Health Law Advisor

The Centers for Medicare & Medicaid Services (“CMS”) has published a final rule that will expand access to telehealth services for Medicare Advantage (“MA”) plan enrollees.[1] CMS Administrator Seema Verma characterized the agency’s latest policymaking efforts as “a historic step in bringing innovative technology to Medicare beneficiaries” and a way for the agency to provide “greater flexibility to Medicare Advantage plans, [so] beneficiaries can receive more benefits, at lower costs and better quality.”[2]

Traditionally, MA plans have been limited to ...

On February 14, 2019, the Centers for Medicare & Medicaid Services (“CMS”) announced the Emergency Triage, Treatment and Transport reimbursement model (the “ET3 Model”), a demonstration project that aims to provide improved flexibility to ambulance crews addressing 911-initiated emergency calls for Medicare beneficiaries.

CMS plans to release its Request for Applications (“RFA”) to solicit participation in the ET3 Model from Medicare-enrolled ambulance providers and suppliers in the summer of 2019. The ET3 Model start date is anticipated for January 2020 for ...

In an announcement about New York’s budget for fiscal year 2020, New York Governor Andrew Cuomo highlighted, among other things, an amendment to Section 3-110 of New York’s Election Law mandating three hours of paid time off for all New Yorkers to vote on election day.

Under the amendment, which is effective immediately, all New York employees who are registered to vote may request up to three hours of paid time off to vote, regardless of their work schedules, as long as the request is made at least two working days before the election.  New York employers may designate that any ...

On March 27, 2019, the FDA announced that it would be proposing new amendments to key regulations regarding mammography facilities that would require these entities “to tell women more about how dense breast tissue can affect their health and increase their cancer risk.”  The proposed changes to mammography facility regulations would be the first issued in more than 20 years.  The FDA believes the change will “expand the information mammography facilities must provide to patients and health care professionals, allowing for more informed medical decision-making.”  In ...

On April 2, 2019, FDA issued a press release featuring a statement from FDA Commissioner Scott Gottlieb announcing the Agency’s latest enforcement actions taken against companies engaging in unlawful marketing of cannabidiol (CBD) products.  Coming just days before Gottlieb’s anticipated departure from the Agency, this news otherwise is unsurprising given recent events on the federal and state level.  In a December 2018 press release issued on the heels of the Farm Bill’s passage, FDA forecast its intention to step up enforcement against CBD products, and earlier this year ...

The importance of the Domain Name System (DNS) to your organization’s cybersecurity cannot be understated. Communications between computers on the Internet depend on DNS to get to their intended destination. Network communications begin with a query to DNS to resolve the human readable domain name to a numeric Internet Protocol (IP) address required by computers to route the transmission. A malicious party who is able to exploit a weakness in DNS can re-route sensitive traffic, including Protected Health Information (PHI), Personally Identifiable Information (PII) and ...

As employers are wrapping up their reporting under the Affordable Care Act (“ACA”) for the 2018 tax year (filings of Forms 1094-B/C and 1095-C/B with the IRS are due by April 1, 2019, if filing electronically), they should start preparing for new reporting obligations for the 2019 tax year.

After a string of failed efforts to repeal the ACA, Congress, through the Tax Cuts and Jobs Act of 2017 (“TCJA”), reduced the federal individual shared responsibility payment assessed (with limited exceptions) against individuals who failed to purchase health insurance to $0 beginning ...

Many physicians rely on publicly available reports to assess the safety of the devices they use on patients, but in some cases, these reports aren’t painting the full picture.  A recent Kaiser Health News (“KHN”) article raises serious questions about FDA’s practice of allowing a significant number of medical device injury and malfunction reports to stay out of the public eye.

Under FDA’s Medical Device Reporting (“MDR”) regulation (21 CFR part 803), device manufacturers, importers, and device user facilities (which include hospitals, ambulatory surgery ...

The information letter issued by the Department of Labor (the “DOL”) on February 27, 2019 (the “Information Letter”) provides a reminder to plan sponsors about the importance of disclosing the procedure for appointing authorized representatives in the benefit claim and appeal procedures for employee benefit plans subject to the Employee Retirement Income Security Act of 1976 (“ERISA”), as amended and also about the extent of the authority of the authorized representative. The Information Letter was in response to a query as to whether an entity that acts as a patient ...

On March 15, 2019, the Centers for Medicare & Medicaid Services (CMS) released proposed changes to its methodology for calculating Civil Money Penalties (CMPs) for Medicare Advantage (MA) and Part D Prescription Drug Plan (MA and Part D) sponsors.  The proposed changes would impact both the calculation methodology for 2019 as well as the CMP amounts for 2019 and beyond in an effort to increase plan accountability.  CMS is accepting comments on these proposed changes until April 15, 2019 at 11:59 PM ET.

Though CMS has exercised its statutory and regulatory authority to impose CMPs on MA ...