MedWorm provides a medical RSS filtering service. Over 6000 RSS medical sources are combined and output via different filters. This feed contains the latest medical blog items that have been tagged with 'inspector general'. Sat, 03 Sep 2011 02:24:26 +0100 http://www.medworm.com/index.php?rid=5103514&cid=t_309804_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FHhaDzWm8_2c%2F After months of mystery, the US Department of Health & Human Services has decided not to exclude Forest Laboratories ceo Howard Solomon from doing business with federal healthcare programs, such as Medicare and Medicaid. The move came four months after the HHS Office of Inspector General shocked the drugmaker with its plan to ban the 83-year-old executive. “Based on a review of the information in our file and consideration of the information that your attorneys provided to us, both in writing and during an in-person meeting, we have decided to close this case. We anticipate no further action related to this matter,” Peter Clark, the OIG exclusions director wrote in a letter to Solomon this afternoon (here is the letter). Last September, Forest made a $313 million payment that incl... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5103514 Fri, 05 Aug 2011 22:32:59 +0100 5103514 http://www.medworm.com/index.php?rid=5051233&cid=t_309804_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F_Ne7ygGc-0w%2F Faced with being banned from doing business with such federal healthcare programs as Medicare and Medicaid, Forest Laboratories ceo and president Howard Solomon recently retained former US Senator John Breaux as a lobbyist. The Louisiana pol is now a senior counsel with the Patton Boggs law firm, which has a large healthcare practice (see here). His lobbying registration form was filed on June 14, two months after the Office of Inspector General of the US Department of Health & Human Services notified the drugmaker that its 83-year-old executive was facing exclusion (read this). The Hill first reported Forest hired Breaux. Last year, Forest pleaded guilty to obstruction of justice and made a $313 million payment that included $164 million in criminal penalties, and signed a corporate ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5051233 Fri, 22 Jul 2011 14:48:51 +0100 5051233 http://www.medworm.com/index.php?rid=4902694&cid=t_309804_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FY9UlTXu6RIU%2F Over the past year, the Office of Inspector General of the US Department of Health and Human Services has regularly issued warnings that more top executives will be held accountable for corporate misdeeds. Specifically, the OIG has warned that execs could be excluded from doing business with federal health care programs, such as Medicare and Medicaid. One example involved Marc Hermelin, the former chairman of KV Pharmaceuticals. And the OIG recently notified Forest Laboratories chairman Howard Solomon that he faces the same fate (see here and here). But no one from any of the world’s largest drugmakers has, so far, been tagged. We spoke with Gregory Demske, the OIG’s assistant inspector general for legal affairs, about this effort and the implications for the pharmaceutical industry…... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4902694 Mon, 06 Jun 2011 14:22:31 +0100 4902694 http://www.medworm.com/index.php?rid=4489743&cid=t_309804_112_f&fid=34971&url=http%3A%2F%2Fdoctorandpatient.blogspot.com%2F2011%2F02%2Fdr-malpani-shows-you-easy-way-of.html It takes a lot of courage to place your life in a doctor's hands ! How can you be sure your doctor is any good ? Or that he will take good care of you when you have a problem ? It's hard to judge a doctor's competence and doctor shopping takes a lot of time and energy. It's also not very smart to go purely by a friend's recommendation !Here's an easy test. Ask the doctor a question about your problem ( preferably an easy question which you already know the answer to !) and see how he responds.Does he get irritated ? Does he brush off your query ? Does he answer brusquely ? Does he use medical jargon ? Does he send you to his assistant for answers ?Does he take the time to explain in simple terms ? Does he bother to check that you have understood his answer ? Does he offer to give you educa... The Patient's Doctor blogs http://www.medworm.com/rss/comments.php?id=4489743 Thu, 17 Feb 2011 17:32:00 +0100 4489743 http://www.medworm.com/index.php?rid=4372247&cid=t_309804_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fsb2Jltl930U%2F At a time when the national deficit is a growing problem, Medicare could have saved $111 million on more than a dozen Part B outpatient drugs, but its system for identifying prices for lower-cost generics is inefficient, according to a new report from the Office of Inspector General at the US Department of Health and Human Services. Here’s how it works: Drugmakers must submit average sales price (ASP) data to the Centers for Medicare & Medicaid Services within 30 days after the close of each quarter, and the data are used to calculate amounts to be paid for the following quarter. But this causes a two-quarter lag between when sales occur and payments reflect the sales, which the OIG says is “especially problematic.” That’s because the OIG found Medicare paid ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4372247 Wed, 19 Jan 2011 14:14:27 +0100 4372247 http://www.medworm.com/index.php?rid=4098461&cid=t_309804_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FHYVbcAf9GOc%2F The recent spate of settlements in which drugmakers are paying whopping fines after acknowledging off-label marketing is prompting a closer look at how and when individual executives may be held accountable for these episodes. The rationale is that big payouts are considered a cost of doing business and the c-suite feels no pain. Now, the FDA is eyeing criminal prosecutions, a move that has rarely been made (look here). And last month, the House passed a bill that would ban corporate execs from doing business with Medicare and Medicaid if their companies were convicted of fraud (see this). But under what circumstances should the Department of Health and Human Services Office of Inspector General exclude an individual owner, officer, or managing employee of a drugmaker that has run afoul of... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4098461 Fri, 22 Oct 2010 13:32:59 +0100 4098461 http://www.medworm.com/index.php?rid=4013547&cid=t_309804_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FjE5Tm3ldd70%2F Drugmakers are going to face some new fines for failing to submit required pricing data on a timely basis to the Centers for Medicare & Medicaid Servicves. Why? The US Department of Health and Human Services Inspector General has issued a new report that finds more than of all drugmakers failed to submit their Average Manufacturers Prices as required. This is a big issue because the AMP provided to CMS each quarter is used to calculate the rebates owed to the states under the Medicaid drug rebate program. These quarterly AMPs are also used to establish ceiling prices in the 340B program, which is administered by the US Health Resources and Services Administration, as the HHS OIG notes. But of 592 drugmakers required to submit quarterly AMP data in 2008, 53 percent failed to do so on ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4013547 Tue, 28 Sep 2010 20:28:35 +0100 4013547 http://www.medworm.com/index.php?rid=4018184&cid=t_309804_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fnew-self-referral-disclosure-protocol-now-in-effect%2F2010.09.28 The Office of Inspector General (OIG) of the U.S. Department of Health and Human Services scrapped its old self-referral voluntary disclosure program in 2009 (it dated back to 1998, and was revisited in 2008), and the Patient Protection and Affordable Care Act (PPACA) mandated that it be replaced. Just like clockwork, on the deadline for its promulgation the OIG obliged, and the new Self-Referral Disclosure Protocol is now posted and effective. The new protocol could be clearer and offer more comfort, but it doesn’t. Makes one pine for the old policy’s clarity: In the old days, voluntary disclosure bought you a discounted fine for Stark violations — not like the new protocol’s wishy-washy, maybe-we’ll-give-you-a-discount language. The new protocol also fa... Better Health blogs http://www.medworm.com/rss/comments.php?id=4018184 Tue, 28 Sep 2010 20:00:00 +0100 4018184 http://www.medworm.com/index.php?rid=3994345&cid=t_309804_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FlxXJubJtsG0%2F The House has just passed a bill that would ban corporate execs from doing business with Medicare and Medicaid if their companies were convicted of fraud. The measure also gives the Department of Health & Human Services Office of the Inspector General the ability to exclude parent companies that may be committing fraud through shell companies, which are otherwise known in polite circles as subsidiaries. The legislation was designed to close a pair of loopholes in existing law. Currently, execs at companies that are convicted of fraud can be excluded from federal health care programs, but if an exec had left the company by the time of conviction, there was no mechanism to enforce a ban. Now, the HHS OIG can ban execs from doing business with these programs, even if they later work els... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3994345 Wed, 22 Sep 2010 21:01:18 +0100 3994345 http://www.medworm.com/index.php?rid=3987034&cid=t_309804_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2FzdMNoYKzbVQ%2F By Julian SanchezHere is the test of whether we still live in a society governed by the rule of law: Will anyone at the FBI be fired over the latest report out of the Office of the Inspector General? Let’s review. Earlier this year, a comprehensive OIG report revealed that for years the FBI had ignored the paper-thin procedures demanded by our National Security Letter statutes to obtain sensitive telecommunications records of thousands of Americans, not just without a court order—because apparently we’re fine with that now—but without any kind of legitimate process at all. With nothing more elaborate than a Post-It Note requesting the data. As far as the public record is concerned, nobody has suffered any consequences for this massive abuse of the public trust. Now we learn... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=3987034 Tue, 21 Sep 2010 10:58:13 +0100 3987034 http://www.medworm.com/index.php?rid=3965414&cid=t_309804_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fmedical-insurance-pre-authorization-services-for-free%2F2010.09.13 The Office of Inspector General (OIG) of the U.S. Department of Health and Human Services released an advisory opinion at the end of last month okaying a hospital’s proposal to provide insurance pre-authorization services free of charge to patients and physicians. This is an issue that has long vexed folks in the imaging world. Clearly, this is a free service provided to referral sources (to the extent they are obligated by contract with third-party payors to obtain the pre-authorization before referring a patient for an MRI, for example), so why is the OIG okay with it? In their opinion, the OIG blesses the arrangement for four reasons. (more…) *This blog post was originally published at HealthBlawg :: David Harlow's Health Care Law Blog* (Source: Better Health) Better Health blogs http://www.medworm.com/rss/comments.php?id=3965414 Mon, 13 Sep 2010 14:00:13 +0100 3965414 http://www.medworm.com/index.php?rid=3729858&cid=t_309804_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2FvC0-g5iObU4%2F By Tad DeHavenThe long-term prospects for the U.S. Postal Service monopoly are bleak. To help stem the flow of red ink, the USPS intends to seek a rate increase. Only a government monopoly would try to raise prices when the demand for its services is plummeting. The rate increase will only push its already declining customer base to use cheaper, more efficient electronic alternatives. The USPS is in need of drastic reform, but instead of looking at big picture, Congress is hung up on the USPS’s request to eliminate Saturday mail delivery service. In contrast, countries around the world are continuing to liberalize their postal markets by embracing competition and private sector involvement. Britain is a good example. In 1969, the British Post Office transformed from a government agency i... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=3729858 Tue, 06 Jul 2010 16:52:58 +0100 3729858 http://www.medworm.com/index.php?rid=3710795&cid=t_309804_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FYYomDF92Fdo%2F For those tracking the ongoing investigation by the Senate Finance Committee investigation into conflicts of interest among academic researchers and industry funding, Charles Nemeroff was one of the targets. The former Emory University professor, who now works at the University of Miami, came to the committee’s attention because he was accepting sizeable consulting fees from GlaxoSmithKline at the same time he was the primary investigator on an NIH-funded grant for research into a Glaxo drug. The Senate investigation, spearheaded by Chuck Grassley, the Iowa Republican, prompted Emory to suspend Nemeroff’s work on an NIH grant and asked him to step down as chair of psychiatry while it studied his conduct. And the Department of Health and Human Services Office of Inspector General began ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3710795 Tue, 29 Jun 2010 14:00:58 +0100 3710795 http://www.medworm.com/index.php?rid=3687358&cid=t_309804_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FaagC3XkOWYA%2F The growing number of clinical trials conducted overseas, which drugmakers are pursuing to hold down costs, has increasingly raised concerns about proper regulatory oversight and the welfare of enrolled patients. Over the last couple of years, for instance, GlaxoSmithKline and Wyeth briefly ran into difficulties in other countries (see here and here). And Pfizer recently paid $75 million to settle civil and criminal charges brought by a state government in Nigeria over the 1996 Trovan scandal (back story). Now, though, a new report quantifies the extent to which drugmakers are researching their meds in other countries and the results suggest the concerns will not go away - 80 percent of drugs approved in 2008 had trials in foreign countries, and 78 percent of all patients were enrolled at... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3687358 Tue, 22 Jun 2010 16:00:07 +0100 3687358 http://www.medworm.com/index.php?rid=3530028&cid=t_309804_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fk9HNoSpWCpM%2F Three years ago, a federal law was enacted that provided incentives to states to pass their own versions of the False Claims Act, which allows people who are not affiliated with the government to file lawsuits against federal contractors claiming fraud against the government. There have been a spate of these whistleblower, or qui tam, lawsuits in the pharma world lately (see here, here and here). The Department of Health and Human Services and the Department of Justice were chartered with overseeing whether the states are meeting the qualifications that would allow them to receive a share of any proceeds recovered. And so last week, Senator Chuck Grassley, the ranking Republican on the Senate Finance Committee, who regularly probes drugmakers, wrote the agencies because only 14 states are... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3530028 Tue, 04 May 2010 15:44:30 +0100 3530028 http://www.medworm.com/index.php?rid=3504939&cid=t_309804_105_f&fid=38964&url=http%3A%2F%2Fdrwes.blogspot.com%2F2010%2F04%2Frats-are-in-house.html I'm not sure I've heard a term that describes the OIG's audit teams that performs inpatient chart reviews better. The name stems from the Office of Audit Service's software used to determine how many charts to review at each facility:RAT-STATS is the primary statistical audit tool used by the Office of Audit Services. Developed by the Regional Advanced Techniques Staff (RATS) in San Francisco, it has been used by the Office of Inspector General since the early 1970s. With the arrival of microcomputers, there was opportunity to move the statistical software from the mainframe timeshare systems. In September 1987, the first microcomputer version of RAT-STATS was developed to run on IBM compatible computers using Microsoft's Disk Operating System (MS-DOS).And like rats, these chart review tea... Dr. Wes blogs http://www.medworm.com/rss/comments.php?id=3504939 Mon, 26 Apr 2010 13:19:00 +0100 3504939 http://www.medworm.com/index.php?rid=3420753&cid=t_309804_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FObN8CO51qgA%2F For those tracking the ongoing investigation by the Senate Finance Committee investigation into conflicts of interest among academic researchers and industry funding, Charles Nemeroff was one of the targets. The former Emory University professor, who now works at the University of Miami, came to the committee’s attention because he was accepting sizeable consulting fees from GlaxoSmithKline at the same time he was the primary investigator on an NIH-funded grant for research into a Glaxo drug. The Senate investigation, spearheaded by Chuck Grassley, the Iowa Republican, prompted Emory to suspend Nemeroff’s work on an NIH grant and asked him to step down as chair of psychiatry while it studied his conduct. And the Department of Health and Human Services Office of Inspector General be... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3420753 Tue, 30 Mar 2010 14:26:41 +0100 3420753 http://www.medworm.com/index.php?rid=2989131&cid=t_309804_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2FSPFVOqcc8Sg%2F The Wall Street Journal is reporting that Fannie Mae and Freddie Mac, which have already consumed $112 billion in taxpayer bailouts, may have additional losses if they can’t recoup claims from struggling private mortgage insurers. From the Journal: Fannie Mae has about $109.5 billion of mortgage-insurance coverage in force, which represents 4 percent of all single-family home loans it owns or guarantees. Freddie Mac had $63.4 billion in mortgage insurance and $12.2 billion in bond insurance. Private mortgage insurance is required for any home loan with less than a 20 percent down payment, and the policies typically cover 12 percent to 35 percent of losses in the event of a default, according to HSH Associates, a financial publisher. Mortgage insurers have been forced to pay up as loan de... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=2989131 Fri, 13 Nov 2009 15:06:03 +0100 2989131 http://www.medworm.com/index.php?rid=2125359&cid=t_309804_131_f&fid=34989&url=http%3A%2F%2Ffeeds.b5media.com%2F%7Er%2Fb5media%2FGeneticsHealth%2F%7E3%2FwoYHOr3kqfM%2F The number of countries, and land areas, growing genetically modified foods has grown tremendously in the last decade. In recent years, several developing countries like Argentina, Brazil, South Africa and China have become rabid growers of transgenic crops. But North America still remains the world’s biggest grower, and exporter, of GM crops. Recently however, the Office of Inspector General warned the US Department of Agriculture to be prepared to block the influx of GM foods from foreign countries, if they are believed to pose threats to our health, environment or agriculture. The OIG is concerned that many GM products produced by other countries are not approved by the USDA, and GM crops could begin entering the US illegally or without proper declaration or labels. Read the comple... Genetics and Health blogs http://www.medworm.com/rss/comments.php?id=2125359 Fri, 23 Jan 2009 01:05:24 +0100 2125359 http://www.medworm.com/index.php?rid=1429315&cid=t_309804_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F286169422%2F Five years after the HHS Office of Inspector General issued its compliance guidance for pharma, 92 percent of drugmakers surveyed say the guidelines “significantly impacted” the structure of their medical affairs teams - for instance, have since shifted medical science liasons and thought-leader development teams away from commercial development. Meanwhile, 8 percent indicate the guidelines had caused a complete overhaul, according to Cutting Edge Information. And none of the 14 drugmakers that responded - a group that included Bayer, Glaxo and Novartis - believes the guidelines failed to have a serious impact. (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1429315 Thu, 08 May 2008 16:00:55 +0100 1429315 http://www.medworm.com/index.php?rid=1323239&cid=t_309804_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F257066199%2F The federal investigation into kickbacks paid by device makers to hip and knee surgeons is now shifting to the docs themselves. After reaching settlements with five hip and knee implant makers last year over payments, the HHS Office of Inspector General is focusing on doc who receive money as paid consultants, The New York Times reports. “We are going to be looking at those soliciting kickbacks,” Lewis Morris, the OIG chief counsel told an audience of docs, device execs and investors earlier this month in San Francisco at a meeting of the American Academy of Orthopedic Surgeons. The same message has gone out to health care lawyers attending legal education seminars and, directly from Christopher Christie Jr., the US Attorney in Newark, who is overseeing the investigation. Execs say Chr... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1323239 Mon, 24 Mar 2008 14:43:07 +0100 1323239 http://www.medworm.com/index.php?rid=1060148&cid=t_309804_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F192523698%2F From now on, the Inspector General for the Department of Health and Human Services will have the pleasure of investigating wrongdoing by an FDA employee - and not share the responsibility with the FDA, a practice that has existed since 1998. Two months ago, the IG notified the FDA that it was withdrawing from the agreement, and all cases - such as theft or conflict of interest - are expected to be transferred by April, according to US Senator Chuck Grassley, who has spent much of the past few years digging into FDA practices. “No other agency within the Department has the kind of joint authority that the FDA had gotten for itself almost ten years ago,” Chuck says in a statement. “Cutting the tie is good for the public. It strengthens the role of the Inspector General. And in our ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1060148 Thu, 29 Nov 2007 19:01:32 +0100 1060148 http://www.medworm.com/index.php?rid=912197&cid=t_309804_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F162285084%2F That’s the finding of a report to be released Friday by Dan Levinson, inspector general of the Department of Health and Human Services. The FDA didn’t know the number of trials being conducted; audited fewer than 1 percent of the testing sites and, on the rare occasions when inspectors did appear, generally showed up long after the tests had been completed, The New York Times reports. The failure affects millions who participate in these trials. The FDA has 200 inspectors, some of whom audit clinical trials part time, to police an estimated 350,000 test sites. Even when those inspectors found serious problems in human trials, top FDA officials in Washington downgraded the findings 68 percent of the time and among the remaining cases, the FDA almost never followed up with inspec... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=912197 Fri, 28 Sep 2007 11:20:36 +0100 912197