Juvan's Health Law Recap--January 28, 2007

It's hard to believe that January is already coming to a close.  I immediately realized that we are full speed ahead into 2007 when I arrived at the gym this week, only to find that the parking lot was half full and that many of the good intentioned New Years resolutioners had dropped off!

President Bush's State of the Union address occupied the media last week.  I covered President Bush's proposed solution to the health care insurance crisis a week ago, so I will not delve too deeply into these issues again.  The Washington Post has followed the fall-out of Bush's proposal in two articles, one of which discusses the winners and losers in the plan (those who would buy individual insurance plans and those with employer-sponsored plans, respectively), and another of which states that the President's proposal received a "frosty reception from the Democrats."  Bush's proposal may be falling on deaf ears, as his support is waning.  As the bid for the White House looms closer, Juvan's Health Law Update will follow objectively (to the greatest extent possible) each of the candidate's views on health care. 

Last week I also had the most sincere pleasure of meeting Rita Schwab, author of the popular health care blog known as the MSSPNexus Blog, which I highly recommend.  For those of you who are unfamiliar, "MSSP" stands for medical staff service professional.  Rita currently works in provider credentialing at the Cleveland Clinic.  In addition to hosting the Health Wonk Review in the past (and receiving many accolades for her incredible coverage, I might add), Rita also covers provider credentialing, Joint Commission accreditation and patient safety concerns on her blog. 

Rita and I had a wonderful conversation over lunch at the "Blog Cafe," as she calls it.  We discussed issues affecting physicians and patients such as malpractice concerns and how the patient and physician communities might be brought more closely together.  We also discussed our love for blogging and how incredible it is to connect to new found friends from all over the globe.  I feel extremely fortunate to have met Rita, and so many other friends, through blogging!

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Meditating to Mental and Physical Health

In this technology age, most of us are wired, and many of us stay connected to the outside world for more hours than we care to admit.  We have blackberries and cellphones, many have their own blogs and some of us even produce our own podcasts.  Whether we are in the car, the grocery store or in a meeting, we're listening to our I-Pods, checking our blackberries or talking on the phone.  If you do decide to put your cell phone or blackberry away even for a few hours, you may feel a sense of regret, as it takes a significant of time to catch up on the hundred e-mails that came in and the several voice mails received.  The new age 24 hour economy often makes execs and employees feel run down and worn out, but, in America at least, most of us just pop a few pills to feel better and go on our way....

....Except for Katherine Ellison and about ten million other Americans, that is.  Like Ellison, many Americans have taken up meditation and yoga to reduce stress and enhance quality of life.  Ellison, who had thyroid surgery and brain surgery within three months and broke both arms not long thereafter, dealt with the physical and emotional trauma by meditating.  Speaking of the growing popularity of Asian healing and spirituality, in a recent Washington Post article, Ellison writes, "As our big demographic bulge of boomers hits the years when mortality truly starts to sink in, Asian spirituality has suddenly become more mainstream than ever." 

Ellison also writes of a woman who, like her, turned to meditation during a time of suffering.  Though the woman said that she initially resisted meditation, writing it off as "New Agey" and weird, and concerned about potential brainwashing, her opinion changed after her first experience, when meditating "brought [her] mind and body into the same timezone, [giving her] a sense of wholeness and peace [she'd] never experienced before."  She also experienced several other defining moments.  During one moment, she recognized the reality of her own mortality and questioned, "So what am I going to do with my life?  Am I doing the right thing with the short time I have on Earth?"

Indeed, as the article suggests, meditation, as well as integrative medicine therapies, can serve to help patients cope with illnesses and individuals in good physical health to deal with the daily stresses of life and emotional traumas.  Meditation, yoga, massotherapy, reiki, and Therapeutic Touch, for example, are just a few non-traditional (at least in a Western sense) therapies available.  I personally have experienced the benefits of these therapies, as I practice yoga to decrease stress and level out energy fields.  My mother, a Her-2 positive breast cancer survivor, also turned to reiki and meditation through her Adriamycin/Cytoxan chemotherapy treatments.  Still to this day, she cites to these treatments when she discusses her treatment experience, saying that they helped her to cope with the horrifying side effects of chemo and the emotional pain that accompanies a cancer diagnosis.

From a legal perspective, though many integrative medicine therapies are safe and may even be effective, the current legal and regulatory scheme in the United States makes it difficult for patients to gain access to these therapies.  Most insurance companies do not provide coverage for integrative therapies.  States and medical boards also fail to license and credential complementary and alternative medicine providers in a fashion similar to that of physicians and other providers of conventional medicine. Such legislative recognition, however, could bring increasing credibility to these practices.  Traditional Western medicine providers can also face direct liability for referrals to CAM providers.  Michael H. Cohen, the leading scholar and authority in the United States on the legal issues facing CAM, provides a table of potential CAM liability grounds on his Complementary and Alternative Medicine Law Blog.  For example, clinicians and associations may be liable for referrals to CAM providers on vicarious liability grounds, for patient abandonment, negligent referral or delay of effective conventional medical treatments.

Cohen has worked tirelessly to bring credibility to CAM and integrative medicine therapies and to bring about change in the law in the United States so that these therapies are made available to more individuals.  In addition to being an assistant professor at Harvard Medical School and the Harvard School of Public Health, he is also the founder of the Institute for Integrative and Energy Medicine.

If you are interested in furthering the development of the Institute, please contact Michael H. Cohen directly.

"Compliance Perspectives from The New York Times Magazine Ethicist" Randy Cohen

The Healthcare Update News Service has made available a presentation by The New York Times ethicist Randy Cohen given in November 2006 at the Seventh Annual Pharmaceutical Regulatory and Compliance Congresses and Best Practices Forum.  In the speech, after discussing the ethics of Benjamin Franklin, Aristotle and the pursuit of "Happiness" (yes, that's Happiness with a capital "H"), Cohen suggested that physicians are insulted by the insinuation that pharmaceutical companies' luxurious gifts have an effect on decision making.  Scoffing at the notion that physicians can truly make independent decisions if they are given gifts by pharmaceutical companies (if gifts do not impact decisions, then are pharmaceutical companies providing them simply because they are altruistic?), Cohen questions whether the character of individual physicians is really what is at the root of the problem.  Is the problem that individual physicians who allow gifts to impact decisions simply have poor character?  Or is the real problem instead that the medical community has failed to set appropriate ethical standards and has ineffectively regulated, thereby leading to unethical decisions and corruption?

Instead of character determining behavior, circumstances and communities, he suggests, are what determine how human beings behave.  If you place good apples in a bad barrel, Cohen says, the bad barrel corrupts everything.  On the other hand, if you create moral and ethical communities, it's amazing how well people will behave.  Most human beings behave in a similar way as their neighbors--the so-called "community effect." 

If what Cohen says is true--that communities determine behavior--then the solution to the issue of the damaging impact of gifts by pharmaceutical companies to physicians requires a moral and ethical regulatory structure.  Additionally, outside oversight (when someone from an outside community comes in and suggests that change is necessary), he suggests, helps.  Decisions cannot be left only to individual judgment.

Moral conduct, Cohen concludes, is a function of circumstances.  Good conduct is possible, but only in a just society.

 

Juvan's Health Law Recap--January 21, 2007

Last week,  many news stories centered around proposals by both the public and private sectors to provide coverage to the millions of uninsured.  President Bush, preparing for his State of the Union address, foreshadowed his proposal in his weekly radio address, and a large coalition of companies also launched a multi-phase proposal to expand coverage.  Meanwhile, Senator Grassley, in a defensive move, is preparing to filibuster the legislation recently passed by the House of Representatives that requires direct negotiation of Medicare Part D covered drugs, and Senator Leahy introduced legislation prohibiting reverse payments, or payments by brand-name drug companies to generic drug companies in return for a promise to delay market entry of generic equivalents. 

Grassley May Filibuster Direct Negotiation Legislation

Recently, the House of Representatives passed legislation requiring direct negotiation with pharmaceutical companies for lower-priced prescription drugs covered under the Medicare Part D program.  As reported by FDA News, Senator Chuck Grassley (R. Iowa) is now considering a filibuster to stop the measure because he believes the legislation may have sufficient bi-partisan support for passage.  Apparently, Grassley believes that he has the requisite backing to make such a move.

Bush Foreshadows Initiative to Help Uninsured

On Saturday, President Bush previewed a plan to provide a financial incentive to Americans to purchase health insurance during his weekly radio address.  Bush stated, "Today, the tax code unfairly penalizes people who do not get health insurance through their job.  It unwisely encourages workers to choose overly expensive, gold-plated plans.  The result is that insurance premiums rise and many Americans cannot afford the coverage they need." 

As reported by the Washington Post, Bush's plan would "add a new tax on employer-provided health-care plans worth more than $15,000 to subsidize those who buy modestly priced plans out of their pockets."  Bush also hopes to provide Medicaid waivers that allow states to shift Medicaid funds away from nursing homes and hospitals instead grant funds to individuals so that they can purchase health insurance.  Bush is expected to provide further details of his plan in his State of the Union Address on Tuesday evening.

Commenting on the proposal Post writer Michael A. Fletcher states that Bush's most recent proposal is his "most ambitious attempt to address the health-care crisis." 

Leahy Introduces Bill Prohibiting Agreements Postponing Generic Entry to Market

On Wednesday, Senate Judiciary Committee Chair Patrick Leahy (D-Vt.) introduced legislation that would effectively prohibit brand-name drug companies from entering into agreements with generic drug companies to delay the entry of generics to the market. 

Portions of the 1984 Hatch-Waxman legislation encourage generic drug companies to challenge brand-name drug patents by awarding a six month market exclusivity period if successful.  In response to suits filed, oftentimes brand name drug makers contract with generic makers to postpone market entry, leading to a win-win situation for both parties.  Many have attacked these arrangements, however, arguing that they are harmful to consumers because they delay the entry of lower priced generics. 

Commenting on the settlements reached between these two market forces, at a Senate Judiciary Committee Hearing, FTC Commissioner Jon Leibowitz stated that these settlements "restrict competition at the expense of consumers, whose access to lower-priced generic drugs is delayed, sometimes for years."  Bruce Downey, CEO of Barr Pharmaceuticals, fired back in a Bloomberg/Winston-Salem Journal article, stating "It's not the settlement that keeps the product off the market, it's the patent."

Coalition Drafts Proposal to Provide Health Care Coverage to Uninsured

Last week, a coalition of sixteen organizations put forth a plan that would provide health insurance coverage for half of America's nearly 47 million uninsured.  According to a press release issued by the Health Coverage Coalition for the Uninsured, the proposal was developed over a two year period. 

The plan proposes providing easier access to SCHIP and Medicaid programs for parents so that they may enroll their children when they simultaneously apply for other assistance programs, such as low cost lunches and food stamps.  Additionally, tax credits for those who earn up to three times the poverty level (or $60,000 for a family of four) would be available.  In addition, states would receive additional funding to enroll additional children and there would be a competitive grant program that would award funds to states that develop innovative approaches to expand coverage.

The second phase of the program expands Medicaid eligibility for adults and creates a refundable credit to help individuals pay for private insurance. 

The coalition organizations include the following:  AARP, American Academy of Family Physicians, American Hospital Association, American Medical Association, American Public Health Association, America's Health Insurance Plans, Catholic Health Association, Families USA, Federation of American Hospitals, Healthcare Leadership Council, Johnson & Johnson, Kaiser Permanente, Pfizer, Inc., United Health Foundation, U.S. Chamber of Commerce and Search for Common Ground-U.S. Consensus Council.

Senators Dorgan and Snowe and Representatives Emerson and Emanuel Introduce Legislation to Allow Drug Importation

On January 10, Senators Dorgan (D-ND) and Snowe (R-ME) and Representatives Emerson (R-MO) and Emanuel (D-IL) introduced the Pharmaceutical Market Access and Drug Safety Act (the "Act"), drafted to allow the importation of drugs from FDA registered and approved pharmacies abroad.  The news release issued by Senator Dorgan indicated more than thirty groups support the move (including the AARP) and that savings that could total up to $50 billion dollars in the next ten years.

Making the case for the proposal, the findings in Section 2 claim that

  • Americans pay the highest price in the world--up to five times the price that consumers worldwide pay--for prescriptions;
  • A drug is neither nafe nor effective if an individual cannot afford the cost; and
  • Allowing the importation of drugs would promote competitive pricing, result in savings, and make for greater access to therapy.

The Act allows for the importation of certain "qualifying drugs" in which there is a "U.S. Label Drug" equivalent.  Such drugs may be imported not only from exporters in Canada, but also from other countries as designated by Secretary of the Department of Health and Human Services.

Commenting on the Act, Dorgan stated, "Currently, the big drug manufacturers can monopoly price their medicines here and, as a result, American consumers pay the highest prices in the world for prescription drugs.  The fact is, miracle drugs perform no miracles for people who can't afford them."  Likewise, Senator Snowe stated, "This legislation leaves no stone unturned to assure that the importation of prescription drugs will be safe and meet the requirements of the Food and Drug Administration, while delivering real savings to American consumers." 

Others have criticized the Act, however.  Dr. Adam Fein of the hit blog Drug Channels, in his article "Real News About Fake Drugs," references prior articles covering the dangers of reimportation and states that he finds "it highly ironic that the proposed legislation includes 'drug safety' in its title."   

FDA Proposes Additional User Fees, Undertakes to Improve Postmarket Safety

Last week, the FDA released a preliminary proposal to increase user fee collections by $87.4 million to enhance postmarket surveillance of drugs, drug development and review of television advertising.  The proposal will only take effect if the FDA ultimately submits the proposal to Congress and Congress, reauthorizing the FDA's Prescription Drug User Fee Act (PDUFA), adopts the FDA's recommendations.  

The FDA intends to allocate $29 million of the increase to postmarket surveillance, allowing the FDA to, among other measures, hire an additional 82 employees, and $6.2 million to fund review of direct-to-consumer advertising, allowing the agency to hire 27 new employees.  An additional 4.6 million would fund the implementation of the guidance for the FDA's reviewers, and $4 million would be spent on the shift to an "all-electronic environment." 

In addition to increasing the user fees, the FDA also recommends that Congress eliminate the statutory provision that allows the FDA to use PDUFA fees only during the first three years after a product receives FDA approval.

The Federal Register Notice is available online.  The FDA will hold a pulic meeting on February 16, 2007, to present its proposals.  Comments are due on February 23, 2007.

Stark, Scully Speeches Available Online

The National Medicare Congress has made available speeches of Congressman Pete Stark and former CMS Administrator Tom Scully given at the Third National Medicare Congress on October 15 through 17, 2006, three weeks before the November 2006 elections.  In his speech, Congressman Stark predicted that, given the divide in power between Democrats and Republicans, there will be no major legislation for the next two years.  With respect to his objectives, Congressman Stark stated that he desires to ensure that Medicare and Social Security do not end as an entitlement and desires to prevent the privatization of these programs.  Former CMS Administrator Scully's speech focuses on the "Role of the Private Sector in the Implementation of Part D," and he states that he's "amazed about how Medicare Part D has turned out." 

PDMA Update: NAIPW and AIPWA Propose National Pedigree Requirements

Last week, the National Association of Independent Pharmaceutical Wholesalers (NAIPW) and the Association of Independent Pharmaceutical Wholesalers of America (AIWPA) issued recommendations for national pedigrees.  The NAIPW and the AIWPA were both founded by Robert C. Drucker, President and CEO of RX USA Wholesale, Inc. and Mark S. Scovotti.  Continue Reading...

Dems Introduce Legislation Requiring Medicare Prescription Drug Price Negotiation

On Friday, Congressman Dingell, on behalf of himself and 189 co-sponsors, introduced H.R. 4 to amend the Social Security Act to require the negotiation of prices for Medicare Part D covered drugs.  Continue Reading...

Kaiser/Harvard Study Finds Most Seniors Pleased with Medicare Part D Coverage

A study conducted by the Kaiser Family Foundation and the Harvard School of Public Health found that 56% of seniors enrolled in a Medicare prescription drug plan have a favorable impression of the drug benefit.  Continue Reading...

OIG Releases "Prescription Drug Plan Sponsors' Compliance Plans" Report, CMS to Audit Compliance Plans Beginning in January 2007

 According to 42 C.F.R. section 423.504(b)(4)(vi), prescription drug plan sponsors approved to provide Part D benefits must have compliance plans that articulate (1) commitment to comply with applicable laws; (2) designation of a compliance officer and committee; (3) effective training and education of employees and agents; (4) effective lines of communication between the compliance officer and the employees and agents; (5) the enforcement of standards through publicized disciplinary guidelines; (6) procedures for audits and internal monitoring; (7) the procedures for ensuring prompt response to detect offenses and development of corrective action; and (8) a comprehensive plan to prevent and detect fraud and abuse, which includes procedures to voluntarily self report fraud or misconduct.  The OIG undertook a review of stand-alone prescription drug plan sponsors' compliance plans to determine compliance with these eight elements, along with the seventeen requirements set forth in CMS's Prescription Drug Benefit Manual. 

Continue Reading...

PDMA Update

Recently, the Department of Health and Human Services filed its Answer in RxUSA Wholesale, Inc. v. Department of Health and Human Services.  The FDA has also issued industry guidance about the injunction, a brief description of which is contained in this article. Continue Reading...

Q & A on Employee Education About False Claims Act Recovery

The Centers for Medicare & Medicaid Services ("CMS") will host a briefing about the requirement mandated by the Deficit Reduction Act of 2005 that certain employers educate their employees about the False Claims Act.  The briefing will take place on Thursday, January 11, 2007, at 1:00 p.m. EST.  The call will last ninety minutes.  To participate on the call, dial 1-888-677-1819 and enter the password "provider."  You will also need to reference the call leader's name, Aaron Wesolowski.

Guidance on the DRA's section 6032 mandate was issued to State Medicaid Directors on December 13, 2006.