July 19, 2018 | Blog | By Joanne Hawana, Muriel M. Liberto, PhD, Esq.
On July 18, 2018, after months of alluding to the various aspects of an upcoming “Biosimilar Action Plan” as another prong within FDA’s broader Drug Competition Action Plan (DCAP), FDA finally unveiled its plan for stimulating and improving the marketplace for biosimilars in the U.S.
July 18, 2018 | Blog | By Ellyn Sternfield
Timing is everything. In yesterday’s post on 340B, I stated in closing: There is still one more shoe to drop.
July 17, 2018 | Blog | By Ellyn Sternfield
It seems like every week, there are multiple new developments in the 340B program. While it has just been a few weeks since my last 340B blog post, since that time we have had another Senate hearing, a new GAO Report, a new House hearing, and introduction of more than a dozen new bills in Congress.
July 16, 2018 | Blog | By Eli Greenspan
Congress is in session this week with six important health care hearings, including hearings on Medicare fraud, mental health, and Stark reform. Meanwhile, the Administration continues to put forth new proposed rules and guidance that will impact many stakeholders between now and the end of the year.
July 15, 2018 | Blog | By Brian Dunphy
The Tenth Circuit Court of Appeals has issued a significant decision, finding that a physician’s medical judgment about the medical necessity of heart procedures can be “false or fraudulent” under the federal False Claims Act (FCA).
July 13, 2018 | Blog | By Ellen Janos
Some very good news for the telehealth community can be found amidst the more than 1,400 pages of the proposed Medicare Physician Fee Schedule for 2019(“Proposed Rule”) issued by CMS yesterday.
FDA Releases Series of Gene Therapy Guidance Documents: From Drug Development to Postmarket Monitoring
July 11, 2018 | Blog | By Joanne Hawana
In a highly anticipated step, which had been teased by agency leadership in their public appearances over the past several months, FDA released a series of draft guidance documents pertaining to the development and approval of gene therapy products on July 11, 2018.
July 9, 2018 | Blog | By Eli Greenspan
This week, Congress returns from recess to another four-week work period. The dynamics of the next four weeks might be in flux now that President Trump has nominated Brett Kavanaugh to the U.S. Supreme Court.
July 8, 2018 | Blog | By Ellyn Sternfield
State Medicaid Agencies have historically engaged in an epic balancing act. Federal law requires State Medicaid Agencies to ensure beneficiaries have access to medically necessary services. Federal law also requires State Medicaid Agencies to safeguard their Medicaid Programs against fraud, waste or abuse in billing for Medicaid services.
July 3, 2018 | Blog
In its most recent Cybersecurity Newsletter, OCR focuses on the intersection of HIPAA and information security. To be sure, HIPAA requires covered entities and business associates to address their organizations’ information security.
June 25, 2018 | Blog | By Eli Greenspan
This week, focus turns to the Senate as the House overwhelmingly passed its opioid package known as H.R. 6 last week (see our previous coverage here). The Senate will look to combine its various proposals into one package for floor consideration and what passes will provide a timeline for reconciling the House and Senate packages.
June 21, 2018 | Blog | By Karen Lovitch
Thousands of laboratories nationwide will be happy to hear that Florida, which licenses in-state as well as out-of-state laboratories, has repealed its laboratory licensure requirements. As of July 1, 2018, laboratories doing business in Florida need only maintain CLIA certification.
June 21, 2018 | Blog | By Bridgette Keller
The government is focusing on opioids. Whether it be program policies, enforcement, or legislation, combating the opioid epidemic continues to be a major focus for government officials. It is also a major piece of the health care legislation moving in both the House and the Senate.
June 20, 2018 | Blog
On June 19, the Health Policy Consensus Group, which is a group led by former Sen. Rick Santorum (R-PA) and composed of several conservative think tanks, released a white paper proposal to repeal and replace the Affordable Care Act (ACA).
June 20, 2018 | Blog | By Joanne Hawana
A lot has happened since we last addressed new biosimilar developments in January 2018. In the intervening months, there have been many significant developments related to FDA’s implementation of an efficient regulatory program for biosimilar products and the abbreviated BLA (aBLA) review process.
June 20, 2018 | Blog | By Kate Stewart, Sarah Beth Kuyers
Privacy and security compliance obligations for health care companies remain hot topics this spring. Health care companies must now contend with data breach laws in all 50 states as well as keeping on top of federal HIPAA developments.
June 19, 2018 | Blog | By Ellyn Sternfield
It has been a few weeks since the publication of the Trump Administration’s Blueprint to Lower Drug Prices, and Secretary Azar’s Request for Information (RFI) on the Blueprint. We previously posted about the Blueprint’s focus on the 340B Drug Discount Program.
June 18, 2018 | Blog | By Eli Greenspan
Welcome to the third week of this four week stretch. This week, the House will continue to vote on a number of proposals to address the opioid crisis.
June 14, 2018 | Blog | By Xavier Hardy
On Thursday June 14, 2018, the US Court of Appeals for the Federal Circuit ruled against two health plans seeking risk corridors payments from the federal government. Inside contains more detailed information on the program.
June 14, 2018 | Blog
Earlier this week, I moderated a panel discussion at an event hosted by the New York chapter of the Health Information and Management Systems Society (HIMSS). The panel was comprised of private sector health information technology and security experts and was tasked with discussing challenges related to the interoperability and security of health information systems.
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