Week in Review, June 15, 2012

Bigger than the secrets of the LOST island, bigger than Sam and Diane, and bigger than the ambiguous fate of Tony Soprano was the question “who shot J.R?”.  If you missed out on that little piece of television history, no need to look for your friendly, local TARDIS to go back and experience it. Dallas is back and re-booted for the 21^st Century! We just ask that this version be free of “it was all just a dream” storylines. But enough of this fiction, let’s get down to some fact-based drama and intrigue with this week’s News Week in Review.

Congressmen Henry Waxman and Elijah Cummings are disappointed that Wal-Mart hasn’t cowboyed up and provided them with information related to the company’s FCPA compliance program.  Prompted by the New York Times story alleging the company was paying bribes to government officials in Mexico, the pair has begun their own investigation into the matter. The congressmen have sent a letter to the CEO, blasting him for his refusal to allow company representatives to speak to them regarding the allegations of bribery in Mexico. They also have criticized the CEO for sending representatives from the company’s law firm to brief their staffs on the company’s FCPA compliance program. The lawyers were unable to answer any questions about the bribery allegations.

Despite hundreds of calls coming in on the SFO hotline, the investigation well remains dry. Last November, the Serious Fraud Office launched the confidential hotline to collect reports of potential violations of the UK Bribery Act. Calls have been coming in since the launch, with 350 logged during the first quarter of the year. However, the SFO has yet to launch an investigation. The agency has been dealing with constant budget cuts, limiting its investigative resources.

Rounding out this week’s anti-corruption roundup is a tale of the importance of third-party due diligence. Tom Fox shares the story of a UK man profiled in the Washington Post who led a life filled with fraud. After the man took his operation to Washington DC, he continued to con businesses and people, despite the information that existed about his activities in the UK. Fox sees the story as a cautionary tale of the need for third party due diligence in regard to the FCPA and UK Bribery Act. Both laws expect companies to understand that its third party relationships stretch beyond the sales end of the business.

In light of the pre-emption that will eventually be brought by the Sunshine Act, the Vermont Attorney General’s Office has amended its guide for 2012 disclosures under the state’s prescribed products gift ban and disclosure law.

The False Claims Act recoveries from the industry may be Texas-sized, but one DOJ official says the prevention of fraud should be the focus. Speaking to a group of lawyers, Acting Assistant Attorney General, Stewart Delery, said that government had recovered just over $11 billion under the False Claims Act. The majority of the recoveries represented healthcare fraud cases. Delery said his office would continue to pursue non-monetary, proactive measures to prevent fraud, and he encouraged those in attendance (and their clients) to implement proactive compliance measures to prevent fraud from occurring in the first place.

The weather may always be pleasant and sunny for breakfast on the South Fork terrace, but for the industry, the Sunshine is obscured by clouds of uncertainty. A group of lawmakers have written to CMS to ask that the final rules for the Sunshine Act be delayed until “appropriate congressional committees of jurisdiction have had a chance to review the proposed rule and its impact on patients and the U.S. health system.”  (*cough*…comment period…*cough*) The letter listed several concerns, including the complexities in certain reporting requirements, the reporting of payments for clinical trial, and the burden on CMS brought on by over reporting due to the low reporting threshold. CMS has yet to respond to the letter.

Well folks, time to saddle up and ride off to the weekend. Have a good one everyone!

The PharmaCertify™ Team

Not so long ago, in a galaxy not so far away, in fact in the galaxy in which we live, there was a planetary event that would not be repeated in our life time…well unless cryogenics ends up working out. The transit of Venus occurred this week. We hope you had the opportunity watch the little black spot on the sun (the Police and Star Wars references in one paragraph…snap!) meander ever so slowly across the disk of the sun for nearly seven hours. As fascinating as it would be to continue this astronomy chat, we’ll bring it back down to earth with this week’s Week in Review.

Let’s start off the Review with a nice sunny story, shall we? A poll of primary and specialty physicians found that 56 percent of them are concerned about the upcoming spend reporting under the Sunshine Act. With the final rules still pending, physicians, hospitals and other stakeholders are concerned about the public presentation of the data. Their primary is that the public release of the data doesn’t paint the complete picture of the relationship between healthcare providers and the pharma/med device and bio industries.

Defying gravity? GSK has filed suit against Louisiana’s Attorney General, claiming the fee arrangement the AG has with private lawyers in the state’s suit against the company violates the state Constitution and the company’s constitutional rights. GSK claims the lawyers have a personal financial stake in the outcome of the trial. Under the agreement, the lawyers do not get paid unless the state wins an award against GSK. The state is seeking $10 billion in civil penalties along with damages, lawyers’ fees and expenses. In its court filing GSK said the company had a “legal right to face law enforcement decisions that are not structurally tainted by substantial financial incentives for the prosecutors to seek and extract substantial penalties.” We’ll end this with a quote from Steel Magnolias: “Louisiana lawyers do well, whether they want to or not.”

The Department of Justice has a settlement offer from Stryker in its orbit. The company has offered the DOJ $33 million to put an end to a federal investigation of one of its knee implants. The investigation concerns violations of federal law dealing with sale of device not cleared by the FDA.

There has been a “big bang theory” released from the Congressional Budget Office regarding the medical device tax. The CBO released analysis that said repealing the med device tax would reduce government revenues $30 billion over 10 years. A bill to repeal the tax was passed by the House Ways and Means Committee and sent to the full House for vote. During the committee hearings, Democrats asked Republicans to show how they would replace the lost revenue. In response, Republicans released a plan showing how they would generate nearly $44 billion in revenues over 10 years, alleviating pay-as-you-go concerns raised by the CBO report.

In other news regarding the med device tax, White House officials have threatened to veto the bill the repealing the tax. There are no plans to consider the bill in the Senate, so it probably would not pass if it gets there. As we all learned from School House Rock, a bill must pass both houses of Congress before the president can sign or veto it. Or, he can let it sit on his desk for 10 days before it comes law without a signature – just gotta love election year politics.

The number of adverse even reports received by the FDA rocketed up nearly 10 percent in 2011. Of the drugs receiving the top number of reports, only three were introduced in the last 10 years. Most of the top drugs carry prominent warnings about potential dangers. The increase in the number of reports is attributed to increased reports from manufacturers.

Is there a black hole of corruption developing in Britain? Transparency International warns corruption is more prevalent than is currently recognized in the country. The group says government and private concerns alike need to recognize the urgency of the problem and deal with it consistently and coherently. The group argues that any plans to dismantle the Serious Fraud Office should be put on hold. It further points out that not dealing with corruption could adversely affect the economic health of the nation, and European nations that are in dire economic straights are also those with weak anti-corruption safeguards.

The pharma Twitter universe is expanding. Some companies have one main feed on the social network, but a number are maintaining multiple Twitter handles. Companies appear to be taking advantage of what social media does best – speak to targeted groups. Companies are targeting their Twitter use for recruiting, communicating disease-specific information, and exploring philanthropy opportunities.

Well, fellow stargazers, that brings us to the end of this week’s News Week in Review. As we head to the weekend, don’t get rid of those eclipse glasses or pin hole viewers you used to observe the transit of Venus just yet.  It may be another 105 years before the next transit, but there is a full solar eclipse due in 2017. Make your plans now!! Have an out-of-this-world galactic weekend everyone!

Week in Review, June 1, 2012

Daaa-da-da-da-daa-daa. Ah, Pomp and Circumstance, (you got that musical reference from da-da’s right?) the perennial anthem of graduation ceremonies everywhere. It’s that time of year, when young ones (and not so young ones) don cap and gown, cross a stage to receive a blank piece of paper that commemorates years of hard work and dedication in pursuit of knowledge and education…always tear jerking for parents and family and liberating for the graduate. We celebrate these graduates’ achievements as they head off in to a brave new world. Whether that world is the work force or the first grade, we congratulate you all. In honor of graduates everywhere, we begin our own little “commencement” address – this week’s News Week in Review.

Brazil seems to be preparing to matriculate into the group of nations passing laws prohibiting the bribery of foreign officials. The Brazilian Congress is considering a law that would prohibit foreign bribery, however, the business community is pushing back against the law. A recent vote on the draft bill was delayed in order for the congress, business community and other stakeholders to work through some of their differences. There are three major areas of contention in the law: successor liability, the level of sanctions, and corporate strict liability.

In other foreign bribery news, we finally say goodbye to our old friend, the Lindsey Manufacturing FCPA case. The government has decided to drop its appeal of a judge’s decision to throw out the conviction of the company and two of its executives. After winning the first ever case against a company for violating the FCPA, the government saw that victory pulled away late last year when a judge tossed the convictions, citing government misconduct. Had the appeal moved forward, opening briefs from the government were due to be submitted June 1.

The state of Massachusetts is on its way to crossing the stage of allowing usage of drug coupons. Budget amendments in the state’s legislature would make the use of  co-pay and discount coupons legal. There are differences between House and Senate amendments that are to be worked out by a six member committee. Two issues to be resolved are the expiration of the coupons, and fines over raising the price of a drug.

The House Ways and Means Committee graduated a repeal of med device tax to the next grade. The republican controlled committee passed the Protect Medical Innovation Act, which would repeal the medical device tax that is due to go into effect next year. The committee has sent the Act to be voted on by the whole House next week. Some democrats on the committee are concerned the bill does not address how the loss in revenue from the repeal will be offset.

Senator Chuck Grassley is questioning the awarding of a “scholarship” by the National Institutes of Health to a doctor who had been previously banned from receiving funds from the NIH. The NIH awarded a $400,000 research grant to a psychiatrist who was previously banned from receiving funds from the institute. The ban came as a result of the physician’s failure to disclose $1.2 million in payments from a pharmaceutical company while he led a multi-million dollar federal study involving that company’s drug. A director at the NIH said the ban against the doctor had expired, and even if it hadn’t, the ban would not apply since he was working for a different university. The doctor in question is still under investigation by the OIG and DOJ, and Grassley questions whether the NIH had taken this into consideration in making its decision to award the grant. Grassley said the NIH risked sending the wrong message to physicians seeking federal grants.

As the industry prepares to take its first steps in the new world of disclosure, a study in the Archives of Internal Medicine finds that the disclosure of payments to physicians has little to no effect on prescribing habits. (insert shocked gasp here). The study focused on two types of drugs: statins and selective serotonin reuptake inhibitors (SSRIs). Using publically available data, researchers compared prescribing habits in states with disclosure laws to those that did not have such laws. The findings showed the laws had little to no effect on increasing the use of generics or reducing the cost of medication. One study author said that transparency was important in its own right, but if the aim of law makers is to reduce costly prescribing, more direct action may be needed.

Well, it’s about time to throw that mortar board and tassel in the air and head out to weekend of our future. (wow, that was hokey) If you’ll be spending part of your weekend packing for a trip to the Big Easy for the SPBT conference, you won’t be alone. We will too! Come on by booth 235 and say hello. And be sure to catch our presentation on creating a values-based compliance program on Wednesday!

In case you haven’t had your fill of graduation-themed fun just yet, here’s one last read. Have a great weekend everyone!

The PharmaCertify™ Team

Break out the white pants and seersucker suits! Its Memorial Day weekend, and summer has unofficially started! Woo hoo! It’s time to take the cover off the pool, fire up the barbeque and get our lazy, hazy summer days on! If you’re reading this, you’re probably in the same boat as us – watching the clock tick ever more slowly to the start of the weekend. Because we care about you, our dear readers, here’s a bit of something to read to pass the time. Without further adieu, this week’s News Week in Review!

So let’s dive right in with a fun little summer read. Good news for the coffee lovers out there. (Let’s face it we’ll all be downing this delicious nectar today as we wait on the clock to mercifully strike 5:00.) Turns out that all that coffee may help you live longer. A study funded by AARP and the National Cancer Institute (and Starbucks)  found that adults 50-71 who consumed two to three cups of coffee a day had a 10% lower risk of death. While the study’s lead author isn’t recommending people go out and start consuming coffee based on the results of the study, the study should make people feel better about consuming coffee (and buying stock in Starbucks).

Okay, onto more serious stuff. Developments related to the FDA user fees bill came crashing onto the beach like waves during high tide this week. The bill was introduced into the Senate early in the week and the amendments were flying fast and furious. First, Senator Orin Hatch of Utah introduced an amendment to repeal the upcoming medical device tax. Then just as quickly, Senator Dan Coates, a co-sponsor of the amendment, announced the amendment would be withdrawn, and that Senator Hatch intended to address the repeal of the tax in “another vehicle.”  Adding an amendment of his own was Senator Bernie Sanders of Vermont. That amendment would cause a pharmaceutical company to lose its product exclusivity if it were “found at fault for fraud involving a particular drug.” In a press release, Sanders cited case after case of incidences involving pharmaceutical companies and healthcare fraud, and said companies that defraud Medicare and Medicaid, or illegally market drugs, should not enjoy the government-provided monopoly for those drugs. Oddly enough, Senator Sanders was the odd-man out when the Senate passed the bill on Thursday with a 96-1 vote.

And you thought getting your brother-in-law to switch from charcoal to a gas grill was tough! A new study finds that physicians who limit contact with, or do not see, drug sales representatives are more likely to continue to prescribe drugs with a black box warning over newer therapies. The study found physicians with restricted access to drug sales representatives were four times less likely to move from a drug with a black box warning to a best in class drug than their peers without such restrictions. The study’s lead author says the increase of access restriction had an effect on physicians’ decision making beyond what is anticipated by healthcare systems and large group practices.

The OIG posted a video and transcript of the keynote address delivered by Inspector General Daniel R. Levinson to the Healthcare Compliance Association’s Compliance Institute. Mr. Levinson opened by commenting about the HCCA survey that revealed six out of ten compliances officers lose sleep over their job. He said he didn’t mind the bad guys stressing over doing the wrong thing, but he knew this audience was filled with the good guys. The Inspector General used a handy acronym to discuss the areas covered by the OIG – EPCOR (um…shouldn’t that be EPCOT?) enrollment, payment, compliance, oversight and remediation. He went on to explain the OIG’s role for each of these. He also covered the OIG’s enforcement authorities and social media presences.

Things are starting to heat up in the House of Representatives regarding Wal-Mart’s foreign bribery fiasco. Democrat House members have sent letters to the U.S. Chamber of Commerce and the Retail Industry Leaders Association (RILA) requesting information about Wal-Mart’s involvement in the lobbying effort for FCPA reform. The House members believe there are conflicts of interest in Wal-Mart being involved in a lobbying effort for reform of the FCPA while they were in the midst of an internal investigation for possible FCPA violations. The lobbying efforts were headed by the Chamber’s Institute for Legal Reform (ILR), and Wal-Mart has a representative on the Institute’s board of directors. Lawmakers have requested minutes of meetings from ILR’s board meetings.

The bribery pool is seeing an increase of folks swimming about. A survey by Ernst and Young finds that the number of top executives willing to pay a bribe to get or keep business increased 6 percent this year. Ernst and Young says top managers are underestimating the risk as they expand into new markets. The findings are particularly concerning due to the level of responsibility for the individuals involved.

Well folks, we’re a few ticks of the clock closer to the weekend. We’ll leave you with one last story to consider as you make your plans for the weekend. The FDA has pushed back the new labeling requirements for sunscreen six months. By my count, that puts us squarely in winter.

Have a safe and enjoyable weekend everyone!

The PharmaCertify™ Team

This past Sunday marked the last drive, walk and face slap on Wisteria Lane.  Desperate Housewives ended its 8 year run, and finally it all makes sense why Mary Alice narrated more seasons of the show than her family’s storyline allowed. Where will we turn for our weekly dose of murder, adultery and backstabbing among neighbors? Hmmm…perhaps this new show called Dallas. It starts next month. Oh well, until then we’ll all just have to make do with real life. Truth is stranger than fiction, right? Let’s find out in this week’s News Week in Review.

The early part of the week brought the unsealing of a whistleblower suit with juicy details alleging that Medtronic installed a surgeon as an editor for a prominent spinal journal to make sure favorable articles about one its products were published. The suit also claims the surgeon allowed authors of the articles to hide their financial ties to the company, and that he did not disclose that he profited from the use of the products. Then a few days later, in a twist worthy of any prime time soap opera, the DOJ announced that it had closed its four year investigation of the company. No charges were issued and no settlement reached.

It’s good news over at the Abbott house. The company closed out a 1999 consent decree with the FDA. The original decree was issued over manufacturing problems at it diagnostic unit.

Everyone’s favorite neighbor, Sen. Charles Grassley, has expressed his disappointment at CMS for postponing the collection of physician spend data required under the Affordable Care Act. The Senator says CMS needs to get the implementation of the law right, and with this new delay, they have no excuse to not get it right. The big question is when will the first reports be due? As of now the March 31, 2013 date still stands. I guess we’ll all have to stay tuned to see how this cliffhanger resolves itself.

The ladies of Wisteria Lane are nothing if not trendy. We like to keep it trendy too, and it seems the big trend in healthcare law enforcement is the enforcement of both state and the federal False Claims Acts. Federal and state enforcement agencies have committed substantial resources to the pursuit of healthcare fraud this year. That trend is likely to continue as recoveries rise and the states become more active in pursuing violations against their own laws, outside of federal efforts.

And speaking of enforcement trends, what about anti-bribery? Much has been made of the DOJ’s commitment to pursuing possible violations of the FCPA, and it has been nearly a year since the UK Bribery Act “went live.” More countries are now passing laws prohibiting the bribery of government officials, foreign officials and bribery in the private sector. Enforcement agencies in various countries are cooperating with each other and fines are rising around globe so this won’t be one trend that is here today and gone tomorrow.

Donald Trump is ready for a fight and he says the FCPA should be overturned. On CNBC’s Squawk Box, the Donald said businesses shouldn’t be prosecuted for going overseas and following the practices and customs of other countries. He went on to say keeping other countries honest shouldn’t be the job of the United States. If those countries want to prosecute bribery, let them do it.

The latest bribery scandal on the block, Wal-Mart, has raised questions about the value of self-disclosure. For its part, Wal-Mart did not disclose its findings of bribery until the 11^th hour. Lawyers say in certain situations, bribery involving a member of senior management for example, self-disclosure is generally recommended.

Well, that’s is for another week of drama in this crazy compliance world of ours. Sometimes, truth really is stranger than fiction. As the storylines continue to evolve, we’ll keep you apprised of all the juicy details right here at the News in Review and through our daily Twitter feed. Have a great weekend everyone!

The PharmaCertify™ Team

Can you believe it is mid-May already? It’s the time of year for weekly release of blockbuster films. Last week’s contribution, Avengers, broke all box office records and we’re just one week in to the summer movie season. However, there is a bit of business to which we must attend before we head out the door to wait in line for this weekend’s premieres: this week’s News Week in Review. It promises to thrill, chill and offer laughs a plenty. All you could want, right? Lights… electrons…read!

The blockbuster news item of the week was the announcement of the federal government’s settlement with Abbott for $1.5 billion, to resolve a criminal and civil investigation into the illegal promotion of the drug, Depakote. The company pleaded guilty to a misdemeanor of misbranding the drug under the FDCA and paid $700 million in criminal fines and forfeiture. According to the government, Abbott promoted the drug for the off-label uses of treating aggression and agitation in dementia patients and for schizophrenia. The drug is approved to treat epileptic seizures, bipolar mania and migraines. Additionally, the company agreed to pay $800 million in civil fines for alleged violations of the False Claims Act and the Anti-kickback Statute. Of the $800 million, about $240 million will go to the states. The whistleblowers in the case will share an $84 million dollar payout, which is the second highest FCA-related payout since the law was revised in 1986.

Like any good blockbuster, there must be a sequel. And in the case of the Abbott settlement it was the litany of stories released from the Attorney Generals’ offices in the states receiving a piece of the settlement. So for your entertainment here’s just a preview of Settlement II, the States Strike Back: Tennessee, Arkansas, Oregon, Iowa and Rhode Island.

What would the summer movie season be without a story of corporate and government intrigue?  A House of Representatives committee widened its investigation into the deal struck between the West Wing and the pharma industry to support the administration’s healthcare reform efforts. Initially, the Republicans on the House Energy and Commerce committee contacted an industry trade group demanding to see documents related to the deal. When that failed, the committee went to drug companies directly to demand documents about the negotiations. At first, the group targeted Pfizer, but the inquiry has widened to include other companies like AstraZeneca, Amgen and Merck.

This week, the Senate green lighted an investigation into the relationship between manufacturers of narcotic pain meds and patient pain advocacy groups. The senate panel is interested in records about the links, financial and otherwise, between the industry and the groups that advocate the use of their products. The panel requested payment information for the past ten years from three drug manufacturers, five patient pain groups, the Joint Commission and the Federation of State Medical Boards. The interest in the relationship comes amid a growing concern about the overprescribing and abuse of narcotic pain killers. Media reports suggest the industry may be responsible, in part, for misuse due to the misrepresentation of the benefits and dangers of the drugs.

A happy ending appears to be on the horizon for the credibility of journal articles on industry sponsored clinical research.  A group representing industry and publishers made 10 recommendations for closing the credibility gap in reports of industry sponsored clinical research. The group says authors and publishers need to employ best practices and clearly communicate the standards and requirements of the studies in order to enhance transparency and credibility. A professor at York University in Canada claims that while the recommendations are a good start, they may have no affect on the problem. Citing non-emphatic language, and some weak recommendations, the professor said there is evidence to show a study funded by industry is more likely to have a positive outcome for the company sponsoring the study. He recommends clinicians consider this bias before applying the study results in their work.

Well we’re about to call it a wrap on this edition of the News Week in Review and this work week. But no blockbuster would be complete without some shameless product placement, so here it is: this week’s top story demonstrates that off-label promotion remains a crucial remains a focus for investigation. Pharmacertify offers a series of customizable off-the-shelf training modules and iPad apps to help integrate an awareness of on-label promotional policies into your staffs’ consciousness. You can learn more and even see a “trailer” at www.pharmacertify.com.

That’s a wrap folks! Cut, check the gate, print, weekend!

The PharmaCertify™ Team

Big news folks! In fact, we’re going to dispense with our usual set up of the News Week in Review, and just get right down to business. We’re sure you will be as shocked as we were when we tell you CMS has pushed back the starting date for collecting physician spend data to January 1, 2013. On the CMS blog, the agency stated that it received over 300 responses during the comment period for the proposed rules for implementation of the Sunshine Act. They also say they would like to give due consideration to the feedback provided during the comment period, and therefore is pushing back the date that data collection is to begin. While not providing a date, the agency says it expects to publish final rules later this year. If we hadn’t bet all our money on Bodemeister to take the Kentucky Derby, we’d be ready to place best on what “later this year” actually means. How about you dear readers? Think we’ll see those rules before Halloween, or will we get another almost Christmas surprise?

Is there anything else worth discussing beyond CMS and the lack of Sunshine regulations? Well actually yes there is. You know how we love a good bribery story, and everyone’s favorite retailer has definitely corned the market in the world of foreign bribery lately. Thomas Fox says the Wal-Mart scandal effectively ends businesses’ push for FCPA reform. The level of the scandal at the company’s Bentonville offices will make the U.S. Chamber of Commerce’s argument for change quite challenging.

On the legal front, Par and the DOJ say they are optimistic a resolution can be reached in the current investigation into the company’s marketing of a drug that treats AIDS-related weight loss. Motions were filed this week asking for a 60-day stay of pending litigation.

There is a good bit of news involving the UK Bribery Act this week. First, the Organization for Economic Cooperation and Development (OECD) issued its review of the Act. The OECD acknowledged that the U.K. had made strides in fighting bribery with the legislation, but the organization does have concerns with several points in the Act. Their concerns include: lack of public information about the settlements, an increase in civil recovery orders (a less transparent process than criminal pleas), and the potential for the SFO to enter into confidentiality agreements, which prevents key information about bribery from being released to the public.

Next we have the results of a survey conducted by Ernst and Young that found only one in four middle managers felt the Bribery Act hurt Britain’s competitiveness. While the results do not paint a completely dire picture of businesses attitude toward the Act, it isn’t completely rosy. Of the respondents that were actually familiar with requirements of the Act, only 30% percent believed Britain’s ability to be competitive would not be harmed by its implementation.

Lawyers specializing in bribery and fraud warn that regulators are stepping up their enforcement of the Bribery Act. New Serious Fraud Office chief, David Green, issued a number of uncompromising messages during his first week in office. In addition, U.K. financial regulators have issued a flurry of guidance about anti-bribery controls. Businesses holding off on putting processes into place until the first big prosecution happens may want to rethink that strategy.

Finally, we take it back to where we started, the Sunshine Act. Michael Loucks and Alexandra Gorman ask the question “who regulates the regulators?” in a blistering opinion piece for Forbes. Loucks and Gorman specifically point to the issue of HHS requiring that payments associated with OTC drugs and Class I medical devices be reported under the Sunshine Act. They claim this is in direct conflict with Congress’ intent for the Sunshine provisions in the healthcare reform law and the requirements will result in higher costs for drug and device manufacturers.

Well gang, we’re off to pick up some mint leaves for the juleps and to grab fixins for some hot browns. Have a great weekend and “may the [horse racing] odds be ever in your favor.”

The PharmaCertify™ Team

Polish up your tiara and grab your glass slippers – it’s National Princess Week!  The princesses among us here at the News Week in Review are looking forward to a weekend of lavish luxuries, but first we must tend to our responsibilities about the castle. So cue the royal trumpeters…by royal proclamation, we proudly present the News Week in Review.

Following last week’s publication of a study showing 11% of Canadian prescriptions are written off-label, the Globe and Mail published an editorial calling for Health Canada to track off-label use of drugs. Citing information from the study that only one in five of drugs prescribed off-label has any scientific evidence to support its use, the publication asserted that patients and doctors need more education about the use of certain medications. They have called for the creation of a computerized system listing drugs and the conditions they are effective in treating.

Over in England, where they have real princesses, off-label prescribing could be sent to the dungeon. The General Medicines Council (GMC) has changed plans to ease the restrictions on off-label prescribing. Currently GPs may prescribe a drug off-label if it better serves the patient’s needs over the licensed drug. The GMC is reviewing whether the current restriction is in conflict with a European law.

Apparently, a certain princess doesn’t need quite as much help from Prince Charming these days. Typically, the federal government (Prince Charming) does the heavy lifting when it comes to investigating and prosecuting pharmaceutical companies for violations of healthcare law and regulations. However, the state of Oregon (our princess) recently struck its own settlement with Pfizer over false and misleading advertising of Zyvox. The settlement requires Pfizer pay the state just over $3M, not promote Zyvox in a false and misleading manner, disclose various payments and transfers of value, and post Zyvox clinical trial results to ClincalTrials.gov. Oregon participated in the government’s investigation of Pfizer over off-label promotion of Zyvox and Bextra. Will more princesses follow Oregon’s lead?

Is the clock about to strike midnight on the Massachusetts gift ban to doctors? Consumer groups certainly hope not, and say that if current effort to repeal the gift ban is successful, it will cost the state $750M (that is one expensive pumpkin!) in increased drug costs over the next ten years.  The repeal would also allow pharma companies to provide prescription coupons to consumers. Opponents say this would drive consumers to use more expensive drugs when cheaper generics are available, costing the state and consumers more in the long run. Supporters say the coupons offer patients more options, and help toward what can be expensive co-pays for drugs that are on that patient’s insurance company formulary.

Sometimes riding off into the Sun(shine)set isn’t always the path to your “happily ever after.” At least that’s the way doctors are feeling about the payment disclosures required by the Sunshine Act. A Massachusetts nurse practitioner who serves on a pharmaceutical company’s speakers bureau says participating in the programs is a catch-22. She is passionate about teaching other healthcare professionals, but she is concerned that patients may think she is “on the take” because of the payments. The NP says she and most healthcare professionals who speak on behalf of pharma companies simply want to help patients by educating their peers, but she understands that some are in it for the money. Physician groups and pharma are concerned that the regulations, as currently written, do not clearly explain the nature of the payments. A representative of PhRMA says patients need to understand that just because their doctor has received a payment from a pharma company, it does not mean the doctor “has been compromised.”

And so we close this proclamation of compliance-related industry news for the week. Our fairy godmother is standing by, with our chariot at the ready, so we bid you all a weekend filled with a little sparkle and a lot of magic. Bippity, boppity, bye!

The PharmaCertify™ Team

There’s a certain chill in the air…a shudder of fear and trepidation that is sweeping through the nation. No, it is not that today is Friday the 13^th, but that tax day looms before us this weekend. Oh, the paper cuts from receipts, oh the hours spent with a calculator, oh the humanity of if all! Okay maybe that’s a bit much, but tax day is just around the corner on April 17^th. We certainly hope you will be sitting back laughing, or feeling pity, for those whose weekend will be spent hunched over a desk diligently working to make the deadline. And if you need a little something to read when you take a break from the 1040s and the line items, we present this week’s News Week in Review?

How long of an “extension” are Senators Grassley and Kohl willing to give CMS to finalize the rules for the Sunshine Act? Only a few more months, according to a letter the Senators sent the acting head of CMS. In the letter, the senators expressed their disappointment (again) that the regulations were not completed by the deadline specified in the law, and demanded (make that “asked”) if CMS could have the regulations ready by the summer. They also asked if the Agency had ramped up its staff and allocated the funds needed to implement the Act. The letter included a request for a response by April 18^th. Stay tuned.

Let the receipt collecting begin! Finance experts for the healthcare industry suggest that hospitals begin collecting information from physicians now about their financial relationships with industry, rather than wait to see how the final regulations shake out for the Sunshine Act. That includes understanding how the information will be perceived by the public. According to one finance expert, there is no down side in the hospital having this information on file now, and as long as all the relationships are on the level, there is no downside for the physician.

Repealing the medical device tax is high on Senator Scott Brown’s list. The topic was a top agenda item during the Senator’s recent visit to three Massachusetts device manufacturers.  Brown says he became aware of the tax when campaigning for his seat back in 2010. His concern is that the tax will lead to a loss of jobs, and negatively impact the economy of the communities that surround the manufacturing facilities. Brown has introduced a bill to repeal the tax, and he encourages device manufacturers to communicate their concerns to their congressional representatives.

No more deductions, revisions or other changes are needed as the FDA has delivered final guidance on agency and medical device industry guidelines for requests for information and applicable user fees. The requests for information, known as 513(g) requests, are generally for device classification, and a user fee is imposed for facilitation. The fees for the 2012 calendar year range from $1,700 to $3,400.

HHS recently handed down the first civil penalties for violations reported under HITECH’s breach notification rule. As part of the Resolution Agreement, Blue Cross Blue Shield of Tennessee (BCBST) agreed to pay $1.5 million in penalties and enter into a Corrective Action Program. BCBST self-reported the theft of 57 hard drives containing the PHI of one million people. The hard drives were left in a network data closet in a building BCBST no longer occupied. The CAP will require BCBST to create policies and procedures addressing risk assessment, risk management and physical security. The company must also increase training and monitoring of its HIPAA policies.

A former VP of sales for a medical device company brought a taxing situation to an end by pleading guilty to violating the Anti-kickback Statute. He faces up to five years in prison and $250,000 in fines and forfeiture. The government claimed the man established a sham consulting agreement with a NY surgeon in order to induce the surgeon to use his company’s bone growth stimulator. The surgeon never actually performed any consulting services for the company. When he became concerned about government scrutiny about such arrangements, the former VP and a territory manager worked with the surgeon to backdate time sheets to make it seem as if the consulting work had happened. Sentencing is set for July.

That brings us to the end of this week’s News Week in Review, and the end of our distraction from completing those lovely tax forms. We hope your Friday is full of good luck. We end with congratulations to Eli Lily CEO, John Lechleiter, who has been named the new chairman of PhRMA.

Have a great and un-taxing weekend everyone!