On Wednesday, July 11, 2018, House lawmakers again signaled their intent to reform the US Department of Health and Human Services (HHS), Health Resources and Services Administration’s (HRSA) 340B Drug Pricing Program (340B) during an Energy and Commerce (E&C) Subcommittee on Health hearing. Since 2015, both E&C and the Senate Health, Education, Labor, and Pensions … Continue Reading
On June 21, 2018, the US Department of Labor (DOL or the Department) published its final rule, amending the definition of “employer” under section 3(5) of the Employee Retirement Income Security Act (ERISA) to allow for the establishment of group or association health plans (AHPs) (Final Rule). Similar to a corresponding proposed rule issued earlier … Continue Reading
The June 13, 2018 publication of Practical Law features a Practice Note co-written by Squire Patton Boggs attorneys Mark A. Salzberg, Elliot M. Smith, John E. Wyand and Sarah H. Stec titled “State Legalized Marijuana Businesses and Access to the Bankruptcy Code”. The Practice Note discusses the federal statutory scheme governing marijuana, its tension with … Continue Reading
PROPOSAL TO INCREASE RURAL HEALTH CARE FUNDING RECEIVES MAJORITY SUPPORT AT FCC Majority Of Federal Communications Commission (FCC) Supports 40%+ Annual Increase In Rural Health Care Program Funding – Following on a proposal to review annual funding for the FCC’s Rural Health Care Program (RHCP), which currently provides $400 million in annual subsidies for telecommunications … Continue Reading
Right to Try Investigational Drugs Signed Into Law On May 30, 2018, S. 204, the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 (Pub. L. No. 115-176, “Right to Try Act”) was signed into law. The Right to Try Act amends the Federal Food, Drug, and Cosmetic Act … Continue Reading
On Thursday, May 17, the House Energy and Commerce Committee (E&C) cleared 32 additional opioid-related measures during its second markup on the issue. In total, E&C has now advanced 57 bills to combat the opioid overdose crisis. While most measures were easily approved on a bipartisan basis, committee members disagreed over a number of bills … Continue Reading
On Friday, May 11, 2018, President Trump vowed to fix “the injustice of high drug prices” by announcing the “Blueprint to Lower Drug Prices” (the Blueprint) to address the following challenges: Excessively high drug prices Seniors and government programs overpaying for drugs High out-of-pocket costs for consumers Lack of transparency in drug pricing Free-riding by … Continue Reading
CMS is Accepting Proposals for New Measures for the Medicare Promoting Interoperability Program until June 29 The Centers for Medicare & Medicaid Services (CMS) is seeking the submittal of measure proposals for the Annual Call for Measures for eligible hospitals and critical access hospitals participating in the Medicare Promoting Interoperability (PI) Program (formally known as … Continue Reading
On Wednesday, May 16, the House Ways and Means Committee advanced four opioid crisis-related packages. The bipartisan measures, which are expected to move with other House bills under consideration, largely focus on combating the epidemic through strengthened prevention, provider and beneficiary education, and treatment options. During the markup, Ways and Means Chairman Kevin Brady (R-TX) … Continue Reading
Earlier this month, the US Department of Health and Human Services (HHS) published a Final Rule in the Federal Register that will scale back regulations applicable to health insurance subject to the Patient Protection and Affordable Care Act (ACA). In issuing the Final Notice of Benefit and Payment Parameters for 2019 Rule (Final Rule), HHS … Continue Reading
The FCC’s Notice of Proposed Rulemaking (NPRM) to consider changes to its Rural Health Care Program (RHCP), which provides $400 million in annual subsidies for telecommunications and broadband services to eligible rural healthcare providers (HCP), has now been published in the Federal Register. Interested parties may submit initial comments on the FCC’s proposals by February … Continue Reading
On December 8, 2017, the Food and Drug Administration (FDA) published a notice of availability for the Clinical and Patient Decision Support Software – Clinical and Patient Decision Support Software – Draft Guidance for Industry and Food and Drug Administration Staff (“Draft Guidance”). The Draft Guidance, available here, provides clarity on the scope of FDA’s … Continue Reading
On December 14, 2017, the Centers for Medicare & Medicaid republished the final rule with comment period for the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2018 (“Final Rule”). The republication included an editorial note stating that the Final Rule was originally published in … Continue Reading
On November 13, CMS published the final rule revising the Medicare hospital Outpatient Prospective Payment System for 2018. Among a number of changes, the final rule dramatically reduces Medicare Part B payments to hospitals for separately payable drugs purchased through the 340B Program. Currently, Medicare pays hospitals the Average Sales Price (ASP) plus 6% for … Continue Reading
Recently, the National Institutes of Health (“NIH”) extended the effective date of its policy on the use of the single Institutional Review Board (“IRB” or “sIRB” if a single IRB) to January 25, 2018. NIH created the sIRB policy to establish the expectation that a sIRB be used in the ethical review of multi-site, domestic, … Continue Reading
Accessories to medical devices play an integral role for their parent medical devices, supporting or adding to the parent device’s functionality. Accessories historically took the classification of the parent device, except in cases where the Food and Drug Administration (“FDA”) classified the accessory in its own right. The 21st Century Cures Act, passed into law … Continue Reading
Last week, the Federal Communications Commission (the Commission) released an Order denying a Petition for Declaratory Ruling by Kohll’s Pharmacy & Homecare, Inc. (Kohll’s) originally filed on March 29, 2016, requesting the Commission to declare that certain faxes describing the health benefits of flu vaccinations did not constitute unsolicited advertising under the Telephone Consumer Protection Act (TCPA) … Continue Reading
On November 1, CMS released final rules implementing Section 603 of the Bipartisan Balanced Budget Act of 2015 (the Final Rule). Section 603 effectively reduces Medicare compensation paid to certain off-campus hospital outpatient departments (HOPDs) beginning January 1, 2017 by eliminating their eligibility for compensation under Medicare’s Hospital Outpatient Prospective Payment System (OPPS). The Final … Continue Reading
Recent medical device adverse events prompted FDA to take a fresh look at the ways it collects data related to medical device adverse events from hospitals. FDA examined some high-profile adverse events, such as the spread of uterine cancer from the use of morcellators and the spread of infections by contaminated duoendoscopes, and found it … Continue Reading
