Healthcare IT Today

NOVEMBER 20, 2022

ONC published a blog post highlighting how to meet the 2015 Edition Cures Update requirements for ONC certification. The Biotech Breakthrough Awards Program announced its 2022 award winners. Specifically, certified health IT developers have a Dec. 31 deadline for meeting requirements for FHIR-based API standardization.

COVID-19 52

COVID-19 Telemedicine Hospitals Nurses 52

Healthcare IT Today

DECEMBER 17, 2023

News In a blog post, ONC highlighted trends in patient access to electronic health information. Though this is a significant increase from 2012, numbers haven’t budged much since 2015. Nearly all (97%) hospitals and roughly almost two-thirds (65%) of physician practices are now capable of enabling patient access.

Hospitals 112

Hospitals Nurses Compliance Regulatory Compliance 112

Healthcare Compliance Blog

APRIL 27, 2022

A Georgia district court has issued a summary judgment against a state rehabilitation center for 808 false claims billed to Medicaid and Tricare between November 2015 and June 2020. The hearing is scheduled for May 2, 2022. 2, 2015–July 31, 2016, and a range of $11,181–$22,363 for violations committed after Jan.

Medicaid 59

Medicaid Medicaid Compliance Governance 59

Provider Trust

FEBRUARY 28, 2022

I started in November of 2015. Looking forward into 2022, what is something you’re looking forward to or hope to accomplish? I love being active and outside, hosting and entertaining and building community wherever I can. I get to lead our SMB and Mid Market Provider Sales Team! How long have you worked at ProviderTrust?

98

98

Hall Render

JULY 25, 2023

On December 14, 2022, the Office of Inspector General (“OIG”) issued an advisory opinion which approved a hospital program (“Arrangement”) to provide advanced practice provider (“APP”) support for inpatients being cared for by primary care physicians (“Participating Physicians”).

Compliance 40

Compliance Hospitals Governance Doctors 40

Hall Render

MAY 2, 2022

AHCA/NCAL published a report on SNF closure data stating that more than 1,000 SNFs have closed since 2015. Additionally, nearly 45,000 SNF residents have been displaced due to closures and more than 400 SNFs are projected to close in 2022. Bain & Company released its 2022 Health Care Private Equity and M&A Report.

Nursing Homes 40

Nursing Homes Nurses Hospitals Medicaid 40

Hall Render

APRIL 6, 2022

3:11-CV-3406, 2022 WL 1012256, (7th Cir. However, some of the defendant’s customers typically paid less than the retail price for their medications through several discount programs that the defendant offered between 2006 and 2015. Hall Render blog posts and articles are intended for informational purposes only. Safeway, Inc.,

Medicare 72

Medicare Medicare Medicaid Medicaid 72

Hall Render

MAY 31, 2022

Gensler published a list of senior living design trends in its 2022 design forecast, finding that: 1) Gerontechnology will extend aging in place; 2) Mixed-use, mixed-income and multigenerational lifestyle developments are emerging models; and 3) Designing experiences for caregivers is a big opportunity for operators per The McMorrow Reports/FMLink.

Nurses 40

Nurses Hospitals Governance 40

Hall Render

AUGUST 1, 2022

Public comments on the payments policies and other proposed policies are due September 13, 2022. CMS is interpreting the Act to mean that the Bipartisan Budget Act of 2015 Section 603 payment limits will not apply to items and services furnished by an off-campus PBD of an REH. Off-Campus Provider-Based Departments.

Hospitals 40

Hospitals Payment Systems Medicare Medicare 40

Healthcare Law Blog

APRIL 6, 2022

On April 1, 2022 , the Centers for Medicare & Medicaid Services (“CMS”) announced states may seek to extend Medicaid postpartum coverage from 60 days to one year through a new state plan option offered by the American Rescue Plan Act (“ARPA”). 31, 2022). [2] 2] Emily E. Peterson, et. 3] Madeline Y.

Medicaid 52

Medicaid Medicaid ACA Public Health 52

SQA

FEBRUARY 15, 2023

Relevant matters are hereby announced as follows: As of 01 December 2022, the Electronic Certificates of Documentation for Export of APIs to the EU and Certificate of a Pharmaceutical Product will be put into use. Efforts should be made to promote and guide the use of electronic certificates.

US Department of Health and Human Services 40

US Department of Health and Human Services FDA COVID-19 World Health 40

Healthcare Law Blog

JANUARY 4, 2023

On December 21, 2022, the Department of Health and Human Services (“HHS”) issued a proposed rule aimed at advancing health equity and mitigating health disparities while minimizing administrative burden.

Health Insurance 52

Health Insurance ACA Medicaid Medicaid 52

Healthcare Blog

AUGUST 23, 2023

2022, December 5). Retrieved July 16, 2023, from [link] Castel, E.S., Ginsburg, L.R., Zaheer, S., & Tamim, H. Understanding nurses’ and physicians’ fear of repercussions for reporting errors: clinician characteristics, organization demographics, or leadership factors? BMC Health Services Research , 15, 326.

Compliance 56

Compliance Nurses Regulatory Compliance Medicaid 56

Healthcare Law Blog

NOVEMBER 21, 2022

9, 2022). [2] 9, 2022). [3] 9, 2022). [6] 9, 2022). [9] 9, 2022). [9] 2, 2015). [10] 17, 2022). [11] In October, we discussed the Office of Inspector General’s (“OIG”) Advisory Opinion No. FOOTNOTES. [1] United States, et al. Case No 3:22-cv-714 (E.D. United States, et al. Case No 3:22-cv-714 (E.D.

Medicare 52

Medicare Medicare Governance Medicaid 52

Healthcare Law Blog

MAY 16, 2022

These Medicaid waivers are part of the “California Advancing and Innovating Medi-Cal” (CalAIM) initiative which was launched in January 2022 to provide aid to California’s most vulnerable residents and to provide more equitable programs and access statewide.

Medicaid 59

Medicaid Medicaid Nurses Health Care Access 59

Provider Trust

JULY 26, 2023

CMS Takes Action Against Inaccurate Directories In 2015, CMS notified insurers via a letter of an enforcement initiative that would impose hefty fines on insurers with inaccurate provider data in their directories. It’s no wonder insurers end up spending as much as $2.1 billion annually to maintain overly-complicated, inaccurate databases.

Medicaid 52

Medicaid Medicaid Compliance Medicare 52

Provider Trust

JULY 26, 2022

On June 7, 2022, Theresa Pickering of Norcross, Georgia was indicted by a federal grand jury on federal charges of health care fraud, aggravated identity theft, and distribution of controlled substances. In addition to these allegations of fraud, waste, and abuse, Pickering had a history of fraud.

Licensing 52

Licensing Fraud Compliance Nurses 52

Health Law RX

JULY 18, 2023

As context, between 2015 and 2022, the DOJ reported FCA settlements with health IT vendors in an amount exceeding $500 million. What would such collaboration look like? Those cases predominantly reflect enhanced DOJ efforts to enforce FCA liability in the kickback and false certification contexts.

Fraud 52

Fraud Compliance Medicaid Medicaid 52

Hall Render

JUNE 22, 2022

On Friday, June 17, 2022, the Centers for Medicare & Medicaid Services (“CMS”) posted a pre-publication copy of the Calendar Year (“CY”) 2023 Home Health Prospective Payment System Rate Update (“PPS Rule”). The following table shows the episodic rate calculation for 2023: CY 2022 National Standardized 30-Day Period Payment.

COVID-19 40

COVID-19 Payment Systems Medicare Medicare 40

SQA

OCTOBER 18, 2023

National Medical Products Administration (NMPA) China GLP Certification Regulation Takes Effect, 01 July 2023 After consulting on the draft in 2022, the NMPA issued the Administrative Measures for Drug Good Laboratory Practice (GLP) Certification earlier this year. These products are widely used by Canadians.

FDA 40

FDA Compliance Licensing World Health 40

Health Law Advisor

FEBRUARY 1, 2023

But I want to point out here that I am actively opposing FDA’s publication of the Final Guidance on Clinical Decision-Support Software (or “CDS Guidance”) [2] published on September 28, 2022. As a result, I would encourage you, if you have concerns about my conclusions, to check my math.

FDA 52

FDA Compliance 52

Drug & Device Law

DECEMBER 4, 2023

2022) (“[i]n making that prediction, the decisions of intermediate Pennsylvania appellate courts receive significant weight”) (citations and quotation marks omitted). In 15 years of blogging we’ve mentioned battery claims exactly once , in passing in a case where the claim was dismissed. Davol, Inc. , 3d 1149, 1158 (S.D.

Fraud 52

Fraud FDA Hospitals Doctors 52

Drug & Device Law

APRIL 28, 2022

This past weekend, there was an NCAA Division I clash of athletic teams ranked #5 and #7, respectively, that included two children of two different authors of this Blog. 155 (2015), spelled out what makes a restriction on speech content-based and, thus, presumptively invalid. Ct. __, 2022 U.S. Town of Gilbert , 576 U.S.

FDA 59

FDA Governance 59

Drug & Device Law

JULY 31, 2023

We have blogged several times about the somewhat esoteric issue of whether intangible items – chiefly computer software, website algorithms, and other electronic information – is treated as a “product” for purposes of imposing strict liability on their creators. 135 (Winter 2015) (citation and quotation marks omitted). 1145, 1165 n.135

Governance 52

Governance Payment Systems Hospitals Licensing 52

Drug & Device Law

DECEMBER 29, 2023

This year’s Drug & Device Law Blog top ten decisions of the year reinforced preemption – the most powerful defense we can assert. As a matter of science, the purported link was imaginary, as discussed at great length in one of the many excellent Zantac ( 2022+4 ) MDL opinions. They excluded bogus expert testimony under Fed.

FDA 105

FDA US Department of Health and Human Services COVID-19 Informed Consent 105

Drug & Device Law

APRIL 10, 2023

That’s why this defense oriented blog has inveighed against claims solely for “ medical monitoring ” ever since it was founded. 2022 WL 2274876, at *10-11 (D. June 23, 2022). 2022 WL 909406, at *3 (E.D.N.C. March 28, 2022). Ohio 2015). 2015); Krottner v. Prosser & P. Louisiana : La. 544, 552 (D.

Malpractice 59

Malpractice Governance Hospitals 59

Drug & Device Law

FEBRUARY 11, 2024

We’ve blogged several times already about the Alliance for Hippocratic Medicine v. et al. , “A Longitudinal Cohort Study of Emergency Room Utilization Following Mifepristone Chemical & Surgical Abortions, 1999–2015,” 8 H. FDA litigation that is now before the Supreme Court. Longbons T., Harrison D.J., & Man’l Epid’y.

FDA 59

FDA Fraud Pharmaceutical Industry Doctors 59

Drug & Device Law

MARCH 7, 2022

Thus, Bexis made a note to blog on it – but only after he finished his chapter update due at the end of February. 2022 WL 610276 (C.D. 31, 2022), fell into our laps. 2015 WL 3466517 (D. 2015); Tapia v. 2015 WL 6828660, at *8 (S.D. 6, 2015); Rhoton v. 2015 WL 7770234, at *4 (N.D. Medtronic Inc.

Fraud 59

Fraud FDA Licensing Pharmaceutical Industry 59

Drug & Device Law

FEBRUARY 20, 2023

0295, 2015 WL 5022618, at *12 (N.J. 14, 2015) (claimed alternative could not be considered for plaintiffs who “had their surgeries prior to the commercial availability of” the claimed alternative because it “was not approved by the Food and Drug Administration until June 2007 and was not commercially available until late” that year).

FDA 59

FDA Licensing Hospitals Governance 59

Drug & Device Law

MAY 13, 2022

2022 WL 1415031 (W.D.N.Y. May 4, 2022), the plaintiff alleged that the defendant’s osteoporosis drug, Fosamax, caused her to suffer serious injuries, including osteonecrosis of the jaw and atrial fibrillation. MacSwain , 2022 WL 1415031 at *4 (citations to Complaint omitted). 2015), leading the charge in the “yes” column.

Fraud 59

Fraud FDA Nurses Hospitals 59

Drug & Device Law

MARCH 15, 2022

2015 WL 12844447, at *2 (D.S.C. June 19, 2015) (granting motion to dismiss for failure to submit plaintiff fact sheets). 4 th –, 2022 WL 594276 (7 th Cir. Sales Pracs. & & Prods. Such was the case presented to the Seventh Circuit in In re Cook Medical, Inc.,

59

59

Drug & Device Law

FEBRUARY 24, 2022

3d —-, 2022 WL 464149 (N.D. 2022), rejected that sophistry. 2022 WL 464149, at *1. 2022 WL 464149, at *4. But, as the Supreme Court has held and readers of this blog know, state-law requirements that parallel federal requirements can be impliedly preempted even if they are not expressly preempted. Kind LLC , — F.

FDA 72

FDA Governance Fraud 72

Drug & Device Law

MARCH 4, 2024

In re Zoloft Products Liability Litigation , 2015 WL 115486 (E.D. In re Zoloft (Sertraline Hydrochloride) Products Liability Litigation , 2015 WL 7776911 (E.D. 10, 2020), aff’d , 2022 WL 11112695 (4th Cir. 2014), the MDL court let plaintiffs try again. The new expert was ultimately excluded as well. Secretary of HHS , 66 Fed.

52

52

Drug & Device Law

APRIL 13, 2023

Back in 2015, in the then-Ethicon mesh MDL, we blogged about a ridiculous procedural decision, Mullins v. 2015), attempting to consolidate no fewer than thirty-seven West Virginia mesh plaintiffs for a single trial. After that, the Shears case became one of the string of Ethicon trial victories that we blogged about last year.

59

59

Drug & Device Law

JUNE 28, 2022

2022 WL 2276808 (U.S. June 24, 2022), we fully expect attempts by such states to ban FDA-approved prescription drugs that can be used to bring about abortions by chemical means. GlaxoSmithKline, LLC , 2022 WL 537004 (Md. A couple of other cases we’ve blogged about also bear on state-law attempts to ban FDA-approved products.

FDA 116

FDA Public Health Federal Policy Doctors 116

Drug & Device Law

JANUARY 9, 2023

The flimsy decision in In re Acetaminophen − ASH-ADHD Products Liability Litigation , 2022 WL 17348351 (S.D.N.Y. 14, 2022), leaves us scratching our heads. 2022 WL 16951538 (S.D.N.Y. 15, 2022), that we blogged about not too long ago , with the monstrosity that follows here. 2022 WL 17348351, at *4.

FDA 59

FDA Governance Nurses 59

Drug & Device Law

APRIL 14, 2022

That order was so long, we blogged about it twice ( here and here ). 21-55342, 2022 WL 898595 (9th Cir. The plaintiffs served their expert reports initially in 2015, and while they served an updated report from their general causation expert in 2019, the newer report failed to account for studies published in the interim.

52

52