examples
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Examples of Overpayments• Claims paid at a higher level of service
than is justified by the documentation
• Claims paid for transports performed or billed by an excluded individual
• Claims paid without a valid signature are overpayments
• Invalid or missing PCS forms
6 Essential Tips for Complying With the New Rules
1. Monitor for Overpayments on a Daily Basis
• Easier to deal with small overpayments on 1 or 2 claims at a time than to deal with 6 years’ worth at once
• Ensure those who perform daily EFT and posting activities are trained on how to spot potential discrepancies
• Don’t wait for audits - make it a daily part of the revenue cycle process
2. Conduct Internal Audits• Verify the accuracy of claim submission
and payments Investigate detected overpayments to
determine if it is a one-time mistake or a larger issue
• At least yearly have an external claims review Can also have monthly or quarterly external
reviews
3. Establish Multiple Reporting Outlets
• Options to report potential overpayments and compliance concerns Hotline Suggestion box Employee surveys
• Empower staff members to speak up through a “Culture of Compliance”
4. Monitor and Investigate
• Consistently monitor compliance data and investigate when unexplained changes occur Level of service mix Medicare revenue Credit balances
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5. Have a Policy!
• Clearly outline the procedures for detecting, investigating, and refunding overpayments Monitor the process to make sure that
overpayments are being refunded within 60 days If you outsource your billing, your agency must
have a clear, written understanding of responsibilities in these situations so overpayment refunds do not fall through the cracks
6. Train Staff Members
• Train staff members so that overpayments can be prevented Thorough and truthful documentation Accurate coding and claim submission Through immediate reporting of issues
The Take Home
• Have a system to detect and preventoverpayments
• Once on notice of a potential overpayment, you must investigate without delay
• Once you’ve determined that an overpayment exists, follow procedures to immediately refund it!
The Stuff That Makes Headlines
$27.8 Billion To Date! Administration Recovers $7.70 for Every Dollar
Spent to Fight Health Care Fraud and Abuse
=
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Revalidation
• As a result of revalidation efforts CMS has Deactivated over 470,000 enrollments Revoked nearly 28,000 enrollments
Keep Your 855B Up to Date
• Authorized and delegated officials• Geographic information • Vehicle information • Billing company information• Record storage information• State licensure • Ownership and managing control
Largest Takedown in Medicare Strike Force History
“Very few investments have a 10:1 return on taxpayer
money."
• Advanced analytics to identify “aberrant and suspicious billing patterns”
• Shifting from “pay and chase”• Real time claims analysis
CMS Fraud Detection System States are Suspending Medicaid Payments
• State governments are suspending Medicaid payments based on pending investigations of “credible allegations of fraud”
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What’s a Credible Allegation of Fraud?
Allegations From any Source
• May include, but not limited to: Fraud hotline complaints Claims data mining Patterns identified through provider audits,
civil false claims cases, and law enforcement investigations
• Have “indicia of reliability”
Providers Now Have to Speculate
Presume it’s criminal
The Yates Memo
Yates Memo: No More DOJ Settlements Without
Individual Responsibility
Focus on Individuals
• Criminal and civil corporate investigations should focus on individuals from the inception of the investigation
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Communication
• Criminal and civil attorneys handling corporate investigations should be in routine communication with one another
A Cozy Relationship
No Release of Liability Unless Approved
• Absent extraordinary circumstances or approved departmental policy, the DOJ will not release culpable individuals from civil or criminal liability when resolving a matter with a corporation
• Individuals on the hook even if the agency settles
• Officials can’t ignore the owners, officers, and others
What The Memo Means
Case of the Convicted Biller And the Convicted EMT…
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Medicare Fraud Strike Forces
• Current conviction rate around 95%
• Average term of incarceration 4 years
“Criminalization” of Medical Necessity
• Several recent criminal cases convicted providers for performing “medically unnecessary” services and billing for them
Providing “Medically Unnecessary Services” = Fraud
The Problem With Medical Necessity Regulations
When Is “Transport By Other Means Contraindicated?”
Utilization Rates Compared to Other Providers
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Be Able to Justify Why Your
Utilization Rates Are Different
• All 911
• Primarily dialysis
• Super rural area
• Older population
What’s the Government Looking at in 2016?
OIG’s 2015 Mid-Year Update
1. Transports to dialysis facilities that potentially Never occurred Were medically unnecessary
2. Improper ALS-E payments
“We will examine Medicare claims data [for]”
And Remember This Report?• “Ghost transports” • High mileage urban transports• High number of transport services per
beneficiary
On the OIG’s Radar
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On the OIG’s Radar
• SCT trips not between facilities• Emergency trips not going to hospitals• Different providers furnishing dialysis
transports to same patient• Transports to/from partial hospitalization
The Media Picked up on This Report
And, the Media Picked up on the 2013 Medicare Ambulance Data
Release Your Action Items
• Document mobility assessments
• Regularly obtain facility records
• Patient video (with permission)
• Log of daily activities• Improve call intake screening
If You Do Dialysis Transports
• Documenting reasons why patient went to a particular facility Remember, “closest appropriate facility”
is the rule Consider the “locality” rule carefully
• Onboard documentation of mileage• Using shortest distance as measure
for mapping programs
If You’re in An Urban Area
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• If the patient is going home or to a nursing facility, it’s not an emergency
If You’re Doing a Discharge If You Are in a Fraud “Hot Spot”
• Likely that other providers could go down, especially for “AKS suspect behavior”
Ambulance Moratoria Extended, Again!
Philadelphia Area
Houston Area
Houston and Philadelphia Ambulance Moratoria
• Effective January 29, 2016 CMS extended moratoria for an additional 6 months
Why the Extensions?
• CMS says the circumstances warranting the moratoria (high number of suppliers compared to similar areas) have not yet abated
Are YOU Next on the Moratorium List?
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Now You Can Predict It!
• No. of fee for service beneficiaries• Avg. no. of users per provider• % of users out of FFS beneficiaries• Avg. no. of providers per county
Recent OIG Guidance for Boards
Small Organizations
• Must demonstrate the same degree of commitment to compliance as larger organizations
• May use less formality and fewer resources
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More Involvement
Boards of smaller organizations should become more involved in the organization’s compliance efforts
Recent AmbulanceFraud Cases
The $11.5M Settlement
• FCA lawsuit filed by competitorWhistleblower will receive $1.7M
• 5 ambulance services allegedly charged deeply discounted rates – often below cost – on Part A transports to hospitals and SNFs for exclusive rights to Part B patients
Regent Management Services Case
“This settlement sends a message to the health care industry that both sides of a swapping arrangement can be held responsible for their improper actions, not just the entity that actually bills Medicare or Medicaid for the services”-Gregory Demske, Chief Counsel to the Inspector General
Another “Swapping” Case
• Ambulance service paid $8 million to resolve FCA allegations
• Allegedly entered into numerous below-cost contracts with SNFs
• Government determined that all the contracts constituted prohibited “swapping” arrangements
Competition Doesn’t Always Yield the Right Thing
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Market This… The Jacksonville Case
• Nine hospitals and one ambulance company paid $7.5M to settle FCA allegations Hospitals paid bulk of settlement
• Government alleged hospitals routinely certified medical necessity of BLS non-emergency transports that were not medically necessary
The Jacksonville Case
• Even though the facilities were the primary target, remember that it is the ambulance service that submits the claims
• Ambulance service must scrutinize PCS forms from hospitals
The Jacksonville Case• Focus on “throughput” - hospitals
benefited by speeding up admissions and discharges
• First case to look at facility liability for ambulance medical necessity certifications
• BUT, burden on ambulance service to scrutinize PCS forms from hospitals
Remember . . .
• The presence of the signed physician certification statement does not alone demonstrate that the ambulance transport was medically necessary.
42 CFR 410.40(d)
The PCR is Critical!
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What About Holding Physicians Responsible?
Is There Any Hope?
Letter Issued by MichiganMedicaid to Practitioners and
Facilities
Excerpt:
• “The physician is held responsible for excessive orders or unnecessary services regardless of who actually renders or who receives payment for the services. The physician may also be subject to any corrective action related to these services, including recovery of funds paid to the physician.”
So Are Ambulance Services Off the Hook in Michigan?
The Bottom Line
• The ambulance service receives the reimbursement
• But this reasoning may be helpful for ambulance providers in medical necessity appeals
There’s No Excuse
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He Was Excluded
• Operator and “de facto owner” of ambulance and wheelchair van service Convicted in 2003 on a New Jersey state
health care charge, and was excluded federal health care programs for 11 years
How He Concealed it
• Never reported on 855B
• Everyone was in on it• Paid employees off
the books
This was a clear case where they knew he was excluded,
but…
Ambulance Services Have Been Hit With Other Exclusions
• Paramedic excluded for offense related to nursing license
• Owner excluded for defaulting on student loans
We mean here…
exclusions.oig.hhs.gov
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Screen Everyone
• Providers• Managers• Billers• Drivers• Vendors• Dispatchers• Owners• Chiefs, etc.
Anyone Who Signs PCS Forms
When?
• Prior to hiring or engaging the employee, volunteer or contractor
• Every 30 days
Watch Less Obvious Kickbacks to Beneficiaries
• Routine waivers of copays
• Discounted wheelchair van services
• Waiver of excess mileage costs
Compliance Risk Management for 2016
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2016 Risk Management• Know unique issues for each type of
transport: dialysis, discharges, SCTs, emergency response, excess mileage Focus on compliance weak spots for each
• Avoid the OIG exclusion quagmire Tune up initial screening and hiring
process Check your people – regularly
2016 Risk Management• Be ready for greater scrutiny of medical
necessity ICD-10 coding and Medicare contractors demand
more detail and specificity Clinical Documentation Improvement (CDI)
program a must
• Aberrant billing patterns Implement system to detect and monitor Audits (internal and external) Continual education
2016 Risk Management• Reduce “whistleblowing” likelihood Anonymous reporting and multiple
channels to report Exit interviews and supervisory training
on people management
• Establish the “Right Culture” The culture must exude compliance every
single day
PRIVACY UPDATE
abc360 General Sessions
Data Breaches
Continue to Abound
Multi-Factor Authentication on the Rise
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Body Camera Use OIG Says OCR Should Do Better Follow-up of Breaches
OCR Didn’t Always Document Things
• 23 percent of cases had incomplete documentation of corrective actions
• OCR also did not record small breach information in its case-tracking system
OCR Didn’t Always Check for Prior Breaches
• 39 percent of staff reported they rarely or never checked to see if a provider had reported a prior large breach Treated providers as if it was first offense
OCR Has Been Cracking Down in 2015-16 • Allowed employees to
leave office with PHI and no policy
• Ex-husband of manager said former wife left documents in his car
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• University of Washington Medicine
• UWM did not ensure that all of its affiliated entities were properly conducting risk assessments
• Employee downloaded malware
• They went much further than just investigating the small breaches the company reported
Provider Fined for File-Sharing
• Massachusetts hospital using an internet file-sharing program to save and share patient data
• Hospital workers reported this practice to HHS
$218,400 fine
Using File-Sharing Apps
• Analyze the risks of using the app and document the “risk analysis”
• Have a business associate agreement in place with cloud provider
Failure to Do Risk Analysis
• OCR received breach notification from a Cancer Care group after unencrypted laptop was stolen from an employee’s car
55,000 current and former patients’ info
$218,400 fine
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Does PHI Leave Your Agency?
• If so, have you documented the risks and do you have policies and procedures? Encrypted devices and storage media Physical storage while in transit Reporting breaches immediately
The Dreaded Dumpster, Again
• Cornell Pharmacy paid $125,000 after media outed them for tossing PHI in the dumpster
But despite these fines, the OIG says OCR is not cracking down
enough
OCR is Still Too Reactive
• OCR’s still investigates possible noncompliance primarily in response to complaints
OCR Isn’t Auditing
• Hasn’t fully implemented the required audit program Only did a pilot audit program in 2011-12
• HITECH Act required permanent audit program as of 2010
OCR Isn’t Documenting Corrective Actions
• Did not have complete documentation of corrective actions taken by covered entities in 26 percent of closed privacy cases
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The Theme for 2016 OCR’s Response
• Updated case-tracking system• Working on policies that ensure staff
check enforcement history• Educating staff to maintain
documentation• Will start permanent audit
program in 2016
Phase 2 HIPAA Audits Are Finally Coming in 2016
OCR is Making Moves
• Office for Civil Rights (OCR) sent pre-audit screening surveys to covered entities that could be selected for Phase 2
The Audit Process
• Data requests and selected entities have 2 weeks to respond OCR will only consider timely responses
• Then OCR will conduct either a desk or on-site audit
Who Will be Audited?
• Approximately 350 covered entities 232 providers
• Approximately 50 business associates
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Primary Focus Areas of Phase 2
Identified Issues From 2011‐12 Pilot Audit
HITECH Act Requirements
Risk Analysis Breach Notification
NPP Right to Pay Out‐of‐Pocket
Patient Access Electronic Access to PHI
Device and MediaControls
Right to Request Transmission of PHI to
Third Party
Transmission Security NPP Updates
Reasonable Safeguards BAA Updates
Steps to Prepare
1. Recent documented risk analysis? –Do one!
2. Updated inventory of your BAs and current BAAs
3. You’ve at least considered encryption4. Breach notification policy
Steps to Prepare
5. Updated NPP (does it mention breach)
6. Training records in order7. Inventory of system assets (ePCRs,
servers, etc.)8. Physical and technical security in
place (keypads, cameras, etc.)
New Guide
https://www.healthit.gov/sites/default/files/pdf/privacy/privacy-and-security-guide.pdf
Recent Advice on Patient Rights
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Patient’s Have a Right to Get Records Via Email
Even, Unencrypted Email
And, you Can’t Do This Stuff…
Make the Patient Physically Come In to Request PHI
Make the Patient Use a Web Portal to Access Their
Records
Make Them Mail a Request for Records
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Notarize an Access Request
HEALTHCARE REFORM UPDATE
abc360 General Sessions
The 2015 SCOTUS Ruling on ACA
The Issue
• The ACA stated that tax credits were available to those who purchased insurance in “an Exchange established by the State”
• IRS regulations interpreted that to mean any exchange, State or Federally run
The Ruling
• Supreme Court ruled 6-3 that tax credits are available to individuals who purchase insurance in State or Federal Exchange
• The ACA remains intact
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The Latest on the Employer Mandate
Mandate Phased in for Large Employers
• Employers with 100 or more FTEs: Must offer insurance to at least 70% of
full-time workers in 2015 Must offer insurance to 95% of full-time
workers in 2016 and beyond
Medium-Sized Employers
• Employers with 50-99 FTEs need to start insuring workers by 2016 or risk paying penalties under ACA
Small Employers
• Employers with up to 50 FTEs are not subject to employer mandate Can offer any coverage or no coverage
without penalty
• Tax credits have been retroactively available to small employers
Small Employer Tax Credits
• Employers with 25 or less FTEs and average annual wages of less than $50K are eligible for credits if: Employer contributes at least 50% of the
total healthcare premium cost
Find Out Much More in This Session
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The Latest on Medicaid Expansion
Source: Kaiser Family Foundation Current as of August 28, 2014
AAPC CODE
The abc360 Compliance and Privacy Update
45111KAK
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