CMS Meaningful Use Audits Begin; Stage 2 Rule Sent to OMB for Review

HITECH Answers reports that CMS has begun audits of providers participating in the Medicare EHR Incentive Program.  With little fanfare and no official introduction of CMS' chosen auditor, health care providers have already received letters from Figliozzi and Company seeking documentation on their Stage 1 meaningful use attestation. 

A two-week timeframe to respond was provided to all letter recipients. Although identifiable or detailed patient records are not being requested at this time, information requested by the audit letters includes;

  • A copy of their certification for the certified EHR technology used to meet Meaningful Use requirements;
  • Documentation showing method used to account for ED admissions; and
  • Documentation supporting attestation for core and menu measures and objectives. 

Several states have already begun audits under the Medicaid EHR Incentive Program, which are separate from those being conducted by CMS.  New Jersey, for example, has already begun audits for Adoption/Implementation/Upgrade payments. 

CMS confirmed last week to BNA that it had indeed begun Meaningful Use audits, as well as posted a FAQ to this effect (#7361).  An insurance specialist at CMS's Office of eHealth Standards & Service has stated CMS will not issue guidance on what providers should expect from the audits as it would defeat the overall purpose of conducting them.

The final regulations for Meaningful Use Stage 2 were sent July 16 to the Office of Management and Budget (OMB) for review. Although this would mean publication is expected in mid-October, as we know from the painstaking delay of the HITECH Omnibus Rule (sent for review in March, but with an extension announced by the OMB on June 22), HHS or the OMB can request extension of the 90-day timeframe for review.  The official kickoff for Stage 2 remains 2014, a one-year delay from the original start-date of 2013.    

HHS Partners with Private Sector to Combat Healthcare Fraud

On Thursday, July 26, the Department of Health and Human Services (HHS) announced a new partnership between the public and private sectors to stomp out healthcare fraud.  With HHS funding, federal, state and private organizations have teamed up to help identify and prevent healthcare fraud through information-sharing and cooperation, along with resources afforded by the Patient Protection and Affordable Care Act (ACA) for anti-fraud activities. 

In the official press release, Secretary Sebelius stated,

"This partnership puts criminals on notice that we will find them and stop them before they steal healthcare dollars.  Thanks to this initiative today and the anti-fraud tools that were made available by the health care law, we are working to stamp out these crimes and abuse in our health care system."

According to the FBI, over $80 billion is lost each year due to healthcare fraud; however, efforts over the past 3 years have resulted in recovery of $10.7 billion. Over 20 federal, state and private organizations have joined forces under this new partnership, including:

  • United States Department of Justice;
  • Centers for Medicare & Medicaid Services;
  • Federal Bureau of Investigation;
  • National Association of Medicaid Fraud Control Units;
  • New York Office of the Medicaid Inspector General;
  • Blue Cross Blue Shield Association;
  • AmeriGroup Corporation;
  • Humana Inc.; and
  • United Health Group.

Initial committee meetings are set to begin in September, with workgroups working to finalize the operational structure and initial work plan of the partnership.  Potential goals include sharing information on billing codes, geographic fraud hotspots and specific fraud schemes to prevent losses before they occur, identifying and stopping payments billed on the same day for the same patient, in different cities to different insurers, as well as utilization in the future of technological solutions and analytics to predict and detect fraud schemes. 

The ACA SCOTUS Decision in Plain English

As we all know from the "media drama" as some might call the countless media coverage, news articles, blogs and other posts, the Supreme Court of the United States ("SCOTUS") upheld the Patient Protection and Affordable Care Act ("ACA") on June 28th, 2012.  Although four questions were before the Court, it focused primarily on one--the challenge to the individual mandate to purchase insurance by 2014 or pay a "penalty". 

In an opinion closing in on almost 200 pages, the Court found, 5-4, that the individual mandate penalty was constitutional.  Although the government's Commerce Clause argument was rejected, Chief Justice Roberts bought one of its alternative arguments: that the individual mandate penalty was the functional equivalent of a "tax."  However, the Court rejected the penalty which would have been imposed on states that refused to expand coverage under their Medicaid programs. Although granting higher funds for Medicaid expansion is permissible, withdrawal of all Medicaid funds to those states that do not would not be. 

For those of you who have not and will not have the time to plow through and digest the lengthy opinion, here are some of the best "plain english" explanations of the Court's decision as well as some interesting commentary:

But for those of you with a spare weekend or a day on the beach, or those of you who may simply miss law school, break out your Kindle and a glass of wine or margarita to read the opinion and the dissents.  You can download the full opinion here, National Federation of Independent Business v. Sebelius, from the SCOTUS website.

CMS Releases Additional Meaningful Use Guidance for EPs; Stage 3 Recommendations Underway

CMS released last week a new comprehensive guide for eligible professionals (EPs) participating in the Medicaid EHR Incentive Program.  The guide covers:

  • Program basics, such as an explanation of the Medicaid EHR Incentive Program and what requirements must be met;
  • Eligibility and registration; 
  • Meaningful use, including first year adoption/implementation/upgrade payments, as well as clinical quality measures (CQMs), core and menu objectives;
  • Steps for attestation; and
  • Resources for EPs

This Medicaid guide compliments the Medicare version which was previously made available for EPs by CMS and can be found on the Educational Materials section on CMS' EHR website. CMS urges EPs, as well as hospitals, to register early to avoid any issues during attestation.  This is the last year for Medicare EPs to begin their participation in the EHR Incentive Program in order to receive full Medicare incentive payments.

While the Stage 2 requirements have not yet been finalized, the HIT Policy Committee Meaningful Use Work Group is hard at work to meet its deadline for initial recommendations for Stage 3 by August 1.  According to Healthcare Informatics, a Request for Comment would be issued in November and final recommendations published by May 2013. 

The committee is considering proposing that solutions for meeting Stage 3 criteria would include those that track individual care goals, the team members involved in an individual's care, and their roles across care settings, track tasks and responsible parties, facilitate population health management, medication reconciliation and problem list reconciliation, and allow for input and access to care information by all team members, the individual and their caregivers.  

FDA Moving Forward with Regulating Mobile Health Apps

This post is prepared by Christopher Dodson.

Mobile medical apps designed for use on phones and tablets are generally unregulated. In July 2011, the FDA published guidance indicating its intention to use the existing regulatorymobile app.png framework for a small subset of apps. It planned to scrutinize apps used as accessories to already-regulated medical devices and apps that use attachments to turn mobile devices into regulated medical devices.

Even as the FDA finalizes its guidelines, President Obama has signed the “Food and Drug Administration Safety and Innovation Act” which includes a provision laying the groundwork for broader regulation of mobile medical apps. Section 618 gives the HHS Secretary until January 2014 to issue a report with a proposed strategy for a risk-based regulatory framework for HIT, including mobile medical apps. The new law requires that the framework promote innovation, protect patient safety and avoid regulatory duplication.

In developing the framework, the Secretary has the option of assembling a working group of stakeholders to provide guidance. If the Secretary does form the group, it is required to have representatives from a variety of groups including patients, providers, health plans, startup companies, venture capitalists, technology vendors and small businesses.

This puts mobile medical app developers in a difficult position.

The FDA is still finalizing a narrow set of guidelines. But in 18 months the Secretary’s report will likely open the door to broader regulations sometime in the future. For now app developers are stuck with the reality that at an unknown point in the future there will probably be more regulations of an unpredictable nature.

Christopher is a former software developer and current J.D. candidate at the Earle Mack School of Law of Drexel University.  He is working with the Attorneys at Oscislawski LLC as a summer intern.