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HHS Proposes Changes to Drug Rebate Safe Harbors Print E-mail
Written by Vitale Health Law   
Tuesday, 12 February 2019 00:00
 
The U.S. Department of Health & Human Services (HHS) has issued a proposed rule that would amend the safe harbor regulation for certain drug rebates that manufacturers pay to pharmacy benefit managers (PBMs) Medicare Part D, and Medicaid managed care organizations (MCOs). Published in the Federal Register on February 6, the proposal is designed to address criticism that these rebates have contributed to the skyrocketing costs of prescription drugs.

"The prominence of rebate arrangements in the prescription drug supply chain has been cited as a potential barrier to lowering drug costs," HHS notes in its proposed rule.
 
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Last Updated on Wednesday, 13 February 2019 08:50
 
What Would You Do? Print E-mail
Written by John Couris   
Thursday, 31 January 2019 00:00
 
As the new legislative session begins here in Florida, politicians from across the state once again consider whether the Certificate of Need (CON) program-the regulatory process designed to limit health care costs and promote planning for new health care services and facilities-is best kept on the books h­­ere in the Sunshine State. Those who know me, have followed me on social media or read my blog posts over the past several years, are familiar with my belief that repealing CON is not good for our consumers, our community or our state. They have read my detailed arguments outlining that the elimination of CON could trigger a chain reaction that would cause three problems for residents: an increase in health care costs, a decline in the quality of care and a decrease in access to care. They also know that my position on CON is deeply informed by my extensive research on quality, clinical outcomes, safety, access and cost. Based on this research, I believe there is no clear indication or definitive proof that a deregulated state drives lower costs, higher quality and greater access to care.
 

Last Updated on Friday, 01 February 2019 18:20
 
FDA plans overhaul of decades-old medical device system Print E-mail
Written by AP via STAT   
Tuesday, 27 November 2018 13:42
 
U.S. health officials said Monday they plan to overhaul the nation's decades-old system for approving most medical devices, which has long been criticized by experts for failing to catch problems with risky implants and medical  instruments. The Food and Drug Administration announced plans aimed at making sure new medical devices reflect up-to-date safety and effectiveness features. The system targeted by the actions generally allows manufacturers to launch new products based on similarities to decades-old products, not new clinical testing in patients.
 
The FDA's move came one day after the publication of a global investigation into medical device safety by more than 50 media organizations, including The Associated Press. Led by the International Consortium of Investigative Journalists, the group found that more than 1.7 million injuries and nearly 83,000 deaths suspected of being linked to medical devices had been reported to the U.S. Food and Drug Administration over a 10-year period.
 
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Last Updated on Tuesday, 27 November 2018 13:44
 
Opioid Law Includes New Kickback Penalties for Drug Treatment Facilities/Labs Print E-mail
Written by Vitale Health Law   
Tuesday, 20 November 2018 18:22
 
Last month, President Trump signed into law a bill designed to address matters relating to opioid use and abuse. Dubbed the "Support Act" an acronym for Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment, it includes a broad assortment of provisions to address the nation's opioid crisis. One of the more significant provisions is Section 8122 known as Eliminating Kickbacks in Recovery Act of 2018 (EKRA). It creates an all-payor, anti-kickback prohibition that extends to arrangements with recovery homes, clinical labs, and clinical treatment facilities and comes with criminal penalties for taking or paying a kickback.
 
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Last Updated on Tuesday, 20 November 2018 18:26
 
EMTALA: What On-call Physicians Need to Know Print E-mail
Written by Karen Civali | Mutual Matters   
Wednesday, 31 October 2018 17:14
 
In 1986, Congress enacted the Emergency Medical Treatment & Labor Act (EMTALA) to ensure public access to emergency services regardless of ability to pay. Section 1867 of the Social Security Act imposes specific obligations on Medicare-participating hospitals that offer emergency services to provide a medical screening examination (MSE) when a request is made for examination or treatment for an emergency medical condition (EMC), including active labor, regardless of an individual's ability to pay. Hospitals are required to provide stabilizing treatment for patients with EMCs. If a hospital is unable to stabilize a patient within its capability, or if the patient requests, an appropriate transfer should be implemented.

Within the EMTALA statute, there are provisions that apply directly to physicians, such as physicians who are “on-call” for a hospital. These include physicians who refer patients to the hospital and should therefore be familiar with and understand their responsibilities when contacted regarding an emergency department (ED) patient, referral or for outpatient care follow up.

Hospitals are required to maintain a list of on-call physicians who can provide the treatment needed to stabilize an emergency medical condition. If permitted by hospital policy, an on-call physician may send a licensed non-physician practitioner to assess and help stabilize the patient. Keep in mind, the on-call physician is ultimately responsible for providing the needed care for the patient, regardless of who responds. Under EMTALA, if the ED physician requests, the on-call physician or his designee (as permitted) must appear in person to assist in stabilizing a patient.

Be familiar with hospital by-laws and medical staff rules and regulations. There may be a contractual obligation if the physician is paid to be on-call and is consulted regarding an emergency patient’s care. A physician may also waive the right to refuse to see a patient when he or she has agreed to be on-call as a condition of being on the medical staff.

If an on-call physician fails to come in when requested or directs that the patient be transferred instead, both the hospital and physician may be in violation of EMTALA and subject to a fine of up to $104,826 per violation for physicians and hospitals over 100 beds and up to $52,414 per violation for hospitals under 100 beds.

The Physician-patient Relationship

In some cases, a physician-patient relationship is established even when the on-call physician does not personally examine or treat the patient. The on-call physician may be “treating” a patient jointly with the ED physician when: 
  • The ED physician relies on the on-call physician’s expertise instead of exercising his or her own judgment in treating the patient
  • The on-call physician interprets patient data such as diagnostics, labs, EKGs or radiology images
  • The on-call physician prescribes treatment for a particular patient or contributes to the diagnosis
  • A physician-patient relationship will most likely not be established:
  • If the on-call physician simply provides general patient care advice
  • If the treating physician uses independent judgment when determining whether to accept or reject a consulting physician’s advice
  • If the on-call physician is consulted for a possible referral of a patient
Just being on-call does not automatically establish a physician-patient relationship and does not necessarily impose a duty on the on-call physician. However, a physician-patient relationship may be established if a patient, or someone on the patient’s behalf, seeks care and the on-call physician provides treatment or other services to the patient.

Documenting “Informal” Conversations

If you are contacted by the emergency department to offer advice that is intended to educate a provider seeking general information, documentation may not be necessary. But, if the advice you are providing is related to a specific patient, treatment plan or includes interpreting diagnostic studies, the conversation should be documented. Also, if the conversation becomes very involved, it is strongly recommended that the consulting physician suggest a formal consult.

Post-ED Care

Upon discharge from the ED, a patient may be stable from an EMTALA standpoint, but still require care of the underlying medical condition, either as an outpatient or later as an inpatient. A hospital does not have any obligation to arrange for ongoing medical care, but it is expected to provide discharged patients with the information they need to obtain follow-up care to prevent a relapse or worsening of their medical condition.
 
In the event that an ED patient is provided a name of an on-call physician for an outpatient referral, generally there is no obligation for the on-call physician to see the patient, unless:
  • The physician agrees to see the patient or
  • The on-call physician is required based on hospital by-laws
It is not uncommon for hospital bylaws to require one follow-up visit rather than ongoing care. The patient should be informed of this at the time of the referral. It is then up to the on-call physician, in collaboration with the patient, whether the relationship will extend beyond the first outpatient visit.
 
Last Updated on Wednesday, 31 October 2018 17:23
 
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