What Makes A Five Star Hospital?

The Affordable Care Act includes many provisions aimed at improving the quality of care provided by different types of health care professionals and providers. Along these lines, the ACA expands the types of facilities and providers for which quality data will be publically available.  The Secretary of the United States Department of Health and Human Services was therefore directed to develop a Hospital Compare website (amongst other similar sites such as Physician Compare and Nursing Home Compare) that would allow Medicare enrollees to compare scientifically sound measures of physician quality and patient experience.

In accordance with these directives, on April 16, 2015 the Centers for Medicare and Medicaid Services (“CMS”) released the first ever Hospital Compare Star Ratings on its public information website.  The site is intended to make it easier for consumers to choose a hospital and understand the quality of care they deliver.  The data set from the website contains hospital-specific quality data for over 4,500 hospitals nationwide.  The ratings are based on the 11 publicly reported measures in the Hospital Consumer Assessment of Healthcare Providers and Systems (“HCAHPS”) survey, which assesses patient experiences.

The star ratings allow for an easy comparison using a five-star scale, with more stars indicating better quality care.  The quality data on Hospital Compare includes clinical process of care, patient outcomes and patient experience of care measures.  The national rankings are based on hospitals’ performance on the clinical process of care measures and a national survey of patients’ experience of care.  The hospitals’ ranks are combined into an overall, composite performance ranking, with process of care measures contributing 70% and patient experience of care measuring 30%.

However, just 251 out of 3,553 hospitals received the highest score in the rating system based on the experiences of patients who were admitted between July 2013 and June 2014.  Hospitals had an opportunity to preview the ratings in the fall and many have already expressed concern.  Hospitals question the methodology and whether the ratings reflect meaningful reflections of performance.  They also assert that the ratings are oversimplifying the hospital’s performance to a single score.

Notably, the patient experience star ratings are only based on the information on quality of care that is reported by patients.  The surveys are provided to a random sampling of patients within two days after discharge from a hospital and must be completed within 42 days.  Further, positive results may mean that the hospital is delivering good care.  However, these results are not taking into account other factors such as timely and efficient care and results or outcomes of care measures.  Moreover, the results places substantial reliance on patient review, which is just one measurement of hospital quality.  Lastly, if one does not review Hospital Compare extensively, information aside from the star ratings may easily be overlooked.  For example, the complete results for each HCAHPS measure can be found in the “Survey of Patients’ experiences” section.

On the other hand, supporters of Hospital Compare argue that while it’s not a perfect measurement system, it creates a healthy competition among hospitals.

For more information on Hospital Compare, other CMS initiatives or related issues, please feel free to contact Daniel Meier or any member of our health care practice group for a further discussion.

Supreme Court Blocks Provider Challenges to Medicaid Program

On March 31, 2015, the Supreme Court issued the first of several expected decisions that will impact the healthcare industry this year, ruling that Medicaid providers have no constitutional or statutory right to challenge a state’s Medicaid reimbursement rates. In Armstrong v. Exceptional Child Center, Inc., a group of Idaho Medicaid providers had challenged the states’ reimbursement rates as violating the federal laws that govern the program, commonly known as the Medicaid Act.

Under the Medicaid Act, both the federal government and the individual states fund and administer the Medicaid program. Each state establishes the rates and other parameters within its Medicaid program, subject to overall federal approval. Each state must submit a plan outlining its Medicaid program to the Department of Health and Human Services (HHS). The Plan, among other things, is supposed to meet the Medicaid Act’s requirements that payments are sufficient to enlist enough providers so that covered care and services are available to Medicaid beneficiaries.

A group of Idaho Medicaid providers challenged Idaho’s Medicaid rates as violating this provision of the Medicaid Act. The Idaho Department of Health and Welfare had proposed rate increases which had been approved by HHS as part of the state’s overall Medicaid plan. However, the increases were never funded by the Idaho state legislature and thus never implemented. The providers filed a lawsuit seeking to impose higher Medicaid reimbursement rates on the grounds that Idaho had failed to follow its approved plan and had set reimbursement rates so low that providers were unwilling to enroll in the Medicaid program, denying Medicaid beneficiaries access to effective care.

Two lower courts had ruled in favor of the providers. However, the Supreme Court ruled that only HHS is entitled to enforce the requirements of the Medicaid Act. It is important to note that the case was purely procedural. While the Supreme Court held that Medicaid providers did not have a constitutional or statutory right to challenge a state’s Medicaid reimbursement rates, it did not rule on whether or not Idaho’s Medicaid reimbursement actually complies with the Medicaid Act requirements.

The increasing downward pressure on Medicaid reimbursement shows no signs of stopping, even as the Affordable Care Act expands Medicaid enrollment in many states. This case is a reminder that providers seeking to increase Medicaid reimbursement will need to also focus on obtaining federal and state legislative, not just judicial, solutions.

CMS Releases the Civil Money Penalty Analytic Tool

The Centers for Medicare and Medicaid Services (“CMS”) recently released the civil money penalty (“CMP”) analytic tool used by CMS Regional Offices (“RO”) to review, approve or modify the proposed fines for nursing facilities (“NF”) and skilled nursing facilities (“SNF”)(collectively “NF”) (Link). Regulatory guidance CMS S&C 15-16-NH was released on December 19, 2014 and includes a description and the components of the analytic tool used by CMS since April, 2013 to determine the adequacy of the proposed CMPs for survey violations for NFs. The RO is required to review and either approve or modify the proposed CMPs issued by each State Agency based upon NF Medicare and Medicaid certification citations. Providers have often wondered about the actual calculation method being utilized by CMS and this analytic tool lays out the interpretation factors being used by CMS when applying the factors in the required by 42 CFR 488.404 for consideration when imposing a CMP on a facility as result of a single survey or for multiple surveys in a survey cycle.

CMPs and other enforcement remedies are required to be imposed based upon the scope and severity of the regulatory citations either for health deficiencies or life safety code deficiencies. CMS indicates that the analytic tool does not replace professional judgment but it to be used as a guideline in the CMP calculation process. The guidance states that the tool is “provide logic, structure, and defined factors for mandatory consideration in the determination of CMPs.” The analytic tool distinguishes between the use of Per Instance penalty use and a Per Day penalty use. A Per Instance penalty is a single defined fine amount between $1,000 and $10,000 for the survey cycle. The analytic tool indicates that a Per Day penalty is to be used unless the specific requirements are met for the Per Day penalty. A Per Instance penalty is often less costly to a provider than a Per Day penalty and is typically preferred by providers due to the certainty of the actual amount being imposed.

Per Instance penalties can only be applied if:
1. The facility is not a special focus facility;
2. Findings are no more than a G level (actual harm, isolated) or an F level (no actual harm, widespread with substandard care) and the facility has a good compliance history for the past 3 standard surveys; and
3. Findings of past noncompliance are not cited at a G level or an F level substandard care.

In addressing the discretion and professional judgment to be used by the RO personnel the guidance provides for a 35% increase or decrease in the CMP amount without CMS Central Office approval. If the RO proposes to increase or decrease the CMP amount by more than 35%, Central Office must provide approval of those changes. The stated purpose of the utilization of the analytic tool is to provide a more consistent application of enforcement remedies. The guidance also states that a Per Day CMP is to begin on the first day of noncompliance which may or may not be during the on-site survey. Also, the Per Day CMP is to start on the first day of identified noncompliance even if that date is prior to the survey. However, the CMP start date cannot be prior to the date of the last standard survey. This guidance reaffirms the imposition of CMPs that are applied retrospectively with a possibility that CMPs may be imposed as far back as 15 months. A retrospective CMP imposition can be in the hundreds of thousands of dollars for providers for an immediate jeopardy citation and can result in significant ramifications for providers.

A few of the factors that change the proposed amount of CMPs and are calculated with the tool include:
1. Scope and severity of the citations;
2. Number of citations;
3. Repeated citations;
4. Facility culpability; and
5. Facility financial condition.

The guidance provides some examples related to application of criteria for facility culpability based upon Departmental Appeals Board (“DAB”) cases. Those examples include repeated failure to follow or clarify doctor’s treatment orders; repeated failure to notify doctor of significant changes; repeated failure to supervise resident with a known history of elopement; staff failure to report physical, verbal or sexual abuse and egregious dignity issues.

Providers should carefully review this recently issued S&C guidance to have a clear understanding of how the CMPs are calculated by CMS and what factors can affect the increase or decrease of those CMPs. Understanding the factors related to fines and sanctions imposed by CMS and the amount of discretion that is allowed in the imposition of fines are important in the operation of NFs on an ongoing basis.

Palliative Care Services Increasing Across the U.S.

Palliative care services are now more accessible to patients with serious and chronic illnesses in the United States. The Mayo Clinic defines palliative care as offering pain and symptom management and emotional and spiritual support when a patient faces a chronic, debilitating or life-threatening illness. Increasingly offered to patients of any age with a range of chronic illnesses such as cancer, multiple sclerosis and Parkinson’s disease, palliative care may be provided at the same time as curative medical regimens to help patients tolerate side effects of disease and treatment, and proceed with everyday life. According to a recent December 22, 2014 Wall Street Journal article, palliative care programs have increased three fold over the past decade. Many hospitals have specialized palliative care programs and 80% of hospitals with 250 beds or more provide such a program.

The provision of palliative care with or without curative treatment can lead increased patient and health care provider satisfaction, equal or better symptom control, less anxiety and depression, less caregiver distress, and potential cost savings. A patient’s quality of life can be enhanced with active and effective pain and symptom management. The need for aggressive pain and symptom management often lead patients to seek out a palliative care program to manage their symptoms during a chronic or terminal illness. Some patients also choose to utilize hospice care towards the end of their life journey after receiving services from a palliative care program. With the better availability of palliative care, those patients seeking pain relief and symptom control at any stage of their chronic or terminal illness care are able to find the services to address their needs including assisting the patient and the family to navigate the often complicated medical system.

Lessons Learned: May a Healthcare Professional Say No To Treating Ebola?

May a licensed healthcare professional refuse to treat a patient?  Healthcare providers have legal, ethical and professional duties to address a patient’s needs that fall within the provider’s scope of practice. However, are doctors, and other health care personnel, required to treat any and all patients, even if doing so might cost them their lives? While this is an issue that has arisen with the recent Ebola outbreak, it is not a new issue and has been previously addressed.

History of Refusing to Treat

During the early HIV/AIDS era in the 1980s, when there was little known about the disease, there were physicians and other health care workers who refused to treat HIV infected patients.  Accordingly, in 1992, the American Medical Association declared in an ethics opinion that “A physician may not ethically refuse to treat a patient whose condition is within the physician’s current realm of competence solely because the patient is seropositive for HIV. Persons who are seropositive should not be subjected to discrimination based on fear or prejudice.” AMA Opinion 9.131 (March 1992, updated June 1996 and June 1998).

Similarly, the American Dental Association stated in its Principles of Ethics and Code of Professional Conduct that, “[a] dentist has a general obligation to provide care to those in need. A decision not to provide treatment to an individual because the individual has AIDS or is HIV seropositive based solely on that fact is unethical.”  American Dental Association, ADA Principles of Ethics and Code of Professional Conduct III § 4.A.1 (2012).

During the recent Ebola outbreak, healthcare personnel were once again refusing to treat infected patients.  Is this acceptable?

EMTALA

The Emergency Medical Treatment and Labor Act (“EMTALA”) is a federal law that requires that any patients that present at an emergency department must be stabilized and treated in a non-discriminatory manner, regardless of their insurance status, ability to pay, national origin, race, creed or color.  42 U.S.C. § 1395dd.  Hospitals may not transfer or discharge patients needing emergency treatment except with the informed consent (itself a legal doctrine) or stabilization of the patient, or when their condition requires transfer to a hospital better equipped to administer the treatment.

Since Ebola qualifies as an emergency medical condition, patients with the disease would fall under EMTALA.  See CMS Bulletin (November 21, 2014).  Upon arrival at the emergency department, even if Ebola is suspected, EMTALA would require the patient be medically screened and treated until the emergency condition is resolved or stabilized.  Hospitals lacking the ability to provide care to such patients may transfer the patients to another facility under strict transfer guidelines.  Both individual providers and hospitals have a legal obligation to comply with EMTALA. If found in violation of the act, hospitals and healthcare providers may lose their Medicare provider agreement and be fined up to $50,000 per violation as well as be subject to any lawsuits that may arise.

Pre-existing or Contractual Relationships

Aside from EMTALA which governs treatment of patients in emergent situations within emergency facilities, U.S. law generally allows healthcare providers to accept or decline patients at will.  There are a few exceptions to this rule.  First, many hospital medical staff bylaws, state medical board licensing and discipline requirements and contractual arrangements require physicians to comply with American Medical Association ethics guidelines. These ethics guidelines may well require a physician to provide care to an Ebola patient, such as the AMA opinion cited above.  Additionally, managed care agreements may also require an assessment of the patient.

A second exception concerns a prior-existing provider-patient relationship. Breaking this relationship without transferring care to another provider constitutes “abandonment.”  For example a patient with whom a healthcare professional has previously established a professional relationship may present in the professional’s office with complaints of fever, muscle ache and abdominal pain.  That patient may also have a history showing that he or she recently travelled to an Ebola hot spot or area with a high risk of Ebola.  As with any other patient, the provider must provide treatment and/or refer them to another source for treatment. Otherwise, the healthcare professional is at risk for abandonment of the patient.

However, if a patient with whom the healthcare professional has no pre-existing care relationship presents in the professional’s office with the above-described complaints, and there is no other duty under any other basis (i.e. not an ER physician, or in any other way obligated to treat the patient), then the question becomes is the healthcare professional qualified to treat the patient.  In most situations, the professional typically has the legal right to decide whether to accept the patient or not.

Third, the American with Disabilities Act of 1991 prohibits providers from refusing care to patients on the basis of disability.

Lastly, states may have their own laws outlining when providers can and cannot refuse to treat certain patients. For example, the Rhode Island Department of Health recently released a statement providing that, “In Rhode Island, licensed healthcare professionals in active practice are obligated to treat and/or care for Ebola patients, while minimizing the risk of Ebola transmission to self and others.”  The statement notes that failure to comply is a potential breach of the state’s healthcare licensing laws and could result in sanctions.

Personal Safety

Healthcare providers also operate along ethical principles concerning their duty to treat.  The general guideline acts to ensure that the provider does not feel threatened for his or her personal safety.  In fact, the preparedness protocols that were designed by the Centers for Disease Control and Prevention (“CDC”) presents a mission to care for those in need, but has an underlying theme of safety as the number one priority.  The protocols emphasize that all healthcare workers involved in the care of Ebola patients:  (i) must have received repeated training and demonstrated competency in performing all Ebola-related infection control practices and procedures; (ii) should have no skin exposed; and (iii) must have an onsite manager at all times overseeing the safe care of Ebola patients in a facility.  Notably, the CDC has also stated that the risk of transmission of Ebola, in and of itself, does not provide a basis for the relaxation of a health professional’s duty to help a patient as the risk of disease transmission is understood and can be readily mitigated.

Ultimately, the decision to treat an Ebola patient is fact dependent, based on the overall safety of the healthcare professional.  For example, a healthcare worker may be situated in a rural area without proper equipment and without any safety mechanisms in place.  If the professional is confronted with a patient diagnosed with Ebola and in the active stages of the disease, the ethical concerns may be trumped by treatment concerns.  Similarly, a leading medical ethicist, Dr. Joseph J. Fins, has stated that a medical team should not try to resuscitate an Ebola patient whose heart has stopped beating.  Dr. Finns explained that the risks of cardiopulmonary resuscitation efforts are too great for health care workers and even for some Ebola patients whose heartbeat is restored.

On the other hand, a healthcare professional may work in a health system that is ripe with safety protocols and mechanisms available.  If that professional is confronted with a patient diagnosed with Ebola, the concern for personal safety may not outweigh the ethical duty to treat.  Ultimately, it will be a decision for the healthcare professional to make concerning his or her personal safety.

National Guidelines

Conflicting laws, ethical guidelines and varying circumstances have created great uncertainty about the duty to treat.  In fact, the decision whether the duty to treat trumps safety concerns has sparked a thorny debate at hospitals across the country along with a call for national guidelines.  See U.S. Hospitals Weigh Staff Safety, WSJ (October 31, 2014).

For more information on legal concerns in the treatment of Ebola or related clinical legal issues, please feel free to contact Daniel Meier or any member of our health care practice group for a further discussion.

OIG Announces Proposed AKS and CMP Regulations

On October 3, 2014, the Office of the Inspector General (“OIG”) issued a proposed rule codifying into regulation several statutory changes to the Antikickback Statute (“AKS”) and the Civil Monetary Penalty (“CMP”) Law. Nearly all of these changes broaden permissible arrangements for certain health care and health service providers. The OIG is seeking public comment regarding how to best balance the promotion of beneficial arrangements that enhance the efficient and effective delivery of health care and promote the best interests of patients, while simultaneously avoiding payment arrangements that risk abuse of Federal health care programs or program beneficiaries. Comments about these proposed regulations are due to the OIG no later than December 2, 2014 at 5:00 p.m. EST. The proposed regulations in their entirety are available here. Selected proposed changes are described below.

Antikickback Regulations

1.   Cost-Sharing Waiver Safe Harbors. The OIG proposes to codify as regulations AKS safe harbors for certain cost-sharing waivers determined to be low risk to Federal health care programs.

a.   Safe Harbor for Part D Cost-Sharing Waivers by Pharmacies. A pharmacy waiving Part D cost-sharing for a beneficiary would qualify for the safe harbor when:
(i) the waiver is not advertised or part of a solicitation;
(ii) the pharmacy does not routinely waive the cost sharing; and
(iii) before waiving cost-sharing, the pharmacy either determines in good faith that the beneficiary has a financial need or the pharmacy fails to collect the cost-sharing amount after making a reasonable effort to do so.
Conditions (ii) and (iii) do not apply to a subsidy-eligible individual.

b.   Safe Harbor for Cost-Sharing Waivers for Emergency Ambulance Services. Emergency ambulance providers and suppliers that are paid by Medicare fee-for-service and are owned and operated by a State, a political subdivision, or a Federally recognized Indian tribe would receive AKS safe harbor protection for arrangements when:
(i) the ambulance provider or supplier is the Medicare Part B provider or supplier of the services;                                                                                                        (ii) the waiver is offered uniformly, without regard to patient-specific factors;
(iii) the waiver is not the furnishing of free services paid for by a government entity; and
(iv) the provider or supplier bears the cost of the waiver.

2.   AKS Remuneration Exceptions. The OIG proposes to codify as regulations two recent statutory exceptions to the definition of remuneration.

a.   Medicare Coverage Gap Discount Program Exception. Applicable drugs provided at a discount to applicable beneficiaries under the Medicare Coverage Gap Discount Program would be excepted from the AKS definition of remuneration if the drug manufacturer is a compliant participant in the Medicare Coverage Gap Discount Program.

b.   Local Transportation Services Exception. Excepted from the AKS definition of remuneration would be free or discounted local (no more than 25 miles away) transportation made available by an individual or entity to established patients who are Federal health care program beneficiaries for the purpose of obtaining medically necessary items or services when:
(i) the individual or entity providing the transportation services does not primarily supply health care items and bears the cost of the transportation services;
(ii) the availability of transportation services is not determined in a manner related to the volume or value of Federal health care program business;
(iii) the transportation services are not air, luxury, or ambulance-level services; and
(iv) the transportation services are not marketed or advertised and drivers or others arranging the transportation are not paid per beneficiary transported.

Civil Monetary Penalty Regulations

1.   CMP Remuneration Exceptions. The OIG proposes to codify as regulations recent statutory exceptions to the CMP rule definition of remuneration. The proposed regulations additionally provide proposed definitions of terms intended to help interpret these exceptions. Proposed exceptions to the CMP rule definition of remuneration include:

(a)   Reductions by a hospital of the copayment amount for covered outpatient department services to no less than 20% of the Medicare outpatient department fee schedule.

(b)   Remuneration promoting access to care and posing a low risk of harm to patients and Federal health care programs.

(c)   Retailer rewards programs consisting of coupons, rebates, or other rewards from a retailer offering items or services on equal terms to all members of the public and which are not tied to the provision of other items or services reimbursed in any part by Medicare or an applicable State health care program.

(d)   The offer of certain items or services for free or at less than fair market value after making a good faith determination that the recipient is in financial need and when the items or services are not advertised.

(e)   Certain copayment waivers for the first fill of a covered Part D generic drug for beneficiaries enrolled in the Medicare Prescription Drug Plan or the Medicare Advantage Part D Plan.

2.   Gainsharing Prohibition. The OIG proposes codify the statutory gainsharing prohibition that forbids hospitals from knowingly making a payment to a physician as an inducement to reduce or limit services provided to Medicare or Medicaid beneficiaries under the care of that physician. In doing so, the OIG acknowledges that it seeks to strike a balance that interprets the prohibition broadly enough to protect Federal health care program beneficiaries, and narrowly enough to allow low risk programs that further the goal of delivering high quality health care at a lower cost. Furthermore, in the proposed regulations the OIG acknowledges that it has previously allowed certain gainsharing arrangements through its advisory opinion process and that it seeks comment regarding an interpretation of the statute that permits the implementation of low risk, beneficial gainsharing arrangements.

If you have questions about these proposed regulations, or about fraud and abuse compliance for Federal health care program participants generally, contact Heather E. Baird, or any member of the Benesch Health Care Department.

Changes Coming to Nursing Home Compare

The Centers for Medicare and Medicaid Services (“CMS”) has announced that the Nursing Home Compare Five Star Quality Rating System will soon undergo some changes. The rating system has experienced recent criticism for relying too heavily on self-reported data and CMS is taking action. A facility’s star rating, from one to five stars, is based upon three categories of information, “onsite inspections,” “quality measures,” and “staffing levels.” Currently, the only category that is not self-reported is onsite inspection.

To address potential weaknesses in the current system, CMS will be implementing improvements to Nursing Home Compare. Look for increased numbers of quality measures that are not solely based on self-reported data and also for staffing information that will be electronically collected quarterly and verified against payroll records. Also expect the addition of new quality indicators, such as staffing turnover and retention and rate of antipsychotics use. This revised rating system is intended to provide greater transparency and objectivity for individuals seeking information on Nursing Home Compare.

A fact sheet from CMS summarizing these new improvements is available here.