On June 22, 2023, the Centers for Medicare & Medicaid Services (CMS) announced its proposed “Transitional Coverage for Technologies” (TCET) pathway—the Biden administration’s highly anticipated take on a mechanism to expedite coverage for certain devices designated by the U.S. Food and Drug Administration (FDA) as breakthrough devices.[1]
As described in the notice with comment period (the “Procedural Notice”), the voluntary TCET pathway aims to streamline efforts between CMS, the FDA, and manufacturers of certain FDA-designated breakthrough devices to more efficiently advance breakthrough devices through the CMS coverage determination processes using a “coverage with evidence development” (CED) approach.
Under the proposed three-phase framework, manufacturers of breakthrough devices accepted into the TCET pathway would enter a period of transitional coverage through a TCET national coverage determination (NCD), during which the device’s manufacturer would be able to generate evidence for CMS to use to determine the breakthrough devices’ post-TCET final coverage status.
Notably, CMS stated that the agency only anticipates accepting five candidates to participate in the TCET pathway each year.[2] Stakeholders must submit comments on the TCET pathway by August 28, 2023.
On Friday October 6, 2017, the Trump administration released two interim final rules expanding the exemptions allowed under the Patient Protection and Affordable Care Act’s (the “ACA’s”) contraceptive coverage mandate. Under the ACA, employer group health plans generally are required to cover contraceptives, sterilization, and related patient education and counseling, with exemptions provided for religious houses of worship. The exemption was expanded by the Department of Health and Human Services (HHS) as a result of the Supreme Court’s decision in Burwell v ...
Kyler Prescott was a 14 year old transgender boy who was receiving puberty-delaying medication to help him transition. Shortly before Kyler’s death he had “suicidal ideation” and was taken to Rady Children’s Hospital - San Diego in April 2015. The hospital has a Gender Management Clinic to provide services to children with gender dysphoria and related issues. A lawsuit under the ACA’s non-discrimination provision, § 1557, alleges that after admission, despite assurances that he would be referred to with masculine pronouns, hospital employees referred to Kyler as a ...
Recently, the Practical Law Company published a Q&A with me regarding issues raised by the Affordable Care Act in mergers and acquisitions. We discussed various items employers should review, such as full-time worker definitions, exposure to tax under the employer mandate, and integration of each party’s health programs. Following is an excerpt:
Q. The ACA is perhaps one of the most talked about pieces of legislation in recent history. ln terms of M&A transactions, what do you think are the ACA's major effects?
A. The ACA has created many new ...
Our colleagues at Epstein Becker Green have issued a client alert: "CMS Issues Final Regulations on Federal 'Sunshine' Law for Manufacturers and GPOs," by Amy K. Dow, Wendy C. Goldstein, Kim Tyrrell-Knott, Sarah K. diFrancesca, David C. Gibbons, Daniel G. Gottlieb, and Natasha F. Thoren.
Following is an excerpt:
On February 1, 2013, the Centers for Medicare & Medicaid Services issued long-awaited final regulations with a lengthy preamble relevant to Section 6002 of the Patient Protection and Affordable Care Act, also known as the "Physician Payment Sunshine Act." This health ...
I wrote the January 2013 edition of Take 5: Views You Can Use, a newsletter published by the Labor and Employment practice of Epstein Becker Green.
In it, I summarize five actions that employers should consider taking in 2013 as the DOL steps up its audit efforts under the leadership of the reenergized Obama administration,
- Assess the Workforce
- Choose Whether to “Pay” or to “Play”
- Evaluate Existing Wellness Programs and/or Implement New Wellness Programs to Enhance Employees’ Health Profiles and to Avoid or Minimize the “Cadillac ...
On August 31, 2012, the Internal Revenue Service (IRS), along with the Department of the Treasury, Department of Labor (DOL) and Department of Health and Human Services (HHS), issued guidance under the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010 (the “Affordable Care Act”) on the application of the employer responsibility standards to large employers (the employer “play or pay” mandate), IRS Notice 2012-58 , and the 90-day limit on waiting periods for group health coverage, IRS Notice 2012-59, DOL ...
by Joan A. Disler, Michelle Capezza, and Gretchen Harders
Now that the Supreme Court of the United States has upheld essentially all of the provisions of the Obama administration’s Affordable Care Act (“ACA”), employers are faced with looming deadlines to bring their group health plans into compliance with the ACA’s numerous new requirements. We have prepared for employers a timeline of the highlights of the upcoming deadlines for compliance with the ACA that apply to non-grandfathered group health plans.
by Joan A. Disler, Michelle Capezza, and Gretchen Harders
Now that the Supreme Court of the United States has upheld essentially all of the provisions of the Obama administration's Affordable Care Act ("ACA"), employers are faced with looming deadlines to bring their group health plans into compliance with the ACA's numerous new requirements. We have prepared for employers a timeline of the highlights of the upcoming deadlines for compliance with the ACA that apply to non-grandfathered group health plans.
Written by: Stuart M. Gerson
The three days of arguments about the constitutionality of the Patient Protection and Affordable Care Act are complete. The Justices of the Supreme Court of the United States have conducted their post-argument conference and are now turning their attention to the drafting and the discussions that will lead to a majority opinion and, likely, several dissents and concurrences. The Court's decision should be issued before the end of June. Health care companies and employers, like the rest of the population, await the ultimate decision. However, there ...
by Shawn M. Gilman and Julia E. Loyd
On February 14, 2012, a final rule implementing Section 2715 of the Public Health Service Act, as added by the Patient Protection and Affordable Care Act, regarding the requirements for group health plans and health insurance issuers to provide a summary of benefits and coverage (“SBC”) to interested parties was published in the Federal Register. As set forth in the final rule, an SBC must be provided upon request or the occurrence of certain events and the content and format of the SBC must be in accordance with the extensive requirements ...
On December 6, 2011, the U.S. Department of Labor (“DOL”) issued a proposed rule on Form M-1 filing requirements, a proposed rule on DOL ex parte cease and desist orders, a notice of proposed form revision to Form M-1 and a notice of proposed form revision to Form 5500 implementing new requirements for multiple employer welfare arrangements (“MEWAs”) under the Patient Protection and Affordable Care Act (“PPACA”) (referred to as the “Proposed Rules”). PPACA prohibits false statements or representations of fact about a MEWA’s financial condition ...
by Gretchen Harders, Daly D.E. Temchine, and Joseph J. Kempf, Jr.
On December 7, 2011, final rules on the medical loss ratio (“MLR”) requirements for insured health plans (and an interim final rule for non-federal governmental plans) were issued by the U.S. Department of Health and Human Services and the Centers for Medicare & Medicaid Services under the Patient Protection and Affordable Care Act. The MLR requirements are effective January 1, 2012, and any issuer who does not meet the MLR requirements for the 2011 MLR reporting year must pay rebates by August 1, 2012. This alert ...
by Ross K. Friedberg, Shawn M. Gilman, Mark E. Lutes, David E. Matyas, René Y. Quashie, Serra J. Schlanger, Carrie Valiant, Dale C. Van Demark, and Lesley R. Yeung
On October 20, 2011, the Centers for Medicare & Medicaid Services ("CMS") released its final rule ("Final Rule") implementing the voluntary Medicare Shared Savings Program ("Program") for accountable care organizations ("ACOs"). The Program was established by Section 3022 of the Patient Protection and Affordable Care Act. The Final Rule was released in conjunction with revised antitrust guidance from the Federal ...
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