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FDA Issues Guidance on December 28, 2016 for Postmarket Management of Cybersecurity in Medical Devices

I am repeating the Introduction of the FDA Guidance, and attaching a link to the 30 page document. The Food and Drug Administration (FDA) is issuing this guidance to inform industry and FDA staff of the Agency’s recommendations for managing postmarket cybersecurity vulnerabilities for marketed and distributed medical devices.  In addition to the specific recommendations … Continue Reading

2017 Medicare Telehealth Changes

The 2017 Medicare Physician Fee Schedule finalizes the CMS changes for Telehealth reimbursement and coverage for 2017.  The CMS fee schedule document also provides a comprehensive explanation of Medicare Telehealth reimbursement and coverage.  I have excerpted those 35 pages and linked them as a PDF to this post: Medicare Telehealth Services. The essential takeaways are as … Continue Reading

Independent Medical Staff Denied Title VII Protection

It has not been unusual for employed physicians to seek the protection provided to independent medical staff members through the due process procedures provided by medical staff by-laws. The case of Levitin and Chicago Surgical Clinic v. Northeast Community Hospital is the exact opposite; Dr. Levitin was an independent medical staff member seeking Title VII … Continue Reading

FTC and Pennsylvania Challenge Penn State Hershey’s Planned Merger with PinnacleHealth System

BNA has reported the planned merger of Penn State Hershey Medical Center with PinnacleHealth System will be challenged in federal court by federal and state officials. The Federal Trade Commission and Pennsylvania’s attorney general said they will join together to seek an injunction delaying consummation of the deal. The FTC voted 4-0 to file the … Continue Reading

Medical Records Fees for EHR

You might have not noticed in the last blog post that there is a provision in the Pennsylvania Notice regarding electronic health records.  The Notice does not establish a fee for electronic health records.  Rather it states that the cost for production of health records in an electronic format shall not exceed the cost of … Continue Reading

2016 Pennsylvania Medical Record Fees

Effective January 1, 2016, the following fees may be charged by a health care facility or health care provider in response to a request for production of medical charts or records: Not to Exceed Amount charged per page for pages 1-20 $1.46 Amount charged per page for pages 21-60 $1.08 Amount charged per page for … Continue Reading

Summary of UPMC/Highmark Resolved Issues

The following issues have been resolved over the last month, at least through June 30, 2019, which is the expiration date of the Consent Decrees entered into with the approval of the Commonwealth Court by the parties in June of 2014. Continuity of Care.  An arbitration award, a copy of which is attached, provides as … Continue Reading

Office of Inspector General Issues Policy Reminder on Information Blocking and the Federal Anti-Kickback Staute

The federal anti-kickback statute (42 USC § 1320a-7b(b), the “Statute”) prohibits individuals and entities from receiving or soliciting any remuneration for the referral of services reimbursable under any federal health care program. The Statute defines remuneration broadly to include kickbacks and rebates but also to include the purchasing or leasing of any products reimbursable under … Continue Reading

TELADOC Sues Texas Over Telehealth Restraint

The Texas Medical Board recently adopted a new rule requiring face to face encounters by physicians with patients before prescribing medication.  Teladoc has sued the Texas Medical Board in Federal Court alleging restraint of trade, stating that the new Texas rule “would raise prices and reduce access” to telehealth services.  The Complaint alleges the same … Continue Reading

Congress Repeals Medicare Sustainable Growth Rate (SGR)

MGMA has published the following alert:   Congress repeals SGR! In a significant victory for physician group practices and MGMA, late this evening the Senate voted (92-8) to approve the Medicare Access and CHIP Reauthorization Act, H.R. 2. This legislation, which passed the House of Representatives on March 26, permanently repeals the Medicare Sustainable Growth … Continue Reading

New York Passes Telehealth Bill

New York Governor Andrew Cuomo signed a Bill late last week, which will take effect as of January 1, expanding telehealth coverage in New York. This law does three things which are on the leading edge of telehealth coverage: First, it requires commercial insurance and medical assistance to provide telehealth coverage, which provision is often … Continue Reading
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