April 11, 2016

Many pain medicine procedures, and, increasingly, perioperative and critical care procedures such as central venous access are performed using ultrasound guidance (U/S).  Indeed, U/S is an integral part of many CPT^® codes, e.g., 20604 [Arthrocentesis, aspiration and/or injection, small joint or bursa, (e.g., fingers, toes), with ultrasound guidance, with permanent recording and reporting].  When and where, and by whom, must those permanent images be stored?  What if another entity, such as a hospital, is responsible for storing them?  According to Sonosite,

All diagnostic ultrasound examinations, including those when ultrasound is used to guide a procedure, require that permanently recorded images be maintained in the patient record. The images can be kept in the patient record or some other archive--they do not need to be submitted with the claim. Images can be stored as printed images, on a tape or electronic medium. Documentation of the study must be available to the insurer upon request. A written report of all ultrasound studies should be maintained in the patient's record. In the case of ultrasound guidance, the written report may be filed as a separate item in the patient’s record or it may be included within the report of the procedure for which the guidance is utilized.

The American Institute of Ultrasound in Medicine has issued the following statement of policy:

Adequate documentation is essential for high-quality patient care, should be performed in accordance with the AIUM Practice Parameter for Documentation of an Ultrasound Examination, and should be permanently documented in the patient’s medical record. Retention of the ultrasound examination should be consistent both with clinical needs and with relevant legal and local health care facility requirements. The procedure documentation should include the following:

 [1.-11. Omitted]
12. Preprocedure, intraprocedure, and postprocedure still image(s) or videos:

a. Images should be labeled with the patient identification, facility identification, procedure date, and side (right or left) of the procedure site.
b. Inclusion of at least one image demonstrating the needle or device placed into the target region is required unless the indirect technique is used (see section VI. Specifications for Ultrasound-Guided Joint Aspirations and Injections).
c. All images should be permanently archived and easily retrievable.
d. Variations from normal size or morphology should be recorded and accompanied by measurements.

Hospitals that participate in the Medicare program are required by regulations to retain imaging report copies and printouts, films, scans and other radiologic services image records for five years.  (42 CFR 482.26(d)).  Some states follow federal regulations, but many require that providers store images for several years longer, or have stricter standards for minors.

Most state statutes address hospitals and other facilities but a few, for example Indiana and Maryland, place the responsibility directly on physicians.  A five-year minimum retention period is the most common, but there is variation.  New Hampshire, for example, provides that “Both hospitals and health facilities must retain medical records of adults for a period of seven years from discharge.  Children’s records must be retained to the age of majority plus seven years, and X-ray film must be stored at least seven years.  The rules for each state are summarized in a table prepared by the American Healthcare Information Management Association.

Thus most states do not require physicians to retain medical records for a specific period of time.  Nor does the HIPAA Privacy Rule, although it does mandate “that covered entities apply appropriate administrative, technical, and physical safeguards to protect the privacy of medical records and other protected health information (PHI) for whatever period such information is maintained by a covered entity, including through disposal.”  (See 45 CFR 164.530(c)).  The statutes of limitations under federal and state fraud statutes can be considered as setting a minimum time period for retention of medical records that might be relevant in a Medicare or Medicaid fraud investigation.  For Medicaid and Medicare fraud, federal law establishes (1) a civil statute of limitations of six years (42 U.S.C. § 1320a-7a(c)(1)) and (2) a criminal statute of limitations of five years (18 U.S.C. § 3282).

An American Medical Association Ethics Opinion directly and very pragmatically addresses the issue:

Opinion 7.05 - Retention of Medical Records

Physicians have an obligation to retain patient records which may reasonably be of value to a patient. The following guidelines are offered to assist physicians in meeting their ethical and legal obligations:

(1) Medical considerations are the primary basis for deciding how long to retain medical records. For example, operative notes and chemotherapy records should always be part of the patient’s chart. In deciding whether to keep certain parts of the record, an appropriate criterion is whether a physician would want the information if he or she were seeing the patient for the first time.
(2) If a particular record no longer needs to be kept for medical reasons, the physician should check state laws to see if there is a requirement that records be kept for a minimum length of time. Most states will not have such a provision. If they do, it will be part of the statutory code or state licensing board.
(3) In all cases, medical records should be kept for at least as long as the length of time of the statute of limitations for medical malpractice claims. The statute of limitations may be three or more years, depending on the state law. State medical associations and insurance carriers are the best resources for this information.
(4) Whatever the statute of limitations, a physician should measure time from the last professional contact with the patient.
(5) If a patient is a minor, the statute of limitations for medical malpractice claims may not apply until the patient reaches the age of majority.
(6) Immunization records always must be kept.
(7) The records of any patient covered by Medicare or Medicaid must be kept at least five years.

Thus we have seen that the permanent image is a part of the medical record and that the physician (as well as the hospital) should retain the medical record for a certain period of time, generally no shorter than the applicable malpractice or fraud statute of limitations.  What if the physician or patient needs access to a part of the medical record that is in the exclusive possession of the hospital—for example, an U/S image?

There should be no problem if the request for the image is made within the statutory period during which the hospital or other facility must retain the medical record.  The Medicare Conditions of Participation provide in this regard (42 CFR 482.24):

The hospital must have a medical record service that has administrative responsibility for medical records. A medical record must be maintained for every individual evaluated or treated in the hospital.

(a) Standard: Organization and staffing. The organization of the medical record service must be appropriate to the scope and complexity of the services performed. The hospital must employ adequate personnel to ensure prompt completion, filing, and retrieval of records.

Sometimes hospitals fall short of this standard.  About 600 million imaging procedures are performed each year by health-care providers in the U.S., including CT scans, X-rays, ultrasounds and MRIs.  (Landro L. Where Do You Keep All Those Images? Wall Street Journal, April 8, 2013).  It is inevitable that some records will get lost and that a hospital will not be able to produce them for the physician who is facing an audit or a malpractice lawsuit.  The patient and/or the physician may have grounds for a lawsuit against the hospital, depending on the state in which they are located—and depending on whether the hospital’s obligation to keep and produce records is stipulated in a contract.

Consider including provisions in your hospital service contracts that require the facility to retain all radiological images for x number of years from the time the images are created, x being at least as long as the applicable statute of limitations.  State that the hospital must give you the images within, e.g., 24, 48 or 72 hours from the time you request them.  (The request will have to be sufficiently specific for the hospital to be able to identify the records).  Include in the contract your right to indemnification if the hospital fails to deliver the documentation (the images) on time and your group is harmed by the breach.  Such protection can be drafted in various ways.  We have seen enough instances in which anesthesiology groups were unable to recover part of the patient record from the hospital to know that the protection may be important. 

Merely including the hospital’s duty in the contract does not guarantee protection.  The best strategy, from the anesthesiologists’ point of view, is to make the hospital aware from the outset that safeguarding the entire medical record is critically important—not just to comply with Medicare’s and The Joint Commission’s accreditation standards, but to immunize the hospital against the financial and legal consequences of losing the records.  The group must be vigilant in making sure that the hospital is meeting its obligation.  If the group knows that it is about to be audited or be the target of a malpractice action, then it should notify the hospital that the records at issue must be retained and not purged or destroyed.

Fortunately, storage space or the lack thereof is no longer an excuse.  The U/S images, like so much else, can be stored conveniently in the cloud.

With best wishes,

Tony Mira
President and CEO