July 2019

On July 30, 2019, The Joint Commission (TJC) issued Sentinel Event Alert 61: Managing the risks of direct oral anticoagulants (“DOACs”).  The alert may be found here.  According to TJC, “anticoagulants have been named second of the top medications involved in error incidents causing death or serious harm.”  Because there are not FDA-approved reversal agents for all DOACs, there can be severe bleeding complications where patients aren’t assessed in line with guidelines regarding the management of DOACs.  The alert notes that intracranial hemorrhage can be the most severe risk and the patient safety concerns apply to all settings.

On July 30, the Centers for Medicare & Medicaid Services (CMS) published two federal fiscal year 2020 final rules: (i) inpatient psychiatric facilities (IPFs) prospective payment system (PPS) and quality reporting updates; and (ii) skilled nursing facilities (SNFs) PPS and consolidated billing, including updates to the quality reporting program and value-based purchasing program.

On July 29, the Centers for Medicare & Medicaid Services (CMS) published three proposed rules for Calendar Year (CY) 2020:

  • Medicare Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System Proposed Rule;
  • Proposed Policy, Payment, and Quality Provisions Changes to the Medicare Physician Fee Schedule (MPFS); and
  • End State Renal Disease (ESRD) and Durable Medical Equipment Prosthetics, Orthotics and Supplies (DMEPOS) Proposed Rule.

Public comments to all three proposed rules are due by September 27.

New Hampshire

“We’ve all seen this movie before” – Judge James Boasberg, Philbrick v. Azar

On July 29 HHS approval of work and community engagement requirements as a condition of eligibility for Medicaid was again found to be arbitrary and capricious.  This time Judge James Boasberg ruled that New Hampshire’s efforts to impose work requirements as a condition of Medicaid eligibility should be halted and vacated the Secretary’s approval.  Judge Boasberg issued similar rulings earlier this year regarding the Arkansas (Gresham v. Azar) and Kentucky (Stewart v. Azar) attempts to impose work requirements. A Health Law Pulse summary may be found here.

This week, the Department of Justice (DOJ) intervened in a False Claims Act (FCA) lawsuit against Life Spine and two of its executives, filed in the U.S. District Court for the Southern District of New York. The lawsuit alleges that Life Spine violated the Anti-Kickback Statute by paying more than $7 million in consulting fees, royalties, and intellectual property acquisition fees to surgeons to induce them to use Life Spine products in spinal surgeries. According to the complaint, the payment of these illegal kickbacks caused the submission of false claims to federal healthcare programs, including Medicare and Medicaid, under the theory that any claim for payment submitted in connection with an illegal kickback is “false” within the meaning of the FCA.

The Office of Inspector General (OIG) has added a new entity, Ridgeview Rehab & Nursing Center, LLC (Ridgeview), to its list of individuals and entities designated as “high risk – heightened scrutiny.” The “high risk – heightened scrutiny” list is part of the OIG’s fraud risk indicator tool, which the OIG made public last year. The fraud risk indicator tool places parties that have settled False Claims Act (FCA) allegations with the government into one of five categories on a risk spectrum.

Recently, the Office of Inspector General (OIG) published newly-issued guidance on the HHS OIG Grant Self-Disclosure Program (“Program”), which creates a formal framework for recipients, sub-recipients, and applicants for federal grant money to disclose potential violations of federal criminal, civil, or administrative law that may impact federally-awarded grants. Similar to the OIG’s Provider Self-Disclosure Protocol, the program offers incentives for self-disclosures in the form of reduced penalties and sanctions. The Program will be particularly important for individuals and  entities, such as research universities, that receive federally-funded grants, as the Program establishes a specific process for making certain mandatory disclosures already required by law as well as provides guidance and incentives for making voluntary disclosures.

The U.S. Centers for Medicare and Medicaid Services (CMS) released Open Payments data reflecting payments and transfers of value from drug and medical device companies to physicians and teaching hospitals in 2018, totaling approximately $9.35 billion in payments and more than 11.4 million payment records. This represents a 4.3% increase from the $8.4 billion reported in 2017.