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Medical Device Legal News with Sam Bernstein: Episode 19
Episode 303 --- Deep Dive into the HHS-OIG Compliance Program Guidance
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HIPAA Tips With Williams Mullen - Telehealth After the Pandemic
As the summer winds down, regulatory updates related to digital health services certainly do not appear to be showing any signs of cooling off. It has been a busy summer, and below we have summarized several key updates for...more
On August 13, 2024, the Centers for Medicare and Medicaid Services (CMS) and its Center for Clinical Standards and Quality / Quality, Safety & Oversight Group issued its memorandum QSO-24-17-EMTALA (the “Memorandum”),...more
The upcoming election, and the approaching end of the President’s four-year term, introduce additional dynamics into the agencies’ rulemaking process and even the guidance process. From now through the November election, the...more
On January 25, 2024, HHS Office for Civil Rights (OCR) issued guidance and responses to frequently asked questions regarding nondiscrimination regulations related to patient visitation. Hospitals, long term care facilities,...more
Medicare Advantage Organizations and Part D sponsors have a responsibility to ensure they offer and provide their members and potential enrollees with content and materials in alternate languages or accessible formats for...more
For diabetic patients and the doctors who treat them, blood sugar levels are crucially important. However, the traditional method of testing one’s blood sugar with a pin-prick is undesirable for many patients, which leads to...more
Cardiovascular stress testing to diagnose patients with coronary artery disease (CAD) and other related types of conditions can be a highly-effective tool in many cases. In fact, many cardiologists routinely recommend stress...more
Durable medical equipment (DME) is particularly important for many Medicare beneficiaries. However, companies that manufacture and sell DME need to be careful because there are strict federal regulations outlining almost...more
The Office of Inspector General is a division of the U.S. Department of Health and Human Services that is tasked with combating fraud committed against Medicare, Medicaid, and other federally funded government programs. The...more
The Centers for Medicare & Medicaid Services (“CMS”) recently released draft guidance for state survey agencies regarding shared space and co-location arrangements between hospitals and other hospitals or health care...more
For the first time since the enactment of the Medicaid Drug Rebate Program (MDRP), the Centers for Medicare and Medicaid Services (CMS) revised the National Medicaid Drug Rebate Agreement (NDRA) entered into between drug...more
According to a recent review of Legionnaires' disease outbreaks, 34 percent were associated with long-term care facilities and hospitals. Patients at risk of contracting Legionnaires' disease include smokers, those with...more
Deadlines are looming to come into compliance with sweeping changes to the Centers for Medicare & Medicaid Services (CMS) requirements for long-term care facilities (LTC) participating in Medicare and Medicaid. The CMS final...more
"Wherefore Art Thou Due Process?" Part III - Why it matters: It is time for another installment in our continuing "Wherefore Art Thou Due Process?" coverage into the ongoing constitutional challenges to the SEC's...more