Kinal Patel

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On Thursday, July 11, 2019, the White House administration reversed course on the Department of Health and Human Services’ (HHS) recent proposal to reform drug manufacturer rebate system. As we previously reported, HHS’s February 6, 2019 proposed rule sought to modify the Anti-Kickback Statute safe harbor protection with the aim of lowering prescription pharmaceutical product prices and out-of-pocket costs for consumers (primarily Medicare Part D and Medicaid Managed Care Plan members). With the proposed…
On February 6, 2019, the Department of Health and Human Services (HHS) published a Proposed Rule modifying the Anti-Kickback Statute safe harbor protection with the aim of lowering prescription pharmaceutical product prices and out-of-pocket costs for (primarily Medicare Part D and Medicaid Managed Care Plan) consumers. With the Proposed Rule, HHS hopes to encourage medication manufacturers to pass discounts directly to consumers and develop a transparent framework for the prescription pharmaceutical product market.  A more…
Last month, CMS updated Chapters 13 and 14 from the Part D Prescription Drug Benefit Manual (PDBM). These updates affect Part D plan sponsor operations as well as network and non-network pharmacies. In Chapter 13, CMS updated its guidance on premium and cost sharing subsidies for low-income beneficiaries under the Part D program. In Chapter 14, CMS updated its guidance on coordination of benefits. A selection of CMS’s updates to those chapters are highlighted below:…
An article authored by Healthcare principal John Wyand and associate Sarah Stec published in the November/December edition of the Food Drug Law Institute’s Update Magazine, looks at the impact of the EU’s regulations governing medical devices and in vitro diagnostic medical devices. The regulations seek to fill the regulatory gaps uncovered as technology evolved faster than the current regulatory regime. The authors predicted that the regulations “will strengthen the rules for placing medical devices on…
On Thursday, CMS announced that it intends to allow providers to “pick their pace of participation” for the first compliance year of Medicare’s new payment reform model emphasizing quality patient care.  The start of the first compliance year is January 1, 2017. Thursday’s announcement lays out four options that allow providers more flexibility to comply with MACRA’s new payment schemes through the Merit-based Incentive Payment System (MIPS) or an alternative payment model (APM). As reported…
On August 22, 2016, the IRS released new safe harbors from private business use of tax-exempt bond-financed facilities for management contracts that substantially change the prior safe harbors under Rev. Proc. 97-13. The new revenue procedure, Rev. Proc. 2016-44, provides more flexibility and appears to be more favorable than Rev. Proc 97-13. The new safe harbors take effect immediately for management contracts entered into, or materially modified, on or after August 22, 2016. However,…
The National Office of the Internal Revenue Service (“IRS”) released Private Letter Ruling (“PLR”) 201622003 on May 27, 2016.  This recent PLR provides additional guidance on management contracts and private business use issues related to tax-exempt bonds.  A full-length commentary on PLR 201622003 authored by Michael Cullers is available on Squire Patton Boggs’ Public Finance Tax Blog.…
As we near the end of May, critical deadlines for participation in the Medicare Shared Savings Program (“MSSP”) for program year 2017 are approaching.  Under the MSSP ACO Final Rule, CMS finalized new regulations that established a process for and the timing of initial applications for participation in the MSSP and renewals of existing participation agreements.  CMS made clear that an application or renewal may be denied if the applicant fails to submit information by…
The Health Resources and Services Administration (“HRSA”) and the Department of Health and Human Services (“HHS”) issued a notice and reopening of comment period for their June 17, 2015 notice of proposed rulemaking, “340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation.”  In light of comments received, HHS is reopening the comment period for 30 days to invite public comments on three areas of rulemaking: the ceiling price for a covered…
  Last legislative session, the Ohio General Assembly passed a measure in House Bill 52 requiring health care cost transparency for non-emergency services.  The new measure requires that most medical service providers provide in writing, prior to a service being rendered, “a good-faith estimate” of (1) the amount the provider will charge the patient’s health plan, (2) the amount the health plan intends to pay, and (3) the difference, if any, that the patient will…