Compliance Regulations and Guidance Affecting your Industry

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Proposed CMS Rule: Medicare, Medicaid, Children's Health Insurance Programs; Transparency Repor ....

  • Industry: Drugs and Chemicals (Pharma)

The Physician Payment Sunshine Act was passed in 2010 as part of President Barack Obama’s legislative agenda to overhaul healthcare. The Centers for Medicine and Medicaid Services (CMS) was tasked with the drafting of the rules to enforce the Act’s requirements. CMS published its proposed rule in December, 2011.

Final Regulatory Reform Plan - Department of Health and Human Services - 2011

  • Industry: Healthcare Compliance (Hospitals)

The White House has announced plans for an ambitious regulatory reform across federal departments and agencies. This is the final regulatory reform plan of the Department of Health and Human Services.

COBRA Continuation Coverage Assistance Under ARRA

  • Industry: HR Compliance

The American Recovery and Reinvestment Act (ARRA) provides a COBRA premium reduction for eligible individuals who are involuntarily terminated from employment through the end of May 2010. The COBRA premium reduction under ARRA is not available for individuals who experience involuntary terminations after May 31, 2010. However, individuals who qualified on or before May 31, 2010 may continue to pay reduced premiums for up to 15 months, as long as they are not eligible for another group health plan or Medicare.

Health Benefits Under Consolidated Omnibus Budget Reconciliation Act

  • Industry: HR Compliance

The Consolidated Omnibus Budget Reconciliation Act (COBRA) gives workers and their families who lose their health benefits the right to choose to continue group health benefits provided by their group health plan for limited periods of time under certain circumstances such as voluntary or involuntary job loss, reduction in the hours worked, transition between jobs, death, divorce, and other life events.

COBRA generally requires that group health plans sponsored by employers with 20 or more employees in the prior year offer employees and their families the opportunity for a temporary extension of health coverage (called continuation coverage) in certain instances where coverage under the plan would otherwise end.

COBRA outlines how employees and family members may elect continuation coverage. It also requires employers and plans to provide notice.

Affordable Health Care for America Act

  • Industry: Healthcare Compliance (Hospitals)

The Affordable Health Care for America Act was introduced in the U.S. House of Representatives on October 29, 2009. The following summary of H.R. 3962 describes key components of this health reform legislation focusing on provisions to expand health coverage, control health care costs, and improve the health care delivery system. This summary will be updated to reflect changes made during the legislative process. It requires individuals to have health insurance. Create a Health Insurance Exchange through which individuals and smaller employers can purchase health coverage, with premium and cost-sharing credits available to individuals/families with incomes up to 400% of the federal poverty level (or $73,240 or a family of three in 2009). Require employers to provide coverage to employees or pay into a Health Insurance Exchange Trust Fund, with exceptions for certain small employers, and provide certain small employers a credit to offset the costs of providing coverage. Impose new regulations on plans participating in the Exchange and in the small group insurance market.

Emergency Medical Treatment and Labor Act

  • Industry: Healthcare Compliance (Hospitals)

This final rule clarifies policies relating to the responsibilities of Medicare-participating hospitals in treating individuals with emergency medical conditions who present to a hospital under the provisions of the Emergency Medical Treatment and Labor Act (EMTALA).

The final rule responds to public comments received on a May 9, 2002 proposed rule (67 FR 31404) that both reiterated the agency’s interpretations under EMTALA and proposed clarifying changes relating to the implementation of the EMTALA provisions. These reiterations and clarifying changes related to, among other areas, seeking prior authorization from insurers for services, emergency patients presenting at off-campus outpatient clinics that do not routinely provide emergency services, the applicability of the EMTALA provisions to hospital inpatients and outpatients, the circumstances under which physicians must serve on hospital medical staff “on-call” lists, and the responsibilities of hospital-owned ambulances.

Lacey Act 2008

  • Industry: Healthcare Compliance (Hospitals)

The Lacey Act (16 U.S.C. 3371) first enacted in 1900 and significantly amended in 1981, is the United States’ oldest wildlife protection
statute. The Act combats trafficking in ‘‘illegal’’ wildlife, fish, or plants. The Food, Conservation, and Energy Act of 2008, effective May 22, 2008, amended the Lacey Act by expanding its protection to a broader range of plants and plant products (Section 8204, Prevention of Illegal Logging Practices).

The Food, Conservation, and Energy Act of 2008 amended the Lacey Act to provide, among other things, that importers submit a declaration at the time of importation for certain plants and plant products. The declaration requirements of the Lacey Act became effective on December 15, 2008, and enforcement of those requirements is being phased in. The purpose of this notice is to inform the public of the Federal Government’s revised plan to phase in enforcement of the declaration requirement and other implementation plans.

Secure and Responsible Drug Disposal Act of 2010. S. 3397

  • Industry: Drugs and Chemicals (Pharma)

Secure and Responsible Drug Disposal Act of 2010 - Amends the Controlled Substances Act to allow an ultimate user of a controlled substance (or, if deceased, any person lawfully entitled to dispose of the ultimate user's property) who has lawfully obtained such substance to deliver that substance to another person, without being registered, for disposal if:

(1) the person receiving the controlled substance is authorized to engage in such activity; and (2) the disposal takes place in accordance with regulations issued by the Attorney General to prevent diversion of controlled substances.


Medicare and Medicaid Programs - Changes to the Hospital and Critical Access Hospital Condition ....

  • Industry: Healthcare Compliance (Hospitals)

This proposed rule would revise the Medicare conditions of participation for hospitals and critical access hospitals (CAHs) to ensure the visitation rights of all patients. Medicare- and Medicaid-participating hospitals and CAHs would be required to have written policies and procedures regarding the visitation rights of patients, including those setting forth any clinically necessary or reasonable restriction or limitation that the hospital or CAH may need to place on such rights as well as the reasons for the clinical restriction or limitation.

DATES: To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on August 27, 2010.

Medicare Prescription Drug, Improvement, and Modernization Act of 2003

  • Industry: Healthcare Compliance (Hospitals)

To amend title XVIII of the Social Security Act to provide for a voluntary program for prescription drug coverage under the Medicare Program, to modernize the Medicare Program, to amend the Internal Revenue Code of 1986 to allow a deduction to individuals for amounts contributed to health savings security accounts and health savings accounts, to provide for the disposition of unused health benefits in cafeteria plans and flexible spending arrangements, and for other purposes.

CMS Legislative Summary of H.R. 1 Medicare Prescription Drug, Improvement, and Modernization Ac ....

  • Industry: Healthcare Compliance (Hospitals)

This document is the CMS Legislative Summary for the H.R. 1, The Medicare Prescription Drug, Improvement, and Modernization Act of 2003, P.L. 108-173, enacted December 8, 2003.

45 CFR Part 159 - Health Care Reform Insurance Web Portal Requirements

  • Industry: Healthcare Compliance (Hospitals)

The Patient Protection and Affordable Care Act (the Affordable Care Act) was enacted on March 23, 2010. It requires the establishment of an internet Web site (hereinafter referred to as a Web portal) through which individuals and small businesses can obtain information about the insurance coverage options that may be available to them in their State. The Department of Health and Human Services (HHS) is issuing this interim final rule in order to implement this mandate. This interim final rule adopts the categories of information that will be collected and displayed as Web portal content, and the data we will require from issuers and request from States, associations, and high risk pools in order to create this content.

Effective Date:
These regulations are effective on May 10, 2010.


Agency Information Collection Activities; Submission for Office of Management and Budget Review ....

  • Industry: Healthcare Compliance (Hospitals)

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

Effective Date: Fax written comments on the collection of information by June 1, 2010.


Implantation or Injectable Dosage Form New Animal Drugs; Butorphanol

  • Industry: Healthcare Compliance (Hospitals)

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original abbreviated new animal drug application (ANADA) filed by Modern Veterinary Therapeutics, LLC. The ANADA provides for use of an injectable solution of butorphanol tartrate in cats for the relief of pain.

Effective Date: This rule is effective April 29, 2010.


Health care coverage: pricing

  • Industry: Healthcare Compliance (Hospitals)

This bill eliminates provisions of law that allow health plans to charge different premiums, prices, or charges, based on gender. The bill’s provisions apply to contracts issued, amended, or renewed on or after January 1, 2011.

Individual health care coverage

  • Industry: Healthcare Compliance (Hospitals)

This bill prohibits a health plan or health insurer from rescinding an individual health plan contract or individual health insurance policy for any reason, or from canceling, limiting, or raising the premiums of the plan contract or policy due to any omission, misrepresentation, or inaccuracy in the application form, after 24 months following the issuance of the plan contract or policy, except as specified.

Cal-COBRA: premium assistance

  • Industry: Healthcare Compliance (Hospitals)

This bill requires heath care service plans and health insurers to provide notice of the availability of premium assistance under the federal American Recovery and Reinvestment Act of 2009 to qualified beneficiaries, as specified. The bill allows a qualified beneficiary eligible for the federal premium assistance to elect Cal-COBRA coverage within a certain period of time, as specified. This bill allows individuals enrolled in Cal-COBRA coverage as of February 17, 2009, to request application of the federal premium assistance, as specified

Medicaid Program: Rescission of School-Based Administration/ Transportation Final Rule, Outpati ....

  • Industry: Healthcare Compliance (Hospitals)

This rule finalizes our proposal to rescind the December 28, 2007 final rule entitled, ‘‘Elimination of Reimbursement under Medicaid for School Administration Expenditures and Costs Related to Transportation of School-Age Children Between Home and School;’’ the November 7, 2008 final rule entitled, ‘‘Clarification of Outpatient Hospital Facility (Including Outpatient Hospital Clinic) Services Definition;’’ and certain provisions of the December 4, 2007 interim final rule entitled, ‘‘Optional State Plan Case Management Services.’’ These regulations have been the subject of Congressional moratoria and have not yet been implemented (or, with respect to the case management interim final rule, have only been partially implemented) by CMS. In light of concerns raised about the adverse effects that could result from these  regulations, in particular, the potential restrictions on services available to beneficiaries and the lack of clear evidence demonstrating that the approaches taken in the regulations are warranted, CMS is rescinding the two final rules in full, and partially rescinding the interim final rule. Rescinding these provisions will permit further opportunity to determine the best approach to further the objectives of the Medicaid program in providing necessary health benefits coverage to needy individuals.

Effective Date: These regulations are effective on July 1, 2009.

Medicare Program; Home Health Prospective Payment System Rate Update for Calendar Year 2007 and ....

  • Industry: Healthcare Compliance (Hospitals)

This final rule sets forth an update to the 60-day national episode rates and the national per-visit amounts under the Medicare prospective payment system for home health services. In addition, this final rule sets forth policy changes related to Medicare payment for certain durable medical equipment for the purpose of implementing sections 1834(a)(5) and 1834(a)(7) of the Social Security Act, as amended by section 5101 of the Deficit Reduction Act of 2005. This final rule also responds to public comments on the August 3, 2006, proposed rule that pertain to a number of issues including  the requirement that home health payments are based on the reporting of specific quality data by home health agencies.

Effective Date: These regulations are effective on January 1, 2007.

Final Rules for Group Health Plans and Health Insurance Issuers Under the Newborn and Mothers, ....

  • Industry: Healthcare Compliance (Hospitals)

This document contains final rules for group health plans and health insurance issuers concerning hospital lengths of stay for mothers and newborns following childbirth, pursuant to the Newborns’ and Mothers’ Health Protection Act of 1996 and the Taxpayer Relief Act of 1997.

Effective Date: These final regulations are effective December 19, 2008.

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