HealthLawProf Blog

Medical Malpractice Crisis:

The Washington Monthly's Kevin Drum reports that medical malpractice insurance premiums are steady for this year, and thus, the end of the "medical malpractice crisis" may be at hand.  He cites to a report from the Americans for Insurance Reform, which  states,

Contrary to the medical and insurance lobbies’ message — that medical malpractice lawsuits and claims were to blame for the increase in insurance rates — the fact is that in 2001, commercial property insurance rates jumped across the board. In other words, rate hikes for doctors were only a small part of a much larger insurance problem that affected homeowners, motorists and all kinds of policyholders..

Gosh, what will lawmakers do now . . . . [bm]

 

Wisconsin Senate Passes Bill Denying Benefits to Undocumented Aliens

From today's Kaiser Famiily Foundation Health Policy Today:

Wisconsin Senate Passes Bill Denying Public Benefits to Undocumented Immigrants
     Applicants for public benefit programs in Wisconsin would have to prove they are legal residents under a bill the state Senate on Thursday voted 19-14 to approve, the AP/Milwaukee Journal Sentinel reports. The bill, which has yet to be considered by the state Assembly, would apply to the state's medical assistance programs such as BadgerCare and SeniorCare, as well as the state's welfare-to-work program and programs that pay for funeral and burial expenses for low-income people and others. Sen. Tom Reynolds (R) said it would be up to each agency to determine the type of documents applicants will have to present to confirm their legal status. The state Department of Health and Family Services currently does not allow undocumented immigrants to receive benefits, according to department spokesperson Stephanie Marquis. She added that one exception is that the federal government requires the state to provide benefits to anyone in a health emergency, and it is uncertain if that practice would be outlawed by the state bill (Foley, AP/Milwaukee Journal Sentinel, 2/23).

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Tenet Settles Outlier Rico Case with Florida

From AISHealth.com's "Government News of the Week" site:

In a Robin Hood-like resolution to allegations of Medicare outlier payment fraud, most of Tenet Healthcare Corp.’s $7 million settlement with the Florida attorney general (AG) will be turned over to the public hospitals that claim they were the losers of Tenet’s alleged outlier games.

AG Charlie Crist alleged that Tenet violated the Racketeer Influenced and Corrupt Organizations (RICO) Act when it engaged in a scheme to leverage more Medicare outlier payments than it was entitled to by inflating charges for its services between 2000 and 2003. Because Medicare caps outlier payments in advance annually, hospitals that take too much are depriving hospitals of needed funds, according to a March 2005 complaint filed by Crist and 13 public hospitals that lost money to Tenet’s activities. (Outlier payments are Medicare add-ons for resource-intensive patients who cost far more money to treat than the money hospitals get from DRG reimbursement.)

The lawsuit, filed in the U.S. District Court for the Southern District of Florida, alleges that Tenet inflated its hospital charges so patients qualified for outlier payments. “By artificially inflating their billed charges, the Tenet Hospitals transformed ordinary or average-cost [inpatient prospective payment system] patients into outlier patients, even though the costs actually incurred by the hospital to treat those patients fell within the norm and, therefore, would not entitle the hospital to receive outlier payments,” the suit says.

The Feb. 21 settlement calls for Tenet to put $4 million into an “Uninsured Patient Fund.” The public hospitals that are parties to this case will submit requests for money from the fund to cover the costs of treating indigent patients who aren’t covered by Medicare, Medicaid or other payers, the settlement states. An additional $2 million will be distributed directly to the hospitals, and $1 million will be returned to the AG to cover the costs of the investigation.

Tenet “explicitly” denies the RICO allegations, says spokesman Harry Anderson. . . .

This settlement is just the tip of the iceberg of outlier cases against Tenet, says former OIG attorney Paul Danello. Anderson says Tenet is cooperating in a DOJ investigation of its pre-2003 outlier payments. . . .

Reprinted from the Feb. 27, 2006, issue of REPORT ON MEDICARE COMPLIANCE,

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South Dakota's New Abortion Law

Some really useful stuff from Law Librarian (and blogger) extraordinaire, Joe Hodnicki, on South Dakota's Women's Health and Human Life Protection Act:

• Legislative History of South Dakota's Women's Health and Human Life Protection Act
• See also "South Dakota Governor Expected to Sign HB 1215, The Women's Health and Human Life Protection Act"

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Changes Coming to Medicare Part D

Kate Steadman, an editor and contributor to TPM Cafe as well as her Healthy Policy blog, writes about some changes that CMS has suggested on Friday to make Medicare Part D work better.  She is not too thrilled with either proposed change.  She states,

In a major reversal, CMS (Center for Medicare and Medicaid Services) sent out a call for suggestions on Friday to fix Medicare Part D. 

Half the battle has been won; the Administration has finally recognized that changes need to be made.  That's a major step towards fixing the legislation.  Unfortunately (but unsurprisingly), CMS's two suggestions are lackluster:

The agency proposed limiting to two the number of drug plans a company can offer per region. Many insurers now offer three, and since there are often more than a dozen insurers per region, consumers often have more than 40 choices.

The agency also said it expects that an insurer's two plans must have meaningful differences to make comparisons easier.

Doing a little math, if there's 40 plans now with insurers offering three, there would be 26 plans per region after limiting plans to two. But there's no qualitative difference between offering 26 and 40 plans.  Both numbers are much too large to compare.    

For more on these suggested changes and Ms. Steadman's views, click here. [bm]

More on Bird Flu

The New York Times has an informative article about the spread of the bird flu to Nigeria and France.  It doesn't look good when your President is eating chicken to calm people's fears.  According to the Times the bird flu seems to be spreading rather rapidly, 

The announcement on Saturday that the deadly strain of bird flu was discovered in domesticated turkeys in France has disrupted the country's $7 billion poultry market and raised fears among the French that they could be vulnerable to the disease.

   

President Jacques Chirac, a former agriculture minister, met with farmers and veterinarians on Saturday morning at the opening of France's annual international agricultural fair and urged calm.

There is no "absolutely no danger in eating poultry and eggs," Mr. Chirac said, eating a chicken dish to press the point. He said that the industry had been "profoundly hurt and disrupted," and that "a completely unjustified sort of total panic" was developing.

For the first time in the fair's 42 years, no live birds are on display.

Detection of the A(H5N1) flu strain on a turkey farm in eastern France represented the first time the virus had been found in farm animals in the 25 countries of the European Union.

France had already been reeling from the news that a wild duck, found dead nearly two weeks ago in the department of Ain, the same area where the turkey farm is situated, had been infected.

Those fears, followed by the confirmation on Saturday that a farm with a flock of 11,000 turkeys had been struck by the disease, have sent poultry sales plummeting.

As always, the Effect Measure blog has excellent reporting on this issue.  [bm]

New Medicaid Case in the Supreme Court

It will be argued on Feb. 27, and Cornell's LII has a fabulous preview of the case today.  Click here for the full Monty.  Meanwhile, if you want the short version, here's an excerpt:

Ark. Dep’t of Human Servs. v. Ahlborn (04-1506)
Court appealed from: United States Court of Appeals for the Eighth Circuit (Feb. 9, 2005)

Oral argument date: Feb. 27, 2006

MEDICAID, SUPREMACY CLAUSE, HEALTH CARE, PROPERTY
Medicaid provides certain needy individuals with funds for medical treatment. The program is administered by the states with federal funding and statutory guidelines. Federal Medicaid law generally forbids states from placing liens on the “pre-death” property of Medicaid beneficiaries. The Arkansas Medicaid program requires beneficiaries to sign over their interest in any future legal claim before receiving benefits. Technically, this case will decide whether the federal statutes prohibit states from doing this. More importantly, the decision will determine to what extent states can recoup Medicare expenses from private tort judgments and settlements, and could have a profound effect on how the costs of the Medicaid are distributed between the states and private parties.

Question(s) Presented
Do federal Medicaid statutes limit the amount a state can recover in reimbursement from a third-party payment to the portion earmarked for medical treatment?

Issues
If a party receives Medicaid benefits for an injury, and later receives a settlement payment from a third party, can the state force the party to use the entire settlement to repay the state’s Medicaid expenses?

LII does a fine job summarizing the case, though the summary does end with a thud: "In this case, the Court will be forced to choose to protect either the assets of poor injury victims or the states. On the one hand, a decision for Ahlborn would ensure that injury victims are properly compensated for lost wages. On the other hand, a victory for the states would ensure that victims don’t improperly structure injury settlements. What is clear, is that one side will end up with less money."  Thanks for that, guys.  [tm]

Implementation of Medicare Part D

Below if the testimony of Walgreen's CEO concerning how Medicare Part D is working from their perspective.

Testimony of David W. Bernauer
Chairman and Chief Executive Officer
Walgreen Co.

February 08, 2006

Chairman Grassley, Ranking Member Baucus, and Members of the Senate Finance Committee, I am David W. Bernauer, Chairman and Chief Executive Officer of Walgreen Company, which is based in

Deerfield

,

Illinois

. I am pleased and honored to be here today to participate in this important hearing of the Senate Finance Committee on implementation of the Medicare Part D prescription drug benefit program.

Walgreens is the nation's largest pharmacy chain with sales of more than $42 billion last year. We have provided pharmacy service to patients for 105 years and have more experience meeting the prescription needs of patients than any other pharmacy in the country. Today, we operate more than 5,100 pharmacies in 45 states and

Puerto Rico

, employ nearly 20,000 pharmacists and will dispense more than 500 million prescriptions this year.

Preparing Walgreens for Medicare Part D

Walgreens and the chain drug industry in general recognize that Medicare Part D is the most significant expansion of Medicare since its inception. We are pleased that millions of additional seniors now have access to prescription drug coverage as a result of the new Part D benefit. However, there have been several important challenges for beneficiaries and pharmacists in transitioning to the new Part D benefit.

We appreciate all the steps that have been taken by CMS, states, and plans to work with us to ease this transition for beneficiaries and pharmacists. For example, we appreciate all the time and effort expended by CMS in working with our industry and the health plans in developing the “TrOOP facilitator”. This tool allows pharmacies to electronically query a special database that is supposed to instantaneously return information to the pharmacist about the Part D plan in which a Medicare beneficiary has been enrolled, including the beneficiary's billing information. It will also facilitate coordination of benefits with other payers. The development of the TrOOP facilitator was a very important public-private partnership that should serve as the model for how current and future Medicare Part D implementation issues are addressed.

We appreciate the fact that many senior HHS and CMS officials have visited dozens of retail pharmacies across the nation over the past few weeks – including Walgreens' pharmacies – to see first hand the challenges that pharmacists and beneficiaries are having with Part D. We know from talking with them that these visits have been an eye-opening educational experience. We hope these visits have helped them better understand the environment in which we provide pharmacy services and result in practical ideas and solutions for addressing the issues that were brought to their attention.

At Walgreens, our pharmacies are committed to helping seniors understand the new Part D drug benefit. Like many other chain pharmacies, we developed an extensive education and outreach program to train our pharmacists, district pharmacy supervisors, and other senior personnel about Part D. We've had more than 1,400 pharmacy staff employees volunteer to speak in their communities to senior groups about Part D and educate them on the benefits and enrollment process. In fact, our pharmacists will continue these senior outreach efforts throughout the enrollment period. Twice last fall, we held week-long Medicare Part D information days at our pharmacies nationwide. We also developed our own Medicare prescription insurance plan report - called the Walgreens Rx Savings Advisor - which provides seniors with a free, personalized list of Part D plan options based on their current prescription drug needs. We have provided 500,000 individually, personalized reports to date, including 282,000 in January alone. Our patients have found this to be an important part of their decision process in selecting a Medicare Part D drug plan.

In addition, many of our pharmacists have taken extra time and effort to learn the “ins and outs” of Part D so they can help beneficiaries understand how to make the most of the new drug benefit. Pharmacists are also doing all they can to be sure that Medicare beneficiaries' prescriptions are filled in a timely manner. I know that many of our pharmacists have worked long hours to obtain correct billing information for beneficiaries as well as correct copay information. I cannot say enough about the dedication of the pharmacists that work for Walgreens – and pharmacists all across the country – in trying to make this benefit work.

Walgreens knew that implementing Part D would be a monumental task, and that the proverbial “rubber would meet the road” at the 52,000 community retail pharmacy counters across the country. Consequently, we did everything possible to prepare our pharmacists and pharmacy staffs understanding they would have an essential role in making the program work. That's because pharmacists know their patients' medication needs, and are ultimately responsible for providing them with their prescriptions. Pharmacists know the importance of medications in managing the chronic medical conditions of the elderly.

Current Implementation Issues with Part D

We want to provide you with an honest assessment of how the Part D program is going from the pharmacy perspective, now that we are well into the second month of the program's operation. In general, implementation of the program is going better as compared to the early weeks of the program. This is due primarily to tens of thousands of individual efforts by CMS staff, the insurance plans, and pharmacists across the country who found ways to navigate through the roadblocks of determining coverage for their Medicare patients.

As more and more beneficiaries receive their actual identification cards from Part D plans, and CMS and the plans enter data into the TrOOP facilitator more quickly, the situation is improving. Today, the chances are greater that the beneficiaries' plan and billing information will be active when the beneficiary comes into the pharmacy as compared to a few weeks ago. In fact, the lack of accurate data in the system was the primary reason why so many low income individuals may have been charged higher copays than they should have been charged.

Walgreens would like to make some recommendations on how CMS, states and Part D plans might address some of the implementation issues we are having with Part D:

Modify Enrollment Effective Dates: Because individuals are becoming eligible for Medicare everyday, and the dual eligibles have the option of changing plans every month, one systemic issue that needs addressing is what's commonly referred to as the “enrollment lag”.

Right now, a beneficiary can join a Part D plan anytime during a month and expect the enrollment to be effective the first day of the next month. But if they apply in the last few days of the month, it is not possible for CMS and the plans to process the beneficiary's application, confirm eligibility with CMS, and provide the critical “4Rx” billing information to TrOOP facilitator – so that it is in the pharmacy system - in such a short timeframe.

In fact, the lack of data in the system as a result of late-month enrollments or plan switches has been, and may continue to be, the single most challenging issue that pharmacists face with Part D. If we don't have the data, we cannot fill the prescription, and that triggers a whole series of potential calls to CMS and the plans to obtain this billing information. For this reason, we suggest that policymakers address the ”enrollment lag” issue.

Multiple options are available to address this issue, and we want to work with CMS and plans to find a solution. Some see the solution as educating beneficiaries that, by enrolling late in a month, there will be delays in the activation of their prescription drug coverage. Others have suggested that an enrollment deadline be established each month so that there is sufficient time to process applications and enter the billing information in the system. Whatever the options, it is important to address this systemic issue soon.

Promote Standardization among Plans' Policies and Procedures: Virtually 100% of all prescription claims are processed electronically today, making pharmacy claims processing far more efficient than any other segment of health care. Yet, third-party prescription administrative issues still consume almost one-quarter of the average pharmacist's work time. These administrative tasks have further multiplied as Part D has come on line due to the dozens of new Part D plans each having their own policies, processes and procedures for pharmacists to follow in order to fill prescriptions.

Like most chain pharmacy companies, Walgreens has developed standard workflow processes in our pharmacies that allow for the most efficient filling of prescriptions. But, these varied and onerous third party prescription processing issues disrupt the pharmacy workflow and dramatically reduce the efficiency in filling prescriptions for Medicare beneficiaries.

We would all agree that the pharmacist's time is better spent interacting with Medicare beneficiaries and other patients, helping them to understand how to take their medications, rather than sorting through paperwork. In addition, the tens of thousands of hours spent each year by pharmacy personnel in resolving these third party administrative issues needlessly drive up the costs of these programs for plans and the Federal government. Thus, it would seem to be to everyone's benefit to reduce the administrative costs of processing prescriptions.

To that end, we urge CMS to use its leverage, as the largest payer for prescription drugs in the nation, to bring plans and pharmacies together to create and require more standardization in third party prescription claims processing, pharmacy messaging, and procedures that would benefit Medicare Part D, Medicaid, and other Federal health care programs. For example:

· Some Part D plans require that we fax forms to physicians to obtain prior authorization to dispense some medications, while other plans require us to call the plans' “help desk.” We need plans to develop consistent and standard messages and procedures for pharmacists. For example, all plans should have the same method for overriding messages on non-formulary drugs and for dispensing transitional supplies of medications. We also suggest that CMS standardize the plans' transition policies to reduce confusion among pharmacies and beneficiaries, and do a much better job of explaining the policies on the front end.

· Part D plans should also develop consistent messages to pharmacies that differentiate when a drug is “non formulary” in contrast to when a drug is “not a Part D covered drug”, such as a benzodiazepine. A message that simply tells the pharmacist that a drug is “non formulary” is not descriptive enough for the pharmacist to make this distinction.

Because of the lack of clarity in the message, some pharmacists may spend time seeking approval from Part D plans for a drug that would never be covered under Part D. This is a poor use of time for the pharmacist, the plan, and the beneficiary.

If a plan is not going to cover a drug because it is not on the formulary, the pharmacist needs to know that information at the point of sale, so they can take necessary steps to bill any other wrap-around coverage that the beneficiary might have.

· Part D plans also need to return information to the pharmacist about formulary medication options if the medication prescribed by the physician is a non-formulary drug. The infrastructure is in place to allow for this, but no one has required plans to do this. This has become, and will continue to be, a big issue with dozens of Part D plans, each with a different formulary and different tiers within their formulary, not to mention that each plan can change the drugs on the formulary with a simple 60 days notice. It is literally impossible for pharmacists to keep track of all these formularies. Part D plans have posted formularies on their websites, and such information is also available through Epocrates, but it remains much more efficient for the pharmacist if the plan returns the information in a message to the pharmacist at point of sale. This reduces the wait time for the beneficiary and can reduce the number of inquiries to the plan; hence, the need for when a plan rejects coverage, it should include a message to the pharmacist indicating formulary options for the prescribed drug.

· It is important that we work through issues relating to when a drug is covered under Medicare Part B versus Part D. There is potential overlap for coverage under both programs depending on how a medication is being used and how it is being administered. We believe it's important to minimize the extent to which plans are using “prior authorization” on drugs that could be covered under either Part B or Part D. We need to work toward a solution that provides Part D plans with important clinical information from the Part B DMERCs so that the plan can determine whether the pharmacist should bill the drug to Part D or Part B without costly and burdensome prior authorizations.

Ensure that States Work Directly with Part D plans and CMS on Reimbursement: Many states felt compelled to step up to the plate during the early days of Part D implementation and cover the prescription drug costs and copays of some of their dual eligibles who couldn't obtain their drugs under Part D. We have been working with the states that have implemented these programs to ensure that we understand their interim policies. Some states have defined and implemented their programs better than others, and the wide variety of these programs has been another challenge to processing claims for dual eligibles.

Almost every state has indicated that they intend to seek recovery of the funds that they are spending for these temporary programs from Part D plans. Pharmacies have worked diligently to only bill these temporary state Medicaid programs as a payer of last resort. Pharmacists are making every reasonable effort to bill a Part D plan or the Wellpoint/Anthem Point of Service (POS) system, if the dual eligible individual comes to the pharmacy without their identification card, and/or the information cannot be found in the TrOOP facilitator. However, pharmacists cannot be expected to spend countless hours on the phone trying to get these two options to work before they bill a state.

States should work directly with Part D plans to recover any monies that they spent for Part D drugs without involving pharmacies as billing intermediaries. CMS has pledged to pay states for the costs of covered Part D drugs – without involving pharmacists - through a temporary demonstration program. To be eligible for this demonstration program, the state must cease operating their emergency coverage programs by February 15 th . That may be an unrealistic deadline if additional problems occur in February with the dual eligibles, so we urge CMS to approach that deadline with flexibility.

However, we think that CMS and the states should recognize that retail pharmacy does not want to be caught in the middle of recovery and collection efforts if states and plans have disputes regarding whether prescriptions should have been dispensed. We encourage states to carefully consider using this demonstration program to recoup their monies. We also ask CMS to use their influence to dissuade any state from using a pharmacy recoupment initiative to recover monies from Part D plans through retail pharmacies. Moreover, we urge CMS to require that states ensure that pharmacies are made whole for the tens of thousands of emergency prescriptions that they dispensed to Medicaid recipients when the pharmacist was unable to file a claim with a Part D plan.

Similarly, as in the case with states that are seeking recoupment of monies from Part D plans, we believe that pharmacies must not be caught in the middle of any payment reconciliation that might have to be made between Part D plans if, for example, the beneficiary has switched from one plan to another. Any adjustments that need to be made between plans in these situations should be done through a plan-to-plan reconciliation process, rather than involving retail pharmacies as billing intermediaries. We encourage CMS to do all they can to encourage plans to complete work on the plan-to-plan reconciliation process that was started several months ago to avoid these potential situations.

Addressing Part D Issues Moving Forward

Right now, we are all working together to address implementation issues in the very early stages of the new Part D benefit. We are making progress, but we obviously have more work to do and we are willing to do our part. The fact of the matter is that we may be fine-tuning this benefit for many years to come. Beyond the issues that we have already described, we see several other critical first-year implementation issues for the Part D program.

For example, we should consider that there will be significant challenges in moving millions of beneficiaries from the non-formulary drugs they currently take to a plan's formulary drugs. This will have to occur before exhausting their transition supplies of non-formulary drugs. This challenge will be especially pronounced for the dual eligibles. These individuals generally take more medications than other Medicare beneficiaries, so transitioning them to formulary medications should occur as soon as possible, but as safely as possible because of the time that it may take. We believe that CMS' recent decision to require plans to provide a 90-day supply of transition medications – rather than just a 30-day supply -- will ease the transition to formulary drugs.

However, plans, beneficiaries, and physicians must use this extended time frame to aggressively start the transition now. To that end, CMS must monitor whether plans are taking the necessary steps over the next few weeks to help beneficiaries understand what they need to do and how they need to do it in order to transition to formulary drugs, so that confusion and delay at the pharmacy are minimized. The burden of helping beneficiaries to transition their medications is a shared responsibility, not just the responsibility of pharmacists.

We also think that there could be a significant last-minute enrollment surge among beneficiaries before the May 15 th open enrollment deadline. This could create a sudden surge of individuals that want to use their benefit on June 1. The entire system needs to be prepared to process these applications quickly, get the information in the TrOOP facilitator, and be ready to fill prescriptions for these beneficiaries.

Finally, we are concerned about managing the expectations of individuals that will fall into the “donut hole” or coverage gap during the middle of the year. While many seniors were probably aware of the “donut hole” when they signed up for a plan, we are concerned that some did not or will not fully understand the issues relating to the “donut hole”. CMS and the plans should consider ways to help educate beneficiaries about the implications of the “donut hole” as the middle of the year approaches so that pharmacists do not bear all the burden of helping seniors understand this component of the benefit design.

Other Challenges Facing the Industry

While this hearing has been called to examine Medicare Part D implementation issues, we want to provide the Committee with our views on another important issue facing the industry. The Budget Reconciliation bill includes significant cuts to Medicaid. In particular, the bill would reduce payments to pharmacies for generic medications by about $6.3 billion over the next 5 years. Walgreens is very concerned about these cuts for several reasons.

· We are concerned that these reductions in payment will take away much of the incentive for pharmacies to dispense generic medications. We are perplexed why policymakers and the Congressional Budget Office (CBO) believe that decreasing generic payments will increase generic drug dispensing. The total reimbursement to Walgreens for a Medicaid single-source brand-name drug averages $128, while the average generic reimbursement is $20. Clearly, increasing generic utilization is the most effective way to reduce Medicaid costs. In fact, with these payment reductions, just the opposite will happen, leading to higher – not lower – drug costs to the government. We believe that many states will need to take action this year to increase their generic dispensing fee, or they may see a reduction in generic drug dispensing in their states.

· There is an aggressive implementation timeline for the new Medicaid pharmacy payment provisions included in the legislation. In fact, the first implementation milestone occurs this July when CMS is supposed to make Average Manufacturers Price (AMP) data available to the states and the public. We are concerned that, under the current definition of AMP, these data will not reflect the actual prices paid by retail pharmacies for brand and generic medications. As a result, they could provide a misleading picture to states, private plans and consumers about the true acquisition costs of retail pharmacies.

Unfortunately, these data will become public a whole year before CMS provides more specific direction to manufacturers on how to calculate AMP. That regulation is expected in July 2007. That means for at least a 12 months, data will be available in the public realm that may not accurately reflect retail pharmacies' acquisition costs for prescription drugs. We believe that these data should not be made public or shared with the states until the AMP can be more accurately, appropriately, and consistently defined.

· Reductions of this magnitude in Medicaid, coupled with the economic impact that Part D is having on pharmacy, will undoubtedly affect access to pharmacies. We do not believe that policymakers have considered the cumulative economic effect of these programs on the ability of retail pharmacies to continue to stay in business. Many pharmacies in the

United   States

– including those operated by Walgreens -- serve a high number of Medicaid recipients as a percentage of their business. If prescription revenues sharply decrease in these pharmacies as a result of Medicare Part D and generic payment reductions, these locations may have no option but to reduce hours or even close. This would seriously harm the ability to meet the health care needs of communities in which these pharmacies are located.

· The new Federal generic upper limits are supposed to be implemented in just 11 months – January 1, 2007. Given all the problems and issues that pharmacies have experienced with the January 1, 2006 implementation of Medicare Part D, we caution policymakers about implementing another major change in pharmacy payment streams in such a short period of time after Part D, and especially on January 1 st – which is already a date of great changes for pharmacies every year.

We urge that policymakers consider the delay or revision of these Medicaid pharmacy payment changes as the industry adjusts to the operational and economic challenges of Medicare Part D.

Conclusion

Walgreens appreciates the opportunity to go on the record regarding these implementation issues in the early stages of the new Medicare Part D benefit. We are committed to working with Congress, CMS, states, plans and beneficiaries to ensure that the benefit is delivered in the most efficient manner. We know that many of these issues will eventually be resolved, but other issues will develop down the road that will also have to be addressed. We ask that you call on us if we can provide any further information about these issues. Thank you.

 

New Health Law Web Resource

Ezra Klein's blog points to a new resource available for health law types, it is called Health Wonk Review.   It looks very useful. 

[bm]

The Return of Pete Stark

Representative Pete Stark (every health care fraud and abuse attorneys favorite lawmaker) is back with some a new idea for combatting fraud in our  health care system.  This time his legislation aims to reduce pharmaceutical companies gift giving to doctors.  The new statute is entitled the "Prescription Drug Safety and Affordability Act," which would eliminate the tax deductions that drug companies currently receive for gifts they give to physicians to influence prescribing behavior.  According to the American Chronical,

“Corruption is no more appropriate in the halls of our nation’s hospitals than it is in the halls of Congress,” Rep. Stark said. “Taxpayers should not pick up the tab for drug industry lobbying that corrupts the doctor-patient relationship. When doctors are influenced to prescribe the wrong drugs, people die.” . . .

“My bill denies tax deductions to pharmaceutical companies for wasteful spending on perks and potentially illegal kickbacks,” Stark said. “Instead of wining and dining doctors, this legislation would encourage drug companies to lower drug prices and conduct additional research.” . . .

“The Hippocratic Oath compels doctors to act in the best interests of their patients,” Stark said. “As Congress investigates its own ethics, it should also review immoral relationships between the pharmaceutical industry and physicians.”

My favorite line, "when physicians are influenced to prescribe the wrong drugs, people die."  Representative Stark seems to have a very negative view of the medical profession and its ethics.  Thanks to Orly Rumberg for this information.  A brief release from the House of Represenatives is here.  [bm]

South Dakota Abortion Ban

Well, that certainly didn't take long, add a few new conservatives to the Supreme Court and abortion laws start changing fast.  The New York Times reports that the South Dakota senate has passed a law that will outline most abortions in the state - no exceptions for rape, incest or for the health of the woman.  The Times states,

After more than an hour of fierce and emotional debate, the senators rejected pleas to add exceptions for incest or rape or for the health of the pregnant woman and instead voted, 23 to 12, to outlaw all abortions, except those to save the woman's life. . . . .

To be enacted, the bill, the most sweeping ban approved in any state in more than a decade, requires the signature of Gov. Mike Rounds, a Republican, who opposes abortion.

After overwhelmingly approving the measure this month, the House, too, has to vote on it again because the Senate slightly reworded it, although the intent of the bill was unchanged and the vote there seems unlikely to shift.

Mr. Rounds has said he will not comment on whether he will sign the measure until it reaches his desk. It is likely to arrive there by next week. He has 15 days to make a decision.

For more on the South Dakota decision, see an interesting post on the Ezra Klein blog, including links to other discussions of this action.  I find this very troubling and hope that people recognize as Ezra's blog points out that this will not be the end abortions.[bm]

More on Physician Participation in Executions

Following up on Betsy's post earlier today about the Michael Morales near-execution, here is a link to the AMA's Opinion 2.06 on "Capital Punishment" (if the link to the specific policy doesn't work, you can navigate to it by starting here).  The opinion broadly prohibits "participation" in an execution and then provides examples of conduct that would run afoul of the prohibition and conduct that would not.

(a) Definition of physician participation in an execution: "actions which would fall into one or more of the following categories: (1) an action which would directly cause the death of the condemned; (2) an action which would assist, supervise, or contribute to the ability of another individual to directly cause the death of the condemned; (3) an action which could automatically cause an execution to be carried out on a condemned prisoner."

(b) Examples of (a): "prescribing or administering tranquilizers and other psychotropic agents and medications that are part of the execution procedure; monitoring vital signs on site or remotely (including monitoring electrocardiograms); attending or observing an execution as a physician; and rendering of technical advice regarding execution."  With respect to lethal injections, the prohibition extends to "selecting injection sites; starting intravenous lines as a port for a lethal injection device; prescribing, preparing, administering, or supervising injection drugs or their doses or types; inspecting, testing, or maintaining lethal injection devices; and consulting with or supervising lethal injection personnel."

(c) Actions that do not fall within (a): "(1) testifying as to medical history and diagnoses or mental state as they relate to competence to stand trial, testifying as to relevant medical evidence during trial, testifying as to medical aspects of aggravating or mitigating circumstances during the penalty phase of a capital case, or testifying as to medical diagnoses as they relate to the legal assessment of competence for execution; (2) certifying death, provided that the condemned has been declared dead by another person; (3) witnessing an execution in a totally nonprofessional capacity; (4) witnessing an execution at the specific voluntary request of the condemned person, provided that the physician observes the execution in a nonprofessional capacity; and (5) relieving the acute suffering of a condemned person while awaiting execution, including providing tranquilizers at the specific voluntary request of the condemned person to help relieve pain or anxiety in anticipation of the execution."

See also the AMA's Report A-1-92 (1992).

Jonathan Groner published "Lethal Injection: The Medical Charade" in Ethics & Medicine in 2004, in which he reviewed the hearing transcripts in State of Georgia v. Michael Wayne Nance.  Groner concludes that

physicians performed seven of the eleven activities that are forbidden by the AMA's ethical code . . . , and the nurses performed five of the eleven prohibited actions . . . . In two cases, the testimony about the role of the physicians was particularly noteworthy. In the execution of Ronald Spivey (executed January 24, 2002), a physician (the testimony does not make clear which specific doctor was present) ordered a second dose of intravenous potassium chloride after the first round of drugs failed to result in cessation of cardiac electrical activity. In the execution of Jose Martinez High (November 6, 2001), the nurses were unable to find veins for intravenous lines despite multiple attempts. Therefore, Dr. Rao, a board certified critical care physician, performed a right subclavian vein catheterization in order to carry out the execution.

Groner offered a more detailed discussion of the subject in the Nov. 2, 2002, issue of BMJ.  The American Public Health Association's policy statement on this subject also confirms the participationby physicians and other health care professionals. 

One of the best articles on this subject agrees: "Despite objections by many professional organizations the participation of physicians and nurses in capital punishment continues and is likely to become more common in the years ahead." See Truog RD & Brennan TA, Participation of Physicians in Capital Punishment. NEJM 1993;329:1346-1350 (paid subscription required).  Among other things, the authors disagree with the AMA's distinction between pronouncing death (not allowed) and certifying death (allowed).

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The Ethics of the Death Penalty for Physicians

As you have probably all been following, physicians in California have put a snag in that state's effort to execute Michael Morales through the use of lethal injection.  Here a story with background informatoin on the case from the LA Times.  The LA Times reports,

The Morales furor began a week ago when U.S. District Judge Jeremy Fogel declared that California's three-stage drug cocktail of a sedative, paralytic drug and heart-stopping chemical — the same protocol used in 37 of the 38 states with lethal injection — could mask, rather than eliminate, an inmate's pain during execution.

Fogel said the state would have to modify its execution procedure or he would hold a full hearing on the process in May.

To address his concern, prison officials elected to go forward just after midnight Monday with two doctors on hand to ensure that the sedative would be sufficient to deaden the pain of the heart-stopping drug. Just before the execution, however, the two anesthesiologists balked, saying the procedures forced them into the role of executioner, in violation of their medical ethics.

Fogel then said officials could go forward later in the day with a lethal dose of the sedative alone — administered by a licensed medical professional stationed within the execution chamber rather than by the usual "unseen hand" delivering the fatal drugs from another room.

But just two hours before the new, 7:30 p.m. time for the execution, a deputy attorney general told court officials that it had been called off.

San Quentin spokesman Crittendon said the state "was not able to find any medical professionals willing to inject medication intravenously, ending the life of a human being."

"The warden felt it was not ethical to approach an individual who would potentially be putting their license in jeopardy," Crittendon said. "How would it affect their careers by being involved in the execution process in the manner we've been discussing?"

Here are links to two interesting NPR stories on this topic from Tuesday on NPR's Day to Day (an overview of the medical ethics involved) and Wednesday on Morning Edition and some additional commentary from the fabulous editors at TalkLeft.  [bm]

Supreme Court to Hear Partial Birth Abortion Case

SCOTUSBLOG reports that the Supreme Court has agreed to hear the case, Gonzales v. Carhart, 05-380, invovling a challenge to the federal Partial-Birth Abortion Ban Act of 2003.  The statute criminalizes a doctor's performance of an abortion during which either the "'entire fetal head" or "any part of the fetal trunk past the navel" is outside the woman's uterus at the time the fetus is killed.'"

The New York Times' Linda Greenhouse provides more background on the case and reports on the changes to Court with the arrival of Justices Alito and Roberts.  She states,

"While supporters of the law maintain that this technique is used only late in pregnancy, and that the law therefore does not present an obstacle to most abortions, abortion-rights advocates say the statute's description applies to procedures used to terminate pregnancies as early as 12 or 13 weeks.

The law makes an exception for instances in which the banned technique is necessary to save a pregnant woman's life, but not for preservation of her health. Six years ago, in a 5-to-4 decision with Justice Sandra Day O'Connor in the majority, the Supreme Court found that the health exception was necessary when it overturned a similar law from Nebraska. In essence, the court will be revisiting that decision in the case it took Tuesday, with Justice Alito now filling the O'Connor seat.

In omitting a health exception, the federal law presents a direct threat to that precedent. In the federal statute, Congress included a "finding" that "partial-birth abortion is never medically indicated to preserve the health of the mother" and that "there is no credible medical evidence that partial-birth abortions are safe or are safer than other abortion procedures."

The four doctors who went to Federal District Court in Lincoln, Neb., to challenge the federal law, including Dr. Leroy Carhart, who had brought the earlier challenge to the Nebraska state law, disputed the Congressional findings. They said the method was safer under some conditions, and could preserve some women's fertility by avoiding such complications as punctures from bone fragments inside the uterus."

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Apology Bill Introduced in Utah Senate

Utah S.B. 41, introduced by Senator David Thomas, "provides admissibility standards for disclosures by health care providers in malpractice actions." In pertinent part, it provides:

78-14-18. Evidence of disclosures -- Civil proceedings -- Unanticipated outcomes -- Medical care.
In any civil action brought by a patient as an alleged victim of an unanticipated outcome of medical care, or in any arbitration proceeding related to such civil action, any and all statements, affirmations, gestures, or conduct expressing apology, fault, sympathy, commiseration, condolence, compassion, or a general sense of benevolence which are made by a health care provider or an employee of a health care provider to the alleged victim, a relative of the alleged victim, or a representative of the alleged victim and which relate to the discomfort, pain, suffering, injury, or death of the alleged victim as the result of the unanticipated outcome of medical care shall be inadmissible as evidence of an admission of liability or as evidence of an admission against interest.

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"Death By Denial": Annals of Health Insurance

News stories of insurance denials are as common as summer rain, but this one (Frankfort (Ind.) Times) caught my eye.  I've heard of denying coverage for a cancer patient because the proposed treatment is experimental or otherwise not medically necessary and appropriate, but oral morphine for a patient with end-stage cancer (primary site in the kidneys, with mets to the lungs and brain)?  [tm]

When Is A Physician Not A Physician?

That's the question asked by Scripps Howard's Dan Thomasson, who continues:

Is it when the doctor refuses to offer treatment because of disapproval of the medicine available or the way the patient's disease occurred? How much leeway is there in the Hippocratic oath to allow a doctor to spurn those in medical need because of religious conviction or concept of morality?

And what about pharmacists who refuse to honor legitimate prescriptions or even to stock certain authorized medicines because the drugs run counter to their religious beliefs? Is there a case to be made for the primacy of conscience in those cases, even though a pharmacist's responsibilities are not dissimilar to a doctor's? Is refusing to fill a prescription tantamount to breaking the law and to making a pharmacist's judgment more important than the doctor's?

These and other questions surrounding the dispensing of modern medicine are being asked by state legislatures, ethics boards and public forums throughout the nation in the wake of controversial new research and compounds and treatments that run counter to fundamental religious convictions on such issues as stem-cell development, abortion, AIDS, the right to die. Chances are excellent that before the debate is over, it will change the way health care is dispensed in this country.

The rest of Thomasson's story, "Faith Shouldn't Outweigh Hippocratic Oath," is here.   [tm]

Health Policy: L.A. Times Editorials

Courtesy of the Harvard World Health News:

Shopping for Health Care...
(Feb. 6, 2006)
"In recent years, most politicians have talked about health care reform as though there is a one-size-fits-all solution out there that we haven't thought of before. There isn't. The president should be commended for seeking to make the economics of medical treatment more efficient. But that must be tied to social programs that can help those on the margins. Extending refundable tax credits for health insurance to the working poor would be a good start."

... As the Bills Come Due
(Feb. 6, 2006)
"The disastrous implementation of the new federal prescription drug benefit has cost the states hundreds of millions of dollars, as they have had to foot the bill for millions of low-income seniors and the disabled who have been left without coverage. But as the states and the federal government argue over reimbursement terms, a far larger battle looms over the troubled new program."

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Medical Marijuana: The Latest Chapter

From the Feb. 3 issue of Health Law Week, we have the following news of the latest -- but surely not the last -- development in the continuing saga of California's Medical Marijuana law:

San Diego Supervisors Sue To Stop Medical Use Of Marijuana; San Diego, Cty. of v. California, State of, No. 06-CV-130 (S.D. Cal. complaint filed Jan. 20, 2006) - DEx 105767

   Three San Diego County supervisors have filed a lawsuit against the state in an attempt to overrule the legal use of medical marijuana. The California Legislature passed a law in 2003 requiring counties to provide identification cards to registered users of marijuana. San Diego County voted to refuse implementation of the identification system.

   Three supervisors -- Bill Horn, Dianne Jacob and Pamela Slater-Price -- also voted to sue the state in opposition to the law. The lawsuit argues that the California Legislature violated federal drug laws by allowing the registration of medical marijuana users.

   In addition, the suit relies on an international treaty signed by the United States in 1961 that prohibits the production and possession of the drug.

Chairman Horn's press release is here and Jacob's is here.  [tm]

Homelessness and Health Care

Today's issue of The New Yorker has an interesting piece on homelessness by Malcolm Gladwell (of Tipping Point fame).  Along the way, there's discussion of the health care bills for the chronically homeless (and mostly chronically inebriated) citizens featured in the article, including "Million-Dollar Murray."  It's compelling reading and a pointed reminder of the intersectionality of health-care and other social issues . . . . [tm]