Bona Fide Relationship Requirement Law. Public Act 247 of 2107, MCL § 333.7303a(2), requires that except as provided in exceptions detailed in administrative rules, a prescriber must be in a bona fide prescriber-patient relationship with a patient before prescribing a schedule 2-5 controlled substance (“CS”) ...
On January 5, 2018, the U.S. Department of Labor (“DOL”) published a much-anticipated proposed rule that would make it easier for groups or associations of employers to band together to form association health plans (“AHPs”).[1] The proposed rule comes in response to an executive order issued by the White House in October 2017 directing the DOL to consider issuing such a rule ...
In a recent opinion out of the U.S. District Court for the District of Columbia, U.S. District Court Judge Rudolph Contreras held that the U.S. Department of Health and Human Services (HHS) exceeded its authority when it substantially reduced the amount Medicare pays for 340B-acquired medications ...
Recently, the Ohio Department of Medicaid (ODM) finalized Ohio Administrative Code 5160-1-32.1 (the Final Rule) which provides two standard authorization forms for the use and disclosure of protected health information (PHI). The standard forms are designed to comply with both the HIPAA Privacy Rule (45 C.F.R. § 164.508) and 45 C.F.R. Part 2, which covers certain substance abuse treatment information ...
On December 14, 2018, the U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) published a Request for Information (RFI) about ways to modify the HIPAA Privacy and Security Rules[1]to promote the transition of the health care industry to a value-based Medicare payment model and improve care coordination for patients. See “Request for Information on Modifying HIPAA Rules to Improve Coordinated Care,” 83 FR 64302 Page:64302-64310 ...
The tsunami of consolidation activity in the dental services industry has created remarkable financial opportunities for dentists and investors. Primarily, these opportunities play out in the form of Dental Services Organizations formed by entrepreneurial dentists and/or private financial interests through the acquisition of established, profitable practices ...
The U.S. Centers for Medicare and Medicaid Services (CMS) has once again stepped up its oversight of Accrediting Organizations (AOs).[1] On December 18, 2018, CMS issued a Request for Information (RFI) seeking to determine whether AOs have a conflict of interest between their governmental contract and their private business. See “Medicare Program: Accrediting Organizations Conflict of Interest and Consulting Services; Request for Information,” 83 FR 65331 ...
On December 23, 2018, new State Medical Board of Ohio regulations became effective which marked another change in the legal standards governing provider use of opiates for treatment of pain ...
The Brazilian Federal Government recently published Medida Provisória No. 863/2018 ("MP 863/18"), a new rule that amends Federal Law No. 7,565, of December 19, 1986 (Brazilian Aviation Code) and lifts the existing restrictions to foreign capital shareholding in Brazilian air transportation companies. As a result, foreign investors are from now on able to hold up to one hundred percent (100%) of the voting capital of Brazilian airlines ...
Several years ago the U.S. Centers for Medicare and Medicaid Services (CMS) required skilled nursing facilities (SNFs) to report nurse staffing levels using the SNF’s payroll records, in an effort to obtain more accurate information about actual daily nurse presence in SNFs. CMS has collected this Payroll Based Journal (PBJ) information for a few quarters now ...
On December 7, 2018, the Food and Drug Administration (FDA) released a Proposed Rule that clarifies procedures and criteria for the de novo medical device clearance pathway. In a statement accompanying the Proposed Rule, FDA Commissioner Scott Gottlieb stated FDA believes the Proposed Rule will help facilitate classification of innovative low- to moderate-risk novel medical devices by providing more structure, clarity, and transparency to the de novo pathway ...
On December 11, 2018, Pennsylvania Auditor General Eugene A. Depasquale released a long-awaited report discussing the role of pharmacy benefit managers (PBMs) in Pennsylvania’s health care system ...
Under the Affordable Care Act (“ACA”), large employers (generally those with 50 or more full-time employees or full-time equivalents) must report annually to the IRS information about the health coverage offered to their full-time employees during the prior year using IRS Form 1095-C. The IRS uses the forms to assess whether an employer "shared responsibility" penalty applies. Employers also must provide copies of the forms to their full-time employees ...
Medicare and Medicaid certified nursing homes are frequently required to pay fines (called “civil money penalties” or “CMPs”) to the U.S. Centers for Medicare and Medicaid Services (“CMS”) when government surveyors find them out of compliance with the Requirements for Participation for Long-Term Care Facilities. It is not uncommon for CMS to assess CMPs in the hundreds of thousands of dollars ...
Increased federal oversight may be on the horizon for skilled nursing facility involuntary transfers and discharges. The Office of Inspector General (OIG) included in its 2019 Work Plan reviewing SNFs’ involuntary transfers and discharges, focusing on reviewing whether State agencies have effectively investigated and enforced proper transfer and discharge procedures ...
Ireland is a key global hub for aviation finance and leasing, having almost 50 years' experience in the sector. Recent reports forecast that the Irish aviation sector will see growth of over 20 per cent in aircraft assets from 2016 to 2021. Aviation finance and leasing is a global industry with investment into Ireland mainly coming from the US, Europe and Asia. Ireland’s aviation finance and leasing sector was a 'disruptive' industry in Ireland long before the term was even coined ...
The deadline for meeting the previously issued nursing home compliance mandate is approaching. The Centers for Medicare & Medicaid Services (CMS) issued the mandate in 2016 and gave facilities three years to become compliant. On November 28, 2019, skilled nursing facilities (SNF) and nursing homes will be required to adopt and implement a compliance program as a condition for participation in Medicare and Medicaid ...
In a letter to state Medicaid directors on Nov.13, 2018, the Secretary of the U.S. Department of Health and Human Services, Alexander Azar, announced a new demonstration opportunity that will allow states to provide improved care for adults with a serious mental illness (SMI) and children with serious emotional disturbance (SED) ...
Obviously, they are all natural disasters that climate scientists believe will increase in severity and intensity in the coming years. And they are all events that nursing homes and assisted living facilities (and all Medicare/Medicaid certified health care providers) are legally required to prepare for in order to protect their residents and patients. More pointedly, though, they are all events which the U.S ...
On November 15, 2018, the Food and Drug Administration (FDA) published a Proposed Rule, which, if finalized, will allow an institutional review board (IRB) to waive or alter certain informed consent requirements if a clinical trial poses minimal risk to human subjects and includes appropriate safeguards to protect the rights, safety, and welfare of those human subjects ...
In the last quarter of 2018, the Office of the Inspector General (OIG) announced that ImmediaDent of Indiana, LLC (ImmediaDent), which operates nine dental care practices, and Samson Dental Partners, LLC (SDP), which provides administrative support to Immediadent, have agreed to pay the United States and the state of Indiana $5.1 million to resolve allegations that they improperly billed Indiana’s Medicaid program ...
Recently, the Ohio Department of Medicaid (ODM) proposed the adoption of Ohio Administrative Code 5160-1-32.1 (the Proposed Rule), which provides two standard authorization forms for the use and disclosure of protected health information (PHI). The standard forms are designed to comply with both the HIPAA privacy rule (45 C.F.R. § 164.508) and 45 C.F.R. Part 2, which covers certain substance abuse treatment information ...
The value of the car is no longer merely associated with the car body, its engine or other material parts. Substantial value is found in the knowledge that controls the car – knowledge that does not only steer the car, but which may form the basis for maintenance and repairs planning, computing insurance premiums or indicating who is liable in the case of damage ...
Today the Health Resources and Services Administration (HRSA) issued a notice of proposed rulemaking (NPRM) that will end HRSA’s delays in implementing a January 5, 2017 final rule concerning 340B drug price calculations and civil monetary penalties (CMPs) against manufacturers who knowingly and intentionally overcharge 340B covered entities for 340B drugs (the Final Rule) ...
