On January 13, 2017, the Food and Drug Administration (FDA) released a discussion paper concerning an updated proposed framework for oversight of laboratory developed tests (LDTs). According to FDA, the updated proposal is the result of ongoing engagement with industry stakeholders. Under the proposal, the FDA generally stands by its position that a complementary risk-based … Continue Reading
The Centers for Medicare & Medicaid Services (CMS) issued a final rule on September 28, 2016, comprehensively updating and extensively revising the requirements for participation (ROPs) for long-term care (LTC) facilities participating in the Medicare and Medicaid programs (the Final Rule). As the first major update to the requirements for LTC facilities in 25 years, the … Continue Reading
On September 30, 2016, the Department of Health and Human Service’s Office of the Inspector General (OIG) issued an “Early Alert” to the Centers for Medicare & Medicaid Services (CMS) on “Incorporating Medical Device-Specific Information on Claim Forms”. This Early Alert urges CMS to update Medicare claims forms to include the “device identifier” (DI) portion … Continue Reading
As previously discussed here on our Health Industry Washington Watch blog, CMS is publishing a notice extending by 30 days the comment period for its July 16, 2015 proposed rule entitled “Reform of Requirements for Long-Term Care Facilities.” The revisions of the “Proposed Rule” indicate an increased cost of $729 million in the first year … Continue Reading
On March 5, 2010, the Office of Pharmacy Affairs published a Final Notice allowing covered entities to use multiple contract pharmacies in order to supplement "in-house" pharmacy services or to increase patient access to 340B drugs. This Final Notice replaces "Notice Regarding Section 602 of the Veterans Health Care Act of 1992; Contract Pharmacy Services (61 Fed. Reg. 43,549) and all other previous 340B Program guidance regarding non-network contract pharmacy services.… Continue Reading
The Centers for Medicare & Medicaid Services (CMS) has issued new "Telemarketing FAQs" to supplement the Office of Inspector General's (OIG) recent revisions to its Special Fraud Alert on Telemarketing by Durable Medical Equipment Suppliers. As you may recall, in January 2010, the OIG amended the Special Fraud Alert to add a warning about suppliers contacting a beneficiary before the supplier receives written beneficiary consent, as it may violate the statutory provision that prohibits Durable Medical Equipment (DME) suppliers from making unsolicited telephone calls to Medicare beneficiaries regarding the furnishing of a Medicare-covered item. Specifically, the OIG stated that it "has also been made aware of instances when DME suppliers, notwithstanding the clear statutory prohibition, contact Medicare beneficiaries by telephone based solely on treating physicians' preliminary written or verbal orders prescribing DME for the beneficiaries." According to the OIG, the "physician's preliminary written or verbal order is not a substitute for the requisite written consent of a Medicare beneficiary."
In response to this new language, Reed Smith contacted the OIG to discuss the adverse impact this policy would have on timely beneficiary access to medically necessary equipment ordered by a physician, since some suppliers call a beneficiary to arrange for equipment deliveries upon receiving an initial physician verbal order. The OIG has just sent us a copy of new CMS Telemarketing FAQs that seek to clarify certain aspects of the revised Special Fraud Alert...… Continue Reading
As as an update to our last post on the Stark Law changes adopted in the 2009 Hospital Inpatient Prospective Payment System final rule, additional changes to the Stark Law regulations will go into effect on October 1, 2009, causing many "under arrangements" relationships between hospitals and physician-owned, third party service providers to fall out of compliance. In addition, new rules governing the compensation terms of lease agreements involving physicians will become effective on the same date. As existing arrangements will not be grandfathered, the final rule's new restrictions will force many arrangements between physicians and hospitals, particularly hospital/physician joint ventures, to be restructured or noncompliant arrangements abandoned. Parties are encouraged to revise potentially noncompliant arrangements.… Continue Reading
The Medicare secondary payer ("MSP") law requires Medicare to be the "secondary" payer of health benefits for Medicare beneficiaries where another entity is the "primary" payer of health benefits. Determining whether another entity is "primary" and when Medicare is "secondary" has often been difficult due to the wide range of circumstances in which another party may be responsible for a Medicare beneficiary's health expenses, the number of potential parties involved, and the somewhat confusing terminology in the law itself. As a result, Congress enacted new rules to enhance the enforcement of the MSP law. Any entity that might pay settlements to Medicare-eligible plaintiffs that would cover any health expenses, or might otherwise compensate Medicare beneficiaries for health expenses as part of group health insurance, workers' compensation, or any other arrangement or plan, needs to become familiar with these new rules. Specifically, Congress now requires such entities to (1) register as a responsible reporting entity ("RRE"), and (2) electronically report information to the Centers for Medicare & Medicaid Services ("CMS").CMS will use this information to track and recover health expenses it incurred on behalf of Medicare beneficiaries but that another entity, as a primary payer under the existing MSP requirements, may be responsible for paying.… Continue Reading
On July 1, 2009, the Centers for Medicare & Medicaid Services ("CMS") proposed to relax its controversial position concerning physician supervision of hospital outpatient services. The hospital industry had recently been vocal in its objection to CMS's position, and the latest proposal signifies a potential important win for hospitals. If adopted, hospitals will be able to meet Medicare supervision requirements for outpatient services, without incurring some of the high costs necessary to ensure physician presence while those services are furnished.… Continue Reading
Regulatory and legislative developments posted on Health Industry Washington Watch include: Regulatory Developments. The Agency for Healthcare Research and Quality (AHRQ) and the HHS Office for Civil Rights have announced the availability of an interim guidance document entitled “Implementing the Patient Safety and Quality Improvement Act of 2005, Including How to Become a Patient Safety … Continue Reading
The Reed Smith Health Industry Washington Watch blog has been updated to discuss a variety of health policy developments, including the following: FDA Transparency Task Force Toll-Free Numbers for Adverse Events Reporting Generic Drugs … Continue Reading
Earlier this week, in Uhm v. Humana, Inc., --- F.3d --- , 2008 WL 3891592, No. 06-35672 (9th Cir. Aug. 25, 2008), the Ninth Circuit upheld a lower court ruling that the express preemption provision of the Medicare Prescription Drug Improvement and Modernization Act preempted state law claims arising from the plaintiffs' prescription drug benefits provided by a Medicare supplement insurer.… Continue Reading
On Aug. 19, 2008, the Centers for Medicare & Medicaid Services ("CMS") published a final rule to implement the Fiscal Year 2009 Hospital Inpatient Prospective Payment System (the "2009 IPPS final rule"). 73 Fed. Reg 48433. The IPPS final rule includes significant changes to the federal Physician Self-Referral Law, or "Stark Law," regulations.… Continue Reading
A lesser-known provision in the Medicare Program allows payment for “reasonable and necessary” items or services provided through clinical trials. At the same time, even for traditional reimbursement, the Centers for Medicare & Medicaid Services (CMS) increasingly is demanding evidence of effectiveness in the Medicare population, rather than simply in the general population, to support a … Continue Reading
This post was also written by Robert J. Hill and Kathleen McGuan. I. INTRODUCTION On July 15, 2008, the House and Senate overrode President Bush’s veto of H.R. 6331, the “Medicare Improvements for Patients and Providers Act of 2008” (“MIPPA”).1 Among many other things, MIPPA delays and reforms the Centers for Medicare & Medicaid Services’ (“CMS”) … Continue Reading
Articles in This Issue: Provider Networks and Joint Ventures: Avoiding Antitrust Scrutiny Through Clinical Integration Stark II, Phase III Final Rule In the Spotlight: Fraud and Abuse Health Law 101: Fraud and Abuse Recent Reed Smith Publications Click here to read the Spring 2008 issue of Health Law Monitor.… Continue Reading
This post was written by Catherine A. Durkin and Areta L. Kupchyk. On May 22, 2008, the Food and Drug Administration (“FDA”) announced plans for what it is calling the “Sentinel System”—a new, national electronic health information surveillance system to track the performance and safety of medical products once they are on the market. In … Continue Reading
I. INTRODUCTION On April 30, 2008, the Centers for Medicare & Medicaid Services (“CMS”) published a proposed rule to implement the Fiscal Year 2009 Hospital Inpatient Prospective Payment System (the “IPPS proposed rule”). 73 Fed. Reg. 23528. The IPPS proposed rule includes possible changes to certain provisions of the federal Physician Self-Referral Law, or “Stark … Continue Reading
Calendar year 2008 has begun where 2007 ended, by presenting us with a number of legal developments impacting the provision of outpatient surgical care. Keeping up with such developments is a challenge for those of us whose careers revolve around representing outpatient surgical facilities. Keeping up for those who actually own and/or operate such facilities … Continue Reading
President Bush has signed into law S. 2499, the “Medicare, Medicaid, and SCHIP Extension Act of 2007.” Most notably, the legislation postpones for six months a 10.1% across-the-board cut in Medicare physician payments that was scheduled to go into effect January 1, 2008.… Continue Reading
I. INTRODUCTION On January 8, 2008, CMS announced the second phase of Medicare competitive bidding for durable medical equipment (“DME”), prosthetics, orthotics, and supplies (“DMEPOS”). In this second round, competitive bidding will be implemented in 70 areas, including the nation’s largest cities. The complete list of areas can be found at Appendix 1. With very … Continue Reading
