There is almost universal agreement regarding predictions for 2022 federal enforcement in the following areas: The use of fraudulently obtained COVID relief funds in both healthcare and in general, but specifically as a foundation for False Claims Act enforcement. Furthermore, the reinstatement of the Yates memo of 2015 by the Deputy Attorney General Lisa Monaco’s … Continue Reading
CMS published the 2015 Open Payment Data on June 30, 2015. This is the link to the notice and the CMS site: https://openpaymentsdata.cms.gov/ CMS has presented tables in its press release showing the highest paid specialties and highest paying companies. Over the last two years, Novartis has paid approximately $842 million to 344,000 recipients, which … Continue Reading
CMS has issued the final regulations to implement that section of the Affordable Care Act amending the Social Security Act to provide that retention of identified overpayment could be a false claim and be subject to both the False Claims Act (FCA) and the Civil Money Penalty Act (CMP). ACA § 6402(a) established new Social … Continue Reading
On December 18, 2015, the Federal Trade Commission (FTC) announced a settlement with Keystone Orthopaedic Associates Specialists and Orthopaedic Associates of Reading, LTD, which were two of six orthopedic practices in Berks County, Pennsylvania that merged in 2011. The FTC initiated the Complaint because they believe the merger of the practices eliminated competition among orthopedists … Continue Reading
PBGH just recently sent out a client alert regarding UPMC/Highmark Continuity of Care Settlement as follows: UPMC and Highmark have announced a settlement agreement that addresses the Consent Decrees’ Continuity of Care provision. This settlement will govern continuity of care beginning January 1, 2016 until the end of the Consent Decrees on June 30, 2019. … Continue Reading
On October 21, 2015 the Department of Health and Human Services Office of Inspector General posted Advisory Opinion No. 15-13. This Opinion relates to a request for Advisory Opinion about a plan to offer free van shuttle services to certain medical facilities in an integrated health system. The Office of Inspector General (the “OIG”) concluded … Continue Reading
In September, 2015, OCR and HHS issued a press release announcing a Resolution Agreement with the Cancer Care Group, P.C., which included entry into the agreement, the adoption of a robust compliance plan, and the payment of a $750,000 penalty. The settlement arose out of an incident involving the theft of an employee laptop containing … Continue Reading
On September 9, 2015, Sally Quillar Yates, Deputy Attorney General of the Department of Justice (DOJ) issued a memo entitled “Individual Accountability for Corporate Wrongdoing” to address the issue of incentivizing executives, as individuals, to follow appropriate compliance protocols by emphasizing potential individual liability. The memo stresses the importance and the difficulty of enforcing personal … Continue Reading
In July 2015, CMS released proposals to provide several new Stark Law exceptions and to clarify issues regarding existing exceptions. The full text of these proposal and CMS comments and explanations is available at: https://www.federalregister.gov/articles/2015/07/15/2015-16875/medicare-program-revisions-to-payment-policies-under-the-physician-fee-schedule-and-other-revisions http://www.gpo.gov/fdsys/pkg/FR-2015-07-15/pdf/2015-16875.pdf Perhaps the most noteworthy of the lesser proposals were clarifications that: “hold over arrangements” are permitted to satisfy the … Continue Reading
CMS issued a special edition MLN Matters meant to be effective August 1, 2015. The guidance reflects CMS instructions to Medicare Administrative Contractors (MACs) and Qualified Independent Contractors (QICs) regarding the scope of review for redeterminations and reconsiderations of certain claims. CMS acknowledges its concern that MACs and QICs were using their discretion to conduct … Continue Reading
CMS has acknowledged that arrangements among providers to satisfy the Stark exceptions need not be created in a single document. Although a single written document memorializing the key facts of an arrangement could provide the surest and most straightforward means of establishing compliance with the applicable exception, there is no requirement under the physician self-referral … Continue Reading
On June 9, 2015, the OIG issued a Fraud Alert entitled “Fraud Alert: Physician Compensation Arrangements May Result in Significant Liability”. This is just a one page letter warning hospitals and physicians by stating the OIG recently reached settlements with 12 individual physicians who entered into questionable medical directorship and office staff arrangements; the settlements … Continue Reading
Cooper v. Pottstown Hospital is another case where a dissatisfied party is attempting to use the federal Anti-Kickback Statute or the Stark Law in litigation arising out of the contracts to which they were willing parties at one time. Usually, breaching parties have used this argument as a defense, claiming that the contracts were illegal, … Continue Reading
In United States ex rel. Martin et al. v. Life Care Centers of American, Inc., the Court held that the government could extrapolate from a random sample in order to impose False Claims Act (FCA) liability against Life Care Centers of American Inc. (Life Care) for a substantially larger universe of claims. In order to … Continue Reading
In OIG Advisory Opinion 14-06, the Office of Inspector General (OIG) concluded that payment by a specialty pharmacy to a retail pharmacy on a “per-fill” basis for services provided by the retail pharmacy could violate the Anti Kickback Statute and Civil Money Penalty provisions. The specialty pharmacy, as the requestor, proposed to pay retail pharmacies … Continue Reading
Community Health Systems announced today, August 18th, that hackers broke into its computers and stole data on 4.5 million patients. The information included names, Social Security numbers, physical addresses, birthdays and telephone numbers. More information on the breach is available at http://money.cnn.com/2014/08/18/technology/security/hospital-chs-hack/index.html … Continue Reading
It is ironic to learn the Office of Inspector General (OIG) believes the Office of the National Coordinator for Health Information Technology (ONC) essentially has an insufficient compliance program to maintain the privacy and security of the protected health information (PHI) hosted by electronic health records (EHR). In an August 2014 report (A-06-11-00063), OIG concluded … Continue Reading
Perhaps not coincidentally, immediately following the release of the Questionable Laboratory Payments Special Fraud Alert by the OIG, posted yesterday on the Med Law Blog, the OIG has followed up with Audit Report OIG – 03-11-00730: Questionable Billing for Medicare Part B Clinical Laboratory Services. Below are two quoted paragraphs from the executive summary stating … Continue Reading
There has been significantly enhanced scrutiny of financial relationships between referring physicians by both the Office of Inspector General (OIG) and Pennsylvania authorities. Pennsylvania Pennsylvania enacted amendments to the Pennsylvania Clinical Laboratory Act on December 18, 2013 (the amendments are referred to as Act 122) and the Department of Health and Bureau of Laboratories just … Continue Reading
The MLN Connects™ Provider eNews contains important news, announcements, and updates for health care professionals. Friday May 2, 2014 ICD-10 Compliance Date On April 1, 2014, the Protecting Access to Medicare Act of 2014 (PAMA) (Pub. L. No. 113-93) was enacted, which said that the Secretary may not adopt ICD-10 prior to October 1, … Continue Reading
U.S. Department of Health and Human Services Office for Civil Rights (OCR) recently announced yet another enforcement action. Specifically, OCR opened a compliance review of Concentra Health Services (Concentra) upon receiving a report that an unencrypted laptop was stolen from the Springfield Missouri Physical Therapy Center. The investigation revealed that Concentra had previously recognized in … Continue Reading
A HIPAA security risk assessment (SRA) tool was recently made available through HHS. The tool was developed as a collaborative effort between the HHS Office of the National Coordinator for Health Information Technology (ONC), the HHS Office of Civil Rights (OCR) and the HHS Office of General Counsel (OGC). This SRA tool is intended to … Continue Reading
OCR PREPARING FOR NEXT ROUND OF HIPAA AUDITS By Paul J. Welk, PT, JD In a February 24, 2014 notice published in the Federal Register, the Department of Health and Human Services announced a pre-audit survey of HIPAA covered entities and business associates. The information collected will involve a survey of up to 1,200 covered … Continue Reading
Microsoft recently announced that, after April 8, 2014, it will not longer provide security updates or technical support for Windows XP. Microsoft’s statement that “businesses that are governed by regulatory obligations such as HIPAA may find that they are no longer able to satisfy compliance requirements” has spurred a certain level of panic among health … Continue Reading
