In a major departure from over 20 years of practice, the EPA announced on January 25 that it is withdrawing the “once in, always in” (OIAI) interpretation of the hazardous air pollutants (HAPs) program. The OIAI required sources of HAPs to permanently comply with Maximum Achievable Control Technology (MACT) standards applicable to major sources of HAPs, even when those sources’ emissions are below major source levels ...
The State Medical Board of Ohio recently proposed amendments to the existing regulations governing light-based medical devices (lasers), which will significantly impact the provision of laser services in Ohio. While the proposal adds a new category to existing delegation authority, it also imposes new regulatory requirements to existing delegation authority which will impact Ohio physicians providing laser services ...
We previously reported on oral arguments before the Supreme Court regarding which court has original jurisdiction to hear challenges to the Clean Water Act’s “waters of the United States” (“WOTUS”) definition. On January 22, 2018, the Supreme Court issued a unanimous decision in National Association of Manufacturers v. Department of Defense that only district courts have original jurisdiction to hear such challenges ...
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 ...
Last week, the U.S. Department of Labor (DOL) issued proposed rules to expand access to “Association Health Plans” for small businesses that are unaffiliated, but are in the same line of business or geographic area. An “Association Health Plan” or “AHP” is a group health plan adopted by members of an employer association to provide health coverage for their employees ...
Originally filed in October 2014, the long-running and high-stakes battle between two powerhouse companies, Amgen and Sandoz, continues to lay out the ground rules for a growing biosimilar industry. The Federal Circuit’s first decision under the Biologics Price Competition and Innovation Act (BPCIA) involved Zarxio, Sandoz’s Neupogen biosimilar product. Amgen v. Sandoz, 794 F.3d 1347 (Fed Cir. 2015) ...
Earlier this year, Decree No. 1 of the Ministry of Health (herein, the "Decree") was published on the Official Gazette. The Decree sets forth the graphic characteristics of the message for the promotion of healthy life habits that must be included in the advertisement of foodstuff products established in Article 5 of Law No. 20,606 -those that qualify as "High in" one or more critical nutrients- made through mass communication ...
How new technologies and changing consumer expectations is signaling disruption to the health industry and the importance of finding ways to better measure and translate patient satisfaction and outcomes. Do you know if your clinician is doing a good job? What about the track record of your surgeon? Should you be entitled to know as a consumer? The industry is being disrupted – no longer is the family GP the dispenser of all health advice ...
The U.S. International Trade Commission (“ITC”) issued a determination at the end of 2017, finding that solar panel imports are hurting domestic businesses that operate in the solar industry. The ITC’s determination was issued in connection with a trade case filedby a Georgia-based company, Suniva, Inc., shortly after filing for bankruptcy protection. SolarWorld Americas, Inc. joined Suniva’s petition ...
On October 16, 2017, EPA Administrator Pruitt issued the “Directive Promoting Transparency and Public Participation in Consent Decrees and Settlement Agreements.” At the same time, Pruitt issued a memorandum to EPA assistant administrators, regional administrators and the office of general counsel explaining the rejection of “sue and settle” tactics by his administration ...
For many years EPA has taken the position it could take enforcement action based on agency review and calculation of projected emissions in determining New Source Review (NSR) applicability for pre-construction permitting for modification of an existing source ...
On October 16, 2017, EPA Administrator Scott Pruitt signed an order reversing a long-standing EPA position that EPA has the authority to review previous state decisions on new source permitting applicability when reviewing Title V permits. The order denied a petition by Sierra Club requesting that EPA object to the issuance of a Title V operating permit to the Hunter Power Plant in Castle Dale, Utah ...
Kentucky Regulatory Amendments On September 15, 2017, the Division for Air Quality submitted amendments to 401 KAR 59:015 for new indirect heat exchangers and 401 KAR 61:015 for existing indirect heat exchangers. The Division stated the amendments were necessary to provide clarity for regulated entities and to remove duplicative requirements covered by federal regulations ...
EPA continues to make progress in its effort to repeal and replace the Clean Power Plan (CPP). EPA held public hearings on November 28-29, 2017, in Charleston, West Virginia to take testimony on its October 10, 2017, proposal to repeal the rule. EPA is accepting comments on the proposal to repeal the rule through January 16, 2018. EPA announced it will hold three additional public comment sessions due to the “overwhelming response” to the West Virginia hearing ...
In its bill, Extended Environmental Crime Provisions, from earlier this year, the government has proposed extending the scope of offences for environmental crime committed in conjunction with waste management. The proposal means that all waste management that can cause significant pollution, which is harmful to human health, animals or plants or that can cause other significant environmental nuisance is to be punishable. The penalty for the crime is a fine or imprisonment for up to two years ...
Inter partes review proceedings for biosimilar products are soaring. Biosimilar makers are taking advantage of IPR proceedings to challenge patents protecting some of the world's most important biologic medicines due to the advantages that these proceedings offer: no standing requirement, no presumption of validity, a lower burden of proof and potentially broader claim construction. More than half of the IPR petitions challenging these patents were filed in fiscal 2017 ...
Ohio prescribers need to be aware of new rules for prescribing controlled substances that will take effect on December 29, 2017. First, prescribers will be required to include the first four characters of the ICD-10 diagnosis code or the full CDT procedure code on all prescriptions for opioids.[1] Similarly, beginning June 1, 2018, prescribers will need to include the ICD-10 diagnosis or CPT procedure code on prescriptions for all other controlled substances ...
Governor Jerry Brown approved California Senate Bill 798 on October 13, 2017. One provision of this bill imposes penalties for failure to file required reports under Business and Professions Code Section 805.01. Beginning January 1, 2018, individuals and entities with reporting obligations under Section 805.01 are subject to fines of up to $100,000 per violation for willful failures to file a Section 805 ...
Californians diverting water should take notice of new measurement and reporting requirements with quickly approaching deadlines. Water right holders diverting between 10 and 100 acre-feet per year have until January 1, 2018, to either (1) install and maintain a measurement device, (2) employ a measurement method capable of measuring the rate of diversion, or (3) submit an alternative compliance plan ...
The revised Phase 2 Requirements of Participation for long-term care facilities will go into effect November 28, 2017. While multiple provider groups have requested a delay of some of the rule's provisions to allow time for additional revisions, officials at the Centers for Medicare and Medicaid Services ("CMS") have indicated that they will not act on those requests at this time and plan to move forward with the November 28, 2017, implementation date for Phase 2 ...
The California Office of Environmental Health Hazard Assessment (OEHHA) announced on November 9, 2017 that it was adding two widely used perfluorinated chemicals to the Proposition 65 list of chemicals known to cause reproductive toxicity: perfluorooctanoic acid (PFOA) and perfluorooctane sulfonate (PFOS) ...
On October 13, 2017, Governor Brown signed SB 798, amending Business and Professions Code Section 805, Civil Code Sections 43.7 and 43.8, and Evidence Code Section 1157 to include licensed midwives within their scope. Notably, these changes only apply to licensed midwives, those professionals who pass the North American Registry of Midwives examination and are licensed by the Medical Board of California ...
View a PDF of the November 2017 edition of the Haynes and Boone Health Law Vitals newsletter. FDA Improving Regulatory Oversight of Stem Cell Therapies and Regenerative Medicine Products Regenerative medicine is a burgeoning interdisciplinary research field aiming to offer new therapies that replace or regenerate human cells, tissues, or organs with the goal of restoring or establishing normal function ...
On November 2, 2017, the State Water Resources Control Board ("State Water Board") published a notice of a proposed water conservation regulation that would permanently prohibit individuals, businesses, and cities, among others, from engaging in certain "wasteful" water practices. The regulation would be part of a new chapter in the California Code of Regulations entitled "Conservation and the Prevention of Waste and Unreasonable Use." See Cal. Code Regs. tit ...
Earlier this year, Michigan’s Department of Licensing and Regulatory Affairs (LARA) announced the formation of “work groups” to provide input as LARA adopts emergency rules to govern activities under the State’s new Medical Marihuana Facilities Licensing Act (MMFLA). Organized around the MMFLA’s five license types, those work groups met last month ...
