Burr & Forman

09.27.2018   |   Articles / Publications

Health Care: Helpful Hints – September 2018

On September 17, 2018, the Centers for Medicare and Medicaid Services (“CMS”) announced a proposed rule that is intended to relieve the regulatory burden on healthcare providers by removing unnecessary, obsolete or excessively burdensome Medicare compliance requirements for healthcare facilities. According to its announcement, CMS developed the proposed rule in response to the current administration’s effort to cut the red tape and reduce current regulations that are overly burdensome. In announcing its proposed rule, CMS is seeking Requests for Information (“RFIs”) in order to receive direct feedback from clinicians who serve Medicare beneficiaries. This effort is designed to simplify and streamline Medicare’s conditions of participation, conditions for coverage, and other requirements for participation for facilities to allow those providers to meet health and safety standards more efficiently while at the same time continuing to protect patient health and safety. The proposed rule would, for example:

  • Streamline hospital outpatient and ambulatory surgical center requirements for conducting comprehensive medical histories and physical assessments;
  • Simplify the ordering process for portable x-rays while modernizing the personnel requirements for that technology;
  • Remove duplicative ownership disclosure requirements for Critical Access Hospitals.

According to CMS, the proposed rule is the latest in a series of steps intended to reduce unnecessary burdens on facilities, generate efficiencies and, perhaps most important, provide health care providers more time to spend with their patients. For more information on the proposed rule click here.

Today, medical practices are often involved in clinical studies. The Food and Drug Administration (“FDA”) regulates those studies that are designed to develop evidence to support the safety and effectiveness of investigational drugs, biological products, and medical devices. Physicians and other qualified experts (“Clinical Investigators”) who conduct these studies are required to comply with applicable statutes and regulations intended to ensure the integrity of the clinical data on which product approvals are based and, for research involving human subjects, to protect the rights, safety, and welfare of those subjects. Clinical Investigators should be aware, however, that the FDA has and will initiate Clinical Investigator Qualification proceedings against any Clinical Investigator who has allegedly violated applicable regulations. A Clinical Investigator who becomes the subject of an investigation proceeding, of course, has procedural rights. That process begins with a “Notice of Initiation of Disqualification Proceeding and Opportunity to Explain” (“NIDPOE”) which informs the recipient Clinical Investigator that the FDA is initiating an administrative proceeding to determine whether that investigator should be disqualified from receiving investigational products pursuant to the FDA’s regulations. Following that initial notice, a Notice of Opportunity for Hearing (“NOOH”) provides that investigator with an opportunity for a hearing on any regulatory action, including a proposed action to disqualify the Clinical Investigator. This hearing would take place before a presiding officer designated by the Commissioner of the FDA. The ultimate outcome of this procedure, of course, depends on the unique facts and circumstances of each case. Fortunately, the FDA provides a database which can be accessed by any Clinical Investigator who receives a NIDPOE. That database and other helpful information can be found on the FDA’s website here.

Download the full article, “Health Care : Helpful Hints – September 2018” written by Robert V. Williams.

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