Health Care Lawyer Blog

A proposal which would have imposed a 3 percent tax on physicians' gross revenues was defeated Wednesday in the Michigan State Senate. HB 5386, which was intended to raise state Medicaid funds and in turn garner additional federal matching funds, was stopped short by a 32-4 vote in the Republican-controlled Senate.

The tax was designed to ultimately increase access to health care by producing higher payments to physicians who treat Medicaid patients. However, opponents to the bill such as the Michigan State Medical Society expressed concerns that such a tax would exacerbate the already-present drought of primary care physicians in Michigan by provoking doctors to look elsewhere for employment.

When it comes to health care reform, health care lobbyists have put their money where their mouth is – literally.

According to a USA Today report, health care lobbyists are on track to set new spending records and some companies have nearly doubled their investment compared to previous years. For example, the Pharmaceutical Research and Manufacturers of America (PhRMA) spent nearly $7 million on lobbying from July through September, bringing their total outlay through 2009 close to $20 million – nearly as much as the group spent in the entire year 2008.

In the first six months of 2009 alone, drug/biotech companies and their trade associations have spent more than $110 million or $609,000 per day on lobbying effectors. Big health-care spenders in the third quarter of 2009 included Pfizer Inc.with $5.42 million; the American Hospital Association with $3.8 million, the American Medical Association with $3.95 million, Amgen Inc. ($3 million); Bayer Corp. ($2.45 million) and America’s Health Insurance Plans ($2.4 million).

Additionally, it seems that drug company expenditures do not just end with lobbying, either – last year Amgen shelled out $5 million in an apparent nod to former Massachusetts Senator Ted Kennedy, who backed a House Amendment which extended the number of years biologics companies can avoid competition from generic drugmakers from five years to 12. Kennedy, whose home state was home to many biotech firms, ushered similar legislation through the Senate Health, Education, labor and Pensions (HELP) Committee. Amgen proceeded to donate $5 million to a nonprofit educational institute being built in Kennedy’s honor. (Source: Tumulty, K. and Scherer, M., "How Drug-Industry Lobbyists Got Their Way On Health Care," Time.com Oct. 22, 2009.)

Today's post was authored by FHWN attorney Michelle D. Bayer

Effective December 4, 2008, Michigan joined 12 other states who have legalized medical marijuana. The Michigan Medical Marihuana Act (“MMA”), MCLA 333.26421 et seq., legalizes the use of medical marijuana to alleviate the pain, nausea and other medical symptoms caused by specific enumerated medical conditions. (Note: The Michigan statute spelling of “marihuana” is different from the mainstream spelling.) After the MMA was passed in 2008, the Michigan Department of Community Health initiated the Michigan Medical Marihuana Program (“Program”) to administer the registration program provided for in the MMA.

Since the Program began in April of 2009, approximately 6,000 Michigan residents have been admitted and received a registry identification card. The Michigan Department of Community Health receives 59 applications daily and number of applicants is increasing. About 88% of applicants are approved into the program. With these kinds of numbers, medical marijuana issues are certain to arise in the workplace.

Despite the passage of the MMA, employers are not required to allow marijuana use in their workplace. Specifically, there is no requirement under the federal Americans with Disabilities Act (“ADA”) for employers to accommodate a disabled employee’s medical marijuana use, since marijuana is considered illegal under Federal law. While the Michigan Persons with Disabilities Civil Rights Act (“PDCRA”) provides that employers may establish work rules and policies prohibiting the use of alcohol or illegal substances in the workplace, Michigan has now legalized the use of medical marijuana to designated individuals under the MMA.

However, the MMA specifically states that an employer does not have to accommodate the ingestion of marihuana in any workplace or any employee working while under the influence of marihuana. Further, the MMA prohibits an individual from (1) undertaking any task under the influence of marihuana, when doing so would constitute negligence or professional malpractice; (2) smoking marijuana in any public place; or (3) operate any motor vehicle while under the influence of marihuana, among other prohibitions.

After the jump - workplace-specific issues created by the legalization of marijuana in Michigan

Continue reading " Medical Marijuana In the Workplace: What Michigan Workers and Employers Need to Know " »

A previous Health Care Lawyer Blog post highlighted the “wellness” amendments to the Senate Finance Committee’s health overhaul bill (a.k.a. the Make American Health Act), which was voted through the Committee last week. The provision, championed through by Sens. John Ensign (R-NV) and Tom Carper (D-DE), expands existing HIPAA wellness program regulations that allow employer-sponsored insurance plans to reduce premiums for employees who lose weight, quit smoking, control their blood pressure or practice other healthy behaviors.

“Weight gain and unhealthy lifestyles that focus on smoking and lack of exercise have sky-rocketed our healthcare costs,” Ensign said in a statement on his website. “These costs could be lowered by focusing on what makes us healthy - through weight loss programs, smoking cessation and preventive care. Voluntary employee participation in these areas should naturally be reflected in lower healthcare costs.”

Some employers have already noticed the benefits associated with such wellness incentives – a previous post centered on the success of the plan introduced by the supermarket chain Safeway. However, the wellness amendment has been met with protest from groups such as the American Cancer Society, American Heart Association, and American Diabetes Association. Specifically, the groups are concerned that lowering premiums for some people may mean raising them for others, and that those others are usually unhealthier people.

"The whole point of health care reform is to make sure that everyone gets insurance," says Dick Woodruff, senior director of federal relations at the American Cancer Society-Cancer Action Network in an NPR interview. "And if people have to pay more because they're unhealthy, that's a barrier. It defeats the whole purpose."

After the jump - why wellness incentives make sense

Continue reading " Editorial: Wellness Incentives May Not Be "Fair" - But Is That OK? " »

It’s not just a new techo-fad – the federal government is serious about Electronic Health Records.

How serious? Enough so that one of the many health care-related provisions tucked into this year’s American Recovery and Reinvestment Act (a.k.a. the Stimulus Bill) mandates that health care providers make “meaningful use” of Electronic Health Records (EHRs) by 2011. Providers who fail to do so will be penalized in the form of reduced Medicare and Medicaid reimbursements. However, the proverbial “carrot” is that providers who do make meaningful use of EHRs can receive thousands of dollars in Medicare/Medicaid incentive payments, as well as grant monies to help implement EHR systems.

According to an open letter released earlier this month by David Blumenthal, the National Coordinator for Health Information Technology, eligible physicians (including those in solo or small practices) who make “meaningful use” of certified EHRs can receive up to $44,000 over five years in Medicare incentive payments, or $63,750 over six years under Medicaid. Hospitals that become meaningful EHR users could receive up to four years of financial incentives payments under Medicare beginning in 2011, and up to six years of incentive payments under Medicaid beginning in October 2012.

What is “Meaningful Use”?
The question most providers are undoubtedly asking at this point is – what exactly does “meaningful use” mean? A formal definition of what constitutes “meaningful use” will be issued by the Centers for Medicare and Medicaid Services (CMS), which is scheduled to publish a definition by December 31.

After the jump - a glimpse at what may constitute "meaningful use"

Continue reading " Health Care Providers Should Prepare to Make “Meaningful Use” of EHR " »

A previous Health Care Lawyer Blog post trumpeted the arrival of the “America’s Health Future Act of 2009”, a.k.a. the Senate Finance Committee’s stab at health care reform legislation. The “bill” which was released in the form of a Chairman’s Mark, will be voted on today by the Finance Committee. The 10-year, $829 billion plan would require all Americans to purchase health insurance, and includes measures to control rapidly-increasing medical costs.

One of the notable amendments to the bill is a “wellness” provision that will “incentivize Americans to lead healthy lifestyles in order to lower their overall health costs.” The provision, championed through by Sens. John Ensign (R-NV) and Tom Carper (D-DE), expands existing HIPAA wellness program regulations that allow employer-sponsored insurance plans to reduce premiums for employees who lose weight, quit smoking, control their blood pressure or practice other healthy behaviors. Current rules allow premiums to vary to up to 20 percent of a worker’s total health insurance premium. Under the Ensign/Carper amendment, that could rise to up to 50 percent.

If approved, the bill – which does not contain a public-option – must be merged with another bill proposed by the Senate Committee on Health, Education, Labor and Pensions, which does include a public option. Since the Democrats hold a 13-to-10 majority on the Finance Committee panel, it is almost certain the bill will pass.

Stopping health care fraud is by no means an easy task. New figures released by the U.S. Department of Justice, however, reveal hundreds of instances where whistleblowers have reported health care fraud, but the U.S. Government has let the cases languish for months or even years while deciding whether to get involved. In effect, the government has been tipped off on potential fraud, but has not taken action.

According to numbers released from the U.S. Department of Justice (USDOJ) to Sen. Charles Grassley (R-Iowa), there are currently 985 health care-related qui tam/False Claims Act cases pending a decision from the USDOJ on whether or not to intervene. Under the federal False Claims Act, a private individual who is aware of fraud against the government can file a whistleblower or "qui tam" lawsuit against the defendants. Once the case is filed, the government must make a decision to intervene. However, as noted by Grassley, such cases often sit stagnant for months or even years while the government makes an intervention decision. Specifically, USDOJ data shows that on average, it takes the Department of Justice 12.3 months to decide whether to intervene on a case.

“These cases were brought forward by patriotic individuals who are sticking their necks out to do what’s right. We can’t just let these whistleblowers sit in limbo for years while the federal bureaucracy takes its time deciding what to do,” Grassley said in a statement Thursday. “I want to know what the Justice Department needs in order to speed up these decisions. People who put everything on the line to speak up when they think there’s fraud against the taxpayers can’t live their lives this way.”

Click here for the full report.

As a follow-up to last week's post about GlaxoSmithKline's new CME standards, it appears that some pharmaceuticals companies are not so keen on self-regulation. Allergan Inc., the company that produces the Botox wrinkle treatment, has filed a lawsuit against the Food and Drug Administration (FDA) claiming that the FDA prohibitions on off-label marketing violate the company's right to freedom of speech.

The lawsuit, which was filed last Thursday in the District of Columbia federal court, names the FDA and U.S. Government as defendants. In the suit, Allergan claims that it should be able to educate physicians about the risks and benefits of using Botox treatments for unapproved uses. While physicians may legally prescribe drugs for uses that are not approved by the FDA, drugmakers are forbidden from actively marketing "off-label" uses or encouraging physicians to prescribe them for such.

Botox is approved by the FDA to smooth wrinkles, as well as treat some kinds of muscle disorders. But last April, government officials warned health care providers and patients about potential deadly risks for unapproved uses, such as treating muscle spasms. Specifically, the drugs carried a risk of botulism symptoms, especially when given to children to help alleviate muscle spasms. The warnings resulted in updates to Botox's "black box" packaging label, which now urges physicians to tell patients about the risks associated with botulin-based drugs.

After the jump - how viable are Allergan's claims?

Continue reading " Drugmaker Claims Off-Label Marketing Restrictions Violate Free Speech " »