On August 28th HRSA released the long-awaited Health Center Program Compliance Manual. HRSA intends for the Manual to provide a streamlined and consolidated resource to assist health centers in understanding and demonstrating compliance with the Program Requirements.
HRSA is proposing to delay enforcement of its final rule imposing civil monetary penalties on manufacturers that overcharge 340B program covered entities (Overcharge CMP Rule) until July 1, 2018. The agency will solicit comments on the proposal for 30 days once it is formally published in the Federal Register on August 21, 2017. Read the FTLF blog.
New requirements for patient consent forms and the sharing of substance use records are now in effect under a Final Rule issued by the Substance Abuse and Mental Health Services Administration (SAMHSA). The Final Rule modernizes 42 CFR Part 2 (Part 2) to allow for information exchange within new health care models while protecting the privacy of patient records related to substance use treatment. The Final Rule makes clear that organizations must comply with Part 2 if they meet the definition of a Part 2 “program” or if they receive a patient’s Part 2 records.
A sovereign Indian tribe recently agreed to pay $245,000 and entered into a five year Compliance Agreement with the Office of the Inspector General to settle allegations that it submitted false claims to Washington State Medicaid for child mental health counseling services.
Failure to Audit EHR Activity and Permissions Leads to Breach of 110,000 Patient’s PHI and $5.5 Million Settlement
The Department of Health and Human Services Office of the Inspector General (OIG) recently issued a Policy Statement increasing the dollar thresholds for gifts of “nominal value” to Medicare and Medicaid beneficiaries from $10 per item to $15 per item or from $50 in the aggregate per patient annually to $75 in the aggregate per patient annually.
A Texas Federal court recently issued a nationwide injunction preventing the implementation of the overtime rule issued by the Department of Labor earlier this year. The rule, which would have updated the overtime regulations under the Fair Labor Standards Act (FLSA) for the first time in nearly twelve years, would have made salaried workers earning less than $47,476 annually eligible for overtime pay. It was scheduled to take effect on December 1.
St. Joseph Health (SJH), a nonprofit health care delivery system, recently agreed to pay $2.14 million and to adopt a comprehensive corrective action plan after it was reported that they potentially disclosed the electronic protected health information (ePHI) of 31,800 individuals.
On October 14th, the former CEO of two Alabama non-profit health clinics was sentenced to 18 years in prison for conspiracy, bank fraud, wire fraud and money laundering. He must also pay $13.5 million in restitution. This sentencing comes after he was convicted on 98 of 112 charged counts in June of this year.
The U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) and the HHS Office of the National Coordinator (ONC) recently updated their Security Risk Assessment (SRA) Tool for small to mid-sized health care organizations. The Tool includes 156 questions designed to help organizations conduct and document that they have performed a security risk assessment.
HRSA recently announced that the Change in Scope (CIS) process will be revised to remove redundant questions, to revise the assurances sections, to remove financial questions, and to align CIS budget changes with annual application processes. The current CIS submission process in the Electronic Handbooks (EHBs) System will undergo a temporary suspension period from October 6 through November 3. No new CIS requests may be submitted during this time. HRSA has advised health centers to work with their project officers on any current in-process CIS requests.
On September 8, 2016, the Centers for Medicare and Medicaid Services (CMS) issued a Final Rule to address gaps in the current Medicare and Medicaid emergency preparedness regulations for providers and suppliers.
The Final Rule dictates that Medicare and Medicaid providers and suppliers are now required to meet common emergency best practice standards in order to continue to participate in these programs. They will need to:
Civil monetary penalties for violations of the False Claims Act, the Program Fraud Civil Remedies Act and the Anti-Kickback Act nearly doubled with the issuance of an interim final rule by the Department of Justice on August 1st. The minimum per claim penalty increased from $5,500 to $10,781 and the maximum per claim penalty increased from $11,000 to $21,563. The increased penalty amounts apply to penalties assessed after August 1, 2016 for violations that occurred after November 2, 2015.