On July 25, 2017, the U.S. House of Representatives passed by voice vote a bipartisan bill which is now in the Senate’s hands for consideration, the Medicare Part B Improvement Act of 2017. The bill would amend the Stark Law (Section 1877(h)(1) of the Social Security Act) and impact other provisions governing Medicare Part B.

The bill would amend the Stark Law:

  • to provide that the writing requirement for certain compensation arrangements may be satisfied by means determined by the HHS Secretary, including “a collection of documents, including contemporaneous documents evidencing the course of conduct between the parties;”
  • to include provisions for “indefinite” holdovers involving certain personal service arrangements and leases of office space or equipment; and
  • to provide for up to 90 days to obtain missing signatures in certain compensation arrangements that have become noncompliant.

These changes codify certain Stark Law changes previously made by the Centers for Medicare and Medicaid Services in the Medicare Physician Fee Schedule that took effect on January 1, 2016 (see related article here). 

The bill also contains provisions relating to dialysis facilities, including:  1) expanded access to home dialysis through the use of telehealth for monthly end stage renal disease (ESRD) visits, and 2) providing for the survey and accreditation of dialysis facilities by accreditation bodies approved by the Secretary.

In addition, the bill would provide a temporary transitional payment methodology for home infusion therapy services, under which home infusion drugs would be assigned to three payment categories, and each category would be designated a single payment amount and billed with Healthcare Common Procedure Coding System (HCPCS) codes specified in the bill.

The bill would also:

  • provide that the documentation created by an orthoptist or prosthetist would be considered part of the medical record to support a determination that orthotics and prosthetics are reasonable and medically necessary; and
  • extend through 2020 the Medicare Patient intravenous immune globulin (IVIG) Access Demonstration Project. The Project evaluates the potential benefits of providing patients with primary immune deficiency disease with in-home administration of IVIG.