The Office for Civil Rights of the Department of Health and Human Services (HHS) recently announced the issuance a proposed modification to the Health Insurance Portability and Accountability Act (HIPAA) Privacy, Security and Enforcement Rules under the Health Information Technology for Economic and Clinical Health (HITECH) Act. Several provisions of this rule are of great interest to pharmaceutical companies and pharmacies.

Prior to the HITECH Act, pharmaceutical companies could pay pharmacies to communicate with their patients for the purpose of either reminding patients to refill their prescription (refill reminders), or to recommend switching to alternative therapies (switch communications). Such communications were considered “health care operations” that did not require a written authorization from the patient. The HITECH Act changed the definition of “health care operations” such that paid switch communications were no longer considered “health care operations” and thus required an authorization.

Thew newly proposed rule provides that since Congress did not make it clear wether the lawmakers intended to  restrict only those subsidized communications about products and services that are less essential to an individual’s health care (i.e., those classified as health care operations) or all subsidized communications about products or services, including treatment communications.  HHS explains that the difference between a switch communication that is healthcare operations and one that is treatment depends on whether the communication is made to all patients, which would be marketing if subsidized by the third party whose product or service is recommended or healthcare operations if unsubsidized, or whether it is based on the treatment needs of an individual, such as a letter to all pregnant patients recommending a particular birthing center.

Under the new rule those paid switch comunication that are to be considered treatment related do not require patient authorization but require only that (1) the covered entity’s Notice of Privacy Practices includes a statement informing patients that the healthcare provider may send the paid switch communications and the individual has the right to opt out of receiving such communication, and (2) that the communication itself disclose the financial payment and the ability to opt out.

Interestingly, HHS asked for comment on whether to expand the HITECH Act exception that permits communications about the drug a patient is currently prescribed (e.g., refill reminders) to be deemed healthcare operations so that the exception includes generic alternatives or new formulations of the drug. This is puzzling, since under the proposed rule, it would appear that such communications could in any event be considered treatment.  It is expected that marketing/treatment distinction will receive numerous comments.

According to a survey of 1,231 physicians nationwide, recently published in Archives of Internal Medicine, lawsuit fears are the main reason for overtreating in the ER.  Ninety percent of physicians surveyed said doctors overtest and overtreat to protect themselves from malpractice lawsuits.  According to this survey, this sentiment is more common among male doctors than female doctors. 

The Accreditation Council for Graduate Medical Education has proposed new guidelines to limit the number of hours medical residents work and to increase supervision for interns.  The proposal slightly revises regulations adopted seven years ago, requiring that doctors in their first year of residency training programs be more closely supervised by experienced doctors with the maximum length of their work shifts to be cut from 24 to 16 hours.  Under the new proposal maximum work shifts would remain 24 hours for residents in their second year and beyond and maximum work week would remain at 80 hours for all hospital residents. 

In addition,  all residents and their supervisors would now be required to explain their roles to patients and clearly state the fact that supervisors are ultimately in charge of their care.  This part of the proposal receives mixed review from physicians and healthcare activists. Many doctors feel that with so much supervision over an intern, they wont be able to develop independent clinical judgment and grow as physicians.  While the chief health care officer at the Association of American Medical Colleges supports the changes, calling the proposal a good comprimise in a challenge to balance revised hours for inters with continuity of care patients, the President of the American Medical Student Association favors the 16-hour shift limit but says the emphasis on increased supervision and informing patients about the roles of residents will certainly make a difference in patient care, and not for the better.

Early this year, New York State government introduced a new provision to the Public Health Law, entitled "Interactions Between Pharmaceutical Companies and Health Care Professionals" (Section 279).  If enacted, the new law, would be the first state law to provide a code of conduct applicable to healthcare professionals to whom companies that sell prescription drugs, biologics or medical devices market their products.   Notably, Section 279 includes provisions that differ from other current state laws and industry codes, such as prohibition agains a pharmaceutical company being a CME provider as well as prohibition  against providing and/or accepting compensation to a healthcare provider for attenting a CME event.  Violations of the proposed law may subject pharmaceutical companies to civil penalities and physicians and other healthcare providers to civil penalties and other disciplinary action.

The Drug Enforcement Administration has issued an interim final rule allowing electronic transmission of prescriptions of controlled substances. The interim rule,published in the March 31 issue of the Federal Register, would give prescribers the option of e-prescribing controlled substances, permit pharmacies to receive, dispense and archive electronic prescriptions. One of the key purposes of the interim rule is to help pharmacies and hospitals integrate prescription records into other medical records and potentially reduce prescription forgeries.

Efforts to block a key provision of the new healthcare reform law are blooming in 33 states. A growing number of mostly Republican officials are mounting legal and legislative challenges to the new law's requirement that, starting in 2014, all Americans buy health insurance or pay a penalty tax.

The challengers contend that Congress lacks the constitutional authority to mandate an individual citizen's participation in an insurance plan and that it has infringed on states' rights by requiring them to extend coverage to low-income residents without fully funding the associated cost. One of the complaints, filed by a conservative public interest law firm in the United States District Court for the Eastern District of Michigan on the same day as the Patient Protection and Affordable Care Act became law, alleges that "The Health Care Reform Act imposes unprecedented governmental mandates that restrict the personal and economic freedoms of American citizens in violation of the Constitution."

The Department of Justice (DOJ), in defending the constitutionality of the healthcare reform law, argues that Congress had a rational basis for the provision, as an individual decision to purchase healthcare insurance, collectively, substantially affects interstate commerce. In addition and apart from its power under the Commerce Clause, Congress, DOJ's lawyers claim, has authority to enact the new law under its power to tax and spend to provide for the general welfare.

Many constitutional scholars have stated that the new law is likely to withstand the challenge, pointing out to Supreme Court's long record of upholding congressional authority to regulate the economy by imposing taxes, to restrict personal freedoms in the national interest and to supersede conflicting state laws. There are many, however, who feel that we are now seeing only the first set of a complex web of lawsuits, which are likely to pose a serious threat to survival of the new law. Beyond all disputes is the fact that the determination of the constitutionality of such severe governmental coercion and such a serious intrusion into personal freedom, will have a profound impact on the political future of our nation.