Health Law

Published on: June 26, 2014

Michigan Supreme Court Issues Ruling on Michigan’s Generic Drug Substitution Statute

On June 11, 2014, the Michigan Supreme Court issued its decision in Michigan ex rel. Gurganus v. CVS Caremark Corp., and ruled that Michigan law requires a pharmacist to pass on the difference in cost between the wholesale cost of a brand-name drug and the wholesale cost of a generic drug to the purchaser when a generic drug is substituted for a brand-name drug (and only then). The case involved two consolidated class actions and a qui tam action against multiple pharmacies alleging that the pharmacies violated MCL 333.17755(2) by failing to pass on the savings to customers when substituting brand-name drugs with generic drugs. The plaintiffs further alleged that the defendant pharmacies necessarily violated the Health Care False Claim Act (HCFCA), MCL 752.1001 et seq, and the Medicaid False Claims Act (MFCA), MCL 400.601 et seq., by violating MCL 333.17755(2) and then submitting claims for reimbursement to the state.

The trial court granted summary disposition to the defendants because it found that the plaintiffs failed to state a claim upon which relief could be granted. The trial court noted that the plaintiffs did not plead with specificity any transactions involving the defendants that purportedly violated MCL 333.17755(2). The plaintiffs relied on a small set of cost data from a single out-of-state pharmacy during a brief time period to support their allegations of systematic fraudulent activity in Michigan by the defendants. The Court of Appeals reversed the trial court’s decision, finding that the plaintiffs’ general allegations were sufficient to avoid summary disposition. The Court of Appeals then reached several issues related to whether the HCFCA and MFCA created private rights of action. The panel also held that MCL 333.17755(2) applied to all transactions in which a generic drug is dispensed – not just to transactions in which a generic drug is substituted for its brand-name equivalent.

In a unanimous decision (with one Justice concurring only in the result), the Michigan Supreme Court reversed the Court of Appeals and reinstated the trial court’s ruling. The Court reversed the Court of Appeals’ construction of MCL 333.17755(2) and its holding that the plaintiffs’ pleadings were sufficient to survive summary disposition. It vacated the remainder of the Court of Appeals’ decision as unnecessary to the resolution of the case.

Published on: June 25, 2014

Federation of State Medical Boards Adopts Model Policy for the Appropriate Use of Telemedicine Technologies

by Wachler & Associates, P.C.

Technological advancements that allow for quicker and more secure electronic communication have encouraged telemedicine. The Federation of State Medical Boards (FSMB) defines telemedicine as “the practice of medicine using electronic communications, information technology or other means between a licensee in one location, and a patient in another location, with or without an intervening healthcare provider.” Telemedicine technologies allow for easier access to health care in rural areas, as well as nearly immediate contact with specialists for individuals involved in an emergency situation. However, widespread usage of telemedicine is still developing and most states have yet to take the appropriate legislative initiative to enact guidelines for state medical boards and health providers to follow when implementing telemedicine systems. As a result, the Federation of State Medical Boards (FSMB), acknowledging the benefits that telemedicine offers, decided to step in.

On April 26, FSMB adopted a Model Policy for the Appropriate Use of Telemedicine Technologies in the Practice of Medicine (Model Policy). The Model Policy comes as a result of the collaborative efforts of the FSMB-appointed State Medical Boards’ Appropriate Regulation of Telemedicine (SMART) Workgroup. The SMART Workgroup, made up of state medical board representatives and telemedicine experts, was tasked with creating uniform guidelines for state medical boards and health providers after:

Conducting a comprehensive literature review of telemedicine services and proposed and/or recommended standards of care;
Identifying and evaluating existing telemedicine standards of care developed and implemented by state medical boards;
Revising the FSMB’s 2002 policy.

In the absence of state legislation, the Model Policy offers a uniform approach to guide state medical boards and health providers in several essential areas.

First, the SMART Workgroup emphasized that the physician-patient relationship is integral in maintaining the integrity of medical care. The Model Policy notes that, before giving any medical advice, physicians utilizing telemedicine should first:

Fully verify and authenticate the location and, to the extent possible, the requesting patient;
Disclose and validate the provider’s identity and applicable credential(s); and
Obtain appropriate consents from requesting patients after disclosures regarding the delivery models and treatment methods or limitations, including any special informed consents regarding the use of telemedicine technologies.

In addition, the Model Policy notes that an appropriate physician-patient relationship has not been established when the physician’s identity is unknown to the patient. Furthermore, a patient must not be randomly assigned to a physician, but rather have a choice, whenever appropriate. So long as the standard of care is met, the physician-patient relationship can be established using telemedicine technologies.

Published on: June 20, 2014

HHS Releases Annual Reports on HIPAA Compliance and Information Breaches

by Wachler & Associates, P.C.

Recently, the Department of Health and Human Services Office for Civil Rights (OCR), released its annual report on breaches of protected health information (PHI). Under the Breach Notification Rule, covered entities are required to issue notifications following breaches of unsecured PHI. Examples of covered entities include health care providers and health plans, such as HMOs. Covered entities must notify affected individuals of a breach without unreasonable delay and no later than 60 calendar days following discovery of the breach. Notification to the individuals affected by the breach must include:

Covered entity’s contact information for individuals to ask questions and learn additional information;
A brief description of the breach, including the date of the breach and discovery of the breach, if known;
A description of the types of unsecured PHI involved in the breach;
Any steps individuals should take to protect themselves from potential harm resulting from the breach; and
A brief description of what the covered entity is doing to investigate the breach, mitigate harm to individuals, and to protect against future breaches.

In addition, for breaches implicating fewer than 500 individuals, covered entities must submit a report to OCR no later than 60 days after the end of the calendar year in which the breach was discovered. Breaches involving 500 or more individuals require the covered entity to provide notice to OCR at the same time the affected individuals are notified. Covered entities must notify OCR by filling out and electronically submitting a form available on OCR’s website.

In its annual report to Congress on breaches of unsecured PHI, OCR reported 236 breaches of PHI which affected over 500 people in 2011 and 222 in 2012. The 236 breaches in 2011 affected in total 11,415,185 individuals, while 3,273,735 were affected in 2012. Per department policy, OCR conducted investigations of each breach that affected over 500 individuals.

Following their investigations, OCR found that the primary reason for breaches affecting over 500 people in 2011 and 2012 was theft of portable electronics or paper containing PHI. The second leading cause of breaches was unauthorized access of records containing PHI. For example, in 2011 the largest breach occurred because of a loss of backup tapes, affecting 4.9 million people. Similarly, in 2012, 116,506 individuals were affected when an unencrypted laptop containing PHI was stolen.

Published on: June 13, 2014

Physicians Nationwide Face Terminations as Insurance Plans Move to Narrow Networks

by Wachler & Associates, P.C.

In the past year, thousands of health care providers across the country have been excluded without cause from their insurance plan’s provider networks. The proliferation of narrow networks – defined as health insurance plans that limit the doctors and hospitals available to their subscribers – has caused a backlash amongst providers, who claim the insurers’ terminations will squeeze beneficiaries on access to care, and disrupt longstanding patient-physician relationship, emergency department care, and referral networks.

Although the Affordable Care Act did not create narrow networks, the reform law accelerated the trend by limiting insurer’s ability to continually lower benefits and exclude unhealthy individuals. Without other ways to compete, controlling providers and limiting choice is the insurers’ best way to lower premiums and thus compete on the exchanges. Insurers claim that narrow networks control costs and allow for higher quality, better coordinated care.

In most cases, however, patients choose insurance plans based on the plan’s access to a specific provider network. Patients subscribe and re-subscribe to one-year commitments with the primary intent to access their long-term primary care physicians or other regularly seen providers. Patients often build relationships with these providers over several years, even decades. Now, without notice or the ability to switch their plan, the patients’ physician is suddenly out-of-network and cost-prohibitive.

Published on: May 30, 2014

Insurance Rule in the Affordable Care Act Worries Doctors

by Wachler & Associates, P.C.

A Centers for Medicare and Medicaid Services (CMS) rule implemented in October of 2012, as the result of the Affordable Care Act, has some doctors very nervous. The rule, commonly dubbed the “grace period rule”, provides that individuals who purchased a government subsidized health insurance plan from the marketplace will have their medical bills covered for 30 days by their insurer if the patient falls behind on their payments for premiums. However, the rule provides that for the following 60 days, insurers may place a “stay” or even ultimately deny payments to the treating physician if the patient does not pay his or her premium. Under the rule, even if insurers cover claims during the last 60 days of the grace period, they may seek to recoup those funds if the insurance coverage is ultimately canceled. Prior to the rule’s implementation, insurers generally cancel a policy if a member falls behind more than 30 days and the insurer is usually on the hook for bills incurred before that cancellation.

The rule makes it so that physicians would have to seek payment for services rendered directly from the patient, which can be a long and uncertain process. The rule could impact solo physicians and small physicians groups, in addition to specialists, on a much greater scale due to their inability to absorb the costs of lost payments. For specialists, the high costs of their services could have an extremely negative impact on their bottom lines if they end up having to absorb the costs of lost payments for services rendered.

The American Medical Association (AMA) has publicly expressed concerns about the rule, fearing that it “could pose a significant financial risk for medical practices” and would leave doctors on the hook for unpaid patient bills after the insurer cancels the patient’s policy. The AMA has also urged the Obama administration to provide further guidance on how and when insurers must notify physicians on when their patients fall behind on premiums. The state of Washington, for example, passed a “prompt notification” law earlier in May. The Washington law would require insurance companies to provide information about whether a member is in the 90 day grace period, if a doctor or hospital requests such information. Other states are debating whether to pass legislation substantially similar to Washington’s “prompt notification” law.

Published on: May 19, 2014

OIG Proposes Significant Changes to Provider Exclusion Authority

by Wachler & Associates, P.C.

Last week, the Office of the Inspector General (OIG) released a Proposed Rule that changes its provider exclusion authority and significantly alters certain provider exclusion procedures and the substantive bases for exclusion from a Federal healthcare program. The Proposed Rule was released in conjunction with another Proposed Rule on the same date regarding Civil Monetary Penalties (CMPs). Comments regarding the rules are due on July 8.

§ 1128 of the Social Security Act grants the OIG authority to exclude certain individuals and entities from participation in Federal healthcare programs. If the OIG determines that an individual or entity has engaged in certain prohibited conduct, it must ban such a person or entity from participation in Federal healthcare programs for a statutorily mandated five year minimum period. However, many bases for exclusion are merely “permissive”, where the OIG retains discretion in deciding whether to exclude an individual or entity.

The Proposed Rule provides the OIG with three new bases upon which they may permissively exclude a provider or entity: the failure of ordering, referring, or prescribing providers to furnish payment information under Section 1128(b)(11); knowingly making, or causing to be made, false statements, omissions, or misstatements of material fact on a federal health care program application under Section 1128(b)(16); or convictions in connection with obstruction of a healthcare audit under Section 1128(b)(2).

Published on: March 21, 2014

Fox 2 Detroit Interviews Wachler & Associates’ Andrew Wachler regarding Beaumont, Botsford, Oakwood Merger

by Wachler & Associates, P.C.

Wachler & Associates partner Andrew Wachler appeared on Fox 2 Detroit this morning to discuss the recent announcement that Beaumont Health System, Botsford Health Care, and Oakwood Healthcare have signed a letter of intent to form a new $3.8 billion nonprofit health system.

In his interview, Mr. Wachler described the advantages this affiliation will provide in improving patient care and accessibility. He indicated that it could allow patients access to each hospitals’ various specializations and also allow the hospitals to share technology and capital resources, which in time has the potential to improve quality of care and reduce costs.

Mr. Wachler also explained that the Affordable Care Act, which includes the concepts of bundled payments and Accountable Care Organizations (ACOs), incentivizes large health systems to manage care efficiently, and may consequently result in a greater focus on wellness and preventive care.

Published on: January 23, 2014

CMS to Make Physician Payment Information Available on Case-by-Case Basis

by Wachler & Associates, P.C.

On January 14, 2014, the Centers for Medicare & Medicaid Services (CMS) modified their policy regarding the disclosure of physician payment information under the Freedom of Information Act (FOIA). Effective March 18, 2014, CMS will now evaluate requests for individual physician payment information on a case-by-case basis.

CMS Principal Deputy Administrator, Jonathon Blum, cites the agency’s commitment to greater transparency and the benefits numerous stakeholders have identified that would result from an increase in the availability of information as reasons for the change in policy. Some benefits CMS hopes the policy will lead to include:

• Provider collaboration on improved care management and lower costs in the delivery of health care;

Published on: January 17, 2014

OIG Approves Industry Stakeholders’ Contributions to a Patient Assistance Program under the Anti-Kickback Statute

by Wachler & Associates, P.C.

The Department of Health and Human Services (HHS), Office of Inspector General (OIG) recently released an advisory opinion that highlights long-standing OIG guidance as to how industry stakeholders can contribute to independent, bona fide charitable assistance programs. In this case, the patient assistance program (“Requestor”) provides grants to patients suffering from a specific disease for insurance premiums and other expenses not covered by insurance. The Requestor is a supporting organization of a nonprofit charitable foundation (“Foundation”) that exists solely to support the disease.

The Requestor’s main source of funding is the Foundation. However, all funds received from the Foundation are ultimately donations by pharmaceutical manufactures of the drugs used to treat the disease. The Requestor thus sought an advisory opinion to determine if such an arrangement would be grounds for civil monetary penalties under section 1128A(a)(5) of the Social Security Act (“Act”), covering improper beneficiary inducements, or other provisions of the Act as those sections relate to the Federal anti-kickback statute.

In the advisory opinion, AO No. 13-19, the OIG reiterates long-standing OIG guidance that industry stakeholders may contribute to the health care safety net for financially needy patients, including beneficiaries of Federal health care programs, by contributing to independent, bona fide charitable assistance programs. The OIG also states that such programs should not exert influence over donors, and donors should not have links to the charity that could directly or indirectly influence the charity’s operations or subsidy programs. Further, such programs cannot function as a conduit for payments from donors to patients, impermissibly influence beneficiary choices, or engage in practices that effectively subsidize a donor’s particular product.

Published on: December 13, 2013

CMS Advisory Opinion Approves Proposed Hospital Expansion under Stark Law’s Whole Hospital Exception

by Wachler & Associates, P.C.

The Centers for Medicare & Medicaid Services (“CMS”) recently released a favorable advisory opinion, CMS AO-2013-03, that interprets the “whole hospital” exception to the physician self-referral prohibition commonly known as the Stark Law. CMS determined that the proposed arrangement, which adds a new observation unit and 14 observation beds to a physician-owned hospital, complies with the “whole hospital” exception’s restriction on facility expansions.

In general, the Stark Law prohibits the referral of Medicare patients for designated health services (“DHS”) to an entity in which the referring physician has a financial relationship. The law also prohibits the entity that furnishes DHS as a result of a prohibited referral from billing Medicare, the beneficiary, or any other entity.

The Stark Law contains several exceptions to which the self-referral prohibition does not apply, including the “whole hospital” exception under Section 1877(d)(3). The “whole hospital” exception allows referring physicians to have physician ownership or investment interests in a hospital provided that the referring physician is authorized to perform services at the hospital and the ownership or investment interest is in the hospital itself.