The Inspector General took an unprecedented step Tuesday, rescinding a favorable Advisory Opinion first issued in 2006 that had provided assurances to the patient assistance charity, Caring Voice Coalition, that its drug subsidy program would not expose the organization to liability under the Anti-Kickback Statute. Continue Reading OIG Rescinds Favorable Advisory Opinion for Patient Assistance Charity, Caring Voice Coalition
Recent press reports are speculating that CVS Health Corporation is seeking to acquire the health insurer Aetna. The rumored transaction would create a new type of health care company that doesn’t currently exist: one that combines a commercial health insurer with a retail pharmacy chain and a pharmacy benefit manager (PBM). According to most reports, CVS would pay $66 – $70 billion to acquire Aetna (with Aetna stockholders receiving cash and CVS stock). It’s said that the parties are trying to enter into a definitive agreement by year-end. Continue Reading CVS Health – Aetna Transaction: Understanding the Business and Legal Issues
On November 2, 2017, the House Ways and Means Committee released draft text of H.R. 1, the Tax Cuts and Jobs Act, proposing significant changes to the Internal Revenue Code. Of particular concern to private hospitals, healthcare systems and educational institutions operating as 501(c)(3) entities is the bill’s proposed termination of the tax exemption available to “qualified 501(c)(3) bonds,” which would substantially increase borrowing costs for these entities. Please visit our website to read the legal alert authored by Jonathan W. Giokas.
On October 17, 2017, the IRS announced that it will not accept electronically filed tax returns for the year 2017 (to be filed in 2018) that fail to address the health coverage requirements of the Affordable Care Act (“ACA”). The “IRS Statement on Health Care Reporting Requirement” notes that “[t]axpayers remain obligated to follow the law and pay what they may owe at the point of filing. The 2018 filing season will be the first time the IRS will not accept tax returns that omit this information.” The prior guidance called into question whether the IRS would enforce the individual mandate provisions of the ACA. The new guidance makes clear that it will do so.
Mere months after the Kindred Healthcare decision enforcing an arbitration agreement between a nursing home and holders of a late resident’s power-of-attorney, the U.S. Supreme Court heard argument in another case that healthcare employers will want to watch. The Court’s decision in Epic Systems Corp. v. Lewis will determine the enforceability of arbitration agreements that provide for individual arbitration alone. The NLRB and certain employees claim that precluding joint, class, or collective claims in the courts or in arbitration violate employees’ rights to collective action under Section 7 of the National Labor Relations Act. Husch Blackwell will keep you updated on the status of the law once the decision comes down from the Court. For now, you can learn more about the concerns of the Justices and the unusual position of two U.S. government agencies in this blog on Husch Blackwell’s Labor Relations Law Insider.
As most healthcare providers know, HIPAA requires that covered entities or business associates conduct an accurate and thorough assessment of the potential risks and vulnerabilities to the confidentiality, integrity, and availability of electronic protected health information (“ePHI”) held by the covered entity or business associate. Providers who receive Meaningful Use incentive payments from the Centers for Medicare and Medicaid Services (“CMS”) for implementing electronic health record (“EHR”) systems into their practices or operations are also likely aware of the fact that one of the many requirements for these incentive payments is to conduct a HIPAA security risk analysis annually. Now, perhaps more than ever before, both CMS and the U.S. Department of Health and Human Services’ Office for Civil Rights (“OCR”) is demonstrating the importance of ensuring that these risk analyses are performed, or providers can face dire consequences. Below are the top reasons to conduct a thorough HIPAA security risk analysis. Continue Reading Top 5 Reasons to Conduct a Thorough HIPAA Security Risk Analysis
The 60-day repayment rule was implemented by the Centers for Medicare and Medicaid Services (CMS) effective March 14, 2016 to clarify Medicare providers’ obligations to investigate, report, and refund identified overpayments under the Affordable Care Act. The rule specifically details what it means to “identify” an overpayment and explains how to report and return identified overpayments to CMS.1 The rule also states that an overpayment must be reported and returned if it is identified within six years of the date it was received. This time period is generally referred to as the “lookback” period. Continue Reading Lookback Periods for Medicaid Overpayments
Hurricane Harvey. On August 26, 2017, the Secretary of Health and Human Services (HHS) issued a waiver of certain compliance requirements, retroactive to August 25, 2017, for providers in areas of Texas affected by Hurricane Harvey. A similar waiver was issued August 28, 2017, for providers in Louisiana, retroactive to August 27, 2017. Along with these waivers, the Secretary of HHS issued disaster declarations for the states of Texas and Louisiana pursuant to section 319 of the Public Health Service Act, and the President issued disaster declarations for the states of Texas and Louisiana pursuant to the Robert T. Stafford Disaster Relief and Emergency Assistance Act.
On July 13, the Centers for Medicare & Medicaid Services (“CMS”) put out its 2018 Medicare Hospital Outpatient Prospective Payment System Proposed Rule. The Rule proposes, among other things, to dramatically reduce Medicare Part B reimbursement of drugs procured by hospitals at 340B prices—from the current rate of Average Sales Price (“ASP”) plus 6 percent to ASP minus 22.5 percent. By CMS’s estimate, this could result in savings to the Part B program of $900 million and a corresponding cut to the 340B hospitals which currently receive those payments (and ostensibly use them in furtherance of the 340B program’s goal of assisting safety net providers in stretching their scarce resources). Continue Reading CMS Proposes Drastic Reduction to Medicare Part B Reimbursement of 340B Drugs
On May 27, 2017 the Texas Governor signed SB 1107 into law, making certain telehealth arrangements possible after the Texas Medical Board imposed limitations on telehealth services in June 2015. Specifically, SB 1107 adds new §§111.005-7 to the Texas Occupations Code allowing a physician to prescribe drugs as part of a telehealth encounter involving only telephonic or text-based communication between the physician and patient if: (i) the physician has access to patient medical records and uses either clinically relevant photographic or video images or the patient’s relevant medical records; and (ii) the physician provides the patient with guidance on appropriate follow-up care and, if the patient consents and has a primary care physician, provides to the patient’s primary care physician within 72 hours after the encounter a medical record or other report containing an explanation of the treatment provided by the physician, including the physician’s evaluation, analysis, or diagnosis. Continue Reading Texas Legislature Gives Telehealth a Call Back