Paging Doctor Blog | Health Care Defense Attorneys | Meiselman, Denlea, Packman, Carton & Eberz

Safety Of Medical Implants Questionable

By James R. Denlea on May 8, 2012

Millions of Americans receive medical implants yearly and those who do presume that the implants are safe and will alleviate, or at least help to ease, their specific medical problem. However, according to a May 2012 article in Consumer Reports, “Dangerous Devices”, most implants (artificial joints, defibrillators, surgical mesh) have not been tested for safety and effectiveness. The “testing” is done on the patient who has the medical device implanted. In other words, patients are living with implants that often times give them more pain and suffering than not having had the implant at all. According to the article, the FDA is not testing medical devices and most times all that is needed for the device to be placed on the market is for the manufacturers to “. . . file some paperwork and pay the Food and Drug Administration a user fee of roughly $4,000 to start selling a product that can rack up millions of dollars in revenue. . . .” Frequently, it takes years before the FDA even tests a product or reclassifies it to a high-risk category.

It is crucial for doctors, as well as their patients, to research a medical implant thoroughly before implantation, as the consequences can be debilitating. An orthopedic surgeon, for example, who had an all-metal hip replacement (the same type of device he implanted in his patients) experienced medical issues of increased chromium and cobalt levels in blood, sleep disturbance, constant pain, mood swings and anxiety, hearing loss, tinnitus, and visual problems.

Meiselman, Denlea, Packman, Carton & Eberz P.C. offers legal advice to physicians on medical issues. If you need legal assistance or guidance on a matter regarding your practice, please call our office.

Careers As Advanced Health Care Practitioner In Demand

By James R. Denlea on April 17, 2012

According to data collected by the American Medical Group Association’s and Cejka Search 2011 Physician Retention Survey, careers in the advanced health care field are growing rapidly. As such, employment in medical groups for nurse practitioners (“NPs”) and physician assistants (“PAs”) has increased significantly in the past five years. According to the data, 75% of the responses to the survey indicated more NPs and PAs will be hired in the next five years.

Growth in these advanced health care professions is due largely to economics, according to an article in U.S. News and World Report. NPs, for example, can provide patients with many primary health care services at a fraction of the cost of an internist. In addition, FiercePracticeManagement reports that due to physician shortages and the demand to create a medical “team” to care for patients (accountable care organizations, “ACO”), medical groups are employing the NP and PA at increasingly high rates. This gives NPs and PAs the advantage of choosing where to work, thus creating a high turnover rate for these positions. In addition, recruiting and retaining these professionals are challenges to medical groups.

Private Practice Or Hospital Employment?

By James R. Denlea on April 12, 2012

According to data released by Medscape Medical News, physician employment by hospitals has increased since 2000. This increase is partly due to the protection that working for a large entity affords a physician. Many physicians feel that they can truly focus upon their specialized field by working in a hospital environment, as opposed to opening a private practice.

Working for a hospital relieves the physician of trying to keep up with complex private health care insurance and government regulations, investing in medical equipment and technology, marketing and HR issues. While owning a private practice gives a physician more independence and the physician is not constrained by the hospital’s policies or procedures, the private-practice physician must be concerned with all the business issues, which could be undertaken by a hospital employer.

It seems the current trend is leaning toward more physicians choosing to work for a hospital, with the private-practice physician becoming rare. But, as Uwe Reinhardt, Ph.D., a healthcare economist at Princeton University, told Medscape, “Don’t forget, there are cycles. Some years from now, there will be a whole new trend. Physicians working in hospitals will see what is profitable and what is not, and will jump out and establish practices in the profitable things.”

Is There A Way Around The Supreme Court’s Generic Drug Ruling?

By James R. Denlea on March 28, 2012

A Supreme Court ruling in June 2011 ended state-law claims against generic drug manufacturers (link to previous article) because the drug manufacturers are obligated by federal law to provide drug labeling that is identical to the drug’s brand-name counterpart. However, there seems to be a way around this ruling, which is being used by some plaintiffs who have been harmed by taking generic brand drugs.

In a recent federal court case, Cooper v. Wyeth, plaintiffs claimed that the manufacturers of the generic drug, metoclopramide (an acid reflux medication), failed to update the warning label, in a timely manner, to match its brand-name drug, Reglan. As such, the claims against the manufacturer were recognized as valid arguments in federal court. This “failure-to-update” claim has been used in other federal court cases (Fisher v. Pelstring and Couick v. Wyeth) with positive results for plaintiffs.

It is federal law that generic drug labels match their brand-name equivalent. Failure to update the labels timely, and in accordance with the FDA-approved changes for the branded label, would give some legal recourse to consumers who may have had an adverse reaction to a generic-brand drug.

Whether the courts will continue to recognize “failure-to-update” claims remains to be seen, but for now, there seems to be a legal avenue for damages for those who have been harmed by taking a generic drug.

Generic Versus Brand-Name Drugs

By James R. Denlea on March 22, 2012

Generic drugs account for almost 80 percent of all prescribed medications in the United States and most states allow generic drugs to be dispensed in place of brand-name drugs. This is quite a large number of generic drugs being taken by quite a large number of the nation’s population. The possibility of people who take generic drugs and having reactions to the drugs is also large – unfortunately, this is what is happening across the country. People, who are taking generic drugs, are having severe complications from taking the drugs. Reactions to these generic drugs are very serious, with some consumers developing inflammatory bowel disease, gangrene, and even movement disorders.

What is even more distressing is that the manufacturers of these generic drugs are protected by a U.S. Supreme Court ruling. In a 5-4 decision, the Supreme Court ruled in June 2011 that makers of generic drugs cannot be sued for not including side-effect warnings on their labels, if the warnings are also not on the labels of their brand-name equivalent. This makes it difficult for consumers who may not know they are receiving a generic form of a drug, such as in a hospital, or may be required by their insurance plan to fill a prescription with a generic drug. If they develop a medical issue while taking a generic form of a prescription drug, they basically have no legal remedy.

The Supreme Court ruling is based on the Hatch-Waxman Act of 1984. This law allowed companies to skip the involved process required to approve new drugs, if they could prove that the generic drug was equivalent to its brand-name counterpart. However, Representative Henry A. Waxman, who co-wrote the Act, has stated that “Congress did not intend for consumers’ rights to be categorically eliminated simply because they purchased a generic rather than a brand-name drug.” Mr. Waxman is investigating a change in the ruling.

Consumers should protect themselves and do their own research before taking any drug – check with your doctor about generic versus brand-name prescriptions and find out about all the possible risks and side effects.

Supreme Court Health Care Law Hearings

By Barry B. Cepelewicz, M.D., J.D. on March 19, 2012

In November of 2011, the Supreme Court announced that it would hear challenges to President Obama’s health care reform law (Patient Protection and Affordable Care Act of 2010). Those hearings are scheduled for March 26-28 and will address the following issues:

Are opponents of the new health care law challenging the law too soon? According to the new law, everyone is required to purchase health insurance, with or without government assistance, or be fined (individual mandate). However, it is unclear as to whether the fine to be imposed is considered a tax. If it is a tax, then the Anti-Injunction Act, a federal law, prohibits anyone challenging the health care law until 2014, when violators will be required to pay the “fine” or “tax”.
Assuming the individual mandate can be challenged now, is the individual mandate constitutional? There is a Commerce Clause in the Constitution, which allows Congress to regulate interstate commerce, but does this clause also allow Congress to require people to purchase health care insurance?
If the individual mandate is found to be unconstitutional, will the rest of the health care law remain in effect? Sometimes a portion of the law can be struck down, if it is found to be unconstitutional, while the rest of the law continues in force. If the Court finds that the unconstitutional part of the law is so intertwined with the rest of the law, then it comes to an all or nothing at all proposition.
Is the health care law’s expansion of the Medicaid program constitutional? The argument is state versus federal rights. The new law requires states to change their Medicaid programs, so that all people will be eligible for coverage. If states do not change their laws, they will lose all of their federal funding for the program.

The Supreme Court plans to release recordings of the arguments on its website (http://www.supremecourt.gov/) around 2 p.m. each day for arguments held that morning and around 4 p.m. for arguments held in the afternoon of March 28. After hearing the challenges to the new health care law, the Court is expected to reach its decision in June 2012.

New York State Governor Investigates Out-Of-Network Costs

By Barry B. Cepelewicz, M.D., J.D. on March 15, 2012

New York State Governor Andrew Cuomo recently announced the continuation of an investigation into out-of-network medical costs. In 2011, the state received more than 2,000 complaints from consumers who unexpectedly received bills from out-of-network specialists and providers after taking measures to choose in-network providers and receive prior insurer approval. Consumers often are not told in advance which specialists are out-of-network, how much they charge, and how much of their fee will be covered by health insurance. The resulting bills contribute to financial strain on consumers, many of whom are unable to pay the amount charged and some of whom are forced into bankruptcy.

To aid consumers in obtaining information on out-of-network care, costs, and coverage, the New York State Department of Financial Services is calling for more transparency, better consumer protection, and system-wide reform. This follows efforts by the Obama administration to require health insurers to provide such easy-to-understand information to consumers. If you are concerned about the potential impact of reforms and new rules, please feel free to contact us to discuss your options and assist you in making decisions regarding your practice.

CMS To Discontinue Second Overpayment Notice

By Barry B. Cepelewicz, M.D., J.D. on March 12, 2012

As any physician knows, handling Medicare and Medicaid payments can be a very complex and time consuming process. As a result, many physicians, through no fault of their own, occasionally overcharge Medicare and Medicaid. To recoup such overpayments, the Centers for Medicare & Medicaid Services (CMS) administers the Medicare Overpayment Notification Process. Until recently, where an alleged overpayment has not been promptly resolved and refunded, CMS would send physicians a series of three letters: an Initial Demand Letter, a Follow-up-Letter 30 days later, and then an Intent to Refer Letter. However, CMS recently determined that the second letter was unnecessary because a substantial number of physicians responded promptly to the Initial Demand Letter with a payment. In addition, a recoupment action occurs on average 41 days after the initial letter, and that action is accompanied with another notice regarding the overpayment.

Thus, it is important for physicians to respond to the Initial Demand Letter in order to avoid further complications such as a referral to a debt collector. In fact, if an overpayment is not resolved within 90 days of the Initial Demand Letter, CMS will provide a notice of intention to refer the debt for collection.

Health Care Fraud Case Points Out CMS Weaknesses

By Barry B. Cepelewicz, M.D., J.D. on March 7, 2012

A recent case shines a spotlight on weaknesses in CMS procedures for preventing and identifying fraudulent claims. Dallas physician Jacques Roy, M.D., and several home health agency owners were charged with fraud for the submission of more than $375 million in Medicare and Medicaid claims over a five-year period. The home health agencies recruited “patients” door-to-door and Roy and his staff certified more than 11,000 of these for medical equipment and services that CMS alleges were medically unnecessary or never provided. By switching to a different provider number, Roy was able to continue the alleged scheme even after CMS started its investigation.

Because the Medicare system trusts its providers to certify patients and deliver services appropriately, it is vulnerable to fraudulent submissions and payments. Additionally, the new analytical system utilized by CMS to spot fraud has not been entirely successful. It is expected that this fraud case and others may force CMS to institute safeguards and monitor the Medicare claims process more closely.

If you have any questions about your Medicare certification and claims process, please feel free to contact us to discuss your current practices and procedures and assist you in making decisions regarding your practice.

Your Medical Records May Be Used For Marketing Campaigns

By Barry B. Cepelewicz, M.D., J.D. on February 15, 2012

Hospitals seeking new avenues to attract patients may engage in a practice called transaction-driven marketing, where they promote services in high-profile areas, such as heart disease, cancer, and orthopedics to particular groups of patients based on spending habits. How do hospitals identify these patients? They share the information on patient medical and financial records with marketing professionals, who create customized advertisements that target the types of patients most likely to pay for medical care through private insurance.

Hospitals justify this practice, which is legal, for promoting important health services to the populations they serve. Critics argue that hospitals should not use information on patient records to sell services and bolster their bottom line. They also point out that individuals at lower socioeconomic levels might not receive information about services that could improve their health.

If you are concerned about this practice, ask your local hospital about its privacy policies, how patients’ personal information is used, and which companies have access to it. Please contact us to discuss your legal rights, if you have additional concerns.