Tag: Centers for Medicare and Medicaid Services (CMS)

HHS Office of Civil Rights Announces Phase 2 HIPAA Audit Review Program

On March 21, 2016, the Office for Civil Rights of the Department of Health and Human Services announced Phase 2 of its HIPAA Audit Program.  The Health Information Technology for Economic and Clinical Health Act (HITECH) required HHS to perform periodic audits of covered entities and business associates to assess their compliance with the HIPAA Privacy, Security and Breach Notification Rules.  These rules are enforced by the HHS Office for Civil Rights (OCR).

Background on Phase 1

In 2011, OCR implemented a pilot audit program to assess the controls and processes covered entities have adopted to meet their HIPAA obligations.  The pilot audit program was conducted in three phases.  OCR first developed a set of audit protocols that it would use to evaluate covered entities’ compliance.  This protocol was then tested using a limited number of audits.   The final step involved using the revised audit protocols on a larger number of covered entities.  Ultimately, 115 covered entities were selected for review, and all audits were concluded by December 31, 2012.

Phase 2

Phase 2 of the HIPAA Audit Program will focus on the policies and procedures adopted and employed by entities to meet the requirements of the Privacy, Security, and Breach Notification Rules.  OCR has indicated that these audits will be conducted primary through desk audits (i.e., document submissions), although by a limited number of on-site audits will also be conducted.

Unlike Phase 1, which focused exclusively on covered entities, OCR is indicating that Phase 2 will involve audits of both covered entities and their business associates.

As with the initial pilot audit program, Phase 2 will consist of several stages.  The first stage involves verification of a covered entity’s or business associate’s address and contact information.  A sample address verification letter can be viewed by clicking here.  OCR has indicated that emails will be sent to entities requesting accurate contact information for the entity.  OCR will then transmit a “pre-audit questionnaire” to the entity.  These questionnaires will be used to gather data about the size, type, and operations of potential auditees.  Based on this data, OCR will create potential audit subject pools.

Note: OCR has indicated that if an entity fails to respond to OCR’s request to validate its contact information and/or fails to return the pre-audit questionnaire, OCR will use publicly available information about the entity to create its audit subject pool.  As a result, an entity that fails to respond may still be selected for audit and/or compliance review.  OCR is specifically reminding entities to check their email “junk” or “spam” folders for any communications from OCR.

Once OCR has developed its audit subject pools, it will randomly select auditees from these pools.  Auditees will then be notified by OCR of their participation.  OCR has indicated that the first set of audits will focus on covered entities, with a subsequent round of audits focused on business associates.  These audits will focus on compliance with specific requirements of the Privacy, Security, or Breach Notification Rules.  Auditees will be notified of the scope of their audit in a document request letter.  Both of these rounds will be desk audits.  OCR indicated that all desk audits will be completed by the end of December 2016.

A third round of on-site audits will take place after the completion of the desk audits, and will examine a broader scope of requirements under HIPAA.  OCR further indicated that desk auditees may also be subject to on-site audits.

If an entity is selected for audit, OCR will notify them by email.  The email will introduce the OCR audit team, explain the audit process, and discuss OCR’s expectations in greater detail.  The email notification letter will also include initial requests for documentation.  OCR has indicated that it will expect entities to respond to these documentation requests within ten (10) business days.  Documents will be submitted through a new secure online portal.  Once received, OCR’s auditors will review the submitted information and inform the entity of its draft findings.  The entity will then have ten (10) business days to respond with written comments, if any.  OCR will then review the entity’s comments and issue a final audit report within thirty (30) business days.

OCR has indicated that the audits are primarily intended as a compliance improvement activity.  OCR will use aggregated data to better understand compliance with respect to particular aspects of the HIPAA rules.  The goal being to understand what types of technical assistance and/or corrective actions would be most helpful.  In other words, OCR is indicating that the goal of these audits is to improve its understanding of the state of compliance, and not to penalize specific companies for violations.  However, OCR indicated that should an audit reveal a serious compliance issue, OCR may initiate a further compliance review of the company.

OCR indicated that it will not post a list of the audited entities, nor will its findings be available in a format that would clearly identify the audited entity.  However, OCR noted that audit notification letters and other information regarding these audits may be discoverable under the Freedom of Information Act (FOIA).

Additional information from OCR regarding the Phase 2 HIPAA Audit Program can be obtained by clicking here.

CMS Publishes Medicare Fee-for-Service Provider & Supplier Lists

Earlier today, AAA representatives participated on an invitation-only stakeholder call in which CMS announced the availability of two new public data sets. The first data set shows through an interactive map the availability and use of services provided to Medicare beneficiaries by ground ambulance suppliers and home health agencies. The second data set is a list of Medicare fee-for-service (FFS) providers and suppliers currently approved to bill Medicare. CMS just released the two data sets to the public.

The first data set, the Moratoria Provider Services and Utilization Data Tool, includes interactive maps and a data-set that shows national, state, and county-level provider and supplier services and utilization data that can be used by CMS to determine which geographic and health service areas might be considered for a moratorium on new provider and supplier enrollments. The data provides the number of Medicare providers and suppliers servicing a geographic region, identifies moratoria regions at the state and county levels, and identifies the number of people with Medicare benefits who use a specific health service in that region. The data can also be used to reveal service levels related to the number of providers and suppliers in a geographic region. Utilization data and geographic regions for these services can be easily compared using interactive maps.

You can access the Moratoria Provider Services and Utilization Data Tool at: https://data.cms.gov/moratoria-data
The provider/supplier enrollment data set can be accessed at: https://data.cms.gov/public-provider-enrollment

CMS Releases Ambulance Cost Data Collection Report

The Centers for Medicare and Medicaid Services (CMS) has released its report on the feasibility of collecting cost data from ambulance service providers.  Under the American Taxpayer Relief Act of 2012, Congress directed CMS to conduct the report entitled “Evaluation of Hospitals’ Ambulance Data on Medicare Cost Reports and Feasibility of Obtaining Cost Data from All Ambulance Providers and Suppliers”. The report can be accessed here.

The report states that due to the diverse nature of our industry with a majority of providers being small entities, traditional mandatory ambulance cost reporting is not feasible.  While it does not make a recommendation on a data collection system, the report highlights the work of the AAA with The Moran Company and will be helpful in our push for a survey approach to collecting ambulance cost data.  Here is AAA’ summary of the report, AAA Summary of CMS Acumen Cost Analysis.

The survey approach to collecting ambulance cost data is a major component of the Medicare Ambulance Access, Fraud Prevention and Reform Act (S. 377, H.R. 745) which would make the current Medicare ambulance increases permanent.  The data collected through the survey would help the AAA make data-driven recommendations to the Congress and CMS on future changes to the Medicare ambulance fee schedule.

The contractor, Acumen, who developed the report, was also asked to look to see if cost data submitted by hospital-based ambulance service providers would be helpful.  Acumen determined that the data submitted varied significantly and thus was not useful.

For questions about the AAA efforts on cost data collection, please contact AAA Senior Vice President of Government Affairs Tristan North at tnorth@ambulance.org.

CMS Announces 2016 Inflation Factor

The Centers for Medicare and Medicare Services (CMS) has officially announced that the inflation factor for payments under the Medicare ambulance fee schedule for 2016 will be negative .4% (-0.4%). As part of the Affordable Care Act, a productivity adjustment has been part of the calculation for the last several years which for 2016 has resulted in a negative update.

The calculation for determining the Medicare ambulance inflation factor is as follows: Consumer Price Index – Urban (which is the change in the CPI-U from June to June) minus the non-farm business multi-factor productivity adjustment (MFP) as projected by the Secretary of HHS (10-year average). The CPI-Urban for 2016 is 0.1% with a MFP of 0.5% which equals negative .4%.

The AAA had projected an inflation factor of negative .5%.

Prior Auth Expansion to MD, DE, DC, NC, VA, WV

CMS Announces Expansion of Prior Authorization Program for Repetitive Scheduled Non-Emergent Ambulance Transports

October 26, 2015

CMS has announced that consistent with the requirements of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), it will expand the current prior authorization demonstration program for repetitive scheduled non-emergent ambulance transports beginning on January 1, 2016, to Maryland, Delaware, the District of Columbia, North Carolina, Virginia, and West Virginia. The current demonstration program is operating in three states (New Jersey, Pennsylvania, and South Carolina).

The demonstration seeks “to test whether prior authorization helps reduce expenditures, while maintaining or improving quality of care, using the established prior authorization process for repetitive scheduled non-emergent ambulance transport to reduce utilization of services that do not comply with Medicare policy.”

The Agency reiterates that the prior authorization process does not create new clinical documentation requirements. Requesting a prior authorization is not mandatory, but CMS encourages ambulance services to submit a request for prior authorization to their MACs along with the relevant documentation to support coverage. If an ambulance service does not request prior authorization, by the fourth round-trip in a 30-day period, the claims will be stopped for pre-payment review.

To be approved, the request must meet all applicable rules and policy, as well as any local coverage determination requirements. The MAC will “make every effort” to review and decide on the request within 10 business days for an initial submission. If an ambulance service requests a subsequent prior authorization after a non-affirmative decision, the MAC will try to review and decide upon the subsequent request within 20 business days. Ambulance services may also request an expedited review.

If granted, the prior authorization may affirm a specified number of trips within a specific amount of time. The maximum number of trips is 40 round trips within a 60-day period.

Member Advisory: CMS Releases the ICD-10 Crosswalk

By Kathy Lester, JD, MPH | AAA Healthcare Regulatory Consultant | October 9, 2015

At the end of last week, CMS posted the ICD-10 crosswalks for medical conditions for ambulance services. The documents can be found here, under the Other Guidance section at the bottom of the webpage.

In creating the crosswalk files, CMS relied upon a program developed by 3M, ICD-10 CTT. The files provide comprehensive crosswalks for both primary and alternative specific codes and are intended to supplement the existing Medical Conditions List.

The AAA has been working with CMS for the past year to create an official document that addresses the medical condition codes upon which some of the Medicare contractors rely for billing and auditing purposes.

While we are pleased that CMS has recognized the need for a crosswalk, we are concerned that the documents posted are a literal crosswalk of the previous ICD-9 list. This document can also be found on the Ambulance Service Center webpage. This approach, which incorporates all potential ICD-10 codes, has resulted in a large number of codes being included in the crosswalk. Some of these codes are inappropriate to use because they require diagnostic skills that extend beyond the scope of ambulance personnel.

The AAA has developed a more streamlined list of condition codes that eliminates those codes that are inappropriate for ambulance services to use.

We continue to work with CMS to refine its crosswalk to ensure that it is useful to ambulance services throughout the country.

Redeterminations/Reconsiderations: Scope of Review Limited

CMS published MLN Matters article number SE1521, which states:

“For redeterminations and reconsiderations of claims denied following a post-payment review or audit, CMS has instructed MACs and QICs to limit their review to the reason(s) the claim or line item at issue was initially denied.”

What this means is that if you have an audit and a claim is denied for a reason, e.g. not medically necessary, then when you appeal that denial, the MAC cannot deny the claim for a different reason, e.g. signature not legible. The same applies to a denial in the Redetermination decision as the QIC cannot deny for a different reason than what was stated in the original denial. Thus, the Redetermination decision and the Reconsideration decision are limited to the original reason for the denial.

This went into effect for Redetermination and Reconsideration requests received by a MAC or QIC on or after August 1, 2015.

It does not apply to denials that result from failing to submit requested documentation needed to process the claim. It also does not apply to denials from pre-payment reviews.

Submit Comment Letters on CY2016 Proposed Rule

The American Ambulance Association (AAA) recently drafted a comment letter in response to the Centers for Medicare and Medicaid Services (CMS) proposed rule for changes to the Medicare ambulance fee schedule for 2016.   The AAA letter requests that CMS make several changes to improve the methodology and data used to determine urban and rural areas under the fee schedule.

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Submit Comments on Proposed Rule to CY2016 Fee Schedule Changes

 

On July 8, 2015, the Centers for Medicare and Medicaid Services (CMS) published a copy of its proposed rule for changes to the Medicare ambulance fee schedule for 2016.  The AAA has drafted a comment letter requesting that CMS make several modifications to improve the methodology and data used for determining urban and rural areas under the fee schedule.  We urge all AAA members to use our letter as a template to submit a similar comment letter to CMS.

Here is how to submit a comment letter.

1) Download the draft template of the AAA comment letter.

2) Modify the letter in the highlighted areas to customize it to your organization.

3) Submit the comment letter by going to the Regulations.gov submissions webpage for the proposed rule at http://www.regulations.gov/#!submitComment;D=CMS-2015-0081-0002

If you have any questions about submitting a comment letter, please contact AAA Senior Vice President Tristan North at tnorth@ambulance.org

CMS Issues Proposed Rule for Calendar Year 2016

On July 8, 2015, the Centers for Medicare and Medicaid Services (CMS) published a display copy of a proposed rule titled “Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY 2016”.  The proposed rule makes a number of changes to the Medicare Physician Fee Schedule.  It also makes certain changes to the Medicare Ambulance Fee Schedule.  These proposed changes are summarized below.

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CMS Ambulance Open Door Forum Thursday, July 9

Mark your calendar to have your voice heard! The next Centers for Medicare and Medicaid Services Ambulance Open Door Forum (CMS ODF) call is scheduled for this Thursday, July 9 from 2–3 p.m. ET.

Call-in Number: 1-800-837-1935
Conference ID: 12780373

“The Ambulance Open Door Forum (ODF) addresses issues related to the payment, billing, coverage and delivery of services in the ambulance industry. The Ambulance Fee Schedule rules, rural and other ambulance payment enhancements, requirements for ambulance service certification and payment determinations, are just some of the many types of issues addressed within the forum. In addition, discussions differentiating the rules related to provider-based and independent ambulance services are facilitated. Timely announcements and clarifications regarding important rulemaking, agency program initiatives and other related areas are also included in the forums.” — CMS

For the agenda and additional information, please visit the CMS website.

Just Released—Compare Your Service With 2013 Medicare Data

See how your service stacks up according to several key Centers for Medicare and Medicaid Services (CMS) measures. The  recently released 2013 Medicare Provider Utilization and Payment Data lists all providers by National Provider Identifier (NPI), and includes figures on utilization, total payments, and submitted charges.

AAA members, read more in today’s Member Advisory by expert Medicare consultant Brian Werfel.

Not yet a member? Learn more about how AAA membership can help you stay up-to-date on critical regulatory and reimbursement issues that impact your ambulance service.

Zip Code Delay Comment Letter

On December 30, 2014, AAA submitted a comment letter to CMS asking the Agency to delay implementation of the changes in zip codes losing their rural status starting in 2015. In its comment letter, the AAA based the one-year delay on the lack of proper notice of the changes in the geographical delineations of zip codes and the omission of a small entity impact certification in the proposed or final rules. In the proposed rule, CMS stated only 122 zip codes would lose rural status but in the final rule cited 3,038 zip codes switching from rural to urban. The AAA was able to get that number corrected to 1,599 zip codes but believes CMS still needs to delay implementation of the change for one-year to give ambulance service providers adequate time to determine and budget for the loss of revenue.

View Letter

Comment Letter on Proposed Fee Schedule Changes

On August 29, 2014, the AAA sent a Proposed Rule Comment Letter to the Centers for Medicare and Medicaid Services (CMS) regarding the CY2015 Fee Schedule Changes.  The AAA determined the recently published proposed rule on updates to the Medicare ambulance fee scheduled for CY 2015 likely significantly underestimated the number of zip codes that would change geographic area designation. In the proposed rule, CMS stated 120 zip codes would change from rural to urban and 100 zip codes would change from urban to rural. The AAA has estimated 1,524 zip codes would change from rural to urban and 449 zip codes would change from urban to rural.

AAA Proposed Rule Comment Letter

2015 Changed Zip Totals by State