Category: Health Care Law

Health Resources and Services Administration (HRSA) Withdraws 340B Program Proposed Rule

Mcdermott Will Emery Law Firm

On November 14, 2014, the U.S. Department of Health and Human Services (HHS) Health Resources and Services Administration (HRSA) withdrew a proposed rule that would have provided guidance on a variety of topics related to the 340B Federal Drug Pricing Program.  The “mega rule,” which had been submitted to the White House Office of Management and Budget in April 2014, was expected to cover important 340B Program matters, such as patient eligibility, contract pharmacy arrangements, and eligibility for hospitals and off-site facilities.  Now, in lieu of the proposed rule, HRSA has announced its intention to release notice-and-comment guidance to “address key policy issues raised by various stakeholders committed to the integrity” of the 340B Program.  Additionally, HRSA plans to issue proposed rules related to civil monetary penalties for manufacturers, calculating the 340B ceiling price and administrative dispute resolution.

The decision to withdraw the proposed rule, coupled with HRSA’s intention to release regulatory guidance on similar issues, may be viewed as a response by HHS to a recent federal court decision limiting HHS’s ability to promulgate notice-and-comment rules.  In a May 23, 2014, decision, the U.S. District Court for the District of Columbia held that HHS did not have the requisite statutory authority to promulgate a notice-and-comment rule pertaining to the purchase of orphan drugs by certain Covered Entities.  Further, the withdrawal may indicate a decision by HRSA to scale back its issuance of notice-and-comment rules for the 340B Program, limiting formal rulemaking to areas where the statutory authority to do so is explicit.  The withdrawal of the proposed mega rule demonstrates HRSA’s position that it does not possess the broad authority necessary to issue a formal rule of this scope.

Without the proposed rule, important facets of the 340B Program remain uncertain.  Manufacturers and Covered Entities that sought guidance on key practical issues such as patient definition now must continue to wait for clarification.  As noted, going forward HRSA will seek to clarify “key policy issues” but has yet to announce whether the topics covered by the proposed rule will be addressed.  HRSA’s regulatory guidance on these issues may never come, however, if the U.S. District Court for the District of Columbia (which is hearing further briefing on the aforementioned case concerning HHS’s regulatory guidance on the orphan drug rule) further restricts HHS’s ability to issue guidance.

In the face of continuing uncertainty, 340B Program participants, including Covered Entities, should stay current and closely follow available guidance from HRSA and the 340B Prime Vendor (Apexus).  Until clear guidance has been issued pertaining to subjects such as patient definition and contract pharmacy compliance, 340B Program participants should continue to follow and document best practices to ensure compliance with all 340B Program requirements.

ARTICLE BY

David S. Ivill
Emily J. Cook
Joseph M. Parise
OF
McDermott Will & Emery

Special Edition Health Care Law Update – November 11, 2014

Mintz Levin Law Firm

Elections Wrap Up, Lame Duck Preview, and a Changing Congress

In this ML Strategies Special Edition Health Care Update, we bring you a detailed look at two of the most pressing health care policy topics facing policymakers:

  1. Sorting out Congressional leadership changes post-midterm elections and looking ahead to the  upcoming Lame Duck session of Congress; and
  2. Monitoring the rapidly escalating effort to combat the Ebola epidemic.

Impact of Midterm Elections

On November 4th, voters cast their ballots giving the Republican Party control of the upcoming 114th Congress. Looking ahead to the new Congress, there will be some significant changes to the leadership on Committees of jurisdiction. While leadership will not be officially decided until Congress convenes in January, some predictions are below.

  • Senate Finance Committee: Senator Orrin Hatch (R-UT) will chair the Committee. As Chairman, Hatch is expected to focus on tax reform and is likely to advance his bill S. 232, to repeal the Affordable Care Act’s (ACA) excise tax on medical devices as part of this process. Hatch can also be expected to push for additional transparency from the Department of Health and Human Services (HHS) and support policy changes to the ACA such as we have seen the House pass in the 113th Congress. Senator Ron Wyden (D-OR) will be the ranking member. Hatch and Wyden have a strong working relationship and share interest in tax reform. Wyden is also a strong supporter of the ACA and is unlikely to support repealing or replacing the health care law, be they partial or wholesale proposals. On the whole, Democrats will likely have to cede at least two seats to the Republicans, meaning they will have to drop at least one member from the committee.
  • Senate Health, Education, Labor and Pensions (HELP) Committee: Senator Lamar Alexander (R-TN) is expected to chair the HELP Committee. Alexander will likely turn first to Ebola, should there be lingering issues unresolved after the Lame Duck. Alexander and the Committee’s current chair, Senator Tom Harkin (D-IA), introduced a bill to accelerate the development of Ebola treatments and vaccines. Alexander will also try to chip away at the ACA. In the past, he has said the Committee will vote early in the next Congress to repeal the ACA, though he conceded that the law will stay in effect as long as President Obama is in office. Alexander is more optimistic about tweaks to the ACA. Among his top priorities are addressing wellness, passing a 40 hour work week bill, and tackling small business insurance.

The Democrats have yet to pick their ranking member. As Senator Barbara Mikulski (D-MD) will opt for the ranking membership of the Appropriations Committee, Senators Patty Murray (D-WA), Bernie Sanders (I-VT), and Bob Casey (D-PA) could all be the lead Democrat on the Committee. The subcommittee chairs will likely be Senator Mike Enzi (R-WY) for Children and Families, Senator Richard Burr (R-NC) for Primary Health and Aging, and Senator Johnny Isakson (R-GA) for Employment and Workplace Safety.

  • House Energy and Commerce Committee: Representative Fred Upton (R-MI) will continue to chair the Committee. His agenda will resemble that in the 113th Congress, promoting the 21st Century Cures Initiative, which, among other things, promotes accelerated discovery of cures, streamlined development of drugs and devices, and greater use of health care technology to offset rising health care costs. He will also likely continue to try and reign in various provisions of the ACA. Other than the law’s repeal, which the Committee will likely take up at the start of the next Congress, Upton may seek to scuttle the employer mandate and the medical device tax. In addition, he may seek to overhaul or even dismantle the Independent Payment Advisory Board (IPAB), which would administer provider cuts unilaterally if certain spending thresholds are surpassed. Upton recently released the Committee’s record of success webpage and outlined several priorities for the new Congress, including building on the work already done on the 21st Century Cures Initiative.

On the Democratic side, with Representatives Henry Waxman (D-CA) and John Dingell (D-MI) retiring, Representative Frank Pallone (D-NJ) is in line to be ranking member. However, Minority Leader Pelosi has been a strong advocate for Representative Eshoo to take the Ranking Membership. With top slots opening up on other committees because of midterm losses, some congressional analysts believe that Pallone could end up moving back to the Natural Resources committee in place of Rep. Peter DeFazio (D-OR), who is likely to become Ranking Member on the House Transportation and Infrastructure Committee, following the loss of current Ranking Member Nick Rahall (D-WV). Of the 10 or so House Democrat losses, including Representatives John Barrow (D-GA) and Brad Schneider (D-IL), that are official, the majority of them have indicated explicitly, or have been characterized by others, as Pallone supporters- so it will be interesting to see how that plays out if it comes down to the last few votes.

  • House Ways and Means Committee: Representatives Paul Ryan (R-WI) and Kevin Brady (R-TX) are jockeying for the chairmanship, but it is widely believed that Representative Ryan will most likely prevail. Like Senator Hatch, Ryan will focus on tax reform. He will inherit Chairman Camp’s template, which he’ll likely keep with some changes. This effort could very well effect the health care community should Ryan join Senator Hatch in an attempt to repeal the medical device tax. Ryan will also address health care, separate from taxes, including holding hearings to critique the law and to demand more transparency and build on efforts in the 113th Congress to pursue Medicare fraud, waste, and abuse legislation. Representative Sander Levin (D-MI) is expected to remain the Ranking Member. However, House Democrats are eyeing Representative Chris Van Hollen (D-MD) to rejoin the committee. A budget expert with a strong grasp on tax policy, Van Hollen could serve as a vocal counterweight to Ryan, reprising a role he played opposite Ryan on the Budget Committee.

Lame Duck Preview

President Obama, who began his presidency with a Democratic majority in the Congress, will now round out his last two years in office with a Republican majority. This leaves the upcoming Lame Duck session as the last opportunity for the president and his Democratic colleagues in the Senate to set the legislative agenda.

Among one of the items most likely to pass is the FY 2015 appropriations legislation. With no appropriations legislation finalized prior to recessing for elections, Congress approved a short-term Continuing Resolution (CR) funding the Federal government at Fiscal Year 2014 levels through December 11, 2014. Before the CR expires, the Lame Duck Congress will likely pass either: 1) another short-term CR running through February or March 2015; 2) a long-term CR for the remainder of the fiscal year ending on September 30, 2015; or 3) an Omnibus appropriations bill setting new spending levels for FY15. Additionally, in the days after the midterm election, President Obama submitted an emergency funding request of $6.18 billion for the fight against Ebola and will push Congress to pass the request during the Lame Duck.

The Lame Duck offers some hope of passing a permanent solution to the Medicare physician payment formula, also known as the “SGR” or the “Doc Fix.” Looking to vehicles such as tax extenders or an omnibus spending bill, Congress still must determine how to pay for reforming the SGR. Members of the House GOP Doctors Caucus wrote to House leadership requesting that Congress take up SGR reform before the end of the year. The letter notes that the Lame Duck is a unique opportunity to bring much-needed stability to the Medicare program that will benefit seniors and physicians alike and requested more discussions on offsetting an SGR repeal.

While stakeholders and experts remain skeptical that such an effort would be successful, lawmakers are pulling out all the stops to engage industry to support a potential SGR fix this year. However, the current temporary extension of the SGR patch continues through March 2015, meaning that action could slip to next year.

Should Congress attempt to push through a comprehensive SGR bill in the Lame Duck, this would provide a vehicle for other Medicare proposals that are kicking around the House Ways and Means Committee—including Representative Brady’s draft fraud, waste, and abuse package, Protecting Integrity in Medicare Act of 2014 (PIMA), and Medicare extenders. Representative Brady reportedly wanted to introduce PIMA in the Lame Duck and, if there is bipartisan interest, pass the legislation under suspension. However, there has been no groundwork laid for this package in the Senate, so passing the package without a larger vehicle (such as SGR) may be unlikely.

Ebola Epidemic and Lame Duck Response

On November 4th, President Obama convened his national security and public health teams to discuss Ebola preparedness at home and the whole-of-government approach to contain the epidemic at its source in West Africa. The President’s advisors noted HHS’ efforts to ensure U.S. hospitals and the broader health system are prepared to identify, isolate, and treat patients. The team also discussed the screening of individuals traveling from the affected West African countries and the monitoring requirements these individuals are subject-to upon arrival in the U.S. There was consensus that, despite initial signs of progress in Liberia, the international community must continue to attack the problem aggressively at the source of the epidemic in West Africa.

Following this meeting, the Obama Administration announced it is seeking $6.18 billion through an emergency funding request to Congress to enhance efforts to address the Ebola crisis. The White House has requested $2.43 billion for HHS, including $1.83 billion for the Centers for Disease Control (CDC) to prevent, detect, and respond to the Ebola epidemic, $333 million for the Public Health and Social Services Emergency Fund (PHSSEF) for health worker training, manufacturing of synthetic therapeutics and vaccines, and modeling and genetic sequencing of the Ebola virus, $238 million for the National Institutes of Health (NIH) to conduct clinical trials of investigational vaccines and therapies, and $25 million for the Food and Drug Administration (FDA) to regulate Ebola vaccines and therapeutics. The Administration is also requesting $1.98 billion for USAID to scale up foreign assistance in West Africa, $127 million for the Department of State to support UN Mission for Ebola Emergency Response (UNMEER)operations, and a $1.54 billion contingency fund.

The President communicated this request to Congress in a November 5th letter to congressional leadership requesting that Congress consider his Administration’s $6.18 billion emergency appropriations request to implement a comprehensive strategy to contain and end the Ebola outbreak at its source in Africa, enhance domestic preparedness, speed procurement and testing of vaccines and therapeutics, and accelerate global capability to prevent spread of future infectious diseases. President Obama urged expeditious consideration of the proposal.

As we enter the Lame Duck, Congress is expected to tackle Ebola as a priority when it reconvenes. On November 12th, the Senate Appropriations Committee will hold a hearing on the U.S. Government response to the Ebola outbreak. Witnesses will include HHS Secretary Sylvia Matthews Burwell, CDC Director Dr. Tom Frieden, National Institute of Allergy and Infectious Diseases (NIAID) Director Dr. Anthony Fauci, DHS Secretary Jeh Johnson, Deputy Secretary of State for Management and Resources Heather Higginbottom, USAID Assistant Administrator for Democracy, Conflict, and Humanitarian Assistance Nancy Lindborg, Assistant Secretary of Defense for Special Operations and Low Intensity Conflict Michael Lumpkin, and Joint Chiefs of Staff Deputy Director for Political-Military Conflict James Lariviere.

On the heels of the Appropriations Committee hearing, the House Foreign Affairs Committee will hold a November 13th hearing to examine international and U.S. efforts to combat the Ebola epidemic in West Africa. The hearing, “Combating Ebola in West Africa: the International Response,” will feature witnesses including: USAID Administrator Rajiv Shah, State Department Deputy Assistant Secretary for the Bureau of African Affairs Bisa Williams, DOD Assistant Secretary of Defense for Special Operations and Low-Intensity Conflict Michael Lumpkin, DOD Deputy Director for Politico-Military Affairs (Africa) Major General James Lariviere, and DOD Joint Staff Surgeon Major General Nadja Y. West.

As Congress turns its attention to the Administration’s response, the FDA continues to work with industry to develop a vaccine to combat Ebola. Outlining a plan at an American Society of Tropical Medicine and Hygiene conference last week, Dr. Luciana Borio, head of the FDA’s Ebola response team, said the FDA is taking a “novel” approach and will test multiple drugs at once in an umbrella study with a single comparison group. This plan is intended to accelerate the testing process as patients will be paired with a drug and with someone from a comparison group to look for patterns.

* * *

Implementation of the Affordable Care Act

In-Patient Hospitalization Guidance: HHS and the Internal Revenue Services (IRS) released guidance stating that group health plans must cover hospitalizations in order to satisfy minimum value under the ACA. The guidance, which will be followed up by proposed regulations, states the agencies “believe that plans that fail to provide substantial coverage for in-patient hospitalization services or for physician services” do not meet minimum value requirements.

Other Federal Regulatory Initiatives

CMS Innovation Center Webinar: On November 10th, the Centers for Medicare & Medicaid Services (CMS) Innovation Center will hold a webinar to provide an update on the work of the Center and the models being tested to improve care for patients, communities, and lower costs. Dr. Patrick Conway, CMS Deputy Administrator for Innovation and Quality and CMS Chief Medical Officer, will be the lead presenter in the webinar.

New Members of the Health IT Policy Committee: HHS Secretary Burwell announced the appointment of a new member to the Health Information Technology Policy Committee (HITPC) and renewed appointments for three members of the Health IT Standards Committee (HITSC). The new appointment is Anjum Khurshid, director of the health systems division of the Louisiana Public Health Institute.

HHS Survey on Health Coverage: The HHS Assistant Secretary for Planning and Evaluation (ASPE) released the findings of a survey of health insurance coverage for 2013 and 2014. Among other things the survey finds that, as of June 2014, 10.3 million nonelderly Americans, age 18 to 64, gained health insurance coverage since the beginning of the ACA open enrollment.

HRSA Awards Mental Health and Substance Abuse Funding: The Health Resources and Services Administration (HRSA) announced $51.3 million in ACA funding to support 210 health centers in 47 states to establish or expand behavioral health services for nearly 440,000 people.

ONC Data Sheds Light on Attestation Rates: The Office of the National Coordinator for Health IT (ONC) released a data analytics update on the 2014 attestation experience. The update shows that 4,656 doctors and other eligible providers and 258 hospitals had attested to Stage 2.

CDC Releases Monitoring Guidance for Ebola: The CDC released updated monitoring and movement guidance defining four risk levels based on degree of exposure to Ebola. The guidance helps to ensure a system is in place to quickly recognize symptoms that may necessitate a person be routed to medical care.

Other Health Care News

Study of Marketplace Insurance Premiums: The Robert Wood Johnson Foundation and the Urban Institute released a study of public filings from 17 states and Washington, DC of marketplace insurance premiums in early approval states. The report finds that premium increases will be low, with 10 states increasing only 5 percent, 2 states increasing more than 5 percent, and 6 states seeing premium reductions.

Specialty Providers Press NAIC on Access: The Alliance of Specialty Medicine sent a letter to the National Association of Insurance Commissioners (NAIC) regarding draft policy models for individual and small group market health insurance coverage. The Alliance urged NAIC to ensure consumers have access to specialists without suffering high out-of-pocket costs.

WHO Recommends Overdose Policies: The World Health Organization, estimating that 69,000 people die a year from opioid overdose, advised that those likely to witness an overdose incident, such as family members, should be given access to the opioid antidote naloxone and trained in its use. The FDA approved use of naloxone injectors for family use in April 2014.

Survey of ICD-10 Preparation: The American Health Information Management Association and the eHealth Initiative released a survey of health delivery organizations and clinicians finding that 65 percent of respondents indicated that they could begin end-to-end testing prior to the fourth quarter of 2015 but that there remain concerns that revenue will decrease during the first year of ICD-10 compliance.

Georgetown University Survey of Children’s Insurance: Georgetown University’s Center for Children and Families found that in 2013, for the first time in five years, children’s health uninsured rates did not drop. The 2013 rate was 7.1 percent, compared to 7.2 percent in 2012. Since 2008, the number of uninsured children has shrunk from 6.9 million to 5.2 million.

Upcoming Congressional Hearings

Senate

On November 12th, The Senate Appropriations Committee will hold a hearing on the U.S. Government response to the Ebola outbreak.

House

On November 13th, the House Committee on Foreign Affairs will hold a hearing titled, “Combating Ebola in West Africa: The International Response.”

ARTICLE BY

Joseph P. Hammang, PhD
Alexander Hecht
Andrew J. Shin
Abby Matousek
OF
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.

Employers: How Prepared Are You for Ebola?

Morgan Lewis logo

Rapidly changing circumstances raise workplace questions.

The Ebola epidemic in 2014 has already been confirmed by the U.S. Centers for Disease Control (CDC) as the worst in history. The extent of this outbreak is still unknown, as reports of Ebola transmissions continue not only in West Africa but also (for the first time in history) inside U.S. and European borders. Because of the potential risks in a globalized economy, the U.S. government, its various agencies, and employers alike are now scrambling to ensure that appropriate rules and procedures are in place to prevent any further exposure to the disease. Reactions have been swift and fluid as officials learn more about the presence of the virus in West Africa and beyond and as they develop strategies to respond. Among the federal agencies that have already taken action, the CDC has recently issued “tightened” guidance for proper personal protective equipment (PPE) in the healthcare industry, and the Occupational Safety and Health Administration (OSHA) has issued guidance covering a number of workplace safety issues. The situation is changing rapidly and further action is expected by the U.S. government, especially after the White House announced the appointment of an Ebola Response Coordinator (or Ebola Czar).

In the United States, employers are facing challenges and questions on how to best address a wide variety of issues, including workplace safety, travel policies, employee relations, leaves of absence, and refusal to work requests. Whether responding to Ebola or other emergencies, employers should use protocols that include emergency preparedness and response plans, such as assigning responsibilities, assessing the hazard, conveying effective communications, and implementing security measures to address those key issues. In the meantime, here is what you need to know right now.

OSHA’s Interim Guidance

OSHA quickly released interim guidance for workers within the United States that focuses on those in industries most likely to be affected by the Ebola crisis:

  • Healthcare workers

  • Airline and other travel industry personnel

  • Mortuary and death care workers

  • Laboratory workers

  • Border, customs, and quarantine workers

  • Emergency responders

  • Employers in critical infrastructure/key resource sectors, such as bus drivers and pharmacists

Employers in these key industries must evaluate how they currently respond to emergencies and if those preparedness and response plans are adequate or need modification, particularly when assessing hazards specific to their jobsites (OSHA lists industry-specific information on its website). These employers should explore ways to proactively combat and contain the virus, such as obtaining PPE, implementing cleaning and sanitation procedures, and evaluating whether engineering controls, such as pressurized glass, respirators, and decontamination devices, should be used. If an employer happens to be a hospital or similarly licensed accredited facility, state licensing and other laws as well as accreditation bodies may require those organizations to activate emergency preparedness plans. Employers should communicate with their workers and train them about sources of Ebola and any required precautions.

On its newly released website dedicated to Ebola, OSHA has asserted jurisdiction over potential worker exposure via several regulations already in place. Most notably, the Ebola virus has been classified as a “bloodborne pathogen” under OSHA’s Bloodborne Pathogens standard,[1] which explicitly covers pathogens like hepatitis B virus (HBV) and human immunodeficiency virus (HIV). The Bloodborne Pathogens standard imposes a range of requirements on employers whose workers can be reasonably anticipated to contact blood or other potentially infectious materials (OPIM), such as saliva and semen. Covered employers must train employees, prepare exposure control plans, and use “universal precautions,” engineering and work practice controls, PPE, and housekeeping measures to contain the virus. Employers must also offer medical evaluations, blood tests, and follow-up evaluations after any worker is exposed to blood or OPIM. The standard contains many other nuanced requirements, including carefully documenting compliance measures. Given the complexities of the regulation, employers are strongly encouraged to seek legal advice if workers could anticipate exposure and to seek emergency, medical, and legal advice if any work-related exposure to blood or OPIM occurs.

Beyond this standard, OSHA has reminded employers that—when undertaking precautions for contact-transmissible diseases and any bioaerosols containing the Ebola virus—they must comply with OSHA’s (1) Respiratory Protection standard[2] if respirators are used on the job and (2) PPE standard[3] wherever PPE is used as a precaution. Finally, OSHA reiterated that it may issue citations against employers under the General Duty Clause of the Occupational Safety and Health Act of 1970[4]—OSHA’s “catch all” provision, which is used if no other regulation applies and where an employer allegedly fails to keep its workplace free of recognized hazards that can cause death or serious bodily harm to workers.

CDC Involvement

The primary U.S. agency embroiled in the fight against Ebola is the CDC. Of the many steps taken by the CDC in this effort, highlights of the latest guidance and advice are outlined below.

“Tightened Guidance” on PPE for U.S. Healthcare Workers

Following widespread criticism after two nurses contracted Ebola while treating a patient in Dallas, Texas, the CDC released on October 20 “tightened guidance” for PPE used by healthcare workers while caring for patients with Ebola. According to the CDC, three guiding principles control: (1) Employees must receive rigorous and repeated training to fully understand how to use PPE, (2) no skin can be exposed when PPE is worn, and (3) a trained monitor must be present to supervise all workers as they put on or take off PPE. The CDC also described “different options for combining PPE to allow a facility to select PPE for their protocols based on availability, healthcare personnel familiarity, comfort and preference while continuing to provide a standardized, high level of protection for healthcare personnel.” Among the recommendations for monitoring the safe use and removal of PPE, the CDC provides advice on step-by-step PPE removal, as well as disinfection of gloved hands.

In addition to PPE, the CDC further underscored other critical prevention activities to respond to the Ebola risk, including (1) prompt screening and triage of potential patients, (2) designating site managers who have the responsibility to ensure proper implementation of precautions, (3) limiting personnel in the isolation room, and (4) effective environmental cleaning. Employers in the healthcare industry should be aware that the CDC has highlighted management responsibility “to provide resources and support for the implementation of effective prevention precautions” and that management “should maintain a culture of worker safety in which appropriate PPE is available and correctly maintained, and workers are provided with appropriate training.” For more information and advice for healthcare workers, visit the CDC’s website.

Health and Travel Advisories

Given the severity of the risk that Ebola poses, the CDC has issued health and travel alerts, which it will continue to update as the situation develops. In the wake of various governors, particularly those from New York, New Jersey, and Illinois, having announced plans to quarantine health workers traveling from West Africa who treated Ebola patients, the CDC has also updated its guidance on October 27 regarding the monitoring and movement of persons with potential Ebola exposure. The guidance applies to anyone who recently traveled to West Africa and may have been exposed to Ebola and includes newly created tiered categories of risk, ranging from high to no risk and based on exposure to Ebola. Depending on the risk category, the CDC recommends that state and local health authorities isolate travelers who are exhibiting signs of illness or conduct “active” or “direct active” monitoring of signs and symptoms of Ebola for other at-risk individuals.

Health officials will make at least daily contact with these travelers, requiring travelers to disclose (1) temperatures and any other Ebola symptoms, such as headache, diarrhea, and vomiting, and (2) intent to travel out of state. For individuals who are under direct active monitoring, the CDC recommends that discussions with the individual include plans to work, travel, take public transportation, or go to busy public places to determine whether these activities are allowed.

Employers, and particularly employers with an international presence, should closely monitor these CDC travel advisories,[5] as well as advisories published by the World Health Organization (WHO).[6] Employers should evaluate their own travel policies and alerts against those published by the CDC and the WHO.

Protecting Employees from Impacted Regions from Harassment and Protecting the Confidentiality of Medical Information

Like the CDC, employers must respect workers’ privacy—and, particularly, the confidentiality of their medical information pursuant to the Americans with Disabilities Act (ADA)—and they must also comply with rules and guidance from OSHA, the CDC, and other agencies. Employers should balance their need to ensure workplace safety with their obligation to avoid unnecessary or overbroad medical inquiries, which are prohibited by the ADA. Of course, if an employee is exhibiting symptoms of Ebola exposure, it is appropriate to urge him or her to see a doctor. However, the decision to send an employee for a medical exam or to request medical documentation should be based on objective information—not unfounded fears that may or may not be grounded in reality. As an example, without some reason to believe there has been Ebola exposure, it could be risky to request medical information simply because an employee visited an Ebola-impacted region.

Employers should also take caution and consult legal counsel before they send home an employee suspected of Ebola exposure. The decision to remove an employee from the workplace for medical reasons must based on objective belief that the employee may present a direct threat of significant, imminent harm to himself or herself or others. These decisions should not be based on rumor or unfounded concerns.

To address these issues, employers should train human resources employees about the CDC guidance so they can understand the medical and scientific realities of Ebola exposure and, therefore, be prepared to respond appropriately if employees express concern about a coworker believed to be at risk for Ebola exposure. Similarly, employers should take all necessary steps to ensure that employees who are, or who are perceived to be, from regions impacted by Ebola do not experience harassment based on race, national origin, or any perceived medical condition.

HIPAA

The Ebola situation has also introduced some Health Insurance Portability and Accountability Act (HIPAA) interpretation questions for employers that are Covered Entities—such as healthcare providers—but also for those that sponsor a Covered Entity group health plan. HIPAA protects an individual’s protected health information (PHI), which includes, for example, medical, demographic, and other identifying information. HIPAA restricts Covered Entities from disclosing PHI about a worker or plan participant, except in limited circumstances. To date, the U.S. Department of Health and Human Services has not indicated that the Ebola crisis will change its enforcement or interpretation of HIPAA. The HIPAA Privacy Rule and Security Rules, as amended by the Health Information Technology for Economic and Clinical Health Act, will still apply to Covered Entities. Although narrow exceptions exist for use or disclosure for certain public health purposes, this exception will likely only apply in limited situations for limited organizations. Covered Entities should review their policies and procedures to determine if and how infectious diseases, particularly Ebola, are addressed. They should also train their Privacy Employees—workers who act on behalf of the Covered Entity—to continue to protect an individual’s PHI. Before disclosing any PHI, Covered Entities should exercise caution and consult with legal counsel to confirm that a use or disclosure will not constitute a HIPAA violation.

Labor Relations

In light of the media furor from various healthcare and service workers’ unions regarding Ebola risks to workers, employers should also expect to receive collective bargaining demands related to training, adequate safety procedures, and protective equipment and medical services provided to exposed employees, potentially including demands for leave (whether paid or unpaid). Employers should be proactive, therefore, in reaching out to union representatives of healthcare workers to develop protocols on how best to handle these types of issues, and, given the labor laws, should not act unilaterally, even if well intentioned and even if the to-be-implemented protocols are favorable to employees. Employers should also review their current collective bargaining agreements for any clauses or language requiring the employer to implement procedures related to infectious diseases or the safety of their workers. Finally, even nonunion workers can exercise rights under the National Labor Relations Act (NLRA) to engage in concerted activity for their mutual aid and protection if workers fear their safety is not adequately protected. A refusal to work because of safety concerns related to Ebola, therefore, could be protected under the NLRA, and employers should carefully consider this issue prior to implementing discipline to employees for refusing to work.

Immigration

In coordination with the CDC, the Department of Homeland Security (DHS) implemented a set of travel restrictions[7] involving additional screening and protective measures for travelers from Ebola-affected countries at U.S. ports of entry. Travelers to the United States who are arriving directly or indirectly from Liberia, Sierra Leone, or Guinea will undergo enhanced screening that includes the following:

  • Identifying and interdicting travelers from the Ebola-affected countries.

  • Isolating these travelers from the rest of the traveling public while the individual completes a questionnaire and contact information form.

  • Medically trained personnel will take the traveler’s temperature. If the traveler has a fever or other symptoms, or may have been exposed to Ebola, U.S. Customs and Border Protection (CBP) will refer the traveler to the CDC for a public health assessment. The CDC will then determine whether the traveler can continue to travel, should be taken to a hospital for further evaluation, or should be referred to a local health department for further monitoring.

  • Encouraging the traveler to seek healthcare at the first sign of any potential illness.

If CBP discovers that a traveler has been in one of the three countries in the prior 21 days, he or she will be referred for additional screening, and, if necessary, the CDC or other medical personnel in the area will be contacted pursuant to existing protocols. The enhanced screening is in place at the five U.S. airports that account for 94% of travelers flying to the United States from Ebola-affected countries. The airports are John F. Kennedy International, Newark Liberty International, Washington Dulles International, Hartsfield-Jackson Atlanta International, and Chicago O’Hare International. DHS has authority under existing law to deny admission to individuals who represent a public health threat.

Given the rapidly changing circumstances, employers are faced with many labor and employment challenges to consider.

[1]. 29 C.F.R. § 1910.1030.

[2]. 29 C.F.R. § 1910.134.

[3]. 29 C.F.R. 1910.132.

[4]. View the act here.

[5]. View the advisories here.

[6]. View the advisories here.

[7]. View the restrictions here.

ARTICLE BY

Jonathan L. Snare
Joyce A. Cowan
Eric S. Bord
Ross H. Friedman
Michelle Seldin Silverman
Georgina L. O’Hara
OF
Morgan, Lewis & Bockius LLP

How Should IME (Independent Medical Examination) Doctors Apportion for Pre-Existing Impairment Using the AMA Guides and Rule 20 Guidelines?

Steptoe Johnson PLLC Law Firm

In West Virginia, Workers’ Compensation statutes provide that an employee who has a definitely ascertainable impairment resulting from an occupational or non-occupational injury, disease, or any other cause, whether or not disabling, and the employee thereafter receives an injury in the course of and resulting from his employment, the prior injury and the effect of the prior injury and aggravation shall not be taken into consideration in fixing the amount of compensation or impairment allowed by reason of the subsequent injury.  The statute provides that compensation, i.e., a permanent partial disability impairment rating, shall be awarded only in the amount that would have been allowable had the employee not had the pre-existing impairment.

No provision in this particular code section requires that the degree of pre-existing impairment be definitely ascertained or rated prior to the injury received in the course of and resulting from the employment or that the benefits must have been specifically granted or paid for the pre-existing impairment.  Additionally, the degree of pre-existing impairment may be established at any time by competent medical evidence.  It is not clear in the rules or statutes whether a reduction of an award for a pre-existing degenerative impairment should be calculated after the application of the tables in Rule 20 for determining impairment in regard to the lumbar, thoracic, or cervical spine or before the application of these tables.

In West Virginia, with regard to permanent partial disability evaluations and awards, such assessments shall be determined based upon the range of motion model contained in the AMA Guides, 4th Edition.  Once an impairment level has been determined by range of motion assessment in regard to a claimant’s spine injury, that level will be compared with the ranges set forth in the corresponding tables for permanent impairment as found in Rule 20, W. Va. C.S.R. § 85-20 et seq.  Permanent partial disabilities in excess of the range provided in the appropriate category as identified by the rating physician are reduced to within the ranges set forth in these tables found in Rule 20.  A single injury or cumulative injuries that lead to permanent impairment to the lumbar, thoracic, or cervical spine area of one’s person shall cause an injured worker to be eligible to receive a permanent partial disability award within the ranges identified in the tables found in Rule 20.

The rating physician must identify the appropriate impairment category and then assign impairment within the appropriate range designated for that category.  Rule 20 provides that all evaluations, examinations, reports, and opinions with regard to the degree of permanent whole body medical impairment which an injured worker has suffered shall be conducted and imposed in accordance with the AMA Guides, 4th Edition.  Rule 20 does not specifically address allocation of physical impairment at any time but does dictate that degenerative conditions are not compensable.  Also, Rule 20 allows for an evaluating physician to deviate from the rule with sufficient explanation for the deviation.

In a memorandum decision issued by the West Virginia Supreme Court of Appeals on June 11, 2014, the Supreme Court reversed and remanded a decision of the Office of Judges and Board of Review based on an employer’s appeal and found that the Office of Judges inappropriately concluded that the reviewing doctor did not correctly apportion for the claimant’s pre-existing condition when she did so after applying the table for impairment found in Rule 20.  The Supreme Court specifically noted that the physician correctly and appropriately apportioned for a pre-existing impairment after applying the tables found in Rule 20.  Even though this is a memorandum decision that does not have any specific syllabus points, it certainly is the only decision we have from the high court which shows that apportionment for a pre-existing condition should be made after applying the tables of impairment for the lumbar, thoracic, or cervical spine found in Rule 20.

ARTICLE BY

Alyssa A Sloan
OF
Steptoe & Johnson PLLC

Managing Ebola Concerns in the Workplace [PODCAST]

Jackson Lewis Law firm

Many employers are struggling to understand the potential workplace implications of Ebola hemorrhagic fever (EHF).  We invite you to listen to a complimentary 48-minute podcast during which three Jackson Lewis practice group leaders discuss some of the legal and practical issues relating to the virus.  Among the issues discussed are:

  • Steps employers should consider taking to ensure OSHA and state workplace health and safety laws are satisfied;

  • ADA, GINA and FMLA compliance challenges that may arise as employers attempt to lawfully identify and manage employees who are or may have been exposed to Ebola; and

  • HIPAA and other sources of privacy and medical confidentiality obligations that should be considered as employers respond to workplace Ebola concerns.

You can access the podcast here.

ARTICLE BY

Bradford T. Hammock
OF
Jackson Lewis P.C.

A Guide to Dealing with Illnesses in the Workplace

Godfrey Kahn Law Firm

As a result of all of the media coverage surrounding the Ebola issues, many of our clients have wondered whether they need to do anything, as employers, to prepare for similar issues and to address related employment issues. Whether it is the Ebola virus or another virus or pandemic, the general rules for employers remain the same.

The Ebola Virus Basics

The key to contracting the Ebola virus is direct contact (through broken skin or mucous membranes in, for example, the eyes, nose or mouth) with someone who is carrying the virus.  The Centers for Disease Control and Prevention (“CDC”) has a website dedicated to understanding, preparing for and preventing the spread of the Ebola virus.  For additional information regarding the Ebola virus, including symptoms and other useful information, please visit the CDC’s website.

For employers, the key is not to panic.  Given that we are at the early stages of flu season, employers should avoid overreacting at the first sight of an employee with flu-like symptoms.  Employers concerned about particular employees should consult with legal counsel before taking any steps that may lead to liability under various employment laws (more on this below).

Important Employment Issues Each Employer Should Consider

Pandemics (whether the Ebola virus, the 2009 H1N1 virus or influenza) implicate a number of employment laws.  Employers must strike a proper balance between protecting employees from infection and operating within the confines of applicable law.

1. Consider the requirements of the Americans with Disabilities Act before requiring employees to undertake a medical examination.

The Americans with Disabilities Act (“ADA”) prohibits, among other things, medical examinations for applicants and employees.  An employer cannot require a current employee to undergo a medical examination unless the examination is job related and consistent with business necessity.  According to the Equal Employment Opportunity Commission (“EEOC”), medical examinations of an employee are job-related and consistent with business necessity when an employer has a reasonable belief, based on objective evidence, that (1) an employee’s ability to perform essential job functions of his/her job will be impaired by a medical condition; or (2) an employee will pose a direct threat due to a medical condition.  “Direct threat” means “a significant risk of substantial harm to the health or safety of the individual or others that cannot be eliminated or reduced by reasonable accommodation.”  29 C.F.R. § 1630.2(r).  For additional guidance on direct threats, please see the EEOC’s website.

The EEOC’s 2009 guidance specific to the H1N1 virus sheds additional light on how employers should make direct threat assessments before requiring a medical examination.  The EEOC states that whether a pandemic virus rises to the level of a direct threat depends on the severity of the illness.  Helpful data points to determine the severity—and associated direct threat—of a virus are the warnings and guidance from government agencies such as the CDC, state health departments and other recognized authorities on illness and disease.

2. Consider the Occupational Safety and Health Act when accessing your workplace practices.

In addition to the ADA’s medical inquiry restrictions, most employers must follow the safety and health regulations dictated by the Occupational Safety and Health Administration (“OSHA”) under the Occupational Safety and Health Act (“OSH Act”).  Although OSHA does not specifically regulate Ebola or other pandemics, employers may trigger workplace safety violations under OSHA’s General Duty Clause if they do not take proper steps to protect their employees.

Employers run the risk of receiving citations under the General Duty Clause if they expose employees to a hazard that the employer could reasonably have reduced and that the employer recognized would cause or likely would cause serious physical harm to employees.  Employers in industries with a high risk of disease contamination (e.g., healthcare employers) should therefore evaluate potential hazards and determine whether they can take steps to reduce the risk of exposure to employees.

Employers should also keep in mind that an employee who reasonably refuses to report to work because of a dangerous work condition—including contracting a pandemic virus—may be protected from retaliation.

OSHA’s guidance about Ebola and pandemic influenza provides useful information for employers who want to prepare for and respond to contagious disease risks in their workplaces.

3. Employees may be entitled to leave under the Family and Medical Leave Act.

Federal and state (where applicable) family and medical leave laws (“FMLA”) complicate the web of responsibilities an employer has to navigate when it comes to dealing with ill employees.  For employers covered by these laws (generally employers with 50 or more employees under federal law), an eligible employee who has contracted the Ebola virus or another pandemic virus may qualify for leave based on a serious health condition.  Similarly, an eligible employee may qualify for leave if an eligible family member contracts a virus that qualifies as a serious health condition.

If an emergency situation prompts the need for FMLA leave, administering the leave in a lawful manner gets more complicated than under normal circumstances.  For example, it may not be practical to solicit and review medical certification forms.  In these situations, employers must have sufficient information (including the employee’s statements) that the underlying condition qualifies as a serious health condition.  Designating leave as FMLA without sufficient information establishing a serious health condition can result in a retaliation claim.  In emergency situations, employers may also need to exercise forbearance on the return of medical certification forms, particularly if an employee needs to assist a family member who is ill.  For additional FMLA guidance, please visit the United States Department of Labor website.

Steps Employers Should Take to Minimize Workplace Safety and Health Issues

As with any other workplace safety and health issues, the recent Ebola-related news has raised many questions about what employers should do when facing similar situations.  Although each employer is unique and each industry must confront different obstacles and risks, employers should, at a minimum, follow the steps outlined below.

  • Have a plan.  Consult with internal safety experts and review the guidance provided by government agencies regarding specific safety issues.  Create a plan (preferably with the assistance of legal counsel) that addresses issues specific to your workplace and your industry.

  • Communicate your plan to employees.  Your company’s protocols for dealing with safety issues should not be a secret to any of your employees.  Publicize the plan internally and ensure that employees have ready access to the plan.

  • Train your employees.  Train your employees about your company’s safety protocols on a yearly basis.  If you are concerned about a particular risk that is not usually common to your workplace or if you update your plan, provide additional training as needed to address these issues.

  • Supervise implementation of the plan.  Having a plan in place and training your employees to follow certain procedures is meaningless if no one supervises the process.  Designate individuals to review employee actions to ensure that the plan’s protocols are followed and to identify potential shortcomings of/improvements to the plan.  Whenever necessary, update your plan to ensure that it addresses all major safety risks and train employees on the changes made to the plan.

Employers that consult government and other advocacy organization websites to adopt ideas, disseminate information and prepare practices and procedures for addressing workplace safety and health issues will be in a good position to protect against unwanted legal action.

ARTICLE BY

Rufino Gaytán
OF
Godfrey & Kahn S.C.

Ebola and Potential Labor Relations Issues

Proskauer Law firm

The Ebola panic presently sweeping the U.S. raises a host of potential issues for employers.  We recently provided guidance to help employers ensure employee safety while also complying with legal obligations under the Americans with Disabilities Act and similar laws.  In addition, the Occupational Health & Safety Administration (OSHA) recently released a comprehensive summary of requirements, recommendations and guidelines for employers and workers.  The escalating concern over Ebola also raises potential labor relations issues.  Many of the workplaces with the potential for employees to come into contact with infected persons or material – health care providers, cleaning services, waste disposal firms, ambulance and other transportation services, to name a few – are unionized, and unions have begun to seek greater protections for their members.  Non-union employers may be affected as well, as at least one group of non-union employees has engaged in a strike to protest inadequate safety measures.

An important step all employers can take, whether unionized or not, is to share information disseminated by the Centers for Disease Control (CDC) and other public health agencies to educate their employees.  Indeed, a recent Washington Post article highlighted the information gap that is fueling public fears.  Sharing accurate, up to date information should help address employee concerns and avoid potential workplace disruptions based on unfounded fears.

Beyond the dissemination of information, in workplaces where employees may have some potential to come into contact with persons or material infected with the Ebola virus, employers must comply with applicable workplace health and safety laws and regulations, including making sure that effective protocols are in place, that protective equipment and clothing are available, and that employees receive appropriate training.  Not surprisingly, healthcare workers – nurses in particular – have been at the forefront in demanding increased protection and training.

National Nurses United (NNU) has been especially outspoken.  In addition to its criticism of the Texas Health Presbyterian Hospital, where two nurses caring for an Ebola patient became infected themselves, it has launched a multi-pronged campaign to achieve increased training and protection for nurses who may be called upon to treat Ebola patients.  As part of their campaign, they have released an Ebola Toolkit that includes a guide to state and federal whistleblower laws and a comprehensive set of collective bargaining demands.  Their demands include detailed proposals for Ebola-specific protocols, training and protective equipment, creation of a joint labor-management infectious disease task force, medical services for exposed or potentially exposed employees, and full paid time off for nurses exposed to an infectious disease.  Healthcare employers should expect to be presented with comparable demands from the unions representing their employees, if they have not done so already.

Other unions are engaging in similar activities.  As the largest union in the U.S. representing healthcare workers, cleaners, and other service employees who could potentially come into contact with a person or material infected by Ebola, the SEIU has been particularly active.  Its public efforts to date have been focused largely on educating union members and training them to use protective equipment.

In addition to union advocacy and education, there has been at least one work stoppage arising from employees’ Ebola concerns.  At LaGuardia airport, a group of more than 200 non-union aircraft cabin cleaners recently engaged in a one-day strike to protest what they claimed were inadequate protections from exposure to Ebola.  In that case, the SEIU is attempting to organize the striking cleaners, but regardless of whether non-union employees are seeking union representation, they have the right under the National Labor Relations Act to engage in concerted activity for their mutual aid and protection, such as a strike to protest working conditions related to Ebola risks.

Education and communication are critical to addressing employees’ Ebola-related concerns and avoiding workplace disruptions based on unfounded fears.  In unionized workplaces, union representatives should be included in the education and communication process. Of course, all employers must comply with applicable workplace safety and health laws and regulations.  Depending upon the circumstances, unionized employers may have bargaining obligations with respect to additional measures they seek to implement in response to Ebola concerns.  They may also be faced with bargaining demands by employees seeking greater protection.  Finally, it is important for non-union employers to understand that their employees also have the right to act in concert for their mutual aid or protection.

ARTICLE BY

Scott Faust
OF
Proskauer Rose LLP

Ebola and Bribery in Liberia?

steptoe-johnsonlogo

With today’s newscasts full of stories about a second Dallas healthcare worker contracting the Ebola virus, people are focused on this woman and the 75 other Dallas healthcare workers (and their pets!) being monitored for symptoms. So what does this have to do with our usual subject of international corruption? Plenty, as it turns out.

More than 4,000 people in Africa have died from the virus. The international community has put on a full court press to contain the virus. But families in Liberia, which is at the epicenter of the epidemic,are reportedly bribing retrieval teams to let them keep their loved ones’ bodies and give them traditional burials. Traditional Liberian funerals include surviving relatives washing the body and keeping it around for a wake that sometimes lasts days, while family and friends stop by to kiss the corpse before it is buried in a shallow grave in the family grave plot nearby.

The Liberian government has ordered that bodies be collected and cremated, and sends retrieval teams out to collect the bodies. But according to news reports, grieving relatives are paying $40 to $150 for death certificates that don’t show Ebola as the cause of death. Having Ebola carries a stigma in Liberia, and it is important to some families that they don’t have to admit that Grandma had the disease. The Liberian government has said that the retrieval teams do not have the authority to issue death certificates, but for $40, they are doing so anyway.

Half of the Ebola deaths have happened in Liberia, so one can imagine the confusion of a young man who lived next door to an Ebola victim. He told the Wall Street Journal that the government tells its citizens to call the body retrieval teams and not to touch the bodies themselves, but then the teams come and don’t insist on taking the corpses. “They told us not to bury the bodies. They told us to call. But now I am not sure if they are the ones trying to eradicate this virus or to make it grow.”

So a small bribe still carries the day in some locations, even in the face of a catastrophic dilemma. Companies doing business, or contemplating doing business, in west Africa are understandably wary of doing so now, and that’s the last thing this impoverished area needs.

Ex Parte Communications between Treating Physician and Attorneys in Tennessee

Dickinson Wright Logo

Under HIPAA, physicians are permitted to disclose “protected health information” to their attorneys for purposes of their own healthcare operations. This allows physicians sued by patients for malpractice to provide their attorneys with the information needed to prepare and present a defense. Ordinarily, subpoenas or orders are a part of a court ordered deposition or trial at which the patients or their attorneys are present, so the need to protect health information is lessened.

HIPAA does not allow treating physicians in one practice to disclose “protected health information” to attorneys for a treating physician in another practice unless a subpoena or an order of a court permits that disclosure. Instead, HIPAA allows members of a group practice to transmit protected health information concerning a patient to business associates of that practice. This means that attorneys representing the other physicians in the group practice can receive information related to the practice’s healthcare operations, including information relating to representing the practice in malpractice lawsuits. A subpoena or court order is not required for this disclosure. Thus, when a physician is being sued for malpractice, HIPAA permits the practice’s attorney to meet with other physicians in that same practice and obtain protected health information related to the plaintiff.

While HIPAA may permit the disclosure of protected health information in this circumstance, state law is another matter altogether. For example, the Tennessee Supreme Court found that an implied covenant of confidentiality exists between the treating physician and his or her patient. Like HIPAA, this implied covenant of confidentiality absolutely prohibits an attorney for a treating physician from meeting with another treating physician unless the patient or the patient’s attorney is present. Like HIPAA, the court assumes that the patient’s interests are protected when the patient is present.

This in turn begs the question – does the implied covenant of confidentiality prohibit a physician employed in a group practice from meeting with the attorneys representing another employee of the practice who has been sued for malpractice without the patient being present? In Tennessee, this issue was recently addressed in Hall v. Crenshaw, W2013-00662-COA-R9-CV (Tenn. Ct. App. July 18, 2014). The court of appeals in Hall held that the implied covenant of confidentiality does not prohibit a physician in a group practice from meeting with attorneys representing another employee physician of the practice. The court of appeals reasoned that a corporation can only function through its agents and employees. Under state law, all knowledge of the corporation’s employees is imputed to the corporation. As a result, the court held that the corporation already possessed this information, meaning the corporation, through its employees, is able to discuss a patient’s medical record and history with the attorneys representing the corporation and its employees.

© Copyright 2014 Dickinson Wright PLLC
ARTICLE BY

Keith C. Dennen
OF
Dickinson Wright PLLC

Reclassification of Hydrocodone Takes Effect This Week

McBrayer NEW logo 1-10-13

The U.S. Drug Enforcement Administration (“DEA”) published a Final Rule on August 22, 2014, which elevates hydrocodone-combination products (“HCPs”) to a Schedule II category of drugs under the Controlled Substances Act. That rule becomes effective this week – on October 6, 2014. While some hydrocodone products are already listed as Schedule II, some combination products (such as Vicodin, Norco, and Tussionex) were previously listed on the less-restrictive Schedule III. In determining whether rescheduling was necessary, the DEA considered multiple factors including the potential for abuse, likelihood of dependence, and the threat to public health posed by the drug.

How does the new rule affect prescribers?

According to DEA, HCPs prescriptions issued prior to October 6, 2014 and authorized to be filled or refilled may be dispensed if such dispensing occurs before April 8, 2015. In some cases, pharmacy dispensing software products may not be able to process existing refills starting on October 6, or pharmacies may simply choose not to dispense refills after the effective date.

Pursuant to the Final Rule, HCPs prescriptions written on or after October 6, may not be refilled. No refills are allowed by any practitioner for Schedule II controlled substances and Schedule II prescriptions may only be given for maximum of a 30-day supply. Commentators to the proposed rule worried that rescheduling would result in more trips to the doctor to receive appropriate pain control. In response to these concerns, the DEA noted in the Final Rule that prescribers may issue multiple prescriptions authorizing patients to receive up to a 90-day supply, provided certain regulatory requirements (established in 21 CFR 1306.12) are met.

Prescription Bottle of Pills Spilled on Table

In addition, in Kentucky, Schedule II controlled substance prescriptions may not be faxed or called in to a pharmacy except as provided for in 902 KAR 55:095. Schedule II controlled substance prescriptions that are electronically prescribed must use a system that has been audited for compliance with the regulations specified in 21 CFR 1311. Further, Schedule II controlled substance prescriptions are valid for 60 days from the date written and controlled substance prescriptions must be signed and dated on the date issued by the prescriber.

Kentucky prescribers should be aware that restrictions on prescribing existing Schedule II pure hydrocodone products remain under current Kentucky statutes and regulations because these products were not rescheduled to Schedule II.

Midlevel providers who operate under collaborative agreements or are limited in their ability to prescribe certain Schedules of medications may be particularly affected by the Final Rule. In Kentucky, KRS 314.011, Section 8 (a) limits APRN prescribing of Schedule II controlled substances to a 72 hour supply with no refills, except certified psychiatric-mental health nurses are permitted to prescribe up to a 30-day supply of a Schedule II psychostimulant with no refills. KRS 314.011, Section 8 (b) limits APRN prescribing of Schedule III controlled substances to a 30-day supply with no refills. Because KRS 314.011, Section 8 (b) was in effect March 19, 2013, all APRNs will continue to be permitted to prescribe a 30-day supply of Schedule II hydrocodone combination products if allowed under their DEA license.

Even if the Final Rule does not specifically affect a prescriber’s abilities, prescribers should be prepared to work with pharmacies in order to minimize dispensing disruptions after the effective date. They should also identify and inform patients who are currently receiving HCPs about the rescheduling and, if necessary, discuss alternative pain management options. And, as prescribers well know, any new regulatory framework also brings with it the expectation of greater scrutiny and oversight in the future from regulatory authorities and law enforcement agencies.

ARTICLE BY

Christopher J. Shaughnessy
OF
McBrayer, McGinnis, Leslie and Kirkland, PLLC