American Medical Compliance

JANUARY 9, 2024

Provider Compliance and Responsibilities Additionally, the federal government’s False Claims Act (FCA) of 1986 explicitly targeted fraud and abuse in the healthcare industry in an effort to eliminate it. HCFAC received $248,459,000 from HHS and the Attorney General in 2007 to combat healthcare fraud and abuse.

Fraud 52

Fraud Compliance HIPAA Health Insurance 52

Health Law RX

JANUARY 31, 2023

In such cases, a defendant is typically accused of falsely attesting to compliance with conditions of payment or other requirements under government programs. In these cases, the relator is not alleging the absence of a product or service for which the government has paid. Below, the U.S. of America v. Burr , 551 U.S.

Governance 52

Governance Fraud Compliance 52

Healthcare IT News - Telehealth

APRIL 10, 2019

Department of Health and Human Services Office of the Inspector General and prosecuted by the DOJ, the defendants are charged with running a complex, multilayered scheme to defraud the Medicare system and avoid detection by government regulators. ON THE RECORD.

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Fraud Telemedicine Medicare Medicare 157

HIT Consultant

DECEMBER 7, 2023

The US Government Accountability Office estimates that a new drug’s development life cycle can take 10–15 years , and regardless of the time and money drug companies spend on research, a medicine may not receive regulatory approval, sending researchers back to the drawing board.

Pharmaceutical Industry 98

Pharmaceutical Industry Governance 98

Healthcare Law Blog

APRIL 19, 2023

The issue is a significant one for both the government and relators on one side, and potential defendants on the other, as False Claims Act (FCA) liability imposes treble damages and penalties exceeding $20,000 per claim as well as relators’ attorneys’ fees and costs. The Court’s questioning did not signal the likely decision.

Governance 52

Governance Fraud Compliance 52

Health Law RX

JUNE 2, 2023

2] Companies that regularly submit claims to the federal government are familiar with the complex maze of rules and regulations that often govern them. 6] These government payor programs limit the amount pharmacies can charge for generic medications to the “usual and customary” price. [7] per 30-day supply). [9] June 1, 2023).

Fraud 52

Fraud Governance Medicaid Medicaid 52

Med-Net Compliance

JULY 20, 2022

The HHS-OIG Fraud Section leads the Criminal Division’s efforts to combat healthcare fraud through its Health Care Fraud Strike Force Program, which since March of 2007 has charged more than 4,200 defendants who have collectively falsely billed the Medicare Program for more than $19 billion. HHS-OIG and OMIG investigated the case.

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Fraud Doctors Medicare Medicare 59

HIT Consultant

DECEMBER 26, 2023

Is anyone still using Microsoft Health Vault (RIP: 2007–2019)? Driven by government mandates , there have been real efforts to enable more fluid sharing of clinical EHR data, but there has still been very little government or industry effort to make administrative and financial healthcare data more interoperable and usable in real time.

Governance 59

Governance Health Insurance 59

HIT Consultant

JANUARY 23, 2023

In 2020, growth in federal government spending on healthcare increased 36 percent , compared to the 5.9 Collaboration between the government and the biotech industry will be essential for creating a portfolio of therapies to treat a variety of patient profiles who experience a range of Covid-19-related health issues.

COVID-19 52

COVID-19 Public Health Hospitals Nurses 52

Health Law RX

JULY 28, 2022

This is a big jump compared to the 2007 legislative session when the legislation first allowing pharmacists themselves to administer only the flu vaccine was enacted, and only after a hard-fought legislative battle when most other states already allowed pharmacists to administer vaccines.

FDA 52

FDA Governance 52

Hall Render

JUNE 7, 2023

3] FCA Requires Subjective Knowledge of and Belief in Falsity of Claims The FCA prohibits an individual from knowingly submitting a false claim for payment to a government health care program. [4] 47 (2007), the U.S. 47, 70 (2007). [10] 8] In Safeco Insurance Company of America v. Burr , 551 U.S. Safeway, Inc.). [2] 4] 31 U.S.C.

Fraud 40

Fraud Medicaid Medicaid Governance 40

Hall Render

APRIL 6, 2022

Turning to the present case, in Safeway , the relator alleged that the defendant engaged in the submission of false claims to the government when it “reported its ‘retail’ price for certain drugs as its ‘usual and customary’ price.” SuperValu Inc., of America v. Burr was applicable to lawsuits brought under the False Claims Act.

Medicare 72

Medicare Medicare Medicaid Medicaid 72

Health Populi

OCTOBER 22, 2019

This latter point was emphasized in the survey noting that 71% of Americans said that drug prices were too high; 78% of people agreed that the government should be permitted to negotiate/regulate prescription drug prices. That was the theme that started the first Health Populi blog post in 2007.

Prescription Drug Pricing 52

Prescription Drug Pricing Health Insurance Doctors Governance 52

Health Populi

MARCH 15, 2019

in December 2007, and tracked “self-care” searches to today, 15 March 2019. Today, the number of searches on Google using the phrase “self-care” reached a high, shown in the line graph I created on Google Trends and marked up in red. A Google search overall yielded over 2 billion results.

World Health 113

World Health Governance 113

Health Law Advisor

AUGUST 14, 2023

5, 2007) (emphasis added). [5] 2, 2023). [2] 2] Centers for Medicare & Medicaid Services, Spotlight: Physician-Owned Hospital Expansion Exception Requests – Changes Effective October 1, 2023 , available at [link] (last accessed August 2, 2023). [3] 2, 2023). [4] 2, 2023). [2] 2, 2023). [4] 51011, 51019 (Sept. at 51020. [6]

COVID-19 52

COVID-19 Medicare Medicare Public Health 52

Pharmacy Law Blog

FEBRUARY 13, 2018

Supreme Court decision in her case holding that the government could not freeze untainted assets. Her case continued in 2017 following a 5-3 ruling by the Supreme Court holding that the government could not freeze assets belonging to her that were not tied to the alleged fraud scheme. To read more on the U.S.

Fraud 40

Fraud Medicare Medicare Governance 40

Healthcare Law Blog

FEBRUARY 13, 2023

Inside and outside healthcare counsel should know that the way they guide clients through legal and business issues may need to change based on a recent Ninth Circuit case governing the protections afforded to attorney-client communications, In re Grand Jury. [1] 2] In re Grand Jury , 23 F.4th 4th 1088 (9th Cir. 2021); Pritchard v.

Compliance 52

Compliance Fraud Governance 52

Innovaare Compliance

FEBRUARY 9, 2021

Launched in 2007, star ratings enable the CMS as well as consumers to compare health plans on metrics other than cost. The higher the ratings, the larger the bonus payments health plans receive from the government. The CMS star ratings challenge. With billions of dollars at stake for payers with CMS star ratings above 3.5,

Medicare 40

Medicare Medicare Medicaid Medicaid 40

Bill of Health

AUGUST 29, 2022

Some children may be unvaccinated by no choice of their own, but instead because of decisions made by parents, guardians, or state or local government officials. Despite pediatric COVID-19 vaccine availability, many youth remain unvaccinated , and are thus at higher risk of life-altering outcomes as a result of contracting COVID-19. [1].

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COVID-19 Vaccine COVID-19 Informed Consent Governance 130

Health Populi

NOVEMBER 22, 2019

Health Populi’s Hot Points: This last chart compares gains in life expectancy (longevity) between two periods, 2002-2007 and 2012-2017. life expectancy gained in the earlier period, 2002-2007, ranked relatively high with OECD countries like the UK, Australia, Canada, Hungary, Italy, New Zealand, and others.

Health Insurance 96

Health Insurance Doctors Governance Hospitals 96

Health Populi

JUNE 12, 2019

“Individuals, charities, businesses and government all have a role in ending hunger,” the organization believes. The prevalence of food insecurity for children in 2017 was equal to that of the 2007 pre-recession level of 8.3%. Publix has worked with the Produce for Kids program for 17 years.

Governance 65

Governance Public Health 65

HIT Consultant

JULY 28, 2022

Post-COVID, the Fed ballooned its balance sheet, caused direct transfer payments from the government to households, and cut interest rates to near zero. With low unemployment, wages are gaining but at a lower rate than prices overall. ?

US Department of Health and Human Services 98

US Department of Health and Human Services COVID-19 Health Insurance Telemedicine 98

Health Populi

FEBRUARY 21, 2019

recorded in 1990-2007. The share of health care spending sponsored/financed by Federal, State and local governments will grow to 2027, reaching 47%. For context, note that general price inflation in the U.S. for the 12 months ending January 2019 according to the U.S. Bureau of Labor Statistics.

Medicare 91

Medicare Medicare Medicaid Medicaid 91

Bill of Health

MAY 5, 2022

Therefore, the Court ordered the government and Congress to craft comprehensive laws and public policies to provide sexual and reproductive health services in the country, including abortion. In Mexico, the National Reproductive Rights Alliance (ANDAR) facilitated the decriminalization of abortion in Mexico City’s Legislature in 2007.

Public Health 69

Public Health Doctors Governance Compliance 69

Healthcare Law Blog

MAY 25, 2022

First, the decision resolved a previous split between the Fifth Circuit and the Eleventh Circuit; the latter of which ruled, in 2007, that emotional distress damages are available under the Rehab Act. [1] The Supreme Court communicated its intent to limit enforcement in several ways. 1] See Sheely v. MRI Radiology Network, P.A., 6] Gebser v.

ACA 52

ACA Governance Medicaid Medicaid 52

Health Populi

JANUARY 17, 2023

For the third year in a row, citizens in most of the world see business as the most-trusted institution, above government, media, and NGOs, found in the 2023 Edelman Trust Barometer , unveiled this week at the annual World Economic Forum in Davos, Switzerland. insights along with those touching on health.

Public Health 85

Public Health Governance World Health Hospitals 85

Drug & Device Law

MAY 19, 2023

In 2007 (during the Bush Administration), Congress amended the FDCA to provide for Risk Evaluation and Mitigation Strategy (“REMS”), “to assure safe use,” which the FDA applied to mifepristone. [T]he Sorsaia , 2023 WL 3211847, at *7 (citations omitted). See also GenBioPro, Inc. Sorsaia , C.A. 2023 WL 3451688, at *1 (S.D.W.

FDA 111

FDA Medical Personnel Telemedicine Licensing 111

Drug & Device Law

OCTOBER 23, 2023

544, 559 (2007). [T]he at 349 (“The FDCA leaves no doubt that it is the Federal Government rather than private litigants who are authorized to file suit for noncompliance”). Twombly , 550 U.S. Moreover, Martin was decided before Buckman Co. Plaintiffs Legal Committee , 531 U.S. at 1207 (citation omitted). McLean County Unit Dist.

FDA 59

FDA Governance Nurses Hospitals 59

Drug & Device Law

JULY 31, 2023

Since digital files were not “articles” under the statute, the government could not rely on this statute to prevent their importation. 2007 WL 2460776, at *6 (D. 2007 WL 218242, at *4 (N.D. 26, 2007) (bespoke software not a UCC good). at 1291-93 (construing 19 U.S.C. at 1291-92. at 1293-94. Similarly, in United States v.

Governance 52

Governance Payment Systems Hospitals Licensing 52

Drug & Device Law

JUNE 1, 2023

2007) (quotation marks and footnote omitted). Moreover, as a New York appellate court observed, the state “has not adopted the Daubert rule,” [and a]ccordingly, the Frye standard governs the admissibility of expert testimony.” 2d 72, 77-78 (Ohio 2007). “The Bayside Health Ass’n Chartered , 942 A.2d 2d 579, 584 (Del. Gonzalez v.

Governance 59

Governance Hospitals 59

Drug & Device Law

NOVEMBER 10, 2023

These class certifications combined 428 different pharmaceutical products, produced and marketed by 28 separate defendants, with claims governed by the laws of 52 separate jurisdictions. A procedural rule, such as Rule 23 governing class actions, should not, and legally cannot , change that result. Valsartan , 2023 WL 1818922, at *24.

FDA 59

FDA Governance Fraud 59

Drug & Device Law

FEBRUARY 20, 2023

Yet another vaccine case addressed at length the reasons why viable design alternatives for products governed by the FDCA must be limited to those that the FDA has allowed onto the market. Applying Restatement (Third) of Torts, Products Liability §6(c) (1998), Militrano v. 2d 839, 851 (N.Y.

FDA 59

FDA Licensing Hospitals Governance 59

Drug & Device Law

AUGUST 8, 2022

Furthermore, trade associations often serve to assist the government in areas that it does not regulate. Ohio 2007) (“courts have repeatedly held that trade associations, themselves, have no duty to users of products in that trade”); Commerce & Industry Insurance Co. at 183 (quoting Meyers v. Donnatacci , 531 A.2d 2d 398, 404 (N.J.

Doctors 52

Doctors Fraud Licensing Compliance 52

Drug & Device Law

APRIL 25, 2022

Back in 2010, we examined one restrictive judicial gloss on Rule 407 – a “policy” based exception that the rule somehow doesn’t apply to government-mandated measures. 2007) (quoting text of Rule 407). But [defendant’s] motive for making the change is irrelevant. Federal Insurance Co. , 3d 692, 700 (7th Cir. Earlier, in Mills v.

FDA 52

FDA Governance 52

Drug & Device Law

MAY 26, 2023

Both talk a fair amount about “commerce” and the respective roles of the states and federal government. One of those laws, FDAAA in 2007, established the REMS system, which reflects the importance of national uniformity in the delivery of healthcare. They look a lot like they are analyzing preemption, the DCC, or the plain old CC.

FDA 59

FDA Licensing Doctors Governance 59

Drug & Device Law

MARCH 31, 2022

The Court accurately perceived the issue as “not.simply a question of creating a new liability in the nature of a tort,” but rather one of “fiscal policy” and what branch of government properly sets such policy. Thus, the Standard Oil court rejected the government’s “tort law analogy” as a basis for “establishing. . . 2d 481, 489 (Md.

Governance 52

Governance FDA Doctors Hospitals 52

Drug & Device Law

APRIL 19, 2022

2007) (precluding expert witness from testifying that a product was “defective,” “unreasonably dangerous,” or was the “proximate cause” of injury); Gallatin Fuels, Inc. Misericordia University , 2019 WL 2867236, at *13 (M.D. July 3, 2019) (expert may not opine about “proximate cause”); Perez v. Townsend Engineering Co. , 2d 647, 652 (M.D.

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FDA Governance 72