Final Rules

News & Analysis as of

CMS Eases 60-Day Overpayment Requirement in Final Rule While Raising New Questions

On February 11, 2016, the Centers for Medicare & Medicaid Services (“CMS”) released the long awaited final rule clarifying the statutory requirement under the Affordable Care Act for providers and suppliers to report and...more

CMS Finalizes 60 Day Overpayment Rule

The final rule relaxes the requirements on “identification” and look-back period. The Centers for Medicare & Medicaid Services (CMS) has released its long-awaited final rule related to the reporting and refunding of...more

CMS Clarifies 60 Day Overpayment Rule

The Department of Health and Human Services’ (HHS) Center for Medicare and Medicaid Services (CMS), is set to publish a final rule that will provide some much needed relief to healthcare providers from the burdens of the...more

CMS Issues Final Overpayment Rule: A Guide On How To Eat An Elephant

On February 11, 2016, the Centers for Medicare & Medicaid Services (CMS) released its final rule (the “Final Rule”) implementing Section 6402(a) of the Affordable Care Act, which created a new Section 1128J(d) of the Social...more

International Food Law Gazette - January 2016

FDA Approves First Genetically Modified Food-Producing Animal - On November 19, 2015, the United States Food and Drug Administration (FDA) approved a new animal drug application (NADA) that authorizes the marketing of...more

Deciphering the Final AMP Rule – Key Provisions Impacting Pharmacies, PBMs, and Manufacturers

In late January, the Centers for Medicare & Medicaid Services (“CMS”) released the much anticipated Covered Outpatient Drugs Final Rule with Comment (the “AMP Final Rule”). The rule creates the regulatory definition for...more

The Final 60-Day Rule Is Finally Here!

The Centers for Medicare & Medicaid Services (CMS) has finally published the long-awaited final rule establishing a process for Medicare Part A and B providers and suppliers to report and return overpayments within 60 days...more

OFCCP’s New Pay Transparency Rule: Are You Prepared?

As we reported in a previous blog post, the Office of Federal Contract Compliance Programs (“OFCCP”) Final Rule implementing Executive Order 13665 (titled Non-Retaliation for Disclosure of Compensation Information) took...more

Also In The News - Health Headlines - January 2016 #4

CBO Projects Medicare Spending Growth – In a report published January 25, 2016, the Congressional Budget Office (CBO) estimates that expenditures for Medicare, Medicaid, and other major healthcare programs will equal...more

CMS Finalizes Medicaid Home Health and Medical Equipment Policy Changes, Including Face-to-Face Encounter Requirements

CMS published a final rule on February 2, 2016 to implement statutory requirements regarding documentation of face-to-face encounters with Medicaid beneficiaries within certain timeframes as a condition of Medicaid coverage...more

Wildlife Agencies Announce Final Critical Habitat Rules and Policy

On February 5, 2016, the U.S. Fish and Wildlife Service and National Marine Fisheries Service (collectively, the “Services”) announced the availability of two final rules and one policy addressing critical habitat under the...more

DHS Enhances Opportunities for H-1B1, E-3, CW-1 Nonimmigrants and Certain EB-1 Immigrants

On January 15, 2016, the Department of Homeland Security (DHS) posted a final rule in the Federal Register which revises its regulations affecting highly skilled workers in the nonimmigrant classifications for specialty...more

SBA Issues Final Rule on ITVAR “Footnote 18” Exception

On January 26, 2016, the Small Business Administration (SBA) published in the Federal Register a final rule modifying the employee-based size standards for 36 industries and sub-industries that are not part of North American...more

CFTC Amends Regulation 1.35

U.S. Commodity Futures Trading Commission (CFTC) Regulation 1.35 requires futures commission merchants (FCMs), retail foreign exchange dealers (RFEDs), introducing brokers (IBs) and members of a swap execution facility (SEF)...more

The CMS Final Covered Outpatient Drug Rule Addresses Many Industry Concerns

The rule implementing the Medicaid Drug Rebate Program is less burdensome and costly than what was originally proposed. In 2010, the Affordable Care Act (ACA) directed the US Centers for Medicare and Medicaid Services...more

Foreign Supplier Verification Programs and Customs Compliance: Three Key Facts Companies Need To Know

On November 27, 2015, the Food and Drug Administration (FDA) published the final rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals under the FDA Food Safety Modernization Act...more

Medicaid Program: Covered Outpatient Drugs, Final Rule with Comment Period Summary

On January 21, 2016, the Centers for Medicare & Medicaid Services (CMS) released the final rule implementing the prescription drug rebate provisions enacted as part of the health care reform law, the Affordable Care Act...more

Prognosticating the Ozone Standard Litigation: EPA to Win, Environmental Petitioners to Place, Murray Energy to Show

Last week, the “Public Health and Environmental Petitioners” challenging EPA’s decision not to reduce the ozone standard below 0.070 ppm filed their “Non-Binding Statement of Issues.” My crystal ball still tells me that the...more

CMS Issues Final Rule on Covered Outpatient Drugs

On January 21, 2016, the Centers for Medicare & Medicaid Services (“CMS”) released a final rule (“Final Rule”) addressing key areas of Medicaid reimbursement for outpatient drugs and changes made to the Medicaid Drug Rebate...more

DOL Sends Fiduciary Rule to OMB for Review

DOL has indicated that the final rule will be released in the first half of the year. The US Department of Labor (DOL) sent its final Conflict of Interest Rule—Investment Advice (with related exemptions and amendments to...more

Breaking Immigration News: F-1 OPT STEM Decision Extended Until May 10, 2016; Gives DHS Additional Time to Implement Final Rule

On January 23, 2016, Judge Huvelle of the U.S. District Court for the District of Columbia granted a motion to extend the current stay of her prior order which will allow the Department of Homeland Security (DHS) to utilize...more

SBA Considers Public Comments on Proposed Size Standard Increases to NAICS Codes 562910 and 541519

According to the pre-publication, the SBA will adopt most of the proposed changes with two key exceptions. The SBA is not increasing the Environmental Remediation Services (“ERS”) exception under NAICS 562910 from 500...more

Weekly Update Newsletter - January 2016 #2

GOVERNMENT CONTRACTS - Payment of Subcontractors - DOD, GSA, and NASA are proposing to amend the Federal Acquisition Regulation to implement the section of the Small Business Jobs Act of 2010 that requires...more

DMEPOS Prior Authorization Rules Expand

On December 30, 2015, CMS published a final rule entitled: "Medicare Program; Prior Authorization Process for Certain Durable Medical Equipment, Prosthetics, Orthotics, and Supplies," implementing Section 1834(a)(15) of the...more

Blog: Final Medicaid Drug Rebate Program AMP Rule: Some Technical Highlights

We reported yesterday that the Centers for Medicare & Medicaid Services (CMS) Final Average Manufacturer Price (AMP) Rule (the “Final Rule”) was released and will be published in the Federal Register next week. If you are...more

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