Tag Archives: Department of Health and Human Services (HHS)

Final Rule on Amending the Anti-Kickback Safe Harbors and Civil Monetary Penalty Rules on Beneficiary Inducements

On December 7, 2016, the Office of Inspector General of the Department of Health and Human Services published a final rule amending the safe harbors to the Anti-Kickback Statute (AKS) and the Civil Monetary Penalty (CMP) rules prohibiting beneficiary inducements. These changes protect certain practices and arrangements from criminal prosecution or civil sanctions under the … Continue Reading

Significant Changes for Long-Term Care Facilities Participating in Medicare and Medicaid Programs Issued by CMS

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

Major Changes To Nondiscrimination Requirements Under ACA Effective Soon: Are Covered Entities Ready?

The HHS Office of Civil Rights (“OCR”) published a final rule May 18, 2016, broadening the nondiscrimination requirements applicable to all health programs and activities receiving federal financial assistance from HHS, those administered by HHS, and Health Insurance Marketplaces. The final rule implements section 1557 of the ACA and adds two important categories of protections: … Continue Reading

HHS Agenda Signals FDA’s Intent to Issue Proposed DSCSA Rules in December 2016

FDA intends to issue long-awaited proposed regulations governing the licensing of prescription drug wholesale distributors and third-party logistics providers (“3PLs”) this December, according to the updated 2016 HHS regulatory agenda.  Under the Drug Supply Chain Security Act (“DSCSA”), FDA was required to issue these regulations no later than two years following the law’s November 2013 … Continue Reading

Expect Increased State AG Enforcement Actions on Health Data Incidents

Businesses working with U.S. customer or employee data are very familiar with the roles the Federal Trade Commission (FTC), U.S. Department of Health and Human Services, and other federal agencies play in privacy regulation and enforcement. But, increasingly, if your company ends up facing a health – or other data – incident, you may find … Continue Reading

FDA to Hold Upcoming Medical Device Cybersecurity Workshop

The FDA announced that it will be holding a public two-day workshop at its White Oak Campus in Silver Spring, Md., on January 20-21, 2016, from 9:00 a.m. to 5:30 p.m. titled, “Moving Forward: Collaborative Approaches to Medical Device Cybersecurity.” The FDA, in collaboration with the National Health Information Sharing Analysis Center (NH-ISAC), the Department … Continue Reading

OCR Creates Online Portal for HIPAA Compliance Questions

In a recent Law360 article (login required), Partner Brad Rostolsky, addressed the establishment of an online portal to receive questions from developers of mobile medical apps about compliance with the Health Insurance Portability and Accountability Act. “Where health information is flowing pretty freely on mobile devices, it’s incredibly important for everyone involved to make the … Continue Reading

Proposed Rule Issued by CMS Modifies Requirements for LTC Facilities Participating in Medicare and Medicaid Programs

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

Federal Departments and Agencies Release Proposed Rule to Modernize Regulations Under Common Rule

As discussed on our Health Industry Washington Watch blog here, on September 2, 2015, the Department of Health and Human Services (HHS),  along with fifteen other federal departments and agencies, released a proposed rule to modernize regulations governing human research subjects under the Common Rule. Currently the Common Rule applies to all research involving human … Continue Reading

HHS and OIG Issue Advisory Opinion Announcing Administrative Sanctions Will Not Be Imposed for Individuals Undergoing Late Insurance Approvals

The Department of Health and Human Services (HHS) and Office of Inspector General (OIG) issued Advisory Opinion 15-11 stating that the OIG will not impose sanctions on individuals for a program that provides free drugs to patients experiencing late insurance approvals. The OIG concluded that, although the arrangement has the potential to generate improper payment under … Continue Reading

House Easily Passes 21st Century Cures Legislation, Includes Significant FDA Reforms

On July 10, 2015, the U.S. House of Representatives passed with an overwhelming majority (344-77), the 21st Century Cures bill (H.R. 6), a high-profile bipartisan bill intended to speed up and improve the process for approving innovative drugs and medical devices, and to address other issues, including those regarding clinical trial design, research funding, and … Continue Reading

Proposed 21st Century Cures Act Addresses Off-Label Promotion Issues for Drugs and Devices

Over on the Health Industry Washington Watch blog, Reed Smith attorneys Katie Pawlitz and Jeremy Alexander highlight the proposed changes to the Sunshine Act contained within H.R. 6, the “21st Century Cures Act,” which (as previously reported on Life Sciences Legal Update) was approved by the House Energy and Commerce Committee last Thursday, May 21, … Continue Reading

FDA Draft Guidance Addresses Electronic Informed Consent in Clinical Investigations

FDA has issued a draft guidance providing recommendations for clinical investigators, sponsors and institutional review boards on the use of electronic informed consent for FDA-regulated clinical investigations of medical products, including drugs, medical devices and biological products. FDA is accepting comments on the draft guidance until May 8, 2015. In addition, the HHS Office for Human Research Protections (OHRP) is considering whether to adopt the positions and recommendations proposed in this guidance for research regulated under the HHS protection of human subjects regulations and to issue a joint OHRP/FDA guidance document on this topic once the FDA's final guidance document has been developed.… Continue Reading

Omnibus Spending Bill Promises Increased Funding for Ebola Response in FY 2015

On December 16, 2014, President Obama signed into law an omnibus spending bill that will provide funding across the federal government in the remainder of FY 2015. The bill includes $5.4 billion designated for several regulatory agencies - including the Centers for Disease Control and Prevention, Department of Defense, Food and Drug Administration, Department of Health and Human Services, National Institutes of Health and Department of State - to use in response to the Ebola epidemic, on both a national and international scale.… Continue Reading

OCR Releases Ebola Bulletin

The recent Ebola outbreak has prompted the US Department of Health and Human Services, Office for Civil Rights ("OCR"), the agency responsible for enforcing the Health Insurance Portability and Accountability Act ("HIPAA"), to release a new bulletin for covered entities and business associates regarding their privacy obligations in emergency situations. The bulletin, entitled "HIPAA Privacy In Emergency Situations," provides an overview of the limited ways in which covered entities and business associates may use and disclose protected health information in emergencies, such as the Ebola outbreak. The bulletin is available at http://www.hhs.gov/ocr/privacy/hipaa/understanding/special/emergency/hipaa-privacy-emergency-situations.pdf.… Continue Reading

Insights About Future Use of Protected Health Information Under HIPAA

In "HIPAA Enforcement: The Next Step," an interview and accompanying article that appeared on HealthcareInfoSecurity on October 14th, Reed Smith partner Brad Rostolsky details the HIPAA-related trends that he expects to see within the next several years. Among these predicted trends is an increase in the number of investigations by the Department of Health and Human Services' Office for Civil Rights regarding the illegal use and distribution of Protected Health Information without the permission of patients, a result of tightened regulations introduced in last year's HIPAA Omnibus Rule. Brad also discusses how companies should prepare for HIPAA compliance audits, the use of health information on social media, and potential privacy issues surrounding wearable consumer health devices.… Continue Reading

Reed Smith Team Analyzes OIG’s Proposed Rule Amending Anti-Kickback Safe Harbors, CMP Rules & Gainsharing Regulations

The Office of Inspector General (OIG) of the Department of Health and Human Services published a major proposed rule on October 3, 2014 amending the Anti-Kickback Statute (AKS) safe harbors and the Civil Monetary Penalty (CMP) rules to protect a number of payment practices not previously allowed under those regulations. The proposed rule and the … Continue Reading

OIG Warns About Ineligibility of Health Care Program Beneficiaries for Pharmaceutical Coupon Programs

The Office of Inspector General (OIG) of the Department of Health & Human Services issued a Special Advisory Bulletin (SAB) on September 19, 2014 discussing the coupon programs employed by many pharmaceutical manufacturers to reduce or entirely eliminate patient copayments to obtain brand-name drugs. As mentioned on our Health Industry Washington Watch blog, the SAB … Continue Reading

OIG Advisory Bulletin Addresses Independent Charity Patient Assistance Program Risks

Patient Assistance Programs (PAPs) provide important help to patients of limited means who do not have insurance coverage for drugs and need assistance covering drug costs, often for chronic illnesses. The Office of the Inspector General (OIG) of the Department of Health and Human Services has now issued an advisory bulletin, dated May 21, 2014, … Continue Reading

OIG Proposes Amendment of Health Care Program Civil Monetary Penalty Regulations

The Office of Inspector General (OIG) of the Department of Health and Human Services has issued a proposed rule that would institute several changes to the health care program civil monetary penalty (CMP) regulations. Under the proposed rule, the OIG would have the expanded authority to enforce significant CMPs on providers and suppliers in a variety of scenarios. Reed Smith has prepared a Client Alert summarizing and analyzing the Proposed Rule, including the various scenarios under which CMPs could be issued under the proposed regulations as well as the changes in technical language proposed by OIG to more clearly define the scope of CMP regulations.… Continue Reading

Exclusion Rules For Those Who Receive Funds From Federal Health Care Programs May Get Even More Complicated

The Office of Inspector General (OIG) of the Department of Health and Human Services identifies the underlying purpose of its exclusion authority as to protect federal health care programs and their beneficiaries from "untrustworthy health care providers, i.e., individuals and entities who pose a risk to program beneficiaries or the integrity of these programs." The OIG now has published a new proposed rule that would greatly expand the bases upon which it could affirmatively exclude an individual or entity from participation in federal health care programs. Reed Smith has prepared a Client Alert that provides an overview of the Proposed Rule, including: proposed revisions to definitions; new grounds for exclusion; clarifications to existing regulations to add mitigating and aggravating factors; early reinstatement procedures; and proposed procedural changes in the OIG's exclusion authorities.… Continue Reading

Recent OCR Enforcement Activities Cause Serious Case of Déjà Vu: Theft of Unencrypted Laptops Leads to Two Separate HIPAA Settlements

Two separate instances of unencrypted laptop theft from different health care providers have resulted in two settlements for potential violations of the HIPAA Privacy and Security Rules. These alleged violations were uncovered following investigations by the Department of Health and Human Services, Office for Civil Rights (OCR). In the first instance, involving Concentra Health Services, OCR found that Concentra had previously recognized its need for increased encryption on its technological devices but had failed to fully address this issue before the breach. In the second instance, involving QCA Health Plan, Inc. of Arkansas, OCR found that QCA had failed to comply with multiple requirements set forth by the HIPAA Security Rule. Both instances resulted in settlements comprised of financial payments to OCR as well as agreement to Corrective Action Plans that will allow for continued oversight by OCR in regards to HIPAA compliance.… Continue Reading

D.C. Circuit Rules in Favor of Providers in DSH Part C/Part A Appeal… Or Does it?

In a much-anticipated decision, the U.S. Court of Appeals for the District of Columbia Circuit last month affirmed the lower court's ruling in favor of the hospital plaintiffs in Allina Health Services, et al. v. Sebelius (D.C. Cir., No. 13-5011, Apr. ___, 2014). The otherwise good news for providers, however, was called into question by the appellate court's instructions as to the proper remedy in the case.… Continue Reading

County Governments Not Immune From HIPAA Enforcement: OCR Announces $215,000 Settlement with Skagit County, Washington

On March 7, 2014, the HHS Office for Civil Rights (“OCR”) announced its first settlement and corrective action plan with a county government. Skagit County in northwest Washington State has agreed to pay $215,000 to settle potential violations of the HIPAA Privacy, Security and Breach Notification Rules. According to Susan McAndrew, deputy director of health … Continue Reading
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