Articles and Blogs

In April 2024, the Food and Drug Administration (“FDA”) issued a Final Rule amending the definition of in vitro diagnostics products (“IVDs”) found in 21 C.F.R. § 809.3. The Final Rule completely changed the regulatory status of Laboratory Developed Tests (“LDTs”) by adding the following additional language: “including when the manufacturer of these products... READ MORE

CMS’s minimum staffing rule for skilled nursing facilities (“SNFs”) continues to make waves in the SNF industry. According to a new article, only one in five SNFs currently meets all the staffing requirements. Of the SNFs that meet the minimum staffing requirements, about 41% are owned by non-profit corporations and 10% by for-profit entities.... READ MORE

NATIONAL Federal bill seeks to curb 340B eligibility Healthcare ransomware attacks lead to uptick in ED visits at nearby hospitals Healthcare rethinks cybersecurity staffing as threats rise Hospitals see gross revenues rise for 12th straight month Hospitals suffer setback in court ruling on federal drug pricing program How M&A scrutiny in Washington could affect... READ MORE

Health care continues to drive private equity (“PE”) activity, creating opportunities for investors and traditional health care providers. Transactions in the health care space are especially complicated, layering health care regulatory and reimbursement considerations on top of a complex securities, antitrust, privacy and security framework. Hall Render’s PE team of attorneys and advisors leverage... READ MORE

NATIONAL AHA, FAH request CMS to extend comment period for TEAM proposed rule CMS launches new option to file EMTALA complaints Cybersecurity execs share healthcare’s biggest vulnerabilities Here’s how much hospital prices are rising – and why Hospital groups seek more time to comment on proposed payment model How noncompete ban could shake up... READ MORE

In a recent decision, the D.C. District Court determined that a Medicare contractor erroneously computed the nursing and allied health pass-through reimbursement in violation of the regulation at 42 C.F.R 413.85(d)(2)(i). The regulation requires that the net cost of approved educational activities be determined by deducting the revenues that a provider receives from tuition and... READ MORE

The Massachusetts Development financing agency issued a $400M tax-exempt bond on behalf of Beth Israel Lahey Health, which will use the proceeds to buy, build, expand, remodel and renovate facilities at multiple locations across the health system. Under a bill introduced in Congress, 11 Veterans Affairs hospitals across the U.S. could obtain up to... READ MORE

Health care continues to drive private equity (“PE”) activity, creating opportunities for investors and traditional health care providers. Transactions in the health care space are especially complicated, layering health care regulatory and reimbursement considerations on top of a complex securities, antitrust, privacy and security framework. Hall Render’s PE team of attorneys and advisors leverage... READ MORE

Earlier this year, the U.S. Food and Drug Administration (“FDA”) announced the availability of new draft guidance titled “Use of Data Monitoring Committees in Clinical Trials” (“Draft Guidance”). When finalized, the Draft Guidance will supersede the March 2006 guidance titled “Establishment and Operation of Clinical Trial Data Monitoring Committees.” A Data Monitoring Committee (“DMC”)... READ MORE

New Consumer Price Index (CPI) data shows that inflation eased up in April. The cost of goods and services increased 0.3% from March to April, which is down from 0.4% the previous month. Overall, the CPI has increased 3.4% year-to-date, down from 3.5% in March. This data “keeps alive the prospect of the Fed... READ MORE