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Policy & Medicine 11/18/2019 05:01
After a brief delay, the Trump administration published the Hospital Outpatient Prospective Payment System (“OPPS”) Price Transparency final rule, which will take effect on January 1, 2021. The final rule requires hospitals to post the prices for services that they privately negotiated with insurance companies. The Centers for Medicare and Medicaid Services (“CMS”) noted that […]
Policy & Medicine 11/13/2019 05:02
While the federal government continues to debate various policies for lowering prescription drug prices, many states have already enacted laws to do just that. According to a report by the National Academy of State Health Policy, 33 states have enacted 51 laws through early September 2019 that address drug pricing, affordability and access. In addition, […]
Policy & Medicine 11/12/2019 05:02
The US Food and Drug Administration (“FDA”) recently issued four final guidance documents related to 510(k) medical device programs. The guidance documents relate to the Special 510(k) and Abbreviated 510(k) Programs, as well as the Format for Traditional and Abbreviated 510(k)s, and the Refuse to Accept Policy for 510(k)s. These final guidance documents come as […]
Policy & Medicine 11/08/2019 05:01
On Thursday, November 7, 2019, Health and Human Services (HHS) Secretary Alex Azar spoke at the American Society of Nephrology Kidney Week. Secretary Azar spoke about American kidney health and the future. Azar first commended all those who support kidney patients: from health professionals to researchers to patients themselves. He noted that those individuals and […]
Policy & Medicine 11/07/2019 05:04
In September 2019, District of Columbia Federal Judge Rosemary Collyer issued a court ruling that struck down the Trump Administration’s rule instituting site-neutral payments. Judge Collyer opined that the Centers for Medicare and Medicaid Services (CMS) overstepped its authority by finalizing a plan to extend a site-neutral payment policy to clinic visits. The CMS plan […]
Policy & Medicine 11/04/2019 05:09
On October 28, 2019, Allergan announced that its subsidiaries, several units of Forest Laboratories, have reached an agreement to settle a class action antitrust lawsuit related to the sales of its Alzheimer’s drug Namenda. In the settlement, Forest has agreed to a $750 million payment to the direct purchaser class, but makes no admission of […]
Policy & Medicine 10/30/2019 05:05
The US Food and Drug Administration ("FDA") Office of Prescription Drug Promotion ("OPDP") announced a study of oncology indications in direct-to-consumer television advertising as these indications are "often complicated and supported by different clinical endpoints such as overall survival, overall response rate, and progression-free survival," and that may be difficult for consumers to understand.
Policy & Medicine 10/29/2019 05:02
Later this week or early next Week CMS will issue the 2020 Physician Fee Schedule. We have previously written about the proposed 2020 Medicare Physician Fee Schedule and its important proposed rules related to CME, Open Payments, Evaluation and Management codes (E/M), and other reimbursement policies. With the release of the final 2020 Fee Schedule […]
Policy & Medicine 10/25/2019 05:02
The Centers for Medicare and Medicare Services (“CMS”) published two final rules intended to reduce provider burdens and improve hospital discharge planning. The rules combine multiple proposals from 2015 through 2018. According to CMS, the burden reduction rule will save providers an estimated 4.4 million hours previously spent on paperwork, and will result in an […]

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