Department of Health & Human Services

On July 25, 2022, the U.S. Department of Health and Human Services (“HHS”) issued a proposed new rule[1] that significantly expands the scope of protection available to vulnerable populations under Section 1557 of the Affordable Care Act (the “ACA”).

Continue Reading Proposed Rule Leverages Section 1557 for Healthcare Equity

On August 19, the Department of Health and Human Services Office of Inspector General (“OIG”) posted a favorable advisory opinion, AO 22-16, with respect to the provision of gift cards to Medicare Advantage (“MA”) plan enrollees who complete certain steps in an online patient education program. This opinion underscores potential flexibility for with Medicare Advantage Organizations (“MAOs”) and their vendor partners to offer incentives to patients to engage in learning and health care engagement activities that may improve health outcomes without inappropriately steering patients toward particular providers or MA plans.

Continue Reading OIG Blesses Gift Cards for Patient Engagement with Education Tool

Last month, the U.S. Department of Health and Human Services Office of Inspector (“OIG”) released a report that studied prior authorization denials and payment denials by Medicare Advantage Organizations (“MAOs”) (the “Report”). While the Report found that the “vast majority” of prior authorizations and payment requests were approved, the Report focused on the finding that MAOs “sometimes” denied prior authorization and payment requests that met Medicare coverage rules claiming that the denials delayed or denied beneficiaries’ access to medically necessary services.
Continue Reading HHS OIG Report On Prior Authorizations Under Medicare Advantage

President Biden issued Executive Order 13985, Advancing Racial Equity and Support for Underserved Communities Through the Federal Government (Executive Order) on inauguration day in 2021, signalizing the Administration’s intent to advance health care equity and racial justice in the United States by minimizing the influence of the social determinants of health. The Executive Order mobilized 90 federal agencies and 50 independent agencies to evaluate and implement action plans to reduce systemic barriers to access.[1] On April 14, 2022, the U.S. Department of Health and Human Services (HHS), published the HHS Equity Action Plan (Action Plan).
Continue Reading The Biden Administration’s and HHS’s Plan to Advance Health Care Equity

The Department of Health & Human Services (DHHS) Office of Civil Rights (OCR) recently announced it will devote more resources to investigate smaller HIPAA breaches. Before this announcement, OCR typically opened investigations for HIPAA breaches affecting more than 500 individuals.
Continue Reading OCR to Focus More Investigative Resources on Smaller HIPAA Breaches with Less Than 500 Individuals Affected

By Robert Rose 

Dr. Harkonen was the CEO of InterMune, Inc, a pharmaceutical company that developed, marketed and sold drugs for lung and liver diseases, including Actimmune. In 2002, the FDA had approved Actimmune to treat only two conditions: chronic granulomatous disease and severe malignant osteopetrosis. A year before the approval, an Austrian clinical trial concluded that Actimmune’s active ingredient was associated with improvement in patients with idiopathic pulmonary fibrosis (IPF), a rare and fatal disease of unknown origin. InterMune did its own clinical trial to confirm whether Actimmune was an effective treatment for IBF.

Continue Reading False Press Release Leads To Exclusion From Federal Programs

By Robert Rose

Last month, in a joint letter by HHS and DOJ to five prominent hospital associations, the government warned that some providers are using electronic medical records (EMR) to “game the system.” The September 24th letter gave examples of “troubling indications” of EMR misuse:

  • Cutting and pasting the same examination findings for multiple patients—known as “cloning”—to make it appear that physicians conducted more thorough exams that were actually done
  • Upcoding the intensity or severity of a patient’s condition simply to profit without improving the quality of care


Continue Reading Switching to Electronic Medical Records May Not Be a Cure for Billing Abuses

By Ken Yood and Lynsey Mitchel

The mission of the Office of the Inspector General ("OIG") is to protect the integrity of the programs and operations of the Department of Health & Human Services, for example Medicare, by detecting and preventing waste, fraud and abuse, and identifying opportunities to improve program economy, efficiency and effectiveness. The Work Plan describes both the ongoing and new audits and evaluations that the OIG plans to address in fiscal year 2011.
 

Continue Reading OIG Releases Fiscal Year 2011 Work Plan