Don’t Fear the Federal Register0

The article was first published on June  24, 2013, at

“’What is the use of a book,’ thought Alice, ‘without pictures or conversations?’”

Lewis Carroll, Alice in Wonderland

When it comes to federal regulations, there is an unfortunate dearth of illustrations. Instead, promulgation comes solely through the written word, as it did recently on the first business day in June 2013, when the Federal Register published volume 78, Number 108.  Born from an act of Congress known as the “Federal Register Act” (49 Stat. 500-503 (July 26, 1935)), the Federal Register will be 78 years old this summer and boasts its own international standard serial number (ISSN 0097-6326). By its own admission, “[t]he Federal Register provides a uniform system for making available to the public regulations and legal notices issued by federal agencies.  These include Presidential proclamations and Executive Orders, federal agency documents having general applicability and legal effect, documents required to be published by act of Congress, and other federal agency documents of public interest.”

The value of the Register is beyond measure. To be sure, regulatory transparency is a fundamental tenet upon which industry leaders must rely, and health care compliance professionals are certainly no exception. In fact, the body of law over which these individuals must take charge is quite the assemblage, and continues to grow at an astounding rate, especially since the passage of the 2010 Affordable Care Act. In a terrain that is often confusing, the Federal Register provides the most reliable roadmap for health care compliance, and the following are some suggestions designed to help keep a compliance program from getting lost:

1.  Know Your Acronyms

Any meaningful regulation comes with its own, often overwhelming list of acronyms. For example, at the beginning of the 339-page (triple columned) 2013 regulations for the Medicare Hospital Inpatient Prospective Payment Systems, scores of acronyms precede an explanation of Medicare’s future from October 1, 2013, until September 30, 2014. That said, not all acronyms are created equal.  Some are of seemingly marginal importance in the context of the regulation, such as “CDI” (clostridium difficile), a severe case of diarrhea caused when an overly aggressive regimen of antibiotics backfires, “NAICS” (North American Industrial Classification System), a system used to distinguish business activity, or “HFCA” (Health Care Financing Administration), the predecessor to the Centers for Medicare & Medicaid Services (“CMS”).  Others have merit, but are firmly entrenched in the vocabulary of industry experts, such as “CMS”, “HHS”, “HIPAA” and “OIG” (see number 3 below).

However, certain recent additions to the list are of such importance as to underscore the transformation of Medicare, such as “VBP” ([Hospital] Value Based Purchasing [Program]), “HAC” (Hospital-acquired condition), “HAI” (Healthcare-associated infection), “HCAHPS” (Hospital Consumer Assessment of Healthcare Providers and Systems), and “DSH” (Disproportionate share hospital, which although not new, has been renovated in the new regulations).  Today’s health care professionals must remain vigilent as they mind a hospital’s “TPS” (Total Performance Score), which combines the HCAHPS with clinical measures such as “SCIP” (Surgical Care Improvement Project) and “VET” (venous thromboembolism) –  among others – all within the VBP, not to mention keeping a steady eye on the number of HACs and HAIs, while maintaining a solid understanding of all “MS-DRGs” (Medicare severity diagnosis-related groups). Failure to do so could result in a loss of as much as 5% of a hospital’s annual Medicare revenue.

2.  Read the Executive Summaries

While all regulations begin with a basic summary, HHS may employ not only this initial brief, but also a more detailed executive overview, and possibly even a table of contents for its lengthier reports. The summary of the 21-page, April 2013 HHS regulation relating to the Medicare Incentive Reward Program underscores the fact that the Federal Government is focused in its campaign against health care fraud and abuse. Increasing the amount to which an individual may be entitled under this program from no more than $1,000 to $9.9 million ruins the chance of a surprise ending for this set of regulations.  Likewise, the concise 17-page, April 2013 regulation introducing the role of the “navigator” in the forthcoming health insurance exchanges will most likely be eclipsed by the events that take place when these new entities try to stake their claim in this latest landmark evolutionary transition in modern American health care.

3.  Listen to the OIG

Although the OIG has not officially updated its published guidelines on hospital compliance programs since 2005, when the premier HHS enforcement agency speaks, all compliance officers should listen.  In April 2013, the OIG updated its Provider Self-Disclosure Protocol, completely revamping the original guidelines released in 1998. Encouraging “health care providers to voluntarily identify, disclose, and resolve instances of potential fraud involving the Federal health care programs,” the OIG discusses such issues as why disclosure is important, the benefits of self-disclosure, eligibility requirements, and appropriate content.  Although only 16 pages long, providers who elect to make a disclosure pursuant to these guidelines would be wise to study this information carefully.

In May 2013, the OIG updated its special advisory bulletin on the Effect of Exclusion from Participation in Health Care Programs, and in particular that modern health care providers must avoid nearly all business interactions with excluded providers.  Through such advisory bulletins, the OIG clarifies the scope of its directive and the technical nuances found within each possible scenario.

Health care’s version of the crystal ball is known as the OIG’s annual Work Plan, although the agency’s Semiannual Report to Congress and Compendium of Unimplemented Recommendations should not be overlooked. Outlining its current focus areas as well as those new to the annual Work Plan, the OIG’s 2013 Work Plan boasted fiscal year (“FY”) 2011 recoveries exceeding $5 billion and identified just under $19 billion in savings for the same FY.  Published at a hefty 150 pages, this is one document that compliance officers do not want to miss.

4.  Never Underestimate the Fine Print

While browsing through the 339-page document regarding regulations for the 2014 Hospital Inpatient Prospective Payment System may not appeal to the casual reader, should ever a question about Medicare reimbursement arise in contexts both social and professional, chances are the answers exist therein.  After perusing a table of contents spanning 5 triple-columned pages within the Federal Register and an even longer executive summary, we learn at last on page 27508 that cardiac catheterization and implantable cardiac devices receive the largest estimated increase in MS-DRG relative weights, while traumatic head injury and concussions are estimated to command the largest reductions.

On the subject of hospital charity care, page 27587 laments that Worksheet S-10 of the Medicare Cost Report is not reliable for calculating the reductions in hospital Medicare DSH payments.  Page 27612 notes that the “addition of Medicare spending measures specific to physician services such as Radiology, Anesthesiology, and Pathology that occur during a hospital stay” are under consideration. On page 27704 HHS identifies methicillin-resistant staphylococcus aureus (MRSA) bacteremia Laboratory-identified (“LabID”) Events and Clostridium difficule LabID as two new HAI measures impacting reimbursement in FY 2016.

 To be sure, the fine print is often the only salient information upon which a provider can rely, such as in the example of accountable care organizations (ACOs).  What began as 9 pages tucked within the Affordable Care Act has transformed into a 190-page section in the Federal Register, to be combined with additional information from the OIG, the Federal Trade Commission (“FTC”) and the Internal Revenue Services (“IRS”), among others.   As the federal statute governing ACOs leaves much to be desired, the federal regulations must not only do the proverbial “heavy lifting,” they are forced to act as an indispensable roadmap for navigating through the ACO application process.

5.  Watch Out for Other Agencies

The May 2013 the Department of the Treasury (“IRS”), Department of Labor (“DOL”) and HHS cooperated in drafting regulations governing incentives for nondiscriminatory wellness programs within group health plans, including the maximum permissible reward for health-contingent wellness programs and incentives to reduce or prevent tobacco use.  An 8-page regulation from the IRS in early May 2013 established the minimum value of eligible employer-sponsored plans, while the February 2013 IRS regulation elucidating the shared responsibility payment for not maintaining minimum essential coverage (also known as the “individual mandate”) established in 18 pages what it took the Federal Courts tens of thousands of pages to cover.

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