Medical Device Legal News with Sam Bernstein: Episode 19
Midyear Premium Increases and Cafeteria Plan Rules
K&L Gates Triage: An Insider’s Perspective on the Health Care Debate in Washington, DC
K&L Gates Triage: 340B Regulatory Update: CMS Proposal and Draft Executive Order Could Have Big Impact on 340B Program
Collaborating Before The PTAB
Although often well-intentioned, offering free or discounted items or services to patients (e.g., gifts, rewards, writing off copays, free screening exams, free supplies, etc.) may violate federal and state laws governing...more
In a recent Advisory Opinion No. 23-11 (Advisory Opinion), the Office of Inspector General (OIG) opined that it will not impose administrative sanctions against a clinical trial sponsor covering up to $2,000 of a clinical...more
Last month, in the last advisory opinion issued by the Office of Inspector General (“OIG”) in 2023 – Advisory Opinion No. 23-11 (the “Opinion”) – OIG “blessed” an arrangement involving a medical device manufacturer (the...more
The Centers for Medicare & Medicaid Services (CMS) has announced new measures to enhance access to behavioral health services for Medicare beneficiaries and improve hospital price transparency as part of the final rule for...more
August 16, 2023 marked the one-year anniversary of the enactment of the Inflation Reduction Act (“IRA”). The first 365 days since the IRA’s passage brought the implementation of a number of significant changes to the Medicare...more
Although most of the recent focus around the implementation of the Inflation Reduction Act (“IRA”) by the press and industry stakeholders has been on the Medicare Drug Price Negotiation Program, the IRA has several other...more
On March 11, 2022, OIG issued Advisory Opinion No. 22-05 in which it responded to a request for an advisory opinion regarding a proposed subsidization of certain cost-sharing obligations in the context of a clinical trial...more
On November 19, 2021, OIG issued Advisory Opinion No. 21-17 in which it responded to a request for an advisory opinion regarding a proposed subsidization of certain Medicare cost-sharing obligations in the context of a...more
2020 saw the courts continuing to play an important role in health policy with several notable lawsuits related to the Affordable Care Act (ACA). Several other Trump administration policies were challenged, including Medicare...more
The Big Picture - Until late December, few if any Medicare policy changes were anticipated as part of a year-end healthcare package, barring extensions of funding for programs that otherwise would have expired. But after...more
On October 28, 2020, CMS released an interim final rule with comment period (IFC) that implements several CARES Act requirements to prepare for the availability of a COVID-19 vaccine. Among other changes, the IFC establishes...more
Over the past week, the Centers for Medicare & Medicaid Services (CMS) has made a number of announcements related to Medicare coverage in connection with the Coronavirus (COVID-19) outbreak. Several of those announcements...more
As the number of coronavirus cases across the country continue to rise, CMS has issued several coronavirus-specific memorandums to healthcare providers and laboratories. In the past two weeks, CMS has issued disease-specific...more
While the COVID-19 emergency continues, Medicare will pay health care professionals to provide care by telehealth for Medicare beneficiaries in their homes, and HIPAA restrictions affecting the use of non-compliant video chat...more
On March 10, 2020 the Centers for Medicare & Medicaid Services released a memo to Medicare Advantage Organizations and Part D Sponsors to inform them of their obligations and permissible flexibilities related to disasters and...more
The Centers for Medicare & Medicaid Services (CMS) published the Contract Year 2021 and 2022 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicaid Program,...more
On December 20, 2019, the Centers for Medicare and Medicaid Services (CMS) issued a final rule on program integrity for Affordable Care Act (ACA) exchange plans. This rule implements a number of provisions from the ACA,...more
CMS just released the 2020 final rule with changes to remote patient monitoring (RPM), officially titled “Chronic Care Remote Physiologic Monitoring,” reimbursed under the Medicare program, as part of the Physician Fee...more
A group of six government-operated fire departments has received a green light from the Office of Inspector General (OIG) to enter into a mutual aid agreement to provide backup emergency ambulance services and to bill for...more
Lawmakers return to Capitol Hill this week ahead of more self-imposed deadlines to resolve a series of thorny healthcare policies, including funding for the Department of Health and Human Services (HHS) and the rest of the...more
The rising cost of drugs in the U.S. is frequently in the news. So it is not surprising that in its contract year 2019 Proposed Medicare Advantage and Part D Regulations (Proposed Rule), the Centers for Medicare & Medicaid...more
Lawmakers returning to Capitol Hill this week after the Thanksgiving recess face a daunting series of tax and budget deadlines that will set the stage for how Congress addresses year-end healthcare priorities. That...more
On November 16, 2017, the Centers for Medicare & Medicaid Services (CMS) released a proposed rule that would revise regulations and clarify requirements for the Medicare Advantage (MA) and Medicare Prescription Drug Benefit...more
The U.S. Department of Health and Human Services, Office of the Inspector General (OIG), issued a favorable advisory opinion, No. 17-02, regarding a proposed arrangement under which the cost-sharing amounts owed by...more
CMS seeks input on potential market stabilization rulemaking; Iowa proposes a single standardized Marketplace plan and reinsurance program; and Centene will expand its Marketplace offerings for 2018, including adding new...more