CMS Changes Nursing Home Rating System

By on February 18, 2015

The Centers for Medicare and Medicaid Services (CMS) announced that it will reveal its new Nursing Home Compare 5-Star Quality Rating System to the public on February 20, 2015.   CMS will change its ratings to raise the bar for achieving a high rating in the Quality Measures category.  Thus, ratings will likely fall for many nursing homes even though there has been no change in the quality of care.

CMS is raising the standards for nursing homes to achieve a high rating in the Quality Measures category by increasing the numbers needed to achieve a particular star category.  According to CMS, in 2008 the initial scoring for the Quality Measures rating was set at a distribution that reflected the status quo with the expectation that there would be progress and changes to the quality measures thresholds over time.  When nursing homes have made progress in raising performance standards, CMS resets the distribution to promote further progress.

In addition to raising performance expectations, CMS is making the following changes to the 5-star rating system:

  • Additional Quality Measures:  CMS added two additional quality measures for antipsychotic medication use in nursing home residents without diagnoses of schizophrenia, Huntington’s disease, or Tourette syndrome.
  • Staffing Algorithms:  CMS adjusted these measures to more accurately reflect staffing levels.
  • Survey Expansion:  CMS announced a plan for State Survey Agencies to conduct specialized, onsite surveys of a sample of nursing homes in the country to assess the adequacy of resident assessments and the accuracy of information reported to CMS that is used to calculate quality measures.

These changes to the 5-Star Quality Rating System are the third major revision to the Nursing Home Compare website since it was launched in 1998.  CMS says that a fourth change is scheduled for 2016.

Filed under Five-Star Rating System, Medicaid, Medicare, Nursing Homes, Quality Measures

HIPAA Privacy and Public Health Emergency Situations

By on January 12, 2015

In light of the Ebola outbreak, the U.S. Department of Health and Human Services (HHS), Office of Civil Rights (OCR) has issued a bulletin reminding health care providers that the protections under the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule are not set aside during an emergency.  OCR reminds covered entities that “the protections of the Privacy Rule are not set aside during an emergency.”  OCR cautions that in an emergency situation, covered entities must continue to implement reasonable safeguards to protect patient information against impermissible uses and disclosures.  Thus, covered entities and their business associates should review the HIPAA Privacy Rule to ensure that uses and disclosures in emergency situations are appropriate, as well as provide training and reminders to employees.

HIPAA recognizes that under certain circumstances it may be necessary to share patient information without authorization.  OCR’s bulletin notes that covered entities may disclose protected health information without a patient’s authorization as necessary to treat the patient or a different patient.  HIPAA also allows covered entities to release patient information without authorization for certain public health activities.  A covered entity may disclose protected health information to a public health authority that is authorized by law to collect or receive the information for the purpose of preventing or controlling disease, injury, or disability.  Information may also be shared at the direction of a public health authority to a foreign government that is acting in collaboration with the public health authority.   In addition, health information may be shared with persons at risk of contracting or spreading a disease or condition if authorized by law.  Finally, health care providers may share patient information with anyone as necessary to prevent or lessen a serious and imminent threat to the health and safety of a person or the public consistent with applicable law and ethical standards.

There are additional circumstances that allow the disclosure of protected health information.  A covered entity may disclose protected health information to a patient’s family members, relatives, friends, or other persons who the patient identifies as being involved in the patient’s care and disaster relief organizations.  Covered entities should review the specific circumstances that allow the release of this information.

Covered entities should also review whether the minimum necessary requirement applies.  For most disclosures, but notably not disclosures to health care providers for treatment purposes, a covered entity must make reasonable efforts to limit the information disclosed to the “minimum necessary” to accomplish the purpose.

Although the media has reported many details about Ebola patients, HIPAA is not suspended when providing information to the media about Ebola or other public health emergencies.  Therefore, covered entities should carefully review the rules surrounding disclosures to the media or others not involved in the care of the patient.  If the media requests information about a particular patient by name, a health care facility may release limited facility directory information to acknowledge that the individual is a patient and provide basic information about the patient’s condition in general terms, if the patient has not objected or restricted the release of this information, but information about an incapacitated patient may only be released if the disclosure is believed to be in the patient’s best interest and is consistent with the patient’s prior expressed preferences.   General information about a patient’s condition includes critical or stable, deceased, or treated and released.  OCR cautions that affirmative reporting or disclosure to the media or the public at large about an identifiable patient or  specific information may not be done without the patient’s or an authorized personal representative’s written authorization, unless one of the limited circumstances described elsewhere in OCR’s bulletin is applicable.

Although HIPAA is not suspended during a public health or other emergency, the HHS Secretary may waive certain provisions under the Project Bioshield Act of 2004 and section 1135(b)(7) of the Social Security Act.  The limited waiver applies to certain sanctions and penalties of the Privacy Rule if the President declares an emergency or disaster and the HHS Secretary declares a public emergency.  The waiver only applies in the emergency area and for the emergency period identified; to hospitals that have instituted a disaster protocol; and for up to 72 hours after the hospital implements its disaster protocol.  Once the Presidential or Secretarial declaration ends, a hospital must comply with the entire Privacy Rule, even if less than 72 hours have elapsed since the hospital implemented its disaster protocol.

Filed under Department of Health and Human Services, Ebola, HIPAA, Office of Civil Rights

HHS Office of Inspector General Issues 2015 Work Plan (Part 2)

By on December 8, 2014

This final post on the OIG’s 2015 Work Plan summarizes many of the OIG’s initiatives in other areas.  To read Part 1, click here.

Medical Equipment and Sales: The OIG plans to examine 10 areas regarding equipment and supplies, including issues relating to power mobility devices, lower limb prosthetics, nebulizer machines and related drugs, diabetes testing supplies, and the payment system for renal dialysis services and drugs.  The OIG will also review claims for frequently replaced medical equipment supplies to determine supplier compliance with medical necessity, frequency, and other Medicare requirements, noting that suppliers have automatically shipped certain device supplies without physician orders for refills.

Other Providers: The OIG plans to review other providers’ policies, practices, and billings and payments, including ambulance, anesthesia, chiropractic, diagnostic radiology, imaging, and clinical laboratory services. The OIG also will examine inappropriate and questionable billing by ophthalmologists, physician place of service coding errors, high use of outpatient physical therapy services, supplier compliance with transportation and set-up fee requirements for portable X-ray equipment, and high use of sleep-testing procedures by sleep disorder clinics.

Prescription Drugs: The OIG will review several areas relating to prescription drugs. Of note, the OIG plans to examine payments for drugs purchased under the 340B Drug Pricing Program by determining how much Medicare Part B spending could be reduced if Medicare could share the savings for drugs purchased under the 340B program.

Part A and B Contractors: The OIG plans to examine seven areas relating to oversight of contracts and contractor functions and performance.

Information Technology Security, Protected Health Information, and Data Accuracy: Of note, the OIG plans to examine whether CMS oversight of hospitals’ security controls over networked medical services is adequate to protect electronic-protected health information. The OIG states that computerized medical devices that are integrated with electronic medical records and a health network are a growing threat to the security and privacy of health information. These medical devices monitor a patient’s health status and transmit and receive health data.

Other Part A and Part B Program Management Issues: The OIG will examine enhanced enrollment screening procedures for Medicare providers under the ACA. For the first time, the OIG will conduct a risk assessment of the Pioneer Accountable Care Organization Model.

Medicare Part C and Part D: The OIG plans several activities regarding Medicare Part C and Part D, including Medicare Advantage Organizations’ compliance with Part C requirements, ensuring dual -eligible patient access to drugs under Part D, and Part D billing and payments including Medicare Part D payments for HIV drugs for deceased beneficiaries.

Medicaid Program: The OIG will investigate several areas relating to Medicaid, noting that protecting Medicaid from fraud, waste, and abuse takes on a heightened urgency as the program continues to expand. Thus, the OIG will investigate a variety of areas in the Medicaid program, including state claims for drug rebates and claims for federal reimbursement. The OIG will also review Medicaid payments by states for home health services and other community-based care, including determining whether adult day care services providers complied with federal and state requirements and whether home health agency health care workers were screened in accordance with federal and state requirements. In addition, the OIG will review issues relating to medical equipment and supplies, transportation, health care-acquired conditions, and managed care. Finally, the OIG will review a variety of issues regarding state management, funding, oversight, and payment for Medicaid.

Other: The OIG plans to review and investigate many other areas. For the first time, the OIG will determine the extent to which hospitals comply with the contingency planning requirements found in the Health Insurance Portability and Accountability Act (HIPAA), as well as compare the hospitals’ contingency plans with government and industry recommended practices.

Filed under Department of Health and Human Services, Information Technology Security, Medicaid, Medical Equipment and Sales, Medicare, Office of Inspector General 2015 Work Plan, Prescription Drugs

HHS Office of Inspector General Issues 2015 Work Plan (Part 1)

By on December 1, 2014

The Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) recently released its 2015 Work Plan. The OIG’s Work Plan outlines the reviews and activities the OIG plans to pursue during the 2015 fiscal year. Thus, the Work Plan gives health care providers an overview of the OIG’s enforcement priorities for the coming year.

The highlights from the OIG’s 2015 Work Plan are summarized in two separate posts.  This first post focuses on hospitals, nursing homes, hospice, and home health providers.

Hospitals: The OIG’s 2015 Work Plan places a major emphasis on hospitals, focusing its review of hospital activities in 22 areas. For the first time, the OIG will focus on adverse events in post-acute care for Medicare beneficiaries. The OIG will estimate the national incidence of adverse and temporary harm events for Medicare beneficiaries who receive care in long-term care hospitals, identify factors contributing to these events, determine the extent that the events were preventable, and estimate the costs to Medicare. According to the OIG, long-term care hospitals are the third most common type of post-acute care facility and account for almost 11 percent of Medicare costs for post-acute care.

The OIG also is focusing on the following hospital-related policies and practices, billing and payment, and quality of care and safety areas.

  • The OIG will study the impact of 2014 inpatient admission criteria known as the “two midnight policy.” The criteria require physicians to admit for inpatient care only those beneficiaries who are expected to need at least two nights of hospital care. If the beneficiary’s care is expected to last less than two nights, the beneficiary should be treated as an outpatient.  The OIG plans to study the impact of the new inpatient admission criteria on hospital billing, Medicare payments, and beneficiary co-payments, as well as determine how billing varied among hospitals.
  • The OIG will compare the Medicare payments for physician office visits in provider-based clinics and freestanding clinics to determine the difference in payments for similar procedures.
  • The OIG will determine the extent to which provider-based facilities meet the criteria of the Centers for Medicare and Medicaid Services (CMS). The OIG noted the financial incentives to bill as provider-based facilities because provider-based status allows facilities owned and operated to bill as hospital outpatient departments.
  • The OIG will examine other policies and practices that include:  reconciliation of outlier payments; costs associated with defective medical devices; salaries included in Medicare cost reports; and the payment policies for swing-bed services.
  • The OIG will examine various billing and payment issues, including inpatient claims for mechanical ventilation, selected inpatient and outpatient billing requirements, duplicate graduate medical education payments, indirect medical education payments, outpatient dental claims, and outpatient evaluation and management services billed at the new patient rate.
  • The OIG will examine other quality of care and safety issues in hospitals including hospital privileging, adverse events in inpatient rehabilitation facilities, and participation in projects with quality improvement organizations.

Nursing Homes: The OIG will review several areas relating to nursing homes, including Medicare Part A billing by skilled nursing facilities. The OIG stated that skilled nursing facilities increasingly bill for the highest level of therapy even though beneficiary characteristics did not change and that in 2009 skilled nursing homes billed one-quarter of all claims in error. In addition, the OIG will review questionable billing patterns for Part B services during nursing home stays. Congress directed the OIG to monitor Part B billing for abuse during non-Part A stays to ensure that excessive services are not provided. Of note, the OIG will also review the extent that Medicare beneficiaries in nursing homes are hospitalized for manageable and preventable conditions.

Hospices:The OIG will continue its focus on hospice care, specifically two areas in 2015: hospices in assisted living facilities and the use of hospice general inpatient care. As part of its review of the extent that hospice plans serve Medicare beneficiaries who reside in assisted living facilities, the OIG will determine the length of stay, levels of care received, and common terminal illnesses. The OIG’s work is intended to provide HHS with information as part of the Affordable Care Act (ACA) requirement that CMS reform the hospice payment system, collect data relating to hospice payment revisions, and develop quality measures for hospice. The OIG will assess the appropriateness of a hospice program’s general inpatient care claims, including a review of hospice medical records to address concerns that the inpatient level of hospice care is misused.

Home Health Services:The OIG will review compliance with the home health prospective payment system, notably the documentation required in support of Medicare claims. In addition, the OIG will examine the extent to which home health agencies employed individuals with criminal convictions.

Filed under Department of Health and Human Services, Home Health Agencies, Hospice Programs, Hospitals, Nursing Homes, Office of Inspector General 2015 Work Plan

Health Care Facilities Should Address Medical Device Cybersecurity Risks

By on November 19, 2014

Hospitals and other health care facilities should evaluate and address the cybersecurity risks posed by medical devices.  There are many medical devices connected to hospital or health care provider networks, including hard-wired devices such as patient monitors, ventilators, and imaging devices (X-ray machines and computer systems used for radiology and cardiac procedures).  Many other devices are connected wirelessly to a hospital or a health care provider network.  For example, a physician might use a wireless electrocardiogram to monitor data from a patient:  The device uses hardware and software connected to a network to transmit data.

PVCY BLOG_shieldConnecting medical devices to an information technology (IT) network makes the network vulnerable to intended and unintended threats.  There have been several media reports about cybersecurity incidents.  The Department of Homeland Security reported that 300 medical devices used by doctors to view MRIs from a single manufacturer were infected with the Conficker Worm.  The computers were older and did not have updated antivirus software and became infected with the Conficker Worm when they were connected to the Internet.  The Wall Street Journal reported  that the Food and Drug Administration (FDA) is aware of “hundreds” of medical devices that have been infected by malware or dangerous computer software.  Further, the article stated that malware has infected at least 327 devices at Veterans Administration hospitals.  Finally, there is the possibility of an intentional attack on a medical device.  Reuters reported that a cybersecurity researcher discovered a bug in an insulin pump and wrote a program that could remotely dose patients with potentially lethal amounts of insulin.

Due to the growing use of medical devices connected to hospital and health care provider networks, the FDA has issued guidance to medical device manufacturers for premarket submissions for management of cybersecurity in medical devices, most recently in November 2014.  The agency’s guidance to medical device manufacturers recognizes that medical device security is a shared responsibility between stakeholders, including health care facilities.  Thus, hospitals and health care facilities should take steps to combat cybersecurity threats.

The Department of Homeland Security and the FDA have listed some best practices to combat cybersecurity threats that can be useful to hospitals and health care facilities, including the following:

  • only purchase and use networkable medical devices with available safety features;
  • only use networkable medical devices that can be configured safely on the hospital and health care facility’s network;
  • purchase vendor support for ongoing firmware, patch, and antivirus updates when they are an appropriate risk mitigation strategy—in other words, update software, firewalls, and antivirus protection as appropriate;
  • operate security features such as firewalls, network monitoring, and intrusion detection to the extent practical;
  • establish strict policies for connecting networked devices;
  • establish policies to maintain, review, and audit network configurations when the network changes;
  • restrict unauthorized access to the network and networked medical devices;
  • do not provide access to the entire network for all users, but grant the least privilege necessary to users;
  • implement patch and software upgrade policies for the network;
  • secure communication channels by using encryption and authentication;
  • use and enforce password policies; and
  • develop a back-up plan to maintain network function during adverse conditions.

Filed under Department of Homeland Security, Food and Drug Administration (FDA), Health Care Provider Networks, Medical Device Cybersecurity

Programs Should Prepare for Increased Oversight of Hospice Length of Stay

By on November 10, 2014

The media and regulators have heightened their focus on perceived hospice fraud and abuse. A Washington Post article describes how Medicare rules create a booming business in hospice care for people who are not dying, resulting in hospice firms draining money from Medicare. The article focuses on how the number of “hospice survivors” in the United States has risen, attributing the rise in part to hospice companies that earn more by recruiting patients who are not actually dying.

According to The Washington Post’s analysis of more than 1 million hospice patient records over 11 years in California, the proportion of patients who were discharged alive from hospice care rose 50 percent between 2002 and 2012. Longer stays are more profitable, the article states, because hospice companies generally spend more on patients when they begin care and again when the patients are at the end of their lives.

The federal government also is studying hospice length of stay, particularly in the nursing home and assisted living settings. According to a May 1, 2014, study titled “Medicare Hospice Payment Reform: A Review of the Literature (2013 Update),”performed by Abt Associates for the Centers for Medicare and Medicaid Services (CMS), hospice length of stay has increased 48 percent between 1998 and 2008. Although the average length of stay for chronic kidney disease and cancers remained relatively stable during this timeframe, the average length of stay increased significantly for most other diagnoses. The largest increase was for nonspecific diagnoses such as “debility, not otherwise specified,” “adult failure to thrive,” Alzheimer’s disease, and non-Alzheimer’s dementia.  According to Abt, some studies also have noted an increased length of stay for hospice patients who live in a nursing home.

The Office of Inspector General (OIG) at the Department of Health and Human Services (HHS) published a July 2011 report – “Medicare Hospices That Focus on Nursing Facility Residents”– on hospices that served a high percentage of nursing home residents. According to the OIG, these hospices served beneficiaries who spent more time in care and typically enrolled beneficiaries whose diagnoses required less complex care. The OIG stated that some hospices may be seeking out beneficiaries with particular characteristics, including those with conditions associated with longer but less complex care who are often found in nursing homes. Among the suggestions the OIG made was to increase monitoring of hospices that depend heavily on nursing facilities and to modify the payment system for hospice care in nursing facilities as the current payment structure provides incentives for hospices to seek out beneficiaries in nursing facilities who often receive longer but less complex care.

In its 2014 work plan, the OIG focused on hospice length of stay in assisted living facilities. The OIG noted that assisted living residents have the longest lengths of stay in hospice care and that the Medicare Payment Advisory Commission has said the long stays bear further monitoring and examination.

Recently signed legislation will soon create greater federal oversight for hospice programs. On October 6, 2014, President Obama signed into law the IMPACT Act of 2014 (Improving Medicare Post-Acute Care Transformation Act of 2014). The hospice provisions increase the frequency of state inspections, mandating surveys not less frequently than once every 36 months until September 30, 2025. In addition, the law focuses on hospice programs that appear to enroll patients who are not near death by requiring a medical review of hospice programs with a high percentage of patients who receive care for 180 days or more. The Secretary of Health and Human Services is required to set a threshold percentage or number of patients receiving care for more than 180 days that will trigger a review.

Hospice programs can begin preparing now for the increased oversight of hospice length of stay. Although CMS still needs to clarify the threshold percentage that will trigger a medical review and the methodology for the review, hospice programs can start to address, monitor, or audit the following areas.

  • Assess clinical documentation supporting hospice eligibility: Describe symptoms and diagnoses that support that the patient has a terminal condition and avoid vague terms or conclusory statements without documentation, such as “declining” or “needs hospice.”
  • Review policies and procedures to ensure that there are protocols in place so that appropriate assessments are performed and documented to demonstrate that a beneficiary is and remains eligible for the hospice benefit.
  • Conduct training on policies and procedures.
  • Create and use audit tools to evaluate that hospice eligibility requirements are met, policies and procedures are followed, and there is appropriate documentation.

Filed under Hospice Length of Stay, Hospice Programs, Medicare Rules

CMS Announces Changes to Nursing Home Five-Star Quality Rating System in 2015

By on October 29, 2014

On October 6, 2014, the Centers for Medicare and Medicaid Services (CMS) announced  that it will implement changes to the Nursing Home Five-Star Quality Rating System in 2015.  CMS launched the five-star system for nursing homes in December 2008.

The current five-star rating for each nursing home is based on the star ratings for three separate categories:  1) health inspections; 2) quality measures; and 3) staffing.  To determine a nursing home’s overall rating, CMS begins with the facility’s health inspection rating and then adds or subtracts “stars” depending on the facility’s staffing rating and its quality measures rating.

CMS will implement the following changes to the Five-Star Rating System in 2015.

Nationwide Focused Survey Inspections:  CMS and states will begin focused survey inspections nationwide in a sample of nursing homes to verify the staffing and quality measure information that is part of the Five-Star Quality Rating System.

Payroll-Based Staffing Reporting:  CMS will use a quarterly electronic reporting system to verify staffing information.  According to CMS, the system can be audited back to payroll to verify staffing information and thus increase the accuracy and timeliness of the data.

Additional Quality Measures:  CMS will increase the number and type of quality measures.  The first new quality measure—usage of antipsychotic medications—will be introduced in January 2015.

Timely and Complete Inspection Data:  CMS will work to ensure that states maintain timely and complete inspection data, including a user-friendly website.

Improved Scoring Methodology:  CMS plans to revise the scoring methodology used to calculate each facility’s quality measure rating, which is one of the three categories used to determine the overall star rating.

Filed under Centers for Medicare and Medicaid Services, Health Inspections, Nursing Home Five-Star Quality Rating System, Quality Measures, Staffing

HHS Issues Guidance on HIPAA and Same-Sex Marriage

By on October 1, 2014

On September 17, the Office for Civil Rights (OCR) at the Department of Health and Human Services (HHS) issued guidance to assist covered entities and business associates in understanding their obligations under the privacy rule. The guidance follows the U.S. Supreme Court’s June 2013 decision in United States v. Windsor, which held that Section 3 of the Defense of Marriage Act (DOMA) – a provision that said federal law recognizes only opposite-sex marriages – is unconstitutional.  As a result of the Supreme Court’s decision, covered entities and business associates must consider their privacy rule obligations regarding lawfully married same-sex spouses and same-sex marriage.

OCR’s guidance clarifies the terms “spouse,” “marriage,” and “family member” as these terms are used in 45 C.F.R. § 160.103.  Based on the Supreme Court’s decision, OCR states tha

t the term “spouse” includes individuals who are in a legally valid same-sex marriage sanctioned by a state, territory, or foreign jurisdiction (as long as a U.S. jurisdiction would recognize a marriage performed in a foreign jurisdiction).  OCR clarifies that the term “marriage” includes same-sex and opposite-sex marriages, and “family member” includes dependents of those marriages.  Finally, OCR states that these terms apply to individuals who are legally married, whether or not they live or receive services in a jurisdiction that recognizes their marriage.

These definitions are relevant to the application of at least two sections of the Health Insurance Portability and Accountability Act (HIPAA) privacy rule.  The definition of “family member” is relevant to the application of 45 C.F.R. § 164.510(b), which relates to sharing an individual’s protected health information with a family member.  According to OCR, legally married same-sex spouses, regardless of where they live, are family members for the purposes of applying this provision.  The definition of “family member” also applies to 45 C.F.R. § 164.502(a)(5)(i), relating to use and disclosure of genetic information for underwriting purposes.

OCR indicates that it plans to issue additional clarifications through guidance or to initiate rulemaking to address same-sex spouses as personal representatives under the privacy rule.

Covered entities and business associates should provide training on this guidance, as well as update policies and procedures.

Filed under are Defense of Marriage Act (DOMA), HIPAA Privacy Rule, Same-Sex Marriage

Regulatory Issues and the Growth of Telemedicine

By on September 25, 2014

The growth of technology is fueling interest in telemedicine.  Although telemedicine has been around for approximately 40 years, it will likely become more widespread as regulators move to ease some of the barriers to telemedicine practice.  In the future, telemedicine could prove to be a powerful tool to increase the accessibility of health care and keep health care costs down.

The American Telemedicine Association (ATA) defines “telemedicine” as “the use of medical information exchanged from one site to another via electronic communications to improve a patient’s clinical health status.”  According to the ATA, telemedicine includes a growing variety of applications and services using two-way video, email, smartphones, wireless tools, and other forms of telecommunications technology.  Many services can be furnished by telemedicine, including primary care and specialist referral services provided by live interactive video or transmission of images and information; remote patient monitoring; and medical education.

HC BLOG_telemedicineRecent newspaper articles describe some of the innovative ways that telemedicine is being used to deliver health care.  The New York Times described a project, known as Project ECHO (short for Extension for Community Healthcare Outcomes), that uses remote technologies to link primary care doctors at the patient’s location with specialists who are based elsewhere.  This project started out treating hepatitis C patients in New Mexico and has branched out to 26 specialties with ECHO hubs at 31 universities.  The ECHO model uses video conferencing to conduct case-based training, collaborative care, and patient tracking.  Another article describes how a Nantucket hospital uses telemedicine so that doctors can examine patients without having to travel to the island.  Two dermatologists in Boston were able to diagnose and treat a patient at the Nantucket hospital.  Using cameras and screens, a nurse held a magnifying camera to a patient’s face and the image was transmitted to the Boston dermatologists.

Despite these articles describing the benefits of telemedicine, barriers remain to its widespread use.  Reimbursement remains an obstacle for telemedicine growth as there are specialized reimbursement rules for Medicare, state Medicaid programs, and private insurance.  Medicare pays physicians and other health care professionals for certain Part B services provided by telemedicine.  Generally, the services must be delivered via an interactive telecommunications system, which is defined as multimedia communications equipment that includes, at a minimum, audio and video equipment permitting two-way, real-time interactive communication between the patient and distant site physician and practitioner.  Telephones, facsimile machines, and electronic mail systems do not meet the definition of an interactive telecommunications system.   Finally, Medicare limits coverage of telemedicine services by geographic area, restricting it to a rural health professional shortage area, a county outside metropolitan statistical areas, and areas approved by the government as telemedicine demonstration areas.  42 C.F.R. § 410.78.

On July 11, 2014, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule expanding the list of Medicare-covered telemedicine services.  In addition, the rule incorporates a CMS policy change effective January 2014 that expanded the definition of “rural” to include geographic areas located in rural census tracts within metropolitan statistical areas.  Comments on the proposed rule were due on September 2, 2014, and CMS will publish the final rule later in 2014 with an effective date of January 1, 2015.

State Medicaid coverage of telehealth services varies greatly.  As of July 1, 2006, Colorado no longer requires in-person contact between a health care or mental health care provider and a patient in order to receive Medicaid reimbursement for services delivered through telemedicine, as long as the services are otherwise eligible for reimbursement.  C.R.S. § 25.5-5-320.  On the other hand, there are still a few states that do not cover telemedicine services or cover very limited services.  Idaho, for example, limits Medicaid payment for telehealth services to psychiatric services for diagnostic assessments, pharmacological management, and psychotherapy with evaluation and management services 20 to 30 minutes in duration.  Idaho Admin. Code Dept. of Health & Welfare § 16.03.09.502.

There have been several recent efforts to strike down barriers to telemedicine.  In 2011, CMS issued a final rule implementing a new credentialing process for physicians and other practitioners in hospitals and critical access hospitals providing telemedicine services.  The final rule, designed to remove barriers to the use of telemedicine, allows the hospital (or critical access hospital) to rely upon the credentialing and privileging decisions made by the telemedicine distant-site entity when making credentialing and privileging decisions for the distant-site physicians and practitioners.

On September 5, 2014, the Federation of State Medical Boards announced it had completed the drafting process for a model Interstate Medical Licensure Compact to streamline the licensing process and allow physicians to become licensed in multiple states.  The compact also adopts the prevailing standard for licensure: The practice of medicine occurs where the patient is located at the time of the encounter.  Thus, the physician must be under the jurisdiction of the state medical board where the patient is located.  The compact, if adopted, could make it easier for physicians to treat patients in other states through telemedicine.  State legislatures and medical boards can begin to consider adopting this legislation.  The compact is located on the federation’s web page.

Finally, in June 2014, the American Medical Association (AMA) adopted a telemedicine policy to improve access to care for patients.  The AMA report calls for telemedicine services to be covered and paid for if they abide by certain principles.  Among the principles listed by the AMA are the following:

  • A valid patient-physician relationship must be established before providing telemedicine services.
  • Physicians and other health care practitioners delivering telemedicine services must abide by state licensure and medical practice laws in the state where the patient receives services.
  • Physicians and other health care practitioners delivering telemedicine services must be licensed in the state where the patient receives services, or be providing these services as otherwise authorized by that state’s medical board.
  • The delivery of telemedicine services must be consistent with state scope of practice laws.

As telemedicine continues its growth, providers should keep aware of changing regulations, particularly in the licensure and reimbursement areas.

Filed under Medical Licensing, Reimbursement, Telemedicine

Colorado Proposes Changes to General Licensure Rules Concerning Review and Approval of Quality Management Plans for Health Care Entities

By on August 18, 2014

The Health Facilities and Emergency Medical Services Division of the Colorado Department of Public Health and Environment (CDPHE) issued proposed amendments to its general licensure rules for health care entities on July 16, 2014.  The division plans to update its rules for the first time since the health facility quality management privilege, C.R.S. § 25-3-109, was enacted in 1988.  A rulemaking hearing is scheduled for Oct. 15, 2014.

The division is amending its regulations to strike language exempting certain health care entities from having a quality management plan, as the statute does not exempt any licensed health care entity from this requirement.  Thus, the proposed rule requires every health care entity licensed or certified by the CDPHE pursuant to C.R.S. § 25-1.5-103(1)(a) to establish a quality management program appropriate to the facility’s size and type that evaluates the quality of patient or resident care and safety.

In addition, the division is amending its rules regarding approval of quality management plans, stating that the current rule language is outdated and is being revised to align with the new health inspection process.  Thus, the proposed rule eliminates the requirement that facilities submit quality management plans for approval.  Instead, every health care entity that must have a quality management plan will be required to develop a quality management plan that shall be available to the CDPHE during the initial licensure survey and each re-licensure survey.  Significantly, the proposed regulations state that the plan for a health care entity’s quality management program shall be considered approved if the CDPHE does not cite any deficient practice related to it.  If the CDPHE finds that a quality management plan does not meet regulatory requirements, it will inform the facility of the specific reasons for disapproval and establish a reasonable date for resubmittal of a revised plan.

On a related note, the Colorado Supreme Court should issue a decision shortly under the former licensing rules.  In Simpson v. Cedar Springs Hospital, Inc., Colo. No. 2013 SA 124, a hospital challenged a trial court’s order to produce documents from its quality management meetings after the trial court found that a hospital had not implemented a quality manage­ment program approved by the CDPHE, such that its quality management materials were subject to the privilege created by C.R.S. § 25-3-109.  The trial court had rejected the hospital’s argument that the evidence that the CDPHE had licensed the hospital and renewed its license established that the hospital had an approved quality management program.

Health care facilities in Colorado should follow the CDPHE’s rulemaking as well as the Colorado Supreme Court’s decision in Simpson as they will provide important information about the scope and requirements of Colorado’s quality management privilege

Filed under Colorado Department of Public Health and Environment, General Licensure Rules, Health Care Entities, Quality Management Plans

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