Navigating the world of outreach program regulations

Laboratory outreach is subject to many rules and regulations. It’s a herculean task to become fluent and then remain current in the ever-changing health care environment. Because of the broad nature of laboratory outreach, there is no single source of knowledge, and when you ask a specific question, the answer is frequently, “It depends.”

We have compiled different sources to help guide you in your journey to understanding the complex environment of laboratory outreach. This is not intended to be an exhaustive list, but it highlights the most common sources of information and their application. Generally, a federal document is the basis for a regulation, but it’s not uncommon for a state regulation, when it’s stricter, to also be applicable. When dealing with regulatory questions, always defer to your own legal counsel. 

Reimbursement. Laboratory outreach testing is paid for by federal and state sources, private health plans, and other customers. The Clinical Laboratory Fee Schedule shows payment by Current Procedural Terminology code and can be found on the Centers for Medicare and Medicaid Services (CMS) website. The Physician Fee Schedule may also be used when a laboratory is performing pathology testing and it can also be found on the CMS website. Medicaid files are state-specific and can be found on the websites of individual state health services. Health plan payments are unique to service provider contracts and are not publically available.

Billing and Payment Regulations. Laboratory outreach testing is billed to the same reimbursors listed above. Medicare provides a Claims Processing Manual, with chapter 16 specifically dedicated to Laboratory Services. This is a critical document to understanding payment policy with the government. Again, there are different policies for Medicaid and for private health plans. Refer to those individual entities for more information.

Chapter 16 of the Medicare Claims Processing Manual is more than 75 pages long and includes key items and guidelines such as:

  • Advanced Beneficiary Notice policy
  • Billing forms and processes
  • Date of Service policy
  • Homebound collection guidelines
  • Medical Necessity
  • Medicare Secondary Payer policy
  • Modifiers
  • Skilled Nursing Facility (Part A and Part B) billing
  • Specimen collection fees and travel allowance

The Medicare Coverage Database (MCD) will help you find National Coverage Decisions and Local Coverage Decisions, which determine what Medicare will or will not cover. The Medicare Claims Processing Manual and the MCD can both be found on the CMS website.

Compliance. In addition to billing compliance, there are other aspects of compliance of which a laboratory outreach program needs to be aware. The Office of Inspector General (OIG) is responsible for fighting fraud and abuse for the U.S. Department of Health and Human Services and is a robust source of information. On the OIG website, you’ll find advisory opinions, fraud alerts, reports and more. Outreach topics of interest include in-office phlebotomy guidelines, provision of collection supplies to physician offices, Electronic Health Record interfacing, pricing, and many other important topics. Although this site is not very intuitive to navigate, the information provided can help keep an outreach laboratory out of hot water. Again, be sure to refer to any state-specific laws to ensure you’re in compliance.

Staying current with industry and regulatory changes is a constant challenge. New bills and laws may be passed at any time. Recent “alphabet soup” topics include PAMA, SALSA, VALID, VITAL, and EKRA. The best sources for keeping up with emerging regulations and challenges are laboratory industry professional associations. Several are listed below.

Many law firms also publish opinions on relevant topics. Regardless of the source of information, please consult your own legal counsel before taking action on regulatory issues. The answer may still be, “It depends,” but when navigating our complex regulatory environment, we sometimes need all the help we can get.

Jane Hermansen

Jane Hermansen is living her childhood dream of being a laboratory professional. With a passion for community-based medicine, she has worked with hundreds of hospitals across the US in outreach program development and growth. She currently directs the outreach consulting activities for Mayo Clinic Laboratories.