Temporary Restraining Order Prevents CMS from Recouping Alleged Medicare Overpayment from Hospice

With the backlog to receive a hearing before an Administrative Law Judge (ALJ) as long as 3 to 5 years, health care providers facing significant recoupments of alleged overpayments should consider whether to pursue additional remedies.

The United States District Court for the Southern District of Georgia recently issued a temporary restraining order enjoining the Centers for Medicare and Medicaid Services (CMS) from collecting an alleged Medicare overpayment from a hospice pending a hearing before an ALJ.  Hospice Savannah, Inc. v. Burwell, 4:15-cv-00253-JRH-GRS, September 21, 2015.  The hospice was a not-for-profit organization that provided services to terminally ill patients and their families.  It had filed appeals through the two initial levels of administrative review.  The next level of administrative appeal involved an ALJ hearing, but due to the administrative backlog, it was likely that the hospice would not receive a hearing for 3 to 5 years, instead of the 90 day period provided by statute.  In the meantime, CMS intended to recoup 100% of the hospice’s current and future Medicare payments (approximately 80% of the hospice’s total revenues), amounting to $8.6 million dollars.  The amount was the result of an extrapolation based on a review of a sample of 100 claims for 95 beneficiaries, for which there was an alleged overpayment of $152,000.

Applying the standards for granting a temporary restraining order, the District Court found:

  • There was a substantial likelihood that the hospice would succeed on the merits because of a “questionable extrapolation” across the universe of patient claims that led CMS to conclude the hospice owed $8.6 million dollars and the fact that the services corresponding to the payments CMS intended to recoup had never been challenged by CMS.
  • The hospice would suffer irreparable harm without the proposed temporary restraining order by being forced to close and by being unable to provide ongoing care to its current hospice patients who were terminally ill and disabled. The risk of  harm of not granting immediate relief to the hospice and its patients was great.
  • There was little or no risk of harm to CMS since, at worst, CMS would be deferred in its ability to pursue collection efforts pending resolution of the hospice’s administrative appeals. CMS had not alleged fraud or any facts to suggest that the hospice was diverting or secreting assets or would do so pending resolution of its administrative appeals.
  • The public had an interest in terminally ill patients being able to continue to have access to the hospice’s services.


If you have questions about Medicare overpayments or require any assistance in responding to a notice of overpayment or determining whether to pursue additional remedies, please contact Rochelle H. Zapol, a partner in Prince Lobel’s Health Care Practice and the author of this Alert.  You can reach Rochelle at 617 456 8036 or rzapol@PrinceLobel.com

Media Forced to Pay State Agency to Do Its Job

Notwithstanding broad support among members of the public and legislators, a desperately-needed bill to reform the Massachusetts Public Records Act has been on hold in the legislature since late July.  Sponsors of the bill have been working to address objections of the Massachusetts Municipal Association that its new limitations on fees would amount to an “unfunded mandate.”  As that debate continues, an investigative report by the New England Center for Investigative Reporting (NECIR) and the Boston Globe on September 19 highlights just how outrageous—and even dangerous—the public records fee charges under current law can be.

In December 2013, NECIR’s investigative reporter Jenifer McKim submitted a request to the Department of Children and Families (DCF) for documents about all child deaths linked to abuse or neglect during the years 2011, 2012 and 2013.  The records shouldn’t have been hard to compile.  The federal Child Abuse and Prevention Treatment Act (“CAPTA”) requires each state receiving federal child protection funding to disclose information about any cases “of child abuse or neglect which [have] resulted in a child fatality or near fatality.”  42 U.S.C. § 5106a(b)(2)(B)(x).  Massachusetts receives about $500,000 in CAPTA funds every year.

Notwithstanding this federal requirement, DCF told McKim that it would take many hours to compile the information, and that the agency would charge NECIR for the time.  McKim therefore narrowed her request to just one year, 2013, in the hopes of speeding up the process.  DCF then provided its “good-faith” estimate of the cost for that one year period:  $2,023.00, comprising 67 hours of a paralegal’s time at the rate of $30.19 per hour.

McKim appealed this fee estimate to Supervisor of Records Shawn Williams at the Secretary of State’s Office.  She noted that she was only seeking federally-required information, and argued that if DCF’s files “are not kept in a manner that would allow the ready retrieval of such critically important information as which children have died of neglect on DCF’s watch, a requesting entity like NECIR should not be required to foot the bill.”  On April 29, 2014, Williams responded, in essence, “yes, you should.”  He upheld the fee estimate as “reasonable” precisely because DCF hadn’t yet compiled the federal CAPTA information.  “[T]he Department’s report lags about two years behind when [fatality] incidents occurred,” Williams explained, and therefore “the Department would need to review every available case in order to determine which information” might relate to a death from abuse or neglect.  Thus, Williams’ ruling essentially required NECIR, a non-profit investigative newsroom, to pay DCF to assemble the fatalities information that it was required to report anyway, on a subject at the very heart of the agency’s mission.

In August, 2014, NECIR teamed up with the Boston Globe and was able to expand its request for fatalities data to five years, from 2009 through 2013.  To its credit (I suppose), DCF did not increase its fee estimate five-fold—instead it doubled it, to $4,468.  The charge was paid in August 2014, but then it took five months—and perhaps not coincidentally, a change in the administration—for the agency to actually begin producing the records.  DCF unloaded the first three years of fatalities data in January 2015, and the rest in March.

The records, as you might expect, are important.  Among other things, they show that at least 110 children died of abuse and neglect during between 2009 and 2013 in Massachusetts.  Of these, 38 had previously received DCF services, and 26 were under DCF supervision at death. In a number of those cases, DCF had assigned the child to a “low risk” track, a designation advocates say ensures some at-risk children will fall through the cracks.  NECIR also published an online interactive display of each of the lost children, complete with heartbreaking photographs and biographical details.  Much like the recent identification of “Baby Doe” as Bella Bond, NECIR’s report puts names and faces on what would otherwise be cold statistics.

If the public records bill, H. 3665, had been in effect last year, it would have prevented DCF from shifting full cost of compiling this important information onto the media.  The bill provides that “[r]ecords shall be furnished without any charge or at a reduced charge if disclosure of the information is in the public interest because it is likely to contribute significantly to public understanding of operations or activities of the government and is not primarily in the commercial interest of the requester.”  It would be hard to argue that the disclosure of these records was not “likely to contribute significantly to public understanding of [the] operations” of DCF. Additionally, in July, Gov. Baker issued a modest directive to state agencies to streamline their public records fee practices by providing the first four hours of agency search and retrieval work at no cost and limiting hourly rates to no more than $25.00.  His directive also states that even where entire databases of information are requested, the production delay should not exceed eight weeks.

We are fortunate that NECIR and the Globe had the resources to pay DCF $4,500 for these important records.  But as McKim reports, advocates for children are worried that such high price tags could be prohibitive to watchdog groups in the future, preventing needed reforms and putting more children at risk.  Will the legislature be content to let such important information go unreported unless a private party can pay the government to do its job?  Or will it instead enact the reforms necessary to allow the public to evaluate how its government is performing?  We should all hope for, and work for, the latter.

-Jeffrey J. Pyle


If you have any questions about the information presented here, or would like to learn more about how Prince Lobel can address any of your media law concerns, please contact Jeffrey Pyle, the author of this post, at 617 456 8143 or jpyle@PrinceLobel.com, or click here to contact any of the attorneys in the firm’s Media Law practice group.

Massachusetts Medical Marijuana Law – Issues Facing Employers

On November 16, 2012, Massachusetts became the 18th state to approve the use of marijuana for medical purposes.  Chapter 369 of the Acts of 2012, which became law on January 1, 2013, allows qualifying patients with certain medical conditions and debilitating symptoms to use marijuana for medical purposes.  The Massachusetts Department of Public Health adopted regulations to implement the law on May 8, 2013.[1]

At least one employment discrimination complaint has been filed with the Massachusetts Commission Against Discrimination (MCAD) related to the use of marijuana for medical purposes since the passage of the law.  In May 2015, a 34-year old woman suffering from Crohn’s disease filed a complaint with MCAD over her termination from a marketing position when a drug test revealed marijuana use.  In the complaint, she alleges she disclosed that she takes marijuana for medical use during her employment interview.  The MCAD has not yet issued a decision in the case.

The rapidly changing medical and legal landscape with respect to marijuana use presents Massachusetts employers with some complex challenges.

What Do Employers Need to Know about the Massachusetts Medical Marijuana Law?  

To qualify to use marijuana for medical purposes, a person must be:

  1. A Massachusetts resident, at least 18 years old, who is diagnosed by a Massachusetts licensed certifying physician as having a debilitating medical condition, or
  2. A Massachusetts resident, under 18 years old, who is diagnosed by two Massachusetts licensed certifying physicians, at least one of whom is a board-certified pediatrician or a board-certified pediatric subspecialist, as having a debilitating medical condition that is also a life-limiting illness.

Under the Department of Public Health’s regulations, debilitating medical conditions include: cancer, glaucoma, HIV positive status, AIDS, Hepatitis C, Amyotrophic lateral sclerosis (ALS), Crohn’s disease, Parkinson’s disease, and Multiple sclerosis (MS).

Patients qualified to use marijuana for medical purposes must obtain a registration card from the Massachusetts Department of Public Health.  The registration card is valid for one year from the date of issue.

Both the statute and the Massachusetts regulations contain a similar limitation with respect to the employment setting: that the law does not limit an employer’s rights under other laws and that an employer need not accommodate any on-site use of marijuana.

Does the New Law Permit Workplace Use or Being Under the Influence at Work? 

It seems quite clear from the statute and regulations that the intent was to leave Massachusetts employers with the flexibility to prohibit workplace use of marijuana or being under the influence of marijuana while at work.  There is nothing in the Massachusetts medical marijuana law that prevents employers from prohibiting employees from working while under the influence of marijuana, and the regulations seem to specifically create a zone of employer discretion in this regard.

Moreover, although no Massachusetts court has yet decided the issue, courts in other states with legalized medical marijuana have consistently found that employers may continue to enforce drug-testing policies that screen for the use of marijuana.  These courts have also upheld the employer’s right to terminate a current employee who tests positive for use of medical marijuana, whether or not the employee was working while under the influence.

Also, there are certain settings where an employer is required to prohibit the possession or use of marijuana in the workplace.  For example, under the Drug Free Workplace Act of 1988, some Federal contractors and all Federal grantees must agree that they will provide drug-free workplaces as a precondition of receiving a contract or grant from a Federal agency.  The prohibited drugs are those that are controlled substances under the Federal Controlled Substances Act, which includes marijuana.  The use of medical marijuana may also be illegal under other Massachusetts laws, such as Mass. General Laws, Chapter 90, § 24, which prohibits operating a motor vehicle while under the influence of intoxicating liquor, marijuana, narcotic drugs, depressants or stimulant substances.

In short, the new law in and of itself does not require Massachusetts employers to tolerate use, possession, or being under the influence, of marijuana in the workplace.  But that is not necessarily the end of the inquiry because an employer must consider how the new law intersects with existing disability accommodation obligations.

Does an Employer Need to Tolerate Use of Medical Marijuana as a Reasonable Accommodation? 

Under the Federal Americans with Disabilities Act (ADA), it appears reasonably clear that an employer does not need to grant an accommodation for the use of drugs that are illegal under Federal law.  The ADA specifically provides that a person currently using illegal drugs is not a qualified individual with a disability and thus is not protected by the ADA.

A Massachusetts employer’s rights, however, could be limited by the Massachusetts anti-discrimination statute (M.G.L. c. 151B, § 4(16)), which -like the ADA- requires an employer to provide a reasonable accommodation to a qualified individual with a disability.  The Massachusetts anti-discrimination statute does not contain the same exclusion as the Federal statute for those currently using illegal drugs.

The question of whether a Massachusetts employer must consider an accommodation allowing an employee’s off-site use (the new law expressly allows an employer to prohibit on-site use) of medically prescribed marijuana, at least where the employee is not under the influence at work, is an unsettled issue.  Among other questions, the courts will have to decide whether the limiting language in the Massachusetts medical marijuana law (preserving an employer’s rights and specifically noting that on-site use does not need to be accommodated) is intended to leave the employer with the flexibility to deny an accommodation that involves the use of medical marijuana.  There are also Constitutional questions about the supremacy of the Federal Controlled Substances Act.

Courts in other states have tended to leave employers with the right to deny such accommodations.  While that seems the likely outcome in Massachusetts as well, it is simply too early to predict how this looming legal battle with play out in the Massachusetts courts.

Of course, it is not permissible for an employer to make an adverse employment decision based on an employee’s or candidate’s underlying medical condition, which he or she happens to be treating with marijuana.  Indeed, the Massachusetts’ anti-discrimination statute prohibits an employer from asking a candidate about any treatments used for his or her medical conditions or diseases.  This issue has arisen in a number of cases around the country where the employee has claimed that the motivating factor in the employer’s decision was his or her disability and not the use of medical marijuana.  The watchword for employers is, as in most employment law situations, consistency.  If employers treat the use of marijuana consistently, they are unlikely to face a viable claim of pretextual decision-making.

[1] The regulations are codified at 105 CMR 725.000 et seq.

If you have any questions about the information presented here, or would like to learn more about how Prince Lobel can address any of your employment law concerns, please contact Daniel S. Tarlow, the author of this Alert and Chair of Prince Lobel’s Employment Law Practice Group at 617 456 8013 or dtarlow@PrinceLobel.com, or Rochelle Zapol, a partner in Prince Lobel’s Health Care Practice Group at 617 456 8036 or rzapol@PrinceLobel.com

Dan Tarlow       Zapol

We’re Moving! Prince Lobel Relocation News

Prince Lobel Tye LLP proudly announces its move to One International Place in Boston. The firm will relocate from its home (since 2006) at 100 Cambridge Street.

The move, which was prompted by the shifting office rental market in Boston, will allow Prince Lobel to retain its core values and reaffirm its commitment to expertly serving client needs. The new location is being designed with the goal of fostering a more collaborative and connected work environment.

Prince Lobel plans to transition to its updated space in 2016. Its attorneys will continue to serve the firm’s diverse array of clients in a wide variety of practice areas and industries, including corporate, construction, domestic relations, data security and privacy, employment, environmental, estate planning, health care, intellectual property, insurance/reinsurance, litigation, media and First Amendment, real estate, social media, nanotechnology, renewable energy, telecommunications, and copyright, trademark and intellectual property.

Prince Lobel Managing Partner Craig M. Tateronis stressed that the firm will retain the value, quality and efficiency its clients have come to expect. “Our new location will only enhance client service and the firm’s commitment to being an active member of its community,” said Tateronis. “Our space has always been a vital connection point with our clients, employees and visitors. Especially now, with law firm space design rapidly evolving, we are excited to design a new home that is on the cutting edge of innovation within our profession and reflects the unique energy and culture of our firm.”


Unwanted Plaque(s): Are Plaque Companies Misappropriating Your Copyrighted Material?

Congratulations!  Your publication has just run a successful awards program honoring local businesses.  Advertising dollars are rolling in, and your readers are engaged.

Then the phone calls come.

Award winners are complaining about the $250.00 bill that accompanied the award plaque from your company. Only problem – you didn’t send the plaque or the invoice.

Our media clients have called us with the same issue before and it’s an unfortunate reoccurrence.  In an attempt to maximize profit, plaque companies reuse and redistribute portions of your publication by either ripping pages and placing the work on a plaque, or digitally reproducing your content without your permission.  So what can you do?

Case-law sends mixed signals, but a 2013 decision from a federal Court of Appeals gives publishers arguments to help stop the plaque-makers.

The Plaque Business Legal Theory

For years, plaque companies have defended claims of infringement under what is called the “first sale” doctrine of copyright law.  For years, this defense has proved difficult, and expensive, to counter.

The first sale doctrine is codified at 17 U.S.C. §109(a) which provides:

Notwithstanding the provisions of Section 106(3), the owner of a particular copy or phonorecord lawfully made under this title, or any person authorized by such owner, is entitled, without the authority of the copyright owner, to sell or otherwise dispose of the possession of that copy or phonorecord.

For example, if an artist sells a postcard, the purchaser of the postcard can re-sell the postcard without artist permission, even though the copyright law grants authors of copyrighted works the exclusive right to distribute their own work.

 When pressed, the plaque companies rely on one court decision in the Ninth Circuit.  In the case of Lee v. A.R.T. Company , an artist alleged copyright infringement against a postcard company when the company purchased postcards and mounted the cards on decorative tiles.  The Ninth Circuit agreed with the postcard company that such action was not copyright infringement.  Lee v. A.R.T. Company , 125 F.3d 580 (1997).  The plaintiff alleged that the bonding of the art onto the ceramic tiles was a violation of the copyright holder’s exclusive right to create derivative works, and thus, falls outside of the “first sale” doctrine exemption.

Specifically, under 17 U.S.C. §101, a “derivative work” is defined as:

…a work based on one or more preexisting works, such as a translation, musical arrangement, dramatization, fictionalization, motion picture version, sound records, art reproduction, abridgment, condensation, or any other form in which a work may be recast, transformed or adapted.  A work consisting of editorial revisions, annotations, elaborations or other modifications which, as a whole, represent an original work of authorship, is a derivative work.

The lower court in Lee had determined that simply applying an epoxy resin to bond the art to the tile does not create a derivative work, any more than re-framing a painting would create a derivative work.  Essentially, the lower court found that the mounting process cannot create a derivative work because the change of the work “as a whole” is not sufficiently original to support a copyright.[1]  Lee disagreed and claimed the mounting created an original and distinct derivative work.

The Court of Appeals chose not to engage in this originality discussion. Rather, the court focused on whether or not the mounted work was derivative as either an art reproduction or as a work that has been recast or adapted.   The court focused on the extent to which the original work was transformed. Citing examples such as the framing of a work, the court reasoned that the works of art were not transformed in the slightest by simply being mounted onto the tile.  The court said that adopting the plaintiff’s position may make simple tourists and art collectors criminals if they chose to frame or otherwise mount original pieces of art that they had purchased.

Attacking the First Sale Argument

Until 2013, attacking the “first sale” doctrine proved difficult with little to no persuasive judicial opinions to debunk the “first sale” defense.  In fact only one case in the country supported the idea that mounting original pieces of art may violate the copyright holder’s rights to create derivative works.  See Mirage Editions, Inc. v. Albuquerque A.R.T. Co., 856 F.2d 1341 (1988).

In the Mirage case, images were removed from a book and then printed onto ceramic tiles. According to the court, by removing the individual images from the purchased book and placing them on tiles, the defendant has transformed the images by incorporating them into the tile-preparing process.  The Mirage court stated:

We recognize that, under the “first sale” doctrine as enunciated at §17 U.S.C. 109(a)… appellant can purchase a copy of [a copyrighted work] and subsequently alienate its ownership in that book. However, the right to transfer applies only to the particular copy of the book which appellant has purchased and nothing else. The mere sale of the book to the appellant without a specific transfer by the copyright holder of its exclusive right to prepare derivative works, does not transfer that right to appellant. The derivative works right, remains unimpaired and with the copyright proprietors… As we have previously concluded that appellant’s tile-preparing process results in derivative works and as the exclusive right to prepare derivative works belongs to the copyright holder, the “first sale” doctrine does not bar the appellees’ copyright infringement claims

Adding strength to the Mirage court theory, on July 24, 2013, a decision in the Fourth Circuit appeared to breathe new life into the theory that a derivative work is created by mounting copyrighted material onto plaques and that the “first sale” doctrine is an inadequate defense.  See Rosebud Entertainment LLC v. Professional Laminating, LLC, 958 F.Supp.2d 600 (2013).  In a fact pattern that closely resembles the actions of most plaque companies today, Rosebud Entertainment (“Rosebud”), a magazine publisher, claims that the defendant, Professional Laminating LLC (“PLL”), was taking covers of Baltimore magazine’s “Top Doctors” edition and mounts the covers onto plaques to sell to the doctor awardees.  PLL countered with the usual defense of the “first sale doctrine” and a “fair use” defense.

PLL’s “first sale” argument is similar in nature to that made in the Lee case: the plaques are not independent works of art, but rather consist of the exact work placed on a different background, and thus have not been transformed in a material fashion.  PLL argues that they simply re-sold the copies of the works.  Rosebud counters by asserting that PLL transformed “…a magazine into a commemorative product through tearing, laminating and framing of the magazine’s cover onto a plaque inscribed with a recognition of the doctor featured in the magazine.”

In deciding the first sale issue, the Rosebud Court explicitly acknowledges the existence of the Lee decision and another similar 11th circuit decision,  Allison v. Vintage Sports Plaques, 136 F.3d 1443 (11th Cir. 1998) (holding that a defendant may purchase trading cards and then frame the cards by mounting them between transparent acrylic sheet and wooden board).  The court, however, is not persuaded by such decisions.  The court distinguishes with such holdings as follows:

Here, unlike in Allison and Lee, the Defendants have done more than add surrounding materials to Rosebud’s Works; instead, they significantly altered the Works by physically separating the magazine covers from the magazines and cutting the cover pages to fit the wooden boards… Because of these alterations to the original Works, the first sale doctrine does not apply to any of the Defendants’ products—including those that contained original pages.

As a result, the court specifically precluded the defendant from raising the “first sale” defense at trial, providing a new weapon to attack the plaque companies’ theory.

The one caveat, however, is as follows: the Rosebud court left open the question, for trial, as to whether or not the use by PLL is to be considered a “fair use.”  The court completed a preliminary analysis of the four prongs of a fair use defense as follows:

  1. Purpose and Character – weighs against a fair use finding (commercial purpose of use by the defendant).
  2. Nature of Work – the need to disseminate factual works weighs in favor of a finding of fair use. The Rosebud court suggested that the material was a mix of factual and creative content, however, it seems closer to factual.    The combination of educational and factual components of the work along with the fact that the works were published weigh in favor of a fair use finding.
  3. Amount of Work Used – the court found that the use of just covers and small pieces of the magazine would weigh in favor of fair use. This reasoning is troubling as the court seems to take a quantitative approach rather than a qualitative approach as to the “amount” of the work used, which is not the correct approach.  The cover and the material that accompanies the “Top Doctors” magazine may go to the “heart” of the feature, no matter the quantity of the material taken.
  4. Effect on the Market – the court made no conclusion on this issue.

Whether the “fair use” defense will ultimately be the argument to replace the “first sale” argument by plaque companies remains to be seen.  The good news, however, is that the courts are finally debunking the “first sale” defense that plaque companies have grown to love – which will aid publishers to combat unwanted solicitations of its advertisers and consumers.

If you would like assistance need more information about  please contact the author of this alert, Peter J. Caruso II, at 617 456 8034 or pcaruso@PrinceLobel.com.


Rob Bertsche Answers NENPA’s Media Law Hotline “Question of the Week” on the Publication of Drone Photos

Question: A drone hobbyist submitted to our paper several photographs of town landmarks, taken from his drone. Can we publish them? Can we pay the hobbyist for them? Can we assign the hobbyist to take additional photos, whether of landmarks or of breaking news events such as fires and motor vehicle accidents?

Short answers: You can publish the photos, and you can compensate the hobbyist for the photos so long as you did not commission them. But if you engage the hobbyist as the equivalent of a freelance photographer on assignment, paid or not, you risk getting a nasty letter from the Federal Aviation Administration.

Click here to read Rob’s complete answer.

The Media Law Hotline is a service offered free of charge to NENPA members in good standing, and is staffed by the media and intellectual property lawyers at Prince Lobel Tye LLP. You can reach the NENPA Hotline at 1-888-428-7490 or by email at media@princelobel.com.


Summertime and the Living is Easy Unless You Operate a Long-Term Care Facility

Summertime and the Living is Easy Unless You Operate a Long-Term Care Facility

After nearly 24 years without any major revisions, last week the Centers for Medicare and Medicaid Services (CMS) proposed major revisions to the Medicare-Medicaid Conditions of Participation governing long-term care facilities to reflect advances made to delivering long-term care over the last several years.  Many of the proposals are designed to implement requirements of the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010.  If the proposed revisions are adopted, long-term care facilities will need to revise a long list of policies and procedures and develop and implement a number of new policies and procedures and programs.  CMS estimates that the total projected cost for long-term care facilities to comply with the proposed revisions will be $729,495,614 in the first year and $638,386,760 in the second year.

New Proposals
The new proposals include but are not limited to:
  • Open visitation to allow residents to have visitors of their choice at the time of their choice, subject to any clinically necessary or reasonable restriction or limitation or any safety restriction or limitation.
  • Alternative suitable and nourishing meals and snacks for residents who want to eat at non-traditional times or outside of scheduled meal times.
  • The right of a resident to share a room with his/her roommate of choice if the residents live in the same facility, consent to the arrangement, and the facility is able to reasonably accommodate the arrangement.
  • Comprehensive Person-Centered Care Planning with a baseline care plan established within 48 hours of a resident’s admission to the facility.
  • The provision of behavioral health services to residents with mental and psychosocial illnesses or substance abuse disorders, in accordance with their comprehensive assessments and plans of care, with appropriate staffing to provide the services, including social workers.
  • The establishment of a facility policy regarding the use and storage of foods brought to residents by family and other visitors.
  • The development, implementation, and maintenance of a Quality Assurance and Performance Improvement Program that focuses on systems of care, outcomes of care, and quality of life.
  • The establishment of an Infection Prevention and Control Program to prevent, identify, report, investigate, and control infections and communicable diseases for residents, staff, volunteers, visitors, and other individuals providing services under an arrangement, and the designation of an Infection Prevention and Control Officer to serve on the facility’s Quality Assessment and Assurance Committee.
  • The establishment of policies regarding smoking which address tobacco cessation, smoking areas, and safety, consistent with state and federal law.
  • The development, implementation, and maintenance of a Compliance and Ethics Program with policies and procedures to reduce criminal, civil, and administrative violations.
  • An annual facility wide assessment of a number of factors such as, size, location, and number of residents; resident population, including types of diseases, conditions, and overall acuity; competencies and knowledge of employed and contracted staff, managers, and volunteers; contracts, memoranda of understanding, and other agreements with third parties to provide services or equipment during normal operations and emergencies.
  • Conditions that must be met before a facility enters into a binding arbitration agreement with a resident and provisions which must be included in a binding arbitration agreement, including but not limited to, explaining the agreement to the resident, not making admission to the facility contingent on signing the agreement, and not prohibiting or discouraging a resident from communicating with federal, state, or local health care or health-related officials.
  • New health and safety standards applicable to facilities that provide outpatient rehabilitative services.
Proposed Revisions to Existing Requirements 
In addition, there are a number of proposed revisions to existing requirements, including but  not limited to:
  • Written policies and procedures to prohibit and prevent abuse, neglect, and mistreatment of residents or misappropriation of their property or exploitation.
  • A prohibition on hiring an individual who has had disciplinary action taken against his/her professional license by a state licensing authority due to a finding of abuse, neglect, or mistreatment of a resident or misappropriation of a resident’s property.
  • Expansion of the Interdisciplinary Care Team’s composition to include a nurse’s aide, a member of food and nutrition services, and a social worker.
  • A written explanation if participation of a resident or the resident’s representative on the Interdisciplinary Care Team meetings is not practicable.
  • Upon a resident’s transfer or discharge, documentation of the history of the present illness, the reason for the transfer or discharge, and the past medical/surgical history.
  • An in-person evaluation by a physician, physician assistant, nurse practitioner, or clinical nurse specialist before an unscheduled transfer of a resident, except in an emergency.
  • Accounting for quality, resource use, other measures, treatment preferences, and goals of care in discharge planning.
  • A summary of arrangements for follow-up care and post-discharge medical and non-medical services in the resident’s discharge plan.
  • Physician delegation of dietary orders to dietitians and therapy orders to therapists if  consistent with their scope of practice under state law.
  • Pharmacist review of a resident’s medical chart at least every 6 months, when a resident is new to the facility, when a prior resident returns to or is transferred to the facility, and during each monthly drug regimen review if a resident is on a psychotropic drug, antibiotic, or any other drug the Quality Assessment and Assurance Committee has requested be included in the monthly drug review.
  • Pharmacist documentation of any irregularities identified during the drug regimen review  in a written report provided to the attending physician, facility medical director, and director of nursing.  Attending physician documentation in the resident’s medical record that he/she has reviewed the identified irregularity, and what action, if any, has been taken to address it.
  • Restrictions on the administration of psychotropic drugs, including but not limited to, limiting PRN (as needed) orders to 48 hours and refraining from renewals unless a resident’s physician reviews the need for the medication prior to the renewal and documents the rationale for the renewal in the resident’s clinical record.
  • The implementation of training programs on communication, resident rights and facility requirements, abuse, neglect, and exploitation, Quality Assurance and Performance Improvement and Infection Control, Compliance and Ethics, in-service training for nurse aides on dementia management and resident abuse prevention, and behavioral health training for the entire staff.

Comments on the proposed rule are due by 5 p.m. on September 14, 2015.



If you have any questions concerning the proposed revisions to the Medicare-Medicaid Conditions of Participation governing long-term care facilities or would like assistance in submitting comments to CMS on the proposal, please contact Rochelle H. Zapol, a partner in Prince Lobel’s Health Care Practice and the author of this alert. You can reach Rochelle at 617 456 8036 or rzapol@PrinceLobel.com.