Thursday, June 28, 2012

Supreme Court Healthcare Ruling: A Victory for the White House

After months of speculation, the United States Supreme Court has upheld the individual mandate requirement of the Patient Protection and Affordable Care Act of 2010, also known as "Obamacare." Opponents of the bill speculated the Supreme Court would strike down the individual mandate due to potential violations of the Commerce Clause, and that would set the tone for questioning the constitutionality of the rest of the bill.

However, on Thursday, June 28, 2012, the Court issued a 193 page opinion, by Chief Justice Roberts, stating that although it violates the Commerce Clause, Congress did not act unconstitutionally in its power to tax Americans who choose not to buy health insurance and it was not the court's "role to forbid it, or pass upon its wisdom or fairness." The "mandate" is in fact a tax that would be imposed on those who choose not to purchase health insurance. While the broad, 900+ bill encompasses far more than just the individual mandate, including free mammograms for Medicare recipients, eligibility requirements, coverage for Americans until 26 years of age, and more, the individual mandate was the center of attention in this long anticipated opinion.

Read the full opinion here.

The court upheld the mandate in a split 5-4 opinion in favor of the provision. Many analysts, political commentators, and lawmakers anticipate this will not be the last legal battle involving President Obama's health care reform bill, and this will not be the only provision in question.
 

Midwest Legal Partners, LLC

Friday, February 10, 2012

After massive uproar, Obama administration gives in on requiring religious institutions to provide coverage for contraception.


With a divided White House staff having weighed in publicly on the issue, President Obama announced today in a press conference a compromise that both Planned Parenthood and the Catholic Health Association approved of regarding employee coverage for contraception.

The compromise would allow for women to obtain birth control directly from their insurance companies rather than requiring religious institutions like Catholic hospitals and universities to provide free contraception.

CLICK HERE FOR MORE DETAILS

Vice President Joe Biden and Defense Secretary Leon Panetta, both Catholics, were very opposed to the initial proposal of requiring Catholic institutions to provide free contraception. At issue was whether employers should be required to broaden the scope of their coverage to include medication or procedures that violate some of their core tenants. While proponents of such a measure argue that Catholic hospitals and universities employ many non-Catholics, opponents argue that the employees are aware they are working for a Catholic institution with a Catholic mission. Also, many of the hospitals and universities in the United States are private or religiously affiliated, and would not want such mandates as part of their health coverage for their employees. Such a requirement may significantly change the dynamic of health care employers.

While their has been a massive backlash by various organizations against this law and the administration for its support of it, the Obama administration has recently voiced its confidence that the issue would be resolved. Other lawmakers, such as Senator John Kerry, also a Catholic and opposed to the mandate, believed it would be resolved. Today, President Obama announced that a compromise had been reached, but time will tell whether the debate will continue and whether all parties will be satisfied. While proponents of the language believe that President Obama has once again caved to the right, and in this case the religious right, Catholic Bishops and other organizations may decide that the compromise does not go far enough.

Posted by Attorney Saif R. Kasmikha

Midwest Legal Partners, LLC

Pfizer Recalls 1 million Birth Control Pills- Both sides brace themselves for potential lawsuits and legal arguments

More than 1 million packets of birth control pills are being recalled after packages were made with the incorrect dosage of active and inactive tablets. The pills themselves are not dangerous, but taking the incorrect dosage could lead to unwanted pregnancies. The affected drugs include Lo/Ovral-28 tablets and generic Norgestrel and Ethinyl Estradiol tablets that have expiration dates ranging between July 31, 2013, and March 31, 2014. It was a packaging problem rather than a safety issue, and Pfizer claims that the problem was promptly corrected.

News outlets have reported on the recall as well.

Many women taking this pill could potentially be pregnant, but does this mean that Pfizer needs to rush to the phone to contact every woman who has taken the pill and start talking settlement? This is one of the many questions the legal experts are now exploring, with mass tort and product liability attorneys in a frenzy to execute an effective marketing plan to bring in the clients.

Experts have offered differing opinions on the viability of a case that may be brought by one of the drug's users.

Pfizer is probably not looking to quickly resolve the matter with 1 million customers. Potential clients will be screened by attorneys and their medical experts to show that they took the drug, got pregnant when they took the drug, took the correct or recommended dosage, and that Pfizer’s negligence was a but-for proximate cause of the pregnancy. Pfizer’s attorneys undoubtedly have been very busy strategizing how to structure settlement packages. Fighting faulty birth control packages in trial could be disastrous for the company that has already been seeing recent diminishing profit margins.

The FDA has also provided details and lot numbers for the recall.


Posted by Attorney Saif R. Kasmikha

Midwest Legal Partners, LLC

Wednesday, January 18, 2012

Conflict of Interest: Onus put on drug firms this time to report on financial relationship with doctors

What has recently become major news for the public regarding the government’s latest steps in healthcare reform has been an ongoing legal matter followed by healthcare attorneys for years.

I have done a lot of work with physicians and hospitals who have had to disclose their relationship with pharmaceutical and medical device companies. Now, the New York Times has published an article on a government initiative requiring the drug makers themselves to disclose their financial relationship with doctors.

http://www.nytimes.com/2012/01/17/health/policy/us-to-tell-drug-makers-to-disclose-payments-to-doctors.html?_r=1

For years the legal and medical community have closely followed the potential conflict of interest issues arising from a relationship between doctors and pharmaceutical companies. While the companies don’t directly pay doctors to endorse their drugs, as that would be illegal, there are other ways around such endorsements. Certain doctors are targeted to do research, publish on, and give their expert opinion and consultation on certain drugs, their side effects, and positive results. They are to be honest and objective. However, they do this while the pharmaceutical companies pay for their trips to overseas seminars, panel discussions, lodging, speaking fees, etc. The assumption is that anything short of a ringing endorsement for the drug will likely lead to the doctor not being invited back. However, the doctors argue that they are not only objective, but base their findings on extensive research and peer reviewed studies and publications. In either case, most leading institutions, like the University of Michigan’s Hospital in Ann Arbor and the Cleveland Clinic agree that such a relationship should be disclosed. These institutions have done so publicly, including on their websites. This has been an epidemic for years with news publications in the past. See the following:

http://www.cchrint.org/cchr-issues/the-corrupt-alliance-of-the-psychiatric-pharmaceutical-industry/

The link above is a ringing indictment on psychiatrists, who the article cites as the top profiteers of such a relationship. It has listed, along with the names, photos, and bona fides, a number of psychiatrists who gained a lot financially while not disclosing their relationship with their patients or the institution that employs them. In some cases, the results of their research was also found to be extremely skewed and flawed. That was published in 2009. One of the concerns underlying this problem was that many psychiatrists who did not work for pharmaceutical companies relied on the expert opinions of these doctors and their publications in prescribing and recommending the drug to their patients.

This past year, ABC news covered a similar story in March 2011. This was an editorial that also focused on psychiatrists.

http://abcnews.go.com/Health/medical-conflicts-interest-disaster-patients/story?id=13060973

On July 2, 2011, another article was published on Harvard Doctors being disciplined for similar issues.

http://www.pharmalot.com/2011/07/harvard-docs-disciplined-for-conflicts-of-interest/

That focuses on how Harvard and Mass General expected, but did not heavily monitor or enforce their physicians to report such financial relationships.

Disclaimer on Assumptions: The public may read about these stories and assume that a drug company is approaching doctors and giving them money directly to promote their drug, praise it as effective, and marginalize any potential side effects. This is not true. As stated earlier, they are hired for objective research and as consultants based on their expertise. The government has now put pressure on the drug companies themselves to report since many institutions and physicians have not done so. It is also worth noting that many of these endorsements are in fact sincere and objective and not based on any financial incentive. Many physicians may actually like the drug and base their opinion on thorough research.

Practical solutions: Institutions have agreed and the government is more intent on enforcing disclosure. Regardless of intent, how do you put aside the insinuation that if a physician is a paid consultant or has any financial arrangement with a drug company that it is impossible to give a truly objective recommendation for treatment? Many respected institutions recognize the difficulty in that and have taken serious measures. One suggestion is that the consulting or endorsing physician not be allowed to prescribe the drug to any of the patients at the institution that employs him/her. Furthermore, they may refer out any patients that may be a candidate for that drug. The key is to keep both jobs separate in order to avoid conflict.

Doctors should not be prohibited from advising pharmaceutical and medical device companies. It helps for the effectiveness of such drugs and even medical devices and may promote innovation. However, disclosure of the relationship and separating the jobs as much as possible to avoid conflict of interest issues is becoming as much a legal necessity as it is a medically ethical one.


Posted by Attorney Saif R. Kasmikha

Midwest Legal Partners, LLC

Tuesday, January 17, 2012

Bruising Piece On Declining Reimbursements Neglects Impact of Legal Counsel

An article was published earlier this month about physicians in small private practices “going broke” due to a number of factors which include the evolving healthcare system, declining reimbursements, and a lack of business acumen. This article details the changes and includes a couple of anecdotes, including that of a respected oncologist.

http://money.cnn.com/2012/01/05/smallbusiness/doctors_broke/index.htm

I am inclined to agree with most experts, citing a lack of business acumen as a leading reason for the decline. However, there is also an important element left from the piece. While the article cited a change in a few laws, it did not emphasize the lack of continuous and/or effective counsel in guiding the physicians through these changes over the decades. While business acumen is important, it wasn’t always necessary to help these practices continue to thrive over the years. On many occasions, a physician’s knowledge, expertise, and exceptional quality of treatment administered among his/her patients was more than enough to not only sustain a practice, but to help it grow and expand. It brought new business and repeat business. On the same token, no amount of business expertise, marketing advice, paid advice by consultant firms, etc. could compensate for inferior care and substandard treatment.

Granted there may be a bias that this is coming from an attorney, but physicians and healthcare institutions, now more than ever, need legal counsel! Every way that a practice is being reimbursed is subject to review and reform by Federal and state government. This even includes reimbursement for prescription drugs. The passing of the Patient Protection and Affordable Care Act is not the end of this chapter. Many of its provisions will be taking effect over the next several years and will have a major impact on private practices. Those that are constantly informed and counseled will stand a better chance of weathering the storm over those who wait until something happens and require counsel for damage control. This article is especially illustrative about how even those physicians who are well respected in their locale and medical community are not safe if they are not made aware of the changes. Many of these incidents may have been prevented with a healthcare attorney advising the practice on a regular basis.

Midwest Legal Partners, LLC


Posted by Attorney Saif R. Kasmikha

Midwest Legal Partners, LLC

Tuesday, November 15, 2011

Michigan Healthcare Law: Governor Signs New Law that Addresses Doctor Shortage



Michigan Gov. Rick Snyder has signed legislation aimed at helping alleviate Michigan's growing doctor shortage. The measure authorizes physician assistants to take on more responsibility for patient care.
The new law makes health care more accessible by authorizing licensed physician assistants under the close supervision of a doctor to prescribe controlled substances, except for Schedule I narcotics.

Physician assistants are already authorized to prescribe seven days worth of Schedule II medications and deliver other medical services such as conducting physical exams, obtaining medical histories and ordering tests. The state says by expanding the services they can provide, doctors will be able to focus their time on patients in the most need. Doctors will still have to sign off on every prescription written. The bill is now Public Act 210 of 2011.

Courtesy of http://www.wnem.com/story/15994929/governor-new-law-to-address-doctor-shortage-in-michigan#

Posted by Attorney Saif R. Kasmikha

Midwest Legal Partners, LLC


Friday, October 28, 2011

CMS Releases Final ACO Regulations-Providers are Happier



For the full rule, click on the following link below. The link is also provided at the end of the article:

http://www.ofr.gov/OFRUpload/OFRData/2011-27461_PI.pdf


Responding to complaints from organized medicine, the Centers for Medicare and Medicaid Services (CMS) published a final version of its regulations for accountable care organizations (ACOs), a cornerstone of healthcare reform, that lowers the bar for physicians to participate in them. Medical societies had called the first draft of regulations, released in March, too complex and financially risky for physicians.


ACOs consist of physicians, hospitals, and other providers in various combinations that attempt to coordinate the care of Medicare patients with the goal of improving its quality while reducing costs. Successful ACOs would share in any savings they produce for Medicare on top of their usual fee-for-service reimbursements.


However, medical societies ranging from the American Medical Association (AMA) to the American Academy of Family Physicians wondered whether any ACO will see those shared savings based on the draft regulations. Under the preliminary plan, ACOs would have had to meet 65 different quality measures, which organized medicine considered too many. They also said it was too much of a stretch that at least 50% of ACO primary care physicians must eventually qualify as meaningful users of electronic health record (EHR) systems. The final ACO regulations released today lowered the number of quality measures to 33 and eliminated the original EHR meaningful use requirement, but retained EHR use as a quality measure.


The changes came as a result of a strong and voluminous outpouring of more than 1,300 comments on the draft regulations that result in significant changes, notably:


-Providers will not be required to share downside risk in order to participate in an ACO and will be able to earn revenue sharing based on ACO savings earlier as opposed to Medicare retaining all the initial savings.

-Quality measures that ACOs will have to meet to qualify for performance bonuses have been reduced to 33 from 65.

-Community health centers and rural health clinics, which were not allowed to form ACOs in the draft proposal, will be allowed to lead ACOs.

-The ACOs will also be told up-front which Medicare beneficiaries are likely to be part of their system as opposed to not knowing which patients were in the ACO until the contract ended.

-The final rule provides a more a flexible starting date in 2012.


The role of community health and rural health centers is important because the new rule addresses another concern, which was that smaller medical practices would lack the capital necessary to invest in technology and other infrastructure needed to create and participate in an ACO. To combat this, CMS announced an Advance Payment Model whereby physician-led practices and rural hospitals participating in the Shared Savings Model could receive upfront payments for ACO participation. This money could then be used for building up the personnel or IT infrastructure needed to effectively participate in an ACO. The upfront payments would be paid back via future incentive earnings. The advance payments are only available to ACOs that do not include inpatient facilities with less than $50 million in revenue, or ACOs in which the only inpatient facilities are critical access hospitals and/or Medicare low-volume rural hospitals and have less than $80 million in total annual revenue.


“Today we have taken another step to improve healthcare for people with Medicare,” said HHS Secretary Kathleen Sebelius. “We are excited to give doctors, hospitals and other providers the flexibility and support they need to work together and focus on making sure patients get the care they need. This model of delivering care may not be right for everyone, but it provides new incentives for doctors, hospitals, and other healthcare providers to work together in new ways.”


“As a physician I understand the complexities of caring for a patient who may have multiple providers,” said Donald M. Berwick, MD, administrator of the Centers for Medicare & Medicaid Services. “This opportunity to coordinate care among providers could greatly improve the quality of care Medicare beneficiaries receive. We listened very carefully to the more than 1,300 comments we received on the proposed rule released this spring, and this final rule includes a number of improvements suggested by those comments that will strengthen the program,” Berwick said. “For example, the final rule will increase the incentives and streamline the Shared Savings Program, extending the benefits of the new program to a broader range of beneficiaries.”


The final ACO regulations did not placate organized medicine entirely. Medical societies said that for the sake of attracting more participants, a typical ACO's cut of Medicare savings should be bigger than what the draft regulations stipulated — 50% under track 1, and 60% under the higher-risk track 2. However, CMS would not budge from those percentages. Nor would it reduce the minimum saving rates established for track-1 and track-2 ACOs. Although they lost on these and other issues, several medical societies today gave a thumb's up response, by and large, to the framework now in place for ACOs.


"We are pleased that the final rule on Medicare ACOs includes many of the important changes recommended by the AMA," said AMA President Peter Carmel, MD, in a press release. “The AMA recommended that the risk and payment structure for potential ACOs should encourage participation by physicians in all practice sizes, and we are very pleased that this rule allows ACOs to share in every dollar of cost savings and includes an option that limits financial risk, which is important for many physician practices.” While the final rule reduced the number of quality measure by about half, Carmel added that “the AMA would have preferred even greater flexibility on which measures practices are required to report.”


Jack Lewin, MD, the chief executive officer of the American College of Cardiology, also praised CMS for listening to the input of organized medicine. "While we do not know for certain how many organizations will form as ACOs in the coming years," Dr. Lewin stated in a press release, "we remain encouraged since these changes make it more feasible for physicians and hospitals to consider participating."


While provider organizations generally hailed the announcement, America’s Health Insurance Plans took a more cautious approach, namely to the removal of the mandatory review of new ACOs for anti-trust violations by the Department of Justice and the Federal Trade Commission.


“Doing away with the mandatory review process raises concerns that provider market power may not be scrutinized sufficiently, potentially increasing healthcare costs for consumers and employers,” said Karen Ignagni, AHIP president and CEO in a prepared statement. “We urge the DOJ and the FTC to take steps to ensure the ACO process is transparent and there is vigorous oversight and enforcement of antitrust laws to protect consumers and employers from higher prices and cost-shifting that could result from increased provider consolidation.”


For the full rule, click on the following link below:

http://www.ofr.gov/OFRUpload/OFRData/2011-27461_PI.pdf

Posted by Attorney Saif R. Kasmikha

Midwest Legal Partners, LLC