Innovaare Compliance

MARCH 1, 2022

Examples of improper payments include: Unusual quantities or administration frequency of Part B drugs; Drugs for non-FDA approved indications (e.g., Since 2008 Inovaare has provided healthcare organizations with cost-effective quality services to help them comply with Medicare regulations and improve their operations, thereby saving costs.

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Medicare Medicare Overpayments Overpayment 52

Health Law Advisor

JANUARY 4, 2022

It is common for FDA and others to show a map of the United States with the states color-coded by intensity to showcase the total number of inspections done in that state. Indeed, FDA includes such a map in its newly released dashboard for FDA inspections. Some years FDA may conduct many inspections; other years not so many.

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FDA Compliance 52

Health Law RX

JULY 25, 2022

The EEOC notes that employers will meet the “business necessity” standard when such testing is consistent with current guidance from Centers for Disease Control and Prevention (“CDC”), Food and Drug Administration (“FDA”), and/or state/local public health authorities.

COVID-19 52

COVID-19 ADA FDA Health Insurance 52

Health Law Advisor

MARCH 7, 2023

Background on the Ryan Haight Act The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (the “Ryan Haight Act”) made certain amendments to the CSA which established controls on the remote prescribing of controlled substances. 18 U.S.C. § Are the proposed record-keeping obligations reasonable and/or sufficient? 1301.28.

Telemedicine 52

Telemedicine COVID-19 FDA Compliance 52

Health Law Advisor

MARCH 1, 2023

1] Originally enacted in 2010, the Online Prescribing Act has allowed health care providers to register with the State to prescribe and dispense certain FDA-approved drugs via online pharmacies and utilization of telehealth visits. Utah Code § 58-83-306. 18 U.S.C. §

Telemedicine 52

Telemedicine COVID-19 Fraud Licensing 52

Healthcare It News

FEBRUARY 20, 2024

EnsoData announced Tuesday that it has received FDA 510(k) clearance for an AI algorithm called EnsoSleep to support the diagnosis of sleep disorders using any FDA-cleared pulse oximeter, which measures the saturation of oxygen carried in red blood cells. between 2008 and 2021, CBS News said in a story on how to apply.

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FDA Governance 254

Bill of Health

JANUARY 30, 2023

Additionally, during the Public Health Emergency, the Drug Enforcement Administration (DEA) waived the Ryan-Haight Online Pharmacy Consumer Protection Act of 2008 , which requires at least one in-person visit prior to the prescription of controlled substances.

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COVID-19 Public Health Doctors Nurses 176

Health Law Advisor

FEBRUARY 1, 2022

The United States Food and Drug Administration (FDA) for many years has been trying to increase the participation of minorities in clinical trials to help ensure that regulated products are tested and labeled in an appropriate cross-section of Americans. National Library of Medicine, with support from FDA.

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FDA Compliance 52

Healthcare IT News - Telehealth

MARCH 18, 2022

Companies like Pear Therapeutics, Limbix, Applied VR and Click Therapeutics are treating people with clinically validated and FDA-approved (or pending) digital interventions. While the growth of telehealth platforms has been substantial, a more exciting area of investment in mental health is in digital therapeutics.

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Medicaid Medicaid COVID-19 Telemedicine 199

Healthcare Law Blog

OCTOBER 25, 2023

Effective October 1, 2008, an individual who operates as a pharmaceutical detailer who sells, provides information on, or promotes a pharmaceutical product in any way must be licensed with the District of Columbia Board of Pharmacy. [ix] xii] SafeRx Amendment Act of 2008. xi] Washington D.C. ix] Municipal Code of Chicago Sec.

Licensing 52

Licensing Compliance FDA Public Health 52

Health Law Advisor

JANUARY 30, 2023

Food and Drug Administration (“FDA”) to withdraw approval of Mifepristone, an FDA-approved drug used to end pregnancies in the first trimester. [1] The lawsuit has sparked concern by both industry and the FDA. Twenty years later, Congress codified the pathway in the FDA Safety and Innovation Act (“FDASIA”) [4].

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FDA US Department of Health and Human Services Governance Doctors 59

Healthcare Law Blog

APRIL 14, 2023

Food and Drug Administration’s (“FDA”) approval of the commonly-used abortion medication, Mifepristone, has been curtailed following dueling federal court decisions in Texas and Washington. Just days after a Texas federal judge’s ruling suspended the FDA’s approval of the drug, the U.S. Following the U.S.

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FDA Governance 52

Healthcare Law Blog

JUNE 15, 2023

Food and Drug Administration’s (“FDA”) approval of the commonly-used abortion medication, Mifepristone, was curtailed. Just days after a Texas federal judge’s ruling suspended the FDA’s approval of the drug, the U.S. May 17, 2023 : The Fifth Circuit heard oral arguments from the FDA, Danco, and the Plaintiffs. Had the U.S.

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FDA Governance Telemedicine Licensing 52

Drug & Device Law

DECEMBER 4, 2023

CPAP II shrugs off plaintiffs’ repeated allegations that defendants “failed to apprise the FDA” of this or that, with the excuse that plaintiffs don’t really “rely” on them. 2008) (applying the rule; rejecting distinction that “this is a ‘no warning’ case as opposed to an inadequate warning case”), aff’d , 321 F. Sinclair v.

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Fraud FDA Hospitals Doctors 52

Drug & Device Law

OCTOBER 23, 2023

Back in 2008, the United States Supreme Court held, in Riegel v. 312 (2008), that essentially all product liability claims against manufacturers of FDA pre-market approved (“PMA”) medical devices were preempted. Medtronic, Inc. , at 1206.

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FDA Governance Nurses Hospitals 59

Drug & Device Law

DECEMBER 21, 2023

FDA , 78 F.4th 2023), was the Fifth Circuit’s blatantly politicized attack on the FDA’s regulation of abortion-related drugs. The questionable allegations of that single complaint thus effectively trumped many years of the FDA’s science-based decision-making. The FDA, for one, advised patients to keep using these drugs.

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FDA Fraud Informed Consent 52

Drug & Device Law

OCTOBER 10, 2022

The drug at issue was an FDA-recognized breakthrough drug that treats a relatively rare, but invariably fatal, condition – transthyretin amyloid cardiomyopathy (“ATTR-CM”). 3 (2008), the court explained that “the word ‘includes,’ when used in a statute, ‘is usually a term of enlargement, and not of limitation.’” Pfizer, Inc. ,

Medicare 52

Medicare Medicare FDA Prescription Drug Pricing 52

Drug & Device Law

MARCH 25, 2022

Even before the anti-osteoporosis drug Fosamax was FDA approved, its manufacturer was aware of a biologically plausible mechanism for that class of drug (“bisphosphonates”) to cause low-energy – later renamed “atypical” ? The manufacturer informed the FDA, but no evidence then established that risk as anything more than hypothetical.

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FDA Governance 52

Drug & Device Law

APRIL 18, 2022

at *3 – which means, as we’ve discussed before , a manufacturer cannot include warnings about such off-label uses absent specific FDA approval. 2008); Herzog v. Apparently, the “no warnings” issue arose because physician in Rennick put the product to an off-label use, id. Even then Rennick ’s rationale didn’t do a very good job.

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FDA 59

Drug & Device Law

MAY 16, 2022

as the FDA acknowledged the warning might be. . . . [W]hen 2008) (see our post here ), that broadly authorize private litigants to enforce state statutory requirements. Under Prop. 65, a “known” carcinogen carries a complex legal meaning that consumers would not glean from the warning without context. 3d 1170, 1181-83 (Cal.

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Governance FDA 59

Drug & Device Law

FEBRUARY 21, 2022

11, 2022), granted a Rule 702 motion excluding plaintiff’s purported FDA expert Peggy Pence, who “began working as an expert witness for plaintiffs in product liability cases in 2008” and “approximately 100% of her work was as a plaintiff’s expert in product liability litigation.” Coloplast Corp. 2022 WL 425206 (N.D.

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FDA Doctors 59

Drug & Device Law

JUNE 2, 2022

2012), addressed a challenge to the application of Idaho’s Pain-Capable Unborn Child Protection Act to criminalize the use of an FDA-approved abortifacient medication obtained through an internet prescription and mailed to the plaintiff from out of state. See this post on one of our decisions from 2008.) Hiedeman, 694 F.3d

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FDA Licensing 127

Drug & Device Law

JUNE 6, 2022

The prescriber] provided explicit, uncontroverted testimony that, even when provided with the most current research and FDA mandated warnings, as well as the information found in [defendant’s] updated. . . 2008) (applying Texas law and discussed here ), several times. 2008); In re Pradaxa Cases , 2019 WL 6043514, at *5-6 (Cal.

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FDA Doctors Malpractice Medical Personnel 59

Drug & Device Law

DECEMBER 14, 2023

It has also been the case for a long time that the use of citizen’s petitions to FDA has been a tool by the plaintiff bar to shape, and sometimes sidestep, the science. ( 2008) (cited in Paraquat, 2023 WL 8372819, * 3 n.3). See, e.g. , here.) See, e.g. , here.) Probably not from the journal that published it.

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FDA 52

Drug & Device Law

APRIL 25, 2022

Fortunately, that 2010 decision has been a pro-plaintiff anomaly, and FDA required label changes, recalls, etc. 2015) (“we will not consider evidence of a subsequent improvement to a drug label as evidence of prior failure to warn, even in cases such as this in which the FDA mandated the change in labeling”) (citing Rule 407).

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FDA Governance 52

Drug & Device Law

MARCH 31, 2022

The Orthopedic Bone Screw would never have occurred – and Bexis might never have found his way to prescription medical product liability litigation – if not for the Kessler-era FDA’s ill-considered salami slicing of the “intended use” of that product. 1396r-8(k)(6).

Medicare 52

Medicare Medicare FDA Governance 52

Drug & Device Law

FEBRUARY 18, 2022

The pacemaker was a Class III medical device, subject to the FDA’s full premarket approval (“PMA”) process. In Feeser , the plaintiff alleged that his pacemaker lacked a protective coating that was an essential element of the device the FDA tested and approved, and that the lack of coating caused the pacemaker to stop working.

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FDA 72

Drug & Device Law

DECEMBER 19, 2022

b)(2)(v), which lists three types of label changes that absolutely, positively must be made by prior approval supplement – and since those changes require FDA preapproval, the Mensing independence principle preempts tort claims demanding such changes. Even further confirmation is found in the FDA’s regulatory history for §314.70(b),

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FDA 59

Drug & Device Law

AUGUST 7, 2023

312 (2008). By contrast, the Riegel preemption clause for medical devices prohibits only state-law requirements that are “different from or in addition to” FDA medical device requirements. FDA regulations do not mandate that sunscreen manufacturers include claims pertaining to the product’s durational capability.

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FDA 52

Drug & Device Law

MARCH 16, 2022

As you must know by now, the pelvic mesh MDL court ruled that the FDA 510(k) regulatory clearance of pelvic mesh devices was irrelevant because such clearance was not probative of safety. After some FDA inquiries, the defendant eventually submitted a separate 510(k) application for the product, and it was cleared in May of 2008.

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FDA Governance Licensing 69

Drug & Device Law

APRIL 15, 2022

312 (2008), state law design defect claims against manufacturers of Class III devices are expressly preempted by the medical device amendments to the FDA. It is not a statement holding Defendants’ product out as meeting a higher standard than that required by the FDA. Medtronic, Inc. , Express Warranty Claim.

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FDA 59

Drug & Device Law

JANUARY 30, 2023

440 (2008) Buckman was not cited at all in the Merck Sharp & Dohme Corp. 470 (1996), was decided – removing express preemption as a defense for manufacturers of §510(k) products So defendants moved on fraud on the FDA under an implied preemption theory and won. Plaintiffs Legal Committee , 531 U.S. Kent , 552 U.S. Lohr , 518 U.S.

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FDA Fraud Governance Medicare 72

Drug & Device Law

MAY 5, 2022

2022), a short decision that came out the right way, but did so based on a problematic statute that creates a rebuttal presumption that warning labels approved by the FDA are adequate as a matter of state law. Stated differently, the rebuttal provision makes allegations and evidence of fraud on the FDA a prerequisite to state-law liability.

Compliance 52

Compliance FDA Fraud 52

Drug & Device Law

MAY 4, 2023

2015), finally gave appellate recognition to the preemption of design defect claims for FDA-approved branded prescription drugs. FDA approved the drug with its particular formulation and the manufacturer could not have changed the formulation on its own. 440 (2008), in the face of a contrary ruling from the Sixth Circuit in Garcia v.

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FDA Fraud Compliance 64

Drug & Device Law

APRIL 11, 2022

312 (2008), and here’s what the Court said about why the “reasonable assurance of safety and effectiveness” standard is preemptive of personal injury claims: [The FDA] may thus approve devices that present great risks if they nonetheless offer great benefits in light of available alternatives. Medtronic, Inc. , Abbott Vascular, Inc. ,

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FDA 59

Drug & Device Law

SEPTEMBER 22, 2023

2008), shows how the OTC express preemption provision should work. As Carter recounts, starting in 1976, FDA developed the OTC Cough and Cold Monograph, 21 C.F.R. 312 (2008), and considering 21 U.S.C. 2d 1271 (C.D. at 1276. Next, addressing 21 C.F.R. 379r right after the U.S. Medtronic, 552 U.S. at 1283-87.

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FDA Public Health 105

Drug & Device Law

SEPTEMBER 18, 2023

He came across several preemption decisions involving defendants who employed the FDA’s “alternative summary reporting” (“ASR”) system that the agency operated for about 20 years, “from 1997 through June 2019.” without adversely affecting FDA’s ability to monitor and react to such events. 18, 2022) ( available here ).

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