In March 2016, the Austrian Supreme Court granted an award for pain and suffering to a patient for mental strain after a piece of broken scissors was left in his body following a surgery despite the fact that the claimant had not suffered any physical pain.… Continue reading
Last week, HHS, OIG, CMS, the Office of the Assistant Secretary for Financial Resources, and the Administration for Children and Families issued an interim final rule (the Rule) that adjusts maximum civil monetary penalties for inflation.… Continue reading
Last week, the United States and New York announced a settlement with Mount Sinai Health System for $3 million dollars to resolve allegations that Mount Sinai violated the False Claims Act by retaining overpayments for longer than 60 days after identifying them. The settlement is the first of its kind regarding the Affordable Care Act’s … Continue reading
On August 11 the Health Resources and Services Administration (HRSA) issued a notice of proposed rulemaking (RIN 0906-AA90) that would implement an administrative dispute resolution (ADR) process that would apply to all drug manufacturers and covered entities that participate in the 340B drug pricing program. The rule if implemented as proposed will establish and implement … Continue reading
CMS’s annual report demonstrates that the government is becoming increasingly effective at ferreting out fraud and abuse from the healthcare system. With a 12-to-1 return on investment, the government will likely continue to make fighting healthcare fraud a priority.… Continue reading
The Texas Supreme Court has temporarily blocked the Texas Health and Human Services Commission’s planned rate reductions for Medicaid home health services for severely disabled children, holding that a temporary injunction issued by a trial court enjoining the rate cuts from taking effect remains binding pending the issuance of a mandate by the Texas Third … Continue reading
On July 6, 2016, CMS published its Calendar Year (CY) 2017 Outpatient Prospective Payment System (OPPS) Proposed Rule. We provide a more detailed analysis of the significant proposals to our July 6 post below.… Continue reading
Last week, CMS posted the 2015 Open Payments data to its website, as well as updated payment records for 2013 and 2014. Overall, manufacturers reported $7.52 billion in payments and ownership interests to 618,931 physicians and 1,116 teaching hospitals in 2015. Nearly 1,500 companies reported making payments in 2015, comprising a total 11.9 million records. … Continue reading
On June 27, 2016, the OIG posted Advisory Opinion No. 16-07 stating that an erectile dysfunction (ED) drug manufacturer would not face sanctions for a planned discount-card promotion for the drug.… Continue reading
On June 17, 2016, CMS published the “Medicare Clinical Diagnostic Laboratory Tests Payment System” final rule. Among the key changes in this final rule, CMS has revised the Medicare Clinical Laboratory Fee Schedule (CLFS) such that payment for clinical diagnostic laboratory tests (CDLTs) beginning January 1, 2018 will reflect the weighted median of private payor … Continue reading
In a closely watched decision, the U.S. Supreme Court has unanimously endorsed a version of the “implied false certification” theory of liability under the False Claims Act (“FCA”). In a decision that leaves almost as many questions unanswered as it resolved, the Court held that a material omission on a claim for payment may give … Continue reading
Background On 25 April 2015, the Minister for Health announced a review of the Guidelines (Guidelines) for Preparing Submissions to the Pharmaceutical Benefits Advisory Committee (PBAC), the body that recommends which products should be reimbursed by Government, and for how much. The Minister said the review sought to ensure that the PBAC Guidelines are “consistent … Continue reading
On May 18, 2016, the U.S. House of Representatives Ways and Means Committee introduced the Helping Hospitals Improve Patient Care Act of 2016 (Act) to exempt certain newly-enrolled provider-based, off campus hospital outpatient departments (HOPDs) from reduced payments under the Bipartisan Budget Act of 2015 (BBA).… Continue reading
On April 27, 2016, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule that would implement changes to reimbursement under the Medicare Physician Fee Schedule (PFS) as required by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). The proposed rule contains the following key elements: (i) a framework for the … Continue reading
On April 27, 2016, CMS published the Inpatient Prospective Payment System (IPPS) and the Long-Term Care Hospital Prospective Payment System (LTCH PPS) proposed rule for fiscal year (FY) 2017 in the Federal Register. Highlights from the proposed rule are explained in further detail below. Completion of Medicare Severity-Diagnosis Related Group (MS-DRG) $11 Billion Overpayment Recoupment … Continue reading
In a report released on February 26, 2016, the federal government announced that it recovered $2.4 billion through its Health Care Fraud and Abuse Control Program (HCFAC) during FY 2015. The $2.4 billion is almost $1 billion lower than the recovery of $3.3 billion in FY 2014. Over the last three years, the return on … Continue reading
This morning the Centers for Medicare and Medicaid Services issued a final rule that addresses the obligation of health care providers and suppliers to report and return overpayments by the later of 60 days from the date an overpayment is identified or the due date of any corresponding cost report. According to the CMS Fact … Continue reading
On February 4th, the Energy & Commerce Committee’s subcommittee on health held a legislative hearing regarding the implementation of the Biologics Price Competition and Innovation Act, which established a shortened FDA approval process for determining when biosimilar products are considered interchangeable with previously-approved FDA products. The subcommittee members expressed concerns regarding plans to reduce reimbursement … Continue reading
If passed, the newly introduced bipartisan telehealth bill, “Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act (S. 2484),” would significantly increase Medicare reimbursement coverage for telehealth services and remote patient monitoring.… Continue reading
CMS issued a proposed rule on January 28, 2016 that would significantly overhaul benchmark calculations for Medicare Shared Savings Program Accountable Care Organizations (MSSP ACOs), which may increase the long-term attractiveness of the MSSP for high-performing ACOs.… Continue reading
On January 21, 2016, the Centers for Medicare and Medicaid Services (CMS) published the final rule with comment period titled “Medicaid Program; Covered Outpatient Drugs.” In the final rule, CMS implements provisions of the Affordable Care Act (ACA) pertaining to Medicaid reimbursement for covered outpatient drugs (CODs) and revises key requirements related to the Medicaid … Continue reading
Last week, a Texas federal court upheld a Medicare Appeals Council (MAC) decision finding that a Medicare contractor properly used statistical sampling to calculate a $773,967 Medicare overpayment to a home healthcare provider, Maxmed.… Continue reading
At a recent DC Bar program called “The Use of Data by the OIG-DHHS and CMS/CPI in Medicare Program Integrity, Investigations and Compliance,” representatives from CMS and the OIG provided their perspectives on the evolving capabilities of government agencies to review and analyze large datasets related to the provision and reimbursement of healthcare services.… Continue reading
On December 30, 2015, the Centers for Medicare and Medicaid Services (CMS) issued a final rule establishing a prior authorization process for certain durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) items that the government maintains are typically subject to unnecessary utilization (i.e. items that do not comply with Medicare’s coverage, coding, and payment rules). … Continue reading