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Effective January 1, 2024, the Corporate Transparency Act (“CTA”) requires most businesses, including healthcare businesses, to report certain information regarding beneficial owners and company applicants. Willful failure to report or update beneficial ownership information may result in the imposition of penalties. CTA in a Nutshell The CTA and its implementing regulations seek to OCR Proposes Changes to the Civil Rights Enforcement Section of the Affordable Care Act Section 1557The Department of Health and Human Services (“HHS”) and the Office of the Civil Rights (“OCR”) recently proposed changes to Section 1557 of the Affordable Care Act (“Act”). This Section of the Act prohibits civil rights discrimination in certain health programs or activities. Some of the major changes, include, among others, revising the regulatory definition of what constitutes discrimination on the “basis of sex”. The proposal also includes healthcare conscience protections. Additionally, the proposed rule would eliminate taglines and notices requirement and it would revise the language access and grievance procedures of the rule. Many website design and development contracts as well as marketing and electronic medical records agreements (“technology contracts”) contain onerous terms and layers of user fees. If a physician or a dentist (“provider”) decides to part ways with the vendor under a technology contract the transition may be costly or cost prohibitive. One of the best ways providers can protect themselves against a slue of additional costs and concerns about possible loss of data is to have the contract reviewed by a healthcare attorney before signing on the dotted line. The Bureau of Compliance (BOC) within the New York State Office of the Medicaid Inspector General (OMIG) recently performed an assessment of providers’ compliance programs. The results indicate that providers sometimes fail in relatively less complicated and readily addressable ways. The New York State Office of the Medicaid Inspector General (OMIG or agency) has recently issued its 2017-2018 Workplan. The Workplan identifies key areas of OMIG’s focus impacting health care providers and suppliers. Failure by a covered entity to timely report a breach of protected health information (PHI) resulted in the first of its kind settlement in the amount of $475,000. Every year the Office of the Inspector General (OIG) issues a workplan that identifies the agency’s planned audit activities for the upcoming year. The workplan offers valuable information for healthcare entities by providing them with an opportunity to conduct appropriate risk assessments, and, where indicated, to modify the entity’s compliance program. The Centers for Medicare & Medicaid Services (CMS) published full year of 2014 financial data about transfers of value by drug and medical device makers to health care providers. The data includes information about 11.4 million financial transactions attributed to over 600,000 physicians and more than 1,100 teaching hospitals, totaling $6.49 billion. The Office of the Civil Rights (OCR) within the US Department of Health and Human Services recebtly settled a HIPAA violation case with a single location compounding pharmacy in Denver, Colorado. This is yet another HIPAA settlement underscoring the importance of properly implementing and maintaining a compliance plan. New York State Social Service Law §363-d and implementing regulations at 18 NYCRR §521 require that certain healthcare providers adopt and implement an effective compliance program and certify their compliance with the law every December. Every year the U.S. Department of Health and Human Services Office of the Inspector General (OIG) publishes a work plan that provides industry stakeholders with insight as to the OIG’s new and ongoing auditing and investigative activities in the upcoming year. Last year’s passing of the new HIPAA requirements signaled the government’s concern that individually identifiable health information needs stronger protection beyond the borders of the healthcare industry. HIPAA already recognized this need by imposing obligations on covered entities and their business associates in prior versions of the rule. In the latest rule update, however, the US Department of Health and Human Services, among other things, expanded the definition and responsibilities of business associates and now made them directly liable for HIPAA noncompliance. It’s that time of the year when qualifying providers enrolled with the NYS Medicaid Program must certify that they have a adopted, implemented and maintained an effective mandatory compliance program. The NYS Office of the Medicaid Inspector General (OMIG) is tasked with responsibility of overseeing that providers meet this requirement. Section 6002 of the Affordable Care Act requires manufacturers of pharmaceuticals, biologicals, medical devices or supplies to publicly report payments made to physicians and teaching hospitals. This article reviews some of the implications the new requirement has on physicians and their relationships with the industry. Last year the Occupational Safety and Health Administration (OSHA) adopted a new OSHA Hazard Communication Standard. The new standard is now aligned with the United Nations’ Globally Harmonized System of Classification and Labeling of Chemicals. All dental and medical providers, pharmacies and other healthcare employers must comply the Hazard Communication Standard as well as other applicable OSHA standards. Section 6002 of the Affordable Care Act (a.k.a. “Sunshine Act”) imposes new reporting requirements on financial relationships between medical and pharmaceutical makers and physicians and teaching hospitals. While lauded for its attempts to bring greater transparency to industry financial relationships some wonder whether the implementation methods planned by the Centers for Medicare & Medicaid Services (CMS) would expand the Act beyond the boundaries envisioned by Congress. Recently, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) calculated the savings its programs brought to the Federal government in 2011. The statistics, which reveal recoveries in the billions, serve as a sobering reminder to providers of the increasing interest by the government in ensuring that providers are complying with the healthcare laws and regulations. This is the third and final article in the series evaluating the NYS Medicaid Compliance Program requirements. The previous two articles looked at those providers required to have a compliance program under the law and the annual certification requirement. In this article, we examine the core elements of a compliance program. This is our second article in a series discussing the New York State Medicaid’s compliance program requirements. In our first article we focused on which providers are required by law to have a compliance program. In this article, we turn our attention to the annual certification requirement. The necessity of having a compliance program is no longer a requirement providers can ignore. In the next series of articles, we briefly address the compliance program requirements for New York State Medicaid providers, starting with the overview of the regulations below. |
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