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Health Law Documents  

The latest Advisory Opinions, rules, reports and other major documents related to health law, with links to Web sites and Adobe Acrobat PDF files where available.


2013
  • August 22 - GAO report, Medicare Program Integrity: Increasing Consistency of Contractor Requirements May Improve Administrative Efficiency (GAO-13-522).
  • August 21 - OIG Advisory Opinion No. 13-11, approving two arrangements in which a basic life support ambulance supplier would not bill certain patients, including federal health care program beneficiaries, for cost-sharing amounts.
  • August 16 - OIG Advisory Opinion No. 13-10,  finding a vendor’s proposal to contract with hospitals to provide services to patients with certain diagnoses following hospital discharge with the goal of reducing preventable hospital readmissions would not risk sanctions under the Anti-Kickback Statute.
  • August 15 - OIG report, Most Critical Access Hospitals Would Not Meet The Location Requirements If Required To Re-Enroll In Medicare (OEI-05-12-00080).
  • August 15 - IRS temporary (78 Fed. Reg. 49681) and proposed (78 Fed. Reg. 49700) rules providing guidance to charitable hospital organizations regarding the requirement of a return to accompany payment of the excise tax under the Affordable Care Act for failure to meet the community health needs assessment requirements for any taxable year.
  • Augsut 14 - IRS final rule (78 Fed. Reg. 49367) on the disclosure of return information for exchanges to perform income verification functions under the Affordable Care Act.
  • August 8 - OPM proposed rule (78 Fed. Reg. 48337) implementing the Affordable Care Act requirement that members of Congress and congressional staff must choose a health plan offered through a health insurance exchange.
  • August 7 - CMS notice (78 Fed. Reg. 48164) updating its process for opening, deciding, or reconsidering national coverage determinations (NCDs) for items and services under Part A or Part B.
  • August 7 - CMS final rule (78 Fed. Reg. 48234) on the FY 2014 hospice wage index and payment rate update.
  • August 7 - OIG report, Observations Noted During the OIG Review of CMS’s Implementation of the Health Insurance Exchange—Data Services Hub (A-18-13-30070).
  • August 6 - OIG report, Medicare Could Save Millions by Strengthening Billing Requirements for Canceled Elective Surgeries (A-01-12-00509).
  • August 1 - OCR request for information (78 Fed. Reg. 46558) regarding nondiscrimination in certain health care programs or activities.
  • August 1 - OIG report, The Centers for Medicare & Medicaid Services Awarded Consumer Operated and Oriented Plan Program Loans in Accordance with Federal Requirements, and Continued Oversight Is Needed (A-05-12-00043).
  • August 1 - GAO report, Higher Use of Costly Prostate Cancer Treatment by Providers Who Self-Refer Warrants Scrutiny (GAO-13-525).
  • July 31 - GAO report, Clear Authority and More Reliable Data Needed to Strengthen FDA Oversight (GAO-13-702).
  • July 31 - CMS notice (78 Fed. Reg. 46339), imposing six-month moratorium on the enrollment of certain new providers and suppliers in three of the country's fraud “hot spots.”
  • July 30 - OIG report, Hospitals’ Use of Observation Stays and Short Inpatient Stays for Medicare Beneficiaries (OEI-12-12-00040).
  • July 29 - GAO report, Medicare: Ownership Status of Inpatient Prospective Payment System Hospitals That Qualify for Payment Adjustments (GAO-13-667R).
  • July 23 - OIG Advisory Opinion No. 13-09, finding problematic a proposed arrangement to transfer an equity interest in the opinion requestor to members of a group purchasing organization (GPO) in exchange for the members’ agreement to extend their GPO contracts under new terms.
  • July 23 - HHS final rule (78 Fed. Reg. 44106) to clarify recent statutory changes that expanded the 340B program but prohibited the purchase of “orphan” drugs, i.e., those used to treat rare diseases or conditions, through the program.
  • July 18 - GAO report, Medicaid Demonstration Waivers: Approval Process Raises Cost Concerns and Lacks Transparency (GAO-13-384). 
  • July 17 - GAO report, Action Needed to Address Higher Use of Anatomic Pathology Services by Providers Who Self-Refer (GAO-13-445).
  • July 17 - CMS final rule (78 Fed. Reg. 42824) on navigators and other assistance personnel who will help consumers understand their coverage options once the new health insurance exchanges, also called marketplaces, become operational. 
  • July 17 - OIG report, Early Implementation of the Consumer Operated and Oriented Plan Loan Program (OEI-01-12-00290).
  • July 15 - CMS final rule (78 Fed. Reg. 42160) on Medicaid and CHIP essential health benefits in alternative benefit plans, eligibility notices, fair hearing and appeal processes, and premiums and cost sharing; exchanges: eligibility and enrollment.
  • July 11 - OIG Modification of OIG Advisory Opinion No. 06-13,

    saying changes to a charity’s previously approved financial assistance program that pays premiums and cost sharing for individuals with specific blood-related cancers posed no increased risk to federal healthcare programs.

    July 10 - OIG report, Medicare’s Currently Not Collectible Overpayments (OEI-03-11-00670).
  • July 9 - OIG Advisory Opinion No. 13-08, saying a fire district’s policy of billing only non-residents and their insurers for emergency medical services is not grounds for permissive exclusion.
  • July 2 - IRS proposed rule in the July 2 Federal Register (78 Fed. Reg. 39644) on what information health insurance exchanges must report to the agency related to the premium tax credit under the Affordable Care Act.
  • July 2 - OIG Some States Improperly Restrict Eligibility for Medicaid Mandatory Home Health Services (OEI-07-13-00060).
  • July 2 - DOL, HHS final rules (78 Fed. Reg. 39870) coverage of certain preventive services under the ACA.
  • July 1 - CMS final rule (78 Fed. Reg. 39494) ACA exchange functions: eligibility exemptions; miscellaneous minimum coverage provisions.
  • July 1 - OIG Advisory Opinion No. 13-07, finding a “tiered rebate” program based on purchases of both federally reimbursable products and non-federally reimbursable products would not trigger administrative sanctions.
  • June 27 - OIG Advisory Opinion No. 13-06, saying Medigap policies may use a "preferred hospital" network without triggering sanctions under federal fraud and abuse laws.
  • June 27 - CMS final rule (78 Fed. Reg. 38594) requiring long term care facilities that provide hospice care to residents to have a written agreement in place with the Medicare-certified hospice provider that specifies the roles and responsibilities of each entity.
  • June 24 - OIG report, Medicare Inappropriately Paid for Drugs Ordered by Individuals Without Prescribing Authority (OEI-02-09-00608).
  • June 21 - OIG Advisory Opinion No. 13-05 , finding an ambulance company may partially reimburse a town for the cost of emergency dispatch services under the company’s exclusive contract with the municipality without triggering administrative sanctions under the Anti-Kickback Statute.
  • June 20 - OIG report, Prescribers with Questionable Patterns in Medicare Part D (OEI-02-09-00603).
  • June 19 - GAO report, Patient Protection and Affordable Care Act: Status of CMS Efforts to Establish Federally Facilitated Health Insurance Exchanges (GAO-13-601).
  • June 18 - HHS Administration on Aging proposed rule (78 Fed. Reg. 36449) aimed at providing states with specific guidance on implementing their long term care ombudsman programs.
  • June 14 - OIG Advisory Opinion No. 13-04, finding an exclusive agreement for a health district to provide non-emergency ambulance transports to a county and several cities within a state would not violate the Anti-Kickback Statute.
  • June 11 - OIG report, Comparing Lab Test Payment Rates: Medicare Could Achieve Substantial Savings (OEI-07-11-00010).
  • June 11 - OIG Advisory Opinion No. 13-02finding a podiatrist may establish a company that would enter into arrangements with manufacturers and other entities to provide industrial orthotics for use by these entities’ employees without violating the Anti-Kickback Statute.
  • June 7 - OIG report, Florida Generally Ensured That Providers Complied With Selected State Durable Medical Equipment Enrollment Requirements (A-04-12-07034).
  • June 4 - OIG report, Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2013 (OEI-05-13-00090).
  • May 31 - GAO report, Establishing Minimum National Standards an Oversight Framework Would Help Ensure Quality and Safety of Advanced Diagnostic Imaging Services (GAO-13-246).
  • May 29 - OIG report, Medicare Could Save Millions by Implementing a Hospital Transfer Payment Policy for Early Discharges to Hospice Care (A-01-12-00507).
  • May 29 - OIG report, Improvements Are Needed to Ensure Provider Enumeration and Medicare Enrollment Data Are Accurate, Complete, and Consistent (OEI 07-09-00440).
  • May 23 - CMS final rule on MLR requirements for MA and Medicare PDP programs (78 Fed. Reg. 31284).
  • May 22 - CMS interim final rule with comment period on pre-existing condition insurance plan program (78 Fed. Reg. 30218).
  • May 15 - CMS proposed rule (78 Fed. Reg. 28551) for reducing Medicaid DSH payments as required under ACA.
  • May 15 - OIG report, Home Health Agencies Received Timely Surveys and Corrected Deficiencies as Required (OEI-06-11-00400).
  • May 10 - GAO report, Medicaid: Alternative Measures Could Be Used to Allocate Funding More Equitably (GAO-13-424).
  • May 10 - OIG report, Medicare and Beneficiaries Could Save Millions If Dialysis Payments Were Adjusted for Anemia Management Drug Utilization (A-01-12-00522).
  • May 10 - CMS proposed rule on hospice wage index and payment rate update for FY 2014 (78 Fed. Reg. 27823).
  • May 8 - OIG updated bulletin on the effect of exclusion from participation in federal healthcare programs.
  • May 6 - OIG report, Medicare Hospice: Use of General Inpatient Care (OEI-02-10-00490).
  • May 6 - OIG report, Medicare Payments for Part B Claims with G Modifiers (OEI-02-00160).
  • May 3 - IRS proposed regulations (78 Fed. Reg. 25909) on the Affordable Care Act’s health insurance premium tax credit.
  • May 1 - GAO report, Enhancements Needed for Improper Payments Reporting and Related Corrective Action Monitoring (GAO-13-229).
  • April 16 - OIG report, Impact on Medicare Program for Investment Income That Medicare Part D Plans Earned and Retained from Medicare Funds in 2009 (A-07-11-05017).
  • April 5 - HRSA final rule (78 Fed. Reg. 20473) to transfer all data in the Healthcare Integrity and Protection Data Bank (HIPDB) to the National Practitioner Data Bank (NPDB).
  • April 5 - CMS proposed rule (78 Fed. Reg. 20581) outlining standards for Navigator organizations that will help consumers understand their coverage options in the new health insurance exchanges.
  • April 5 - IRS proposed regulations (78 Fed. Reg. 20523) providing guidance to charitable hospital organizations on the community health needs assessment requirements, and related excise tax and reporting obligations, enacted under the Affordable Care Act. 
  • April 2 - OIG report, Oversight of Private Health Insurance Submissions to the HealthCare.gov Plan Finder (OEI-03-11-00560).
  • April 2 - CMS final rule with comment period (78 Fed. Reg. 19918) on the increased Federal Medical Assistance Percentage (FMAP) available to states under the Affordable Care Act for beneficiaries in the new Medicaid eligibility group for adults up to 133% of the poverty level.
  • April 2 - IRS notice of proposed rulemaking (78 Fed. Reg. 19950) on the application of the $500,000 deduction limitation for remuneration provided by certain health insurance providers.
  • March 27 - OIG report,  Surety Bonds Remain An Underutilized Tool To Protect Medicare From Supplier Overpayments (OEI-03-11-00350).
  • March 26 - OIG Advisory Opinion No. 13-01approving arrangement under which providers of Medicare Supplemental Health Insurance (Medigap) policies would indirectly contract with hospitals for discounts on the otherwise applicable Medicare inpatient deductibles for their policyholders.
  • March 26 - OIG report, New York Improperly Claimed Medicaid Reimbursement for Family-Based Treatment Rehabilitation Services (A-02-10-01024).
  • March 25 - FDA proposed order (78 Fed. Reg. 17890) that would require manufacturers to file a premarket approval application (PMA) or a notice of completion of a product development protocol for automated external defibrillators systems (AEDs).
  • March 21 - Departments of Treasury, Labor and HHS proposed rule (78 Fed. Reg. 17313), that would prohibit, for plan years beginning on or after January 1, 2014, group health plans or health insurance issuers offering group coverage from using a waiting period for coverage to become effective that exceeds 90 days.
  • March 19 - CMS final rule requiring LTC facilities that participate in Medicare and Medicaid to provide prior written notice of an impending closure and a plan for relocating residents at least 60 days in advance (78 Fed. Reg. 16795).
  • March 18 - CMS notice of ruling revising current policy on Part B billing following the denial of a Part A inpatient hospital claim by a Medicare review contractor on the basis that the inpatient admission was determined not reasonable and necessary (78 Fed. Reg. 16614).
  • March 18 - CMS proposed rule on Part B inpatient billing in hospitals (78 Fed. Reg. 16632).
  • March 18 - OIG report, U.S. Department of Health and Human Services Met Many Requirements of the Improper Payments Information Act of 2002 but Was Not Fully Compliant (A-17-13-52000).
  • March 15 - OIG updated guidelines for evaluating state FCA legislation.
  • March 11 - CMS final rule on notice of benefit and payment parameters for 2014 under ACA (78 Fed. Reg. 15410).
  • March 11 - CMS interim final rule with comment (78 Fed. Reg. 15541) amendments to HHS notice of benefit and payment paratmenters.
  • March 11 - CMS proposed rule on establishment of exchanges and qualified health plans; small business health options program (78 Fed. Reg. 15553).
  • March 7 - OIG report, Gaps in Oversight of Conflicts of Interest in Medicare Prescription Drug Decisions (OEI-05-10-00450).
  • March 7 - GAO report, End Stage Renal Disease: CMS Should Improve Design and Strengthen Monitoring of Low-Volume Adjustment (GAO-13-287).
  • March 7 - CMS notice (78 Fed. Reg. 14689) announcing changes to the payment adjustment for low-volume hospitals and to the Medicare-dependent hospital (MDH) program under the fiscal year (FY) 2013 inpatient prospective payment system (IPPS) as mandated by the American Taxpayer Relief Act of 2012 (ATRA).
  • March 7 - OIG report, Co-Located Long-Term Care Hospitals Remain Unidentified, Resulting in Potential Overpayments (OEI-04-12-00491).
  • March 7 - OIG report, Comparison of Average Sales Prices and Average Manufacturer Prices: An Overview of 2011 (OEI-02-12-00670).
  • March 4 - GAO report, Medicare Advantage: Substantial Excess Payments Underscore Need for CMS to Improve Accuracy of Risk Score Adjustments (GAO-13-206).
  • February 28 - OIG report, Skilled Nursing Facilities Often Fail to Meet Care Planning and Discharge Planning Requirements (OEI-02-09-00201).
  • February 27 - GAO report, High Risk Series: An Update.
  • February 27 - HHS final rule on health insurance market rules; rate review under ACA (78 Fed. Reg. 13406).
  • February 25 - HHS final rule on EHBs, actuarial value, and accreditation (78 Fed. Reg. 12834).
  • February 21 - GAO report, Sustained and Coordinated Efforts Could Facilitate Data Sharing While Protecting Privacy (GAO-13-106).
  • February 20 -  Most States Anticipated Implementing Streamlined Eligibility and Enrollment by 2014 (OEI-07-10-00530).
  • February 20 - OIG report, The Centers for Medicare & Medicaid Services Collected the Majority of Medicaid Overpayments But Millions Remain Uncollected (A-05-11-00071).
  • February 20 - OIG report, Part B Payments for Drugs Infused Through Durable Medical Equipment (OEI-12-12-00310).
  • February 13 - OIG report, FDA Lacks Comprehensive Data to Determine Whether REMS Improve Drug Safety (OEI-04-11-00510).
  • February 8 - CMS final rule on the Physician Payments Sunshine Act (78 Fed. Reg. 9458).
  • February 7 - CMS proposed rule aimed at reducing unnecessary, obsolete, and burdensome regulations on hospitals and healthcare providers (78 Fed. Reg. 9216).
  • February 7 - CMS request for information (78 Fed. Reg. 9057) on the use of clinical quality measures (CQMs) reported under the Physician Quality Reporting System (PQRS), the Electronic Health Record (EHR) Incentive Program, and other reporting programs.
  • February 6 - CMS notice (78 Fed. Reg. 8535) seeking participants for an initiative aimed at testing a new payment and service delivery model for Medicare beneficiaries with end-stage renal disease (ESRD). 
  • February 6 - HHS, Labor, and Treasury proposed rules on coverage of certain preventive services under the ACA (78 Fed. Reg. 8456).
  • February 1 - CMS proposed rule clarifying exemptions to the individual mandate  (78 Fed. Reg. 7348).
  • February 1 - IRS proposed rule on liability under individual mandate (78 Fed. Reg. 7314).
  • February 1 - IRS final rule (78 Fed. Reg. 7264) providing guidance on claiming the premium tax credit available under theACA for individuals related to employees who may enroll in employer-sponsored coverage and who wish to enroll in qualified health plans through the exchanges.
  • January 31 - GAO report, Expiration of the Health Coverage Tax Credit Will Affect Participants’ Costs and Coverage Choices as Health Reform Provisions Are Implemented (GAO-13-147).
  • January 24 - OIG report, Medicare Improperly Paid Providers Millions of Dollars for Unlawfully Present Beneficiaries Who Received Services During 2009 Through 2011 (A-07-12-01116).
  • January 24 - Medicare Improperly Paid Providers Millions of Dollars for Incarcerated Beneficiaries Who Received Services During 2009 Through 2011 (A-07-12-01113).
  • January 23 - OIG Advisory Opinion No. 12-21 , blessing a federally qualified healthcare center’s proposal to offer grocery store gift cards to certain patients in capitated Medicaid managed care plans as an incentive to receive health screenings or other clinical services.
  • January 22 - FDA final rule 78 Fed. Reg. 4307 setting forth current good manufacturing practice (CGMP) requirements applicable to combination products.
  • January 22 - CMS proposed rule (78 Fed. Reg. 4594 ) on Medicaid, CHIP and eschanges--EHBs in alternative benefit plans, eligibility notices, fair hearing and appeal processes for Medicaid and exchange eligibility appeals.
  • January 15 - Vulnerabilities In CMS’s And Contractors’ Activities To Detect And Deter Fraud In Community Mental Health Centers (OEI-04-11-00101).
  • January 14 - Review of Medicare Contractor Information Security Program Evaluations for Fiscal Year 2010 (A-18-12-30100)
  • January 10 - OIG report, Comparison of Second-Quarter 2012 Average Sales Prices and Average Manufacturer Prices: Impact on Medicare Reimbursement for Fourth Quarter 2012 (OIG-03-13-00100).
  • January 10 - OIG report, MEDIC Benefit Integrity Activities in Medicare Parts C and D (OEI-03-11-00310).
  • January 9 - GAO report, Medicaid: More Transparency of and Accountability for Supplemental Payments Are Needed (GAO-13-48).
2012
  • December 28 - OIG notice (77 Fed. Reg. 76434) seeking proposals and recommendations for developing new and modifying existing safe harbor provisions under the Anti-Kickback Statute.
  • December 26 - OIG report, Limited Supplier Solicitation of Prescribing Physicians Under Medicare DMEPOS Competitive Bidding Program (OEI-06-11-00081).
  • December 26 - GAO report, Medicare Physician Payment: Private Sector Initiatives Can Help Inform CMS Quality and Efficiency Incentive Efforts (GAO-13-160)
  • December 19 - OIG Advisory Opinion No. 12-20 , finding a hospital’s proposal to provide free access to an electronic interface to community physicians and physician practices would not generate prohibited remuneration under the Anti-Kickback Statute.
  • December 17 - GAO report, CMS Innovation Center: Early Implementation Efforts Suggest Need for Additional Actions to Help Ensure Coordination with Other CMS Offices (GAO-13-12).
  • December 13 - GAO report , Electronic Health Records: Number and Characteristics of Providers Awarded Medicaid Incentive Payments for 2011 (GAO-13-146R).
  • December 11 - OIG report, Home and Community-Based Services in Assisted Living Facilities (OEI-09-08-00360).
  • December 11 - GAO report, End-Stage Renal Disease: Reduction in Drug Utilization Suggests Bundled Payment Is Too High (GAO-13-190R).
  • December 10 - GAO report, Medicaid Integrity Program: CMS Should Take Steps to Eliminate Duplication and Improve Efficiency (GAO-13-50).
  • Decmeber 10 - GAO report, Medicare Program Integrity: Greater Prepayment Control Efforts Could Increase Savings and Better Ensure Proper Payment (GAO-13-102).
  • December 7 - IRS final regulation (77 Fed. Reg. 72924) implementing a provision of the ACA imposing an excise tax on the sale of certain medical devices under Section 4191 of the Internal Revenue Code.
  • December 7 - OIG report, Comparison of First-Quarter 2012 Average Sales Prices and Average Manufacturer Prices:  Impact on Medicare Reimbursement for Third Quarter 2012 (OEI-03-12-00730).
  • December 7 - OIG Advisory Opinion No. 12-19 finding three of four proposed arrangements involving a pharmacy company’s provision of items and services to community homes in which its customers reside would not trigger administrative sanctions, but the fourth proposed arrangement would furnish free access to certain software to the homes, could potentially generate prohibited remuneration under the Anti-Kickback Statute.
  • December 7 - CMS proposed rule providing further detail and parameters related to: the risk adjustment, reinsurance, and risk corridors programs; cost-sharing reducitons; user fees for a federally-facilitated exchange, advance payments of the premium tax credit, a federally-facilitated small business health business option program, and the medical loss ratio program (77 Fed. Reg. 73118).
  • December 6 - IRS final regulations (77 Fed. Reg. 72721) final regulations to implement and provide guidance on the fees the ACA imposes on issuers of certain health insurance policies and plan sponsors of certain self-insured health plans.
  • November 29 - OIG report,  Early Assessment Finds That CMS Faces Obstacles in Overseeing the Medicare EHR Incentive Program (OEI-05-11-00250).
  • November 29 - GAO report, Medicaid: Data Sets Provide Inconsistent Picture of Expenditures (GAO-13-47),
  • November 26 - OIG report, Assessment of Hospital Reporting of Present on Admission Indicators on Medicare Claims (OEI-06-09-00310).
  • November 26 - Treasury, Labor, and HHS notice of proposed rulemaking on incentives for nondiscriminatory wellness programs in group health plans (77 Fed. Reg. 70620).
  • November 26 - HHS proposed rule on ACA standardads related to essential health benefits, actuarial value, and accreditation (77 Fed. Reg. 70644).
  • November 26 - CMS proposed rule on ACA health insurance rate reviews (77 Fed. Reg. 70584).
  • November 21 - GAO report, Medicare Fraud Prevention: CMS Has Implemented a Predictive Analytics System, but Needs to Define Measures to Determine Its Effectiveness (GAO-13-104).
  • November 15 - OIG report, Improvements Are Needed at the Administrative Law Judge Level of Medicare Appeals (OEI-02-10-00340).
  • November 15 - OIG report, Personal Care Services: Trends, Vulnerabilities, and Recommendations for Improvement: A Portfolio (OIG-12-12-01).
  • November 15 - CMS final rule on CY 2013 OPPS and ASC payment system (77 Fed. Reg. 68210).
  • November 13 - GAO  report, Medicare: High-Expenditure Part B Drugs (GAO-13-46R). 
  • November 9 - OIG Advisory Opinion No. 12-17 , saying a hospital-based hospice agency may establish a volunteer program to provide non-skilled services to terminally ill individuals who do not otherwise qualify for hospice care without risking administrative sanctions under the AKS.
  • November 1 - GAO report, Higher Use of Advanced Imaging Services by Providers Who Self-Refer Costing Medicare Millions (GAO-12-966).
  • October 23 - GAO report, Discount Program Effects and Brand-Name Drug Price Trends (GAO-12-914).
  • October 23 - OIG Advisory Opinion No. 12-15, saying a hospital could pay a per diem fee to physicians for providing on-call coverage for the hospital’s emergency department without risking sanctions.
  • October 16 - OIG Advisory Opinion No. 12-14, approving supermarket gas rewards program including cost-sharing amounts paid for items covered by federal healthcare programs purchased in the in-store pharmacies.
  • October 15 - GAO report, Prevention And Public Health Fund: Activities Funded in Fiscal Years 2010 and 2011 (GAO-12-788).
  • October 11 - OIG report, CMS Has Not Promulgated Regulations to Establish Payment Requirements for Prosthetics and Custom-Fabricated Orthotics (OEI-07-10-00410).
  • October 10 - GAO report, Health Care Fraud: Types of Providers Involved in Medicare, Medicaid, and the Children’s Health Insurance Program Cases (GAO-12-820).
  • October 9 - OIG report, Criminal Convictions for Nurse Aides With Substantiated Findings of Abuse, Neglect, and Misappropriation (OEI-07-10-00422).
  • October 5 - OIG Advisory Opinion No. 12-13 approving proposal by a hearing aid supplier to begin billing Medicare for certain audiometric testing while continuing to offer free hearing tests to customers would not trigger sanctions.
  • October 4 - OIG  Fiscal Year (FY) 2013 Work Plan.
  • October 4 - OIG report, Excluded Individuals Employed by Providers Enrolled in Medicaid Managed Care Entities (OEI-07-09-00632).
  • September 28 - OIG report, Surety Bonds Remain an Unused Tool to Protect Medicare from Home Health Overpayments (OEI-03-12-00070). 
  • September 27 - GAO report, FDA Should Expand Its Consideration of Information Security for Certain Types of Devices (GAO-12-816).
  • September 27 - OIG report, Inappropriate Medicare Part D Payments for Schedule II Drugs Billed as Refills (OEI-02-09-00605).
  • September 19 - GAO report, Medicare Special Needs Plans: CMS Should Improve Information Available about Dual-Eligible Plans' Performance (GAO-12-864).
  • September 17 - GAO report, Medicaid: States’ Use of Managed Care (GAO-12-872R).
  • September 13 - OIG report, Medicare Overpaid Inpatient Rehabilitation Facilities Millions of Dollars for Claims With Late Patient Assessment Instruments for Calendar Years 2009 and 2010 (A-01-11-00534).
  • September 13 - OIG report, CMS Reporting to the Healthcare Integrity and Protection Data Bank (OEI-07-09-00292).
  • September 13 - OIG Advisory Opinion No. 12-12, finding a proposed bundle billing arrangement for basic life support /advance life support joint responses would not generate prohibited remuneration under the Anti-Kickback Statute.
  • September 11 - OIG Advisory Opinion No. 12-11, saying an ambulance supplier’s proposal to routinely waive cost-sharing amounts for emergency medical services rendered on a part-time basis could constitute grounds for the imposition of sanctions.
  • September 10 - OIG report, States Collection of Medicaid Rebates for Drugs Paid Through Medicaid Managed Care Organizations (OEI-03-11-00480).
  • September 5 - CMS final rule adopting the standard for a national unique health plan identifier (77 Fed. Reg. 54664).
  • September 4 - CMS final rule on Stage 2 criteria for EHR incentive program (77 Fed. Reg. 53968).
  • September 4 - ONC final rule establishing standards, implementation specifications and certification criteria for EHR technology (77 Fed. Reg. 54163).
  • August 30 - OIG Advisory Opinion No. 12-10 saying OIG would not impose administrative sanctions in connection with a radiology group’s proposal to offer free insurance pre-authorization services to physicians and patients.
  • August 28 - GAO report, Medicaid Long-Term Care: Information Obtained by States about Applicants’ Assets Varies and May Be Insufficient (GAO-12-749).
  • August 23 - GAO report, Medicaid: States Reported Billions More in Supplemental Payments in Recent Years (GAO-12-694).
  • August 21 - OIG report, Questionable Billing by Community Mental Health Centers (OEI-04-11-00100).
  • August 15 - OIG report, Comparison of Fourth-Quarter 2011 Average Sales Prices and Average Manufacturer Prices: Impact on Medicare Reimbursement for Second Quarter 2012 (OEI-03-12-00410).
  • August 13 - GAO report, Patient Protection and Affordable Care Act: Estimates of the Effect on the Prevalence of Employer-Sponsored Health Coverage (GAO-12-768).
  • August 10 - HHS interim final rule (77 Fed. Reg. 48008) with comment period adopting operating rules for the healthcare electronic funds transfers and remittance advice transactions under HIPAA. 
  • August 6 - GAO report, Providers in Three States with Unpaid Federal Taxes Received Over $6 Billion in Medicaid Reimbursements (GAO-12-857).
  • August 2 - OIG report, Inappropriate and Questionable Billing by Medicare Home Health Agencies (OEI-04-11-00240).
  • August 1 - OIG report, U.S. Department of Health and Human Services Did Not Fully Comply With Executive Order 13520 When Reporting Fiscal Year 2010 High-Dollar Improper Payments (A-02-11-01007).
  • July 30 - OIG Advisory Opinion No. 12-09saying reduced-rate arrangements for the provision of therapy services at veterans’ homes would not result in sanctions.  
  • July 27 - CMS notice of hospice Medicare payment rates for FY 2013 (77 Fed. Reg. 44242). 
  • July 26 - GAO report, Electronic Health Records: Number and Characteristics of Providers Awarded Medicare Incentive Payments for 2011 (GAO-12-778R).
  • July 23 - GAO report, Opportunities Exist for Improved Access to Affordable Insurance (GAO-12-648).
  • July 20 - OIG report, Few Adverse Events in Hospitals Were Reported to State Adverse Event Reporting Systems (OEI-06-09-00092).
  • July 20 - HHS final rule (77 Fed. Reg. 42658) that would require issuers of the largest three small group market products in each state to report information on covered benefits.
  • July 19 - OIG report, The Centers for Medicare & Medicaid Services Did Not Reconcile Medicare Outlier Payments in Accordance With Federal Regulations and Guidance (A-07-10-02764).
  • July 18 - OIG report, States Inappropriately Retained Federal Funds for Medicaid Collections for the First Recovery Act Quarter (A-06-11-00064).
  • July 9 - OIG report, Conflicts and Financial Relationships Among Potential Zone Program Integrity Contractors (OEI-03-10-00300).
  • July 9 - OIG report, Nursing Facility Assessments and Care Plans for Residents Receiving Atypical Antipsychotic Drugs (OEI-07-08-00151).
  • July 3 - OIG report, Medicare Could Be Paying Twice for Prescription Drugs for Beneficiaries in Hospice (A-06-10-00059).
     
  • June 29 - OIG Advisory Opinion No. 12-08 approving arrangement where an independent diagnostic testing facility would hire a physician, who is closely related to the IDTF’s owners, to read and interpret sleep test results.
     
  • June 22 - GAO report, Prescription Drug Data: HHS Has Issued Health Privacy and Security Regulations but Needs to Improve Guidance and Oversight (GAO-12-605).
  • June 22 - OIG report, Oversight of Quality of Care in Medicaid Home and Community Based Services Waiver Programs (OEI-02-08-00170),
  • June 22 - OIG report, Use of Electronic Health Record Systems in 2011 Among Medicare Physicians Providing Evaluation and Management Services (OEI-04-10-00184).
  • June 20 - OIG Advisory Opinion No. 12-07 , saying n exclusive contract between an EMS company and a county for emergency ambulance services would not trigger administrative sanctions.
  • June 18 - OIG notice (77 Fed. Reg. 36281) asking for comments, recommendations, and other suggestions on how best to revise the Provider Self-Disclosure Protocol “to address relevant issues and to provide useful guidance to the health care industry.”
  • June 15 - CMS advance notice of proposed rulemaking (77 Fed. Reg. 35917) seeking comments on standardized options beneficiaries and their representatives can use to resolve MSP obligations related to settlements, judgments, awards, or other payments with respect to future medical care. 
  • June 13 - GAO report, Patient Protection and Affordable Care Act: IRS Managing Implementation Risks, but Its Approach Could Be Refined (GAO-12-690).
  • June 8 - OIG report, Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2012 (OEI-05-12-00060).
  • June 8 - OIG report, Medicare Continues to Pay Twice for Nonphysician Outpatient Services Provided Shortly Before or During an Inpatient Stay (A-01-10-00508).
  • June 5 - HHS proposed rule that would require issuers of the largest three small group market products in each state to report information on covered benefits (77 Fed. Reg. 33133).
  • June 1 - OIG Advisory Opinion 12-06, saying two proposals by an anesthesia services provider to enter into contracts with physician-owned companies to provide anesthesia services could lead to administrative sanctions.
  • May 24 - OIG report, Obstacles to Collection of Millions in Medicare Overpayments (A-04-10-03059).
  • May 23 - IRS final rule implementing a premium tax credit that aims to make it easier for individuals to purchase affordable health insurance (77 Fed. Reg. 30377.)

  • May 21 - GAO report, Food and Drug Administration: Employee Performance Standards for the Timely Review of Medical Product Applications (GAO-12-650-R). 

  • May 21 - GAO report, Small Employer Health Tax Credit: Factors Contributing to Low Use and Complexity (GAO-12-549).
  • May 16 - CMS final rule revising Medicare CoPs for hospitals and CAHs (77 Fed. Reg. 29034).
  • May 16 - CMS final rule identifying reforms to promote efficiency, transparency, and reduce burdens in Medicare and Medicaid regulations (77 Fed. Reg. 29002).
  • May 16- HHS rule finalizing a notice for insurance companies to send to consumers informing them if they meet or exceed the MLR standards in the Affordable Care Act (ACA). (77 Fed. Reg. 28790).

  • May 11- CMS proposed rule on FY 2013 IPPS and LTCH rates, resident caps for GME payment purposes, quality reporting requirements for ASCs (77 Fed. Reg. 27870).
  • May 10 - OIG report, Retail Pharmacies with Questionable Part D Billing (OEI-02-09-00600).
  • May 7 - CMS final rule implementing ACA Community First Choice Option for state Medicaid programs (77 Fed. Reg. 26828).
  • May 1 - OIG Advisory Opinion No. 12-05 , finding proposed rewards program that would allow consumers to earn gasoline discounts based on the amount spent on purchases in retail stores and pharmacies, including cost-sharing amounts paid for items covered by federal healthcare programs, would not trigger administrative sanctions.
  • April 30 - OIG Advisory Opinion No. 12-04, saying it would not impose administrative sanctions related to an exclusive contract for emergency transport services between a municipality and an ambulance company that reimburses the municipality for dispatch services and for certain costs incurred when municipal firefighters drive transports.
  • April 30 - GAO report, Group Purchasing Organizations: Federal Oversight and Self-Regulation (GAO-12-399R).
  • April 30 - GAO report, Prescription Drugs: FDA Has Met Most Performance Goals for Reviewing Applications (GAO-12-500).
  • April 30 - GAO report, Medicare: Implementation of Financial Incentive Programs under Federal Fraud and Abuse Laws (GAO-12-355).
  • April 30 - GAO report, First Year of CMS’s Incentive Programs Shows Opportunities to Improve Processes to Verify Providers Met Requirements (GAO-12-481).
  • April 27 - CMS final rule (77 Fed. Reg. 25284) finalizes provisions mandated under the ACA that require all providers of medical or other items or services and suppliers that qualify for a NPI to include their NPI on all applications to enroll in the Medicare and Medicaid programs and on all claims for payment submitted under those programs.
  • April 26 - OIG Advisory Opinion No. 12-03 , saying it would not impose administrative sanctions in connection with a proposed arrangement in which a municipal fire department would share certain costs related to dispatch and other services with hospital-based ambulance providers that participate in the local 911 emergency dispatch system.
  • April 23 - GAO report, Medicare Advantage: Quality Bonus Payment Demonstration Undermined by High Estimated Costs and Design Shortcomings (GAO-12-409R).
  • April 23 - GAO report, CMS Continues Efforts to Strengthen the Screening of Providers and Suppliers (GAO-12-351).
  • April 18 - OIG report, Gaps Continue To Exist in Nursing Home Emergency Preparedness and Response During Disasters: 2007-2010 (OEI-06-09-00270).
  • April 18 - OIG report, The Medicare-Medicaid (Medi-Medi) Data Match Program (OEI-09-08-00370).
  • April 16 - GAO report, Federal Antitrust Policy: Stakeholders: Perspectives Differed on the Adequacy of Guidance for Collaboration among Health Care Providers (GAO-12-291R).
     
  • April 12 - CMS final rule with comment period on changes to MA and Medicare Part D benefit programs for CY 2013 (77 Fed. Reg. 22072).
  • March 30 - GAO report, Agency for Healthcare Research and Quality’s Process for Awarding Recovery Act Funds and Disseminating Results (GAO-12-332).
  • March 29 - GAO report, FDA Has Met Most Performance Goals but Device Reviews Are Taking Longer (GAO-12-418).
  • March 27 - OIG Advisory Opinion No. 12-02saying it would not impose administrative sanctions on a proposal to operate a website that would display coupons and advertising from healthcare providers, suppliers, and other entities, even though the arrangement could potentially generate prohibited remuneration under the AKS.
  • March 23 - CMS final rule, interim final rule, on Medicaid Eligibility changes pursuant to ACA (77 Fed. Reg. 17144).
  • March 23 - HHS final rule, interim final rule, on establishment of exchanges and qualified health plans under the ACA (77 Fed. Reg. 18310).
  • March 23 - HHS final rule on ACA standards related to reinsurance, risk corridors, and risk adjustment (77 Fed. Reg. 17220).
  • March 22 - OIG report, Medicaid Payments for Therapy Services in Excess of State Limits (OEI-07-10-00370).
  • March 21 - HHS, Treasury, and DOL advance notice of proposed rulemaking regarding certain preventative services under the ACA (77 Fed. Reg. 16501).
  • March 21 - CMS final rule on student health coverage under PHS Act and ACA (77 Fed. Reg. 16453).
  • March 20 - OIG report, Early Assessment Of Audit Medicaid Integrity Contractors (OEI-05-10-00210).
  • March 16 - OIG report, Documentation of Coverage Requirements for Medicare Home Health Claims (OEI-01-08-00390).
  • March 15 - OIG report, Questionable Billing for Medicare Independent Diagnostic Testing Facility Services (OEI-09-09-00380).
  • March 15 - OIG Advisory Opinion No. 12-01, finding a proposed GPO that would be wholly owned by the parent organization of many of the potential participants and that would pass through to the GPO participants a portion of the payments received by the GPO from vendors would not trigger administrative sanctions under the AKS. 
  • March 14 - OIG report, Review of CERT Errors Overturned Through the Appeals Process for Fiscal Years 2009 and 2010 (A-01-11-00504).
  • March 7 - HHS/ONC proposed rule revising the initial set of standards, implementation specifications, and certification criteria for EHR technology (77 Fed. Reg. 13832).
  • March 5 - OIG report, Intermediate Sanctions for Noncompliant Home Health Agencies (OEI-06-11-00401).
  • March 2 - GAO report, CMS Should Improve Efforts to Monitor Implementation of the Quality Indicator Survey (GAO-12-214).
  • March 1 - GAO report, Drug Pricing Research on Savings from Generic Drug Use (GAO-12-371R).
  • February 27 - OIG report, Excluded Providers in Medicaid Managed Care Entities (OEI-07-09-00630).
  • February 27 - CMS final rule review and approval process for Section 1115 demonstrations (77 Fed. Reg. 11678).
  • February 27 - HHS, Treasury final rule on application, review, and reporting process for waivers for state innovation (77 Fed. Reg. 11700).
  • February 27 - OIG report, Limited Oversight Of Home Health Agency OASIS Data (OEI-01-10-00460).
  • February 17 - GAO report, Use of Preventive Services Could Be Better Aligned with Clinical Recommendations (GAO-12-81).
  • February 17 - CMS proposed rule on refunding and returning identified overpayments (77 Fed. Reg. 9179).
  • February 16 - OIG report, Pilot Project to Obtain Missing Documentation Identified in the Fiscal Year 2010 CERT Program (A-01-1100502).
  • February 15 - HRSA proposed rule (77 Fed. Reg. 9138) for transferring all data in the Healthcare Integrity and Protection Data Bank to the National Practitioner Data Bank.
  • February 15 - HHS, Treasury, Labor final rules on group health plans and health insurance issuers relating to coverage of preventative services under ACA (77 Fed. Reg. 8725).
  • February 14 - HHS, Treasury, Labor final rule on summary of benefits and coverage and uniform glossary (77 Fed. Reg. 8668).
  • February 14 - HHS, Treasury, Labor guidance of complaince and notice of availability of templates, instructions and related materials on summary of benefits and coverage and uniform glossary (77 Fed. Reg. 8706).
  • February 14 - HHS, DOJ annual HCFAC report.
  • February 2 - CMS proposed rule (77 Fed. Reg. 5318) on Medicaid prescription drug pricing.
  • February 2 - CMS notice indicating decision not to propose any changes to its current EMTALA  as they pertain to hospital inpatients (77 Fed. Reg. 5213).
  • February 3 - GAO report, Lack of Price Transparency May Hamper Hospitals’ Ability to Be Prudent Purchasers of Implantable Medical Devices (GAO-12-126).
  • February 7 - IRS proposed rule (77 Fed. Reg. 6028) on ACA provision imposing an excise tax on the sale of certain medical devices under Section 4191 of the Internal Revenue Code. 
  • February 7 - IRS temporary (77 Fed. Reg. 6005) and proposed (77 Fed. Reg. 6027) rules for nonprofit health insurance issuers participating in the Consumer Operated and Oriented Plan (CO-OP) program concerning tax-exempt status.
  • January 31 - GAO report, FDA Needs to Do More to Ensure That Drug Labels Contain Up-to-Date Information (GAO-12-218).
  • January 27 - OIG report, Lack of Data Regarding Physicians Opting Out of Medicare (OEI-07-11-00340).
  • January 27 - FDA proposed rule on DTC prescription drug advertising regarding whether presentation of major statement in ads are clear, conspicuous, and neutral (77 Fed. Reg. 4273).
  • January 26 - GAO report, Medicare Advantage: CMS Should Improve the Accuracy of Risk Score Adjustments for Diagnostic Coding Practices (GAO-12-51).
  • January 26 - GAO report, Prescription Pain Reliever Abuse: Agencies Have Begun Coordinating Education Efforts, but Need to Assess Effectiveness (GAO-12-115).
  • January 18 - CMS proposed rule (77 Fed. Reg. 2500) that would implement a service-specific basis to define the uninsured for purposes of determining the hospital-specific limitation on disproportionate share hospital payments.
  • January 13 - GAO report, Health Care Quality Measurement: HHS Should Address Contractor Performance and Plan for Needed Measures (GAO-12-136).
  • January 12 - CMS final rule on reporting of gross covered retiree plan-related prescription drug costs and retained rebates by retiree drug subsidy sponsors and the scope of waiver authority (77 Fed. Reg. 1877).
  • January 12 - OIG report, Comparison of Average Sales Prices to Widely Available Market Prices for Selected Drugs (OEI-03-10-00280).
  • January 10 - HHS interim final rule with comment period on adopting standards for healthcare electronic funds transfers and remittance advice (77 Fed. Reg. 1556).
  • January 10 - GAO report, Medicare Advantage: Changes Improved Accuracy of Risk Adjustment for Certain Beneficiaries (GAO-12-52).
  • January 6 - OIG report, Hospital Incident Reporting Systems Do Not Capture Most Patient Harm (OEI-06-09-0091).
  • January 4 - HHS notice (77 Fed. Reg. 286) of a final core set of health quality measures recommended for Medicaid-eligible adults for voluntary use by state programs, health insurance issuers, and managed care entities that enter into contracts with Medicaid.

  • January 4 - OIG report, Comparison of Second-Quarter 2011 Average Sales Prices and Average Manufacturer Prices: Impact on Medicare Reimbursement for Fourth Quarter 2011 (OEI-03-12-00020).
2011
  • December 30 - OIG report, Review of Excluded Providers in the Medicare Part D Program (A-07-10-06004).
  • December 29 - OIG annual notice Federal Register (76 Fed. Reg. 81904) seeking proposals and recommendations for developing new and modifying existing safe harbor provisions under the Anti-Kickback Statute.
  • December 28 - OIG report, Questionable Billing Patterns of Portable X-Ray Suppliers (OEI-12-10-00190).
  • December 23 - OIG report, Program Integrity Problems with Newly Enrolled Medicare Equipment Suppliers (OEI-06-09-00230).
  • December 20 - GAO report, Pediatric Medical Devices: Provisions Support Development, but Better Data Needed for Required Reporting (GAO-12-225).
  • December 20 - OIG Advisory Opinion No. 11-19 , saying Medigap policies may use a "preferred hospital" network without running afoul of federal fraud and abuse laws
  • December 19 - CMS proposed rule on Physician Payments Sunshine Act provision of ACA (76 Fed. Reg. 78742).
  • December 15 - GAO report, Drug Shortages: FDA’s Ability to Respond Should Be Strengthened (GAO-12-116).
  • December 13 - GAO report, Pre-Existing Condition Insurance Plan: Comparison of Implementation and Early Enrollment with the Children’s Health Insurance Program (GAO-12-62R).
  • December 7 - CMS final rule (76 Fed. Reg. 76542) giving “qualified entities” access to Medicare claims data for purposes of aggregating the information with private sector data and publicly disseminating healthcare provider and supplier performance reports. 
  • December 7 - CMS interim final rule with request for comments on MLR rebate requirements for non-federal governmental health plans (76 Fed. Reg. 76596).
  • December 7 - CMS final rule with comment period on MLR requirements under ACA (76 Fed. Reg. 76574).
  • December 7 - OIG Advisory Opinion No. 11-18, approving a proposal for an online service that would facilitate the exchange of information between healthcare practitioners, providers, and suppliers.
  • December 5 - OIG report, Review of the Centers for Medicare & Medicaid Services' Audits of Part D Sponsors' Financial Records (A-03-10-00007).
  • November 30 - GAO report, Private Health Insurance: Early Indicators Show That Most Insurers Would Have Met or Exceeded New Medical Loss Ratio Standards (GAO-12-90R).
  • November 30 - GAO report, Mental Health and Substance Abuse: Employers’ Insurance Coverage Maintained or Enhanced Since Parity Act, but Effect of Coverage on Enrollees Varied (GAO-12-63),
  • November 30 - GAO report, Medicare Advantage: Enrollment Increased from 2010-2011 While Premiums Decreased and Benefit Packages Were Stable (GAO-12-93).
  • November 28 - CMS final rule on Medicare physician fee schedule for 2012 (76 Fed. Reg. 73026).
  • November 23 - OIG Advisory Opinion No. 11-17 saying an arrangement under which a laboratory services management company would furnish allergy testing and immunotherapy laboratory services within various primary care physicians’ medical offices could potentially generate prohibited remuneration under the Anti-Kickback Statute and would risk the imposition of sanctions.
  • November 23 - GAO report, Better Coordination Could Enhance Efforts to Address Economic Adulteration and Protect Public Health (GAO-12-46).
  • November 22 - OIG report, South Florida Medicare Comprehensive Outpatient Rehabilitation Facilities (OEI-05-10-00090).
  • November 15 - OIG Advisory Opinion No. 11-16, finding a hospital’s domiciliary services program that provides transportation, lodging, and meal assistance to certain patients and their family members would not fun afoul of federal fraud and abuse laws and thus would not risk sanctions.
  • November 14 - OIG report, Zone Program Integrity Contractors' Data Issues Hinder Effective Oversight (OEI-03-09-00520).
  • November 14 - OIG report, Ensuring that Medicare Part D Reimbursement Is Limited to Drugs Provided for Medically Accepted Indications (OEI-07-08-00152).
  • November 13 - OIG report, Comparison of Average Sales Prices and Average Manufacturer Prices: An Overview of 2010 (OEI-03-110410).
  • November 10 - GAO report, Medicaid: Prototype Formula Would Provide Automatic, Targeted Assistance to States during Economic Downturns (GAO-12-38).
  • November 4 - CMS final rule (76 Fed. Reg. 68526) establishing Medicare payments and policies for HHAs for CY 2012.
  • November 2 - CMS/OIG interim final rule (76 Fed. Reg. 67992) establishing waivers of physicial self-referall law, anti-kickback statute, and CMP to specified arrangements involving ACOs.
  • November 2 - CMS notice (76 Fed. Reg. 68012) announcing the testing of the Advance Payment Model for certain ACOs in the MSSP.
  • October 31 - OIG report, Adverse Events in Hospitals: Medicare's Responses to Alleged Serious Events (OEI-01-08-00590).
  • October 31 - GAO report, Private Health Insurance: Implementation of the Early Retiree Reinsurance Program (GAO-11-875R).
  • October 24 - GAO report, Health Care Price Transparency: Meaningful Price Information Is Difficult for Consumers to Obtain Prior to Receiving Care (GAO-11-791).
  • October 24 - OIG report, Multi-State Review of Centers for Medicare & Medicaid Services Medicaid Drug Expenditure Controls (A-07-10-06003).
  • October 24 - CMS final rule changes to ASC patient rights conditions of coverage (76 Fed. Reg. 655886).
  • October 24 - CMS proposed rule to reform hospital and CAH conditions of participation (76 Fed. Reg. 65891).
  • October 24 - CMS proposed rule identifyin reforms to streamline Medicare and Medicaid regulations and promote efficiency and transparency (76 Fed. Reg. 65909).
  • October 20 - OIG report, Review of Drug Costs to Medicaid Pharmacies and Their Relation to Benchmark Prices (A-06-11-00002).
  • October 18 - OIG Modification of Advisory Opinion No. 07-18, saying a charitable foundation could modify its previously approved patient assistance program to focus on expensive “specialty therapeutics” and to enroll “participating pharmacies” to process claims more efficiently without risking administrative sanctions.
     
  • October 17 - GAO report, Long-Term Care Hospitals: CMS Oversight Is Limited and Should Be Strengthened (GAO-11-810).
  • October 11 - OIG Advisory Opinion No. 11-15, finding proposed arrangement under which physicians would invest in a company that would provide pathology laboratory management services to a third party could potentially generate prohibited remuneration under the Anti-Kickback Statute and would risk administrative sanctions.
  • October 11 - CMS/FDA notice on pilot program for parallel review of medical products (76 Fed. Reg. 62808).
  • October 11 - CMS proposed rule on changes to MA and Medicare Prescription Drug Benefit Programs for CY 2013; Considering Changes of Participation for LTC Facilities (76 Fed. Reg. 63018).
  • October 7 - OIG Advisory Opinion No. 11-14, finding an ophthalmology group practice’s proposal to co-manage cataract surgery patients with optometrists external to the group would not generate prohibited remuneration under the Anti-Kickback Statute
  • October 6 - OIG notice (76 Fed. Reg. 62074) seeking comments on revised standards for assessing the performance of the State Medicaid Fraud Control Units.
  • September 30 - OIG Modified Advisory Opinion 07-06, concluding a nonprofit foundation’s request to modify its original arrangement to provide cost-sharing and premium subsidies for the chronically ill would not increase risk to federal healthcare programs and therefore would not change OIG’s original determination that the foundation’s program would not run afoul of federal fraud and abuse laws.
  • September 23 - GAO report, Manufacturer Discounts in the 340B Program Offer Benefits, but Federal Oversight Needs Improvement (GAO-11-836).
  • September 19 - CMS notice (76 Fed. Reg. 58007) to establish a new system of records for personally identifiable information (PII) about certain individuals who participate in, or whose PII is used to determine eligibility of an ACO to participate in, a Medicare shared savings program.
  • September 16 - OIG report, Review of Place-of-Service Coding for Physician Services Processed by Medicare Part B Contractors During Calendar Year 2009 (A-01-10-00516),
  • September 16 - OIG report, Review of Place-of-Service Coding for Physician Services Processed by Medicare Part B Contractors During Calendar Year 2008 (A-01-10-00513).
  • September 14 - HHS proposed rule (76 Fed. Reg. 56712) allowing patients direct access to their lab results.  
  • September 13 - OIG report, Use of Surety Bonds to Recover Overpayments Made to Suppliers of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies: Early Findings (OIG-03-11-00351).
  • September 6 - CMS final rule on changes to the e-prescribing incentive program (76 Fed. Reg. 54953).
  • September 6 - CMS final rule on rate increase disclosure and review (76 Fed. Reg. 54969).
  • September 1 - CMS final rule revising marketing and prompt pay requirements for MA and Part D plans mandated by MIPAA. (76 Fed. Reg. 54600).
  • August 30 - GAO report, Private Health Insurance: Early Experiences Implementing New Medical Loss Ratio Requirements (GAO-11-711).
  • August 29 - GAO report, Medicare Integrity Program: CMS Used Increased Funding for New Activities but Could Improve Measurement of Program Effectiveness (GAO-11-592).
  • August 26 - GAO report, Pre-Existing Condition Insurance Plans: Program Features, Early Enrollment and Spending Trends, and Federal Oversight Activities (GAO-11-662).
  • August 25 - CMS notice requesting applications for bundled payments for care improvement initiative (76 Fed. Reg. 53137).
  • August 25 - OIG report, Conflict-of-Interest Waivers Granted to HHS Employees in 2009 (OEI-04-10-00010).
  • August 22 - DOL, HHS, IRS notice of proposed rulemaking on summary of benefits and coverage and the uniform glossary (76 Fed. Reg. 52442).
  • August 22- DOL, HHS, IRS solicitation of comments on template for summary of benefits (76 Fed. Reg. 52475).
  • August 18 - OIG report, Medicaid Brand-Name Drugs: Rising Prices Are Offset by Manufacturer Rebates (OEI-03-10-00260).
  • August 18 - IRS temporary regulations (76 Fed. Reg. 51245) and proposed regulations (76 Fed. Reg. 51310)describing how the agency will implement new annual fees imposed on manufacturers and importers of brand-name prescription drugs under the ACA.

  • August 17 - HHS proposed rule establishing health insurance exchange eligibility and employer standards under ACA (76 Fed. Reg. 51202).
  • August 17 - CMS proposed rule (76 Fed. Reg. 51148) expanding and simplifying Medicaid eligibility and coordinating Medicaid and CHIP with the new Exchanges per ACA.  
  • August 17 - OIG report, Nationwide Rollup Report for Medicaid Drug Rebate Collections (A-06-10-00011).
  • August 16 - GAO report, Private Investment Homes Sometimes Differed from Others in Deficiencies, Staffing, and Financial Performance (GAO-11-571).
  • August 16 - OIG report, Higher Rebates for Brand-Name Drugs Result in Lower Costs for Medicaid Compared To Medicare Part D (OEI-03-10-00320).
  • August 12 - GAO report, Medicare Physician Feedback Program: CMS Faces Challenges with Methodology and Distribution of Physician Reports (GAO-11-720).
  • August 11 - OIG report, Medicaid Hospital Outlier Payment Followup for Fiscal Years 2004 Through 2006 (A-07-10-04160).
  • August 11 - OIG report, Comparison of First-Quarter 2011 Average Sales Prices and Average Manufacturer Prices: Impact on Medicare Reimbursement for Third Quarter 2011 (OEI-03-11-00540).
  • August 4 - OIG Advisory Opinion No. 11-11, finding two possible options for a medical supplier contract with a SNF to supply both items that are covered by Medicare Part B and items that are not covered could potentially generate prohibited remuneration under the Anti-Kickback Statute and trigger administrative sanctions.
  • August 3 - Treasury, HHS, and DOL interim final rules with request for comments amending rules on coverage of preventive services under ACA (76 Fed. Reg. 46621).
  • August 1 - OIG Advisory Opinion No. 11-10, finding a healthcare management services company may disburse pay-for-performance financial incentives on behalf of a state’s Medicaid program without risking sanctions. 
  • August 1 - Medicare Part D Formularies: CMS Conducts Oversight of Mid-Year Changes; Most Mid-Year Changes Were Enhancements (GAO-11-366R).
  • July 27 - OIG report, Comparison of Fourth-Quarter 2010 Average Sales Prices and Average Manufacturer Prices: Impact on Medicare Reimbursement for Second Quarter 2011 (OEI-O3-11-00360).
  • July 26 - GAO report, Key Information for Policymakers to Assess Efforts to Improve Quality While Reducing Costs (GAO-11-445).
  • July 26 - HHS advanced notice of proposed rulemaking on human subject research protections (76 Fed. Reg. 44512).
  • July 25 - Medicare Part D Changes in Utilization Similar for Randomly Reassigned and other Low-Income Subsidy Beneficiaries (GAO-11-546R).
  • July 20 - HHS proposed rule for establishing Consumer Operated and Oriented Plans (CO-OPs) (76 Fed. Reg. 43237).
  • July 19 - OIG report, Medicare Hospices That Focus on Nursing Facility Residents (OEI-02-10-00070).
  • July 19 - CMS proposed rule on CY 2012 Medicare physician fee schedule (76 Fed. Reg. 42772).
  • July 18 - OIG report, Early Review of States’ Planned Medicaid Electronic Health Record Incentive Program Oversight (OEI-05-10-00080).
  • July 15 - HHS NPRMs for state-based health insurance exchanges (76 Fed. Reg. 41866), and standards related to reinsurance, risk corridors, and risk adjustment to ensure premium stability for plans and enrollees in the newly established market (76 Fed. Reg. 41930). 
  • July 15 - OIG report, Payments for Medicare Part B Services During Non-Part A Nursing Home Stays in 2008 (OEI-06-07-00580).
  • July 12 - GAO report, Fraud Detection Systems: Centers for Medicare and Medicaid Services Needs to Do More to Ensure Widespread Use (GAO-11-475).
  • July 12 - CMS proposed rule on face-to-face requirements for home health under Medicaid (76 Fed. Reg. 41032).
  • July 11 - OIG report, Changes in Skilled Nursing Facilities Billing in Fiscal Year 2011 (OEI-02-09-00204).
  • July 8 - CMS proposed rule on ESRD PPS for CY 2012 and QIP Program for PY 2013 and PY 2014 (76 Fed. Reg. 40498).
  • July 8 - HHS interim final rule with comment period on HIPAA administrative simplification, adoption of operating rules for eligibility for a health plan and healthcare claim status transactions (76 Fed. Reg. 40458).
  • July 7 - OIG report, Most Power Wheelchairs in the Medicare Program Did Not Meet Medical Necessity Guidelines (OEI-04-09-00260).
  • June 30 - CMS proposed rule (76 Fed. Reg. 38342) that would retract the requirement in the calendar year 2011 Physician Fee Schedule final rule for the signature of a physician or qualified non-physician practitioner on a requisition for clinical diagnostic laboratory tests paid under the Clinical Laboratory Fee Schedule.
  • June 29 - GAO report, Patient Protection and Affordable Care Act: IRS Should Expand Its Strategic Approach to Implementation (GAO-11-719).
  • June 29 - GAO report, Medicare: Issues for Manufacturer-Level Competitive Bidding for Durable Medical Equipment (GAO-11-337R).
  • June 24 - HHS, Treasury, and DOL amended interim final regulations (76 Fed. Reg. 37208) concerning ACA-mandated internal claims and appeals and external review processes for group health plans and health insurance coverage.
  • June 22 - GAO report, Medical Devices: FDA Should Enhance Its Oversight of Recalls (GAO-11-468).
  • June 21 - OIG Advisory Opinion No. 11-08, existing and proposed contracts between DME supplier and IDTFs, pursuant to which IDTF staff members perform certain services on behalf of the DME supplier, could potentially generate prohibited remuneration under the Anti-Kickback Statute and trigger sanctions 
  • June 17 - CMS proposed rule (76 Fed. Reg. 35684) that would establish Conditions of Participation (CoPs) for Community Mental Health Centers.
  • June 15 - GAO report, HHS Research Awards: Use of Recovery Act and Patient Protection and Affordable Care Act Funds for Comparative Effectiveness Research (GAO-11-712R). proposed rule
  • June 15 - OIG report, State Medicaid Policies and Oversight Activities Related to 340B-Purchased Drugs (OEI-05-09-00321).
  • June 13 - GAO report, Private Health Insurance Waivers of Restrictions on Annual Limits on Health Benefits (GAO-11-725R).
  • June 9 - GAO report, Health Care Fraud And Abuse Control Program: Improvements Needed in Controls over Reporting Deposits and Expenditures (GAO-11-446).
  • June 8 - CMS proposed rule on the availability of Medicare data for performance management (76 Fed. Reg. 33566).
  • June 6 - HHS request for information on reducing regulatory burdens (76 Fed. Reg. 32330).
  • June 6 - CMS proposed notice on five-year review of physician work RVUs (76 Fed. Reg. 32410).
  • June 6 - CMS final rule on Medicaid payment adjustments for provider-preventable conditions (76 Fed. Reg. 32816).
  • June 1 - CMS proposed changes to electronic prescribing incentive program (76 Fed. Reg. 31547).
  • May 31 - GAO report, Products Studied under Two Related Laws, but Improved Tracking Needed by FDA (GAO-11-457).
  • May 31 - ONC proposed rule on permanent certification program for HIT (76 Fed. Reg. 31272).
  • May 31 - OCR proposed rule on HIPAA accounting for disclosures under HITECH (76 Fed. Reg. 31426).
  • May 26 - OIG report, Review of Medicare Payments to Prescription Drug Plans on Behalf of Deceased Enrollees (A-05-09-00027).
  • May 26 - OIG Advisory Opinion 10-07, approving modifications to previously approved charitable assistance program.
  • May 20 - OIG Advisory Opinion No. 11-06saying charging providers to use an online referral service could violate Anti-Kickback Statute and trigger sanctions.    
  • May 20 - HHS proposed rule on orphan-drug exclusion from newly expanded 340B drug pricing program (76 Fed. Reg. 29183).
  • May 17 - OIG report, Nationwide Rollup Review of the Centers for Medicare & Medicaid Services Health Insurance Portability and Accountability Act of 1996 Oversight (A-04-08-05069).
  • May 17 - OIG report, Audit of Information Technology Security Included in Health Information Technology Standards (A-18-09-30160).
  • May 13 - OIG Advisory Opinion No. 11-04 , finding military training affiliation agreement with hospital presented minimal risk of fraud and abuse.
  • May 11 - GAO report, Hospital Emergency Departments: Health Center Strategies That May Help Reduce Their Use (GAO-11-414R).
  • May 9 - OIG report, Medicare Atypical Antipsychotic Drug Claims for Elderly Nursing Home Residents (OEI-07-08-00150).
  • May 6 - GAO report, More Reliable Data and Consistent Guidance Would Improve CMS Oversight of State Complaint Investigations (GAO-11-280).
  • May 6 - CMS proposed rule (76 Fed. Reg. 26342) providing guidance to states on how to assure that people with Medicaid have the same access to healthcare services as people with other types of health insurance in the face of state budget troubles.

  • May 6 - CMS final rule (76 Fed. Reg. 26432) on the inpatient psychiatric facilities PPS for RY 2012.
  • May 6 - CMS proposed rule (76 Fed. Reg. 26364) on PPS and consolidated billing for SNFs.
  • May 6 - CMS final rule (76 Fed. Reg. 26490) on hospital inpatient value based purchasing program.
  • May 5 - CMS final rule (76 Fed. Reg. 25550) revising the process hospitals and critical access hospitals use for credentialing and granting privileges to physicians and practitioners providing telemedicine services.
  • April 26 - OIG report, Part D Plans Generally Cover Drugs Commonly Used By Dual Eligibles (OEI-05-10-00390).
  • April 22 - OIG report, Comparison of Average Sales Prices and Average Manufacturer Prices: An Overview of 2009 (OEI-03-10-00380).
  • April 19 - FTC/DOJ Proposed Statement of Antitrust Enforcement Policy on ACOs (76 Fed. Reg. 21894)
  • April 19 - CMS final rule (76 Fed. Reg. 21950) concerning federal funding for Medicaid eligibility determination and enrollment activities.
  • April 18 - OIG report, Medicare Payments for Diagnostic Radiology Services in Emergency Departments (OEI-07-09-00450).
  • April 15 - CMS proposed rule (76 Fed. Reg. 21311) allowing states to target multiple groups in a single home and community based (HCBS) waiver demonstration.

  • April 15 - CMS final rule (76 Fed. Reg. 21432) on changes to MA and Medicare Prescription Drug Benefit Program for CY 2012.
  • April 14 -OIG Advisory Opinion No. 11-03, refusing to rule out sanctions in connection with a proposal in which LTC pharmacy joint venture. 
  • April 7 - CMS proposed rule (76 Fed. Reg. 19528) on Medicare Shared Savings Program, ACOs.
  • April 7 - CMS/OIG Notice with Comment Period (76 Fed. Reg. 19655) on waivers in connection with Medicare Shared Savings Program.
  • April 6 - CMS interim final rule (76 Fed. Reg. 18930) that revises the end-stage renal disease (ESRD) transition budget-neutrality adjustment.
  • April 5, GAO report, Medicaid and CHIP: Reports for Monitoring Children’s Health Care Services Need Improvement (GAO-11-293R).
  • April 4 - CMS proposed rule (76 Fed. Reg. 18472) making additional changes to final rule imposing stricter Medicare enrollment standards for DMEPOS suppliers.
  • March 25 - GAO report, Private Health Insurance Coverage: Expert Views on Approaches to Encourage Voluntary Enrollment (GAO-11-392R).
  • March 24 - GAO report, End Stage Renal Disease: CMS Should Assess Adequacy Of Payment When Certain Oral Drugs Are Included and Ensure Availability of Quality Monitoring Data (GAO-11-365).
  • March 21 - GAO report, Medicare Part D: CMS Conducted Fraud and Abuse Compliance Plan Audits, but All Audit Findings Are Not Yet Available (GAO-11-269R).
  • March 18 - CMS final rule (76 Fed. Reg. 15601) revising and expanding Medicare and Medicaid regulations regarding the imposition and collection of CMPs against nursing homes not in compliance with federal participation requirements.
  • March 17 - OIG proposed rule (76 Fed. Reg. 14637) that would allow state Medicaid Fraud Control Units (MFCUs) to use federal matching funds for certain data mining activities. 
  • March 16 - GAO report, Private Health Insurance: Data on Application and Coverage Denials (GAO-11-268).
  • March 14 - CMS interim final rule regarding the treatment of teaching hospitals that are members of the same Medicare GME affiliated groups for purposes of determining possble FTE resident cap reductions (76 Fed. Reg. 13515).
  • March 14 - GAO report, Prescription Drugs: Trends in Usual and Customary Prices for Commonly Used Drugs (GAO-11-306r).
  • March 4 - OIG report, Concerns with Rebates in the Medicare Part D Program (OEI-02-08-00050).
  • February 23 - OIG final rule (76 Fed. Reg. 9968) concerning discrimination or retaliation against healthcare providers who refuse to perform (or participate in performing) abortion-related services based on their conscience objections. 
  • February 18 - CMS interim final rule (76 Fed. Reg. 9503), amending the requirements that a LTC must meet to qualify to participate as a SNF in Medicare or NF in Medicaid.
  • February 17 - GAO report, Electronic Prescribing: CMS Should Address Inconsistencies In Its Two Incentive Programs That Encourage The Use Of Health Information Technology (GAO-11-159).
  • February 17 - CMS proposed rule (76 Fed. Reg. 9283) that would bar federal payment to states for amounts expended in providing medical assistance for healthcare-acquired conditions.
  • February 15 - FDA final rule (76 Fed. Reg. 8637) exempting Medical Device Data Systems (MDDSs) from premarket notification requirements.
  • February 14 - GAO report, Refining Payment Methodology Has Potential to Lower Program and Beneficiary Spending (GAO-11-56).
  • February 14 - OIG report, Comparison of Second-Quarter 2010 Average Sales Prices and Average Manufacturer Prices: Impact on Medicare Reimbursement for Fourth Quarter 2010  OEI-03-11-00030).
  • February 11 - HHS proposed rule (76 Fed. Reg. 7767) clarifying that student insurance plans offered through colleges and universities will be defined as “individual health insurance coverage,” thus ensuring that students benefit from critical consumer protections created by PPACA. 
  • February 5 - GAO report, Medicare Advantage: Comparison of Plan Bids to Fee-for-Service Spending by Plan and Market Characteristics (GAO-11-247R).
  • February 4 - GAO report, Medicaid And CHIP: Given the Association between Parent and Child Insurance Status, New Expansions May Benefit Families (GAO-11-264).
  • February 2 - CMS final rule (76 Fed. Reg. 5862) on Medicare, Medicaid, CHIP additional screening requirements, application fees, temporary enrollment moratoria, payment supsensions, and compliance plans for providers and suppliers.
  • February 2 - OCIIO request for comments (76 Fed. Reg. 5774) on the establishment of the Consumer Operated and Oriented Plan program (CO–OP program).
  • February 2 - CMS proposed rule (76 Fed. Reg. 5755) that would require most Medicare-participating providers and suppliers to give beneficiaries written notice about their right to contact a Medicare Quality Improvement Organization (QIO) with concerns about the quality of care they receive under the Medicare program.
  • January - 27 - CMS proposed rule (76 Fed. Reg. 4998) on inpatient psychiatric facility PPS for rate year 2012.
  • January 18 - OIG report, Rollup Review of Impact on Medicare Program for Investment Income That Medicare Advantage Organizations Earned and Retained From Medicare Funds in 2007 (A-07-10-01080).
  • January 13 - CMS proposed rule (76 Fed. Reg. 2454) rule establishing a new hospital value-based purchasing program for hospitals paid under the Medicare IPPS.
  • January 10 - OIG Advisory Opinion No. 11-01 , finding several proposals by a long-standing network of hospitals that provide charity care to sick children would not run afoul of federal fraud and abuse laws.
  • January 10 -OIG report, Medicare Payments for Newly Available Generic Drugs (OEI-03-09-00510).
  • January 7 - ONC final rul (76 Fed. Reg. 1262) establishing a permanent certification program for HIT.
  • January 5 - CMS final rule (76 Fed. Reg. 628) establishing a Quality Incentive Program for ESRD facilities.
  • January 4 - OIG report, Payments for Ambulatory Surgical Center Services Provided to Beneficiaries in Skilled Nursing Facility Stays Covered Under Medicare Part A in Calendar Years 2006 through 2008 (A-01-09-00521).
  • January 1 - GAO report, Public Health Information Technology: Additional Strategic Planning Needed to Guide HHS’s Efforts to Establish Electronic Situational Awareness Capabilities (GAO-11-99).

2010

  • December 30 - HHS notice (75 Fed. Reg. 82397) setting out an initial core set of health quality measures recommended for Medicaid-eligible adults for voluntary use by state programs, health insurance issuers, and managed care entities that enter into contracts with Medicaid.
  • December 28 - OIG Advisory Opinion No. 10-26 finding payment plans for emergency and non-emergency transportation services provided for Medicaid-covered residents of SNFs could generate prohibited remuneration under the Anti-Kickback Statute.
  • December 28 - request for information on how group health plans and health insurance issuers can employ value-based insurance design in the coverage of recommended preventive services.
  • December 23- CMS advance notice of proposed rulemaking soliciting comments on the need to publish a proposed rule to address certain EMTALA policies (75 Fed. Reg. 80762).
  • December 23 - OCIIO notice of proposed rulemaking (75 Fed. Reg. 81004) on implmenting rules for health insurance issuers regarding the disclosure and review of unreasonable premium increases.
  • December 22 - OIG report, Questionable Billing by Skilled Nursing Facilities (OEI-02-09-00202).
  • December 22 - Questionable Billing for Medicare Outpatient Therapy Services (OEI-04-09-00540).
  • December 22 - Questionable Billing for Brand-Name Inhalation Drugs in South Florida (OEI-03-09-00530).
  • December 15 - OIG report, Inappropriate Claims for Medicaid Personal Care Services (OEI-07-08-00430).
  • December 10 - HHS ONC request for information on President's Council of Advisors on Science and Technology Report entitled "Realizing the Full Potential of HIT to Improve Healthcare for Americans: The Path Forward" (75 Fed. Reg. 76986).
  • December 7 - SSA interim final rule (75 Fed. Reg. 75884) setting forth the additional Medicare Part D premiums higher-income beneficiaries will pay starting in January 2011. 

  • December 1 - HHS OCIIO interim final rule implementing MLR requirements (75 Fed. Reg. 74864).
  • November 30 - CMS final rule (75 Fed. Reg. 73972) removing regulatory text pertaining to Medicaid state financing arrangements that was previously vacated by a federal district court.
  • November 29 - CMS final rule on Medicare physician fee schedule for CY 2011 (75 Fed. Reg. 73170).  
  • November 24 - CMS final rule hospital OPPS and Calendar Year 2011 payment rates (75 Fed. Reg. 71800).
  • November 24 - OIG report, FDA's Approval Status of Drugs Paid for by Medicaid (OEI-03-08-00500).
  • November 22 - CMS proposed rule on MA and Medicare PDP proposed changes for contract year 2012 (75 Fed. Reg. 71190).
  • November 19 - CMS final rule requiring hospitals to protect patients' right to choose their own visitors during a hospital stay (75 Fed. Reg. 70831).
  • November 18 - OIG report, Medicare Part D Pharmacy Discounts for 2008 (OEI-02-10-00120).
  • November 17 - HHS and DOL request for information (75 Fed. Reg. 70160) soliciting input on conducting a market analysis for planning and developing a federal external review process for health plan denials and other decisions.
  • November 17 - CMS - request for information (75 Fed. Reg. 70165) on policies and standards that will apply to ACOs participating in Medicare shared savings program.
  • November 17 - HHS, DOL, and Treasury amendment to interim final regulation (75 Fed. Reg. 70114) on “grandfathered status” for group health plans and health insurance coverage in the group and individual markets.
  • November 16 - HHS notice establishing the Independence Advisory Counsel (75 Fed. Reg. 70006).
  • November 16 - CDC request for information (75 Fed. Reg. 70009) seeking public comment on the development of guidance on health risk assessments.
  • November 16 - OIG report, Adverse Events in Hospitals: National Incidence Among Medicare Beneficiaries (OEI-06-09-00090).
  • November 15 - CMS final notice announcing approval of Det Norske Veritas Healthcare as a national accreditation program for CAHs (75 Fed. Reg. 69682).
  • November 15 - CMS final rule witdrawing Medicaid AMP, multiple source drug definition, and upper limits for multiple source drugs (75 Fed. Reg. 69591).
  • November 12 - OIG notice seeking comments on updating guidance on effects of exclusion (75 Fed. Reg. 69452).
  • November 10 - OIG Advisory Opinion No. 10-25, saying ambulance company may reimbruse city for dispatch, quality monitoring services.
  • November 8 - GAO report, Response to Heparin Contamination Helped Protect Public Health; Controls That Were Needed for Working With External Entities Were Recently Added (GAO-11-95). 
  • November 5 - OIG roadmap for new physicians to guide them in learning how to comply with federal fraud and abuse laws.
  • November 4 - OIG report, Comparison of First--Quarter 2009 Average Sales Prices and Average Manufacturer Prices: Impact on Medicare Reimbursement for Third Quarter 2010 (OEI-03-10-00400).
  • November 4 - OIG report, The Use of Payment Suspensions to Prevent Inappropriate Medicare Payments (OEI-01-09-00180).
  • November 4 - OIG report, Oversight and Evaluation of the Fiscal Year 2008 Payment Error Rate Measurement Program (A-06-09-00037). 
  • October 29 - GAO report, Drug Safety: FDA Has Conducted More Foreign Inspections and Begun to Improve Its Information on Foreign Establishments, but More Progress Is Needed (GAO-10-961).
  • October 29 - GAO report, Food And Drug Administration: Overseas Offices Have Taken Steps to Help Ensure Import Safety, but More Long-Term Planning Is Needed (GAO-10-960).
  • October 27 - OIG report, Payment for Drugs Under the Hospital Outpatient Prospective Payment System (OEI-03-09-00420).
  • October 22 - CMS proposed rule adding written agreement requirement for LTC facilities that provide hospice care to residents (75 Fed. Reg. 652842).
  • October 20 - OIG guidance for implementing its permissive exclusion authority under Section 1128(b)(15) of the Social Security Act. 
  • October 19 - OIG report, Medicare and Medicaid Fraud and Abuse Training in Medical Education (OEI-01-10-00140).
  • October 13 - ONC interim final rule (75 Fed. Reg. 62686) revising its final rule implementing EHR standards and specifications to remove a particular adopted implementation specification.
  • October 13 - GAO report, Medicare Advantage, CMS Actions Regarding Health Plans' Health Reform Communications (GAO-10-953-R).
  • October 13 - OIG report, Centers for Medicare & Medicaid Services’ Use of Medicare Fee-for-Service Error Rate Data to Identify and Focus on Error-Prone Providers (A-05-08-00080).  
  • October 13 - OIG report, Quality Improvement Organizations' Final Responses to Beneficiary Complaints (OEI-01-09-00620).
  • September 29 - FDA final rule (75 Fed. Reg. 59935) clarifying what safety information must be reported during clinical trials of investigational drugs and biologics.
  • September 28 - OIG Special Advisory Bulletin notifying pharmaceutical manufacturers that it intends to pursue enforcement actions against those that fail to comply with drug pricing and product information reporting requirements.
  • September 28 - OIG report, Drug Manufacturers' Noncompliance with AMP Reporting Requirements (OEI-03-09-00060).
  • September 28 - OIG Advisory Opinion No. 10-20saying a radiology group may offer free insurance pre-authorization services to referring physicians.
  • September 27 - OIG report, Review of Medicare Parts A and B Services Billed With Dates of Service After Beneficiaries' Deaths (A-01-09-00519).

    September 27 - OIG Advisory Opinion No. 10-19approving nonprofit organization’s proposal to receive donations of cash and DME to provide funding grants and DME to entities that serve individuals suffering from coagulation disorders and to provide DME directly to certain financially needy individuals.

  • September 27 - OIG Advisory Opinion No. 10-18 , finding a health system’s proposal to provide pediatric patients who undergo a tonsillectomy at its outpatient surgery center and their families a free night’s stay in a nearby hotel following the procedure would not trigger administrative sanctions. 
  • September 23 - CMS proposed role (75 Fed. Reg. 58204), aimed at enhancing measures to prevent fraud and abuse in federal healthcare programs that ties various screening tools to the level of risk associated with different provider and supplier types.
  • September 21 - OIG report CMS Reporting to the Healthcare Integrity and Protection Data Bank (OEI-07-09-00290).
  • September 20 - OIG Advisory Opinion, No. 10-17  approving a proposed arrangement in which a children’s health system would donate funds to another health system’s programs for children and families as part of a private settlement of an administrative dispute involving the issuance of a CON.  
  • September 16 - OIG report, End Stage Renal Disease Drugs: Facility Acquisition Costs and Future Medicare Payment Concerns (OEI-03-09-00280).
  • September 17 - CMS proposed rule (75 Fed. Reg. 56946) to increase the transparency of Medicaid and CHIP demonstration applications and approved demonstration projects.
  • September 17 - CMS and FDA notice seeking comments on establishing a process for parallel evaluations of premarket, FDA-regulated medical products (75 Fed. Reg. 57045).
  • September 10 - OIG Advisory Opinion No. 10-16 saying a cochlear implant manufacturer’s proposal to reimburse providers for certain services rendered in connection with faulty external components while the product is still under warranty may trigger sanctions under AKS.
  • September 9 - GAO legal opinion finding brochure sent by the HHS to Medicare beneficiaries describing changes in the program resulting from the newly enacted healthcare reform law did not violate the prohibition against using appropriated funds for publicity or propaganda.
  • September 8 - OIG Advisory Opinion No. 10-15 , approving joint venture between health system and physicians organization for ambulatory care center. 
  • September 8 - OIG Advisory Opinion No. 10-14 , finding agreement between sleep testing provider, hospital posed low risk of fraud and abuse. 
  • September 3 - CMS proposed rule (75 Fed. Reg. 54073) to withdraw certain challenged provisions of a Medicaid rule pertaining to AMP and FULs for multiple source drugs.

  • August 31 - OIG Advisory Opinion No. 10-13, finding hospital could provide free pre-authorization services to patients and physicians.
  • August 30 - OIG Advisory Opinion No. 10-12, saying organization could establish PAP to defray cost of drugs and devices for needy patients.
  • August 30 - GAO report, FDA’s Consideration of Evidence from Certain Clinical Trials (GAO-10-798).
  • August 27 - CMS final rule (75 Fed. Reg. 52629) setting forth more stringent enrollment standards for DMEPOS suppliers to help reduce fraud and protect beneficiaries.
  • August 16 - OIG report, report, Review of Less-Than-Effective Drugs in the Medicare Part D Program (A-07-09-04138).
  • August 16 - CMS final rules and interim final rule with comment period for hospital IPPS and LTCH PPS for FY 2011 (75 Fed. Reg. 50042).
  • August 16 - GAO report, Consumer-Directed Health Plans: Health Status, Spending, and Utilization of Enrollees in Plans Based on Health Reimbursement Arrangements (GAO-10-616).
  • August 12 - OIG report, Review of Place-of-Service Coding for Physician Services Processed by Medicare Part B Carriers During Calendar Year 2007 (A-01-09-00503).
  • August 11 - CMS final rule implementing MEQC and PERM for Medicaid and CHIP (75 Fed. Reg. 48816).
  • August 10 - OIG report, A Review of Claims for Capped Rental Durable Medical Equipment (OEI-07-08-00550).
  • August 4 - FDA notice of new FY 2011 fee rates for drug applications and establishments (75 Fed. Reg. 46952).
  • August 4 - GAO report, Medicaid Managed Care: CMS’s Oversight of States’ Rate Setting Needs Improvement (GAO-10-810).
  • August 4 - CMS final agreement drug manufacturers of applicable Part D drugs must sign to provide Medicare beneficiaries in the coverage gap a discount on their medications.
  • August 4 - GAO report, Medicare Payments to Federally Qualified Health Centers (GAO-10-576R).
  • August 3 - OCIIO request for comments on planning and establishing state-level exchanges (75 Fed. Reg. 45584).
  • August 3 - CMS proposed rule updating payment rates for CY 2011 OPPS and ASC payment system (75 Fed. Reg. 46170).
  • August 3 - CMS notice of final wage indices, hospital reclassifications, payment rates, impacts, and addenda for payments made under the OPPS for CY 2011 (75 Fed. Reg. 45769).
  • July 30 - OIG Advisory Opinion No. 10-11, approving charitable contributions to encourage provider use of online scheduling program with drug makers.
  • July 30 - HHS OCIIO interim final rule on Pre-Existing Condition Insurance Plan (75 Fed. Reg. 45014).
  • July 28 - CMS final rule on Electronic Health Record Incentive Program (75 Fed. Reg. 44314).
  • July 28 - ONC, HHS - final rule on HIT standards, specifications, and certification criteria for EHR technology (75 Fed. Reg. 44590).
  • July 23 - HHS, DOL, Treasury interim final regulations (75 Fed. Reg. 43330) giving consumers in new health plans broad appeals rights provided for under the healthcare reform law.
  • July 23 - CMS proposed rule (75 Fed. Reg. 43330) updating the home health PPS for CY 2011.
  • July 22 - CMS notice (75 Fed. Reg. 42944) updating hospice payment rates for FY 2011.
  • July 22 - CMS notice updating SNF payment rates for FY 2011.
  • July 20 - FDA notice withdrawing rule requiring device makers to include information on pediatric studies (75 Fed. Reg. 41986).
  • July 20 - OIG report, Review of Medicare Contractor Information Security Program Evaluations for Fiscal Year 2007 (A-18-07-30291).
  • July 19 - Interim final rules for group health plans and health insurance issuers relating to coverage of preventive services under the PPACA (75 Fed. Reg. 41726).
  • July 14 - OIG report, Analysis of Errors Identified in the Fiscal Year 2009 Comprehensive Error Rate Testing Program (A-01-10-01000).
  • July 14 - GAO report, Health Care Quality Measurement: The National Quality Forum Has Begun a 4-Year Contract with HHS (GAO-10-737).
  • July 14 - OCR notice of proposed rulemaking implementing modifications to HIPAA privacy, security, and enforcement rules under the HITECH Act (75 Fed. Reg. 40868).
  • July 13 - CMS proposed rule to the physician fee schedule and other Part B payment policies for CY 2011 (75 Fed. Reg. 40040).
  • July 8 - OIG report, Medicare Part B Services During Non-Part A Nursing Home Stays: Mental Health (OEI-06-06-00580).
  • July 6 - OIG report, Review of Inpatient Rehabilitation Facilities’ Compliance with Medicare’s Transfer Regulation During Fiscal years 2004 Through 2007 (A-04-09-00059).
  • June 29 - OIG report, Invalid Prescriber Identifiers on Medicare Part D claims (OEI - 03-09-00140).
  • June 28 - CMS proposed rule on changes to the hospital and critical access hospital COPs to ensure visitation rights for all patients (75 Fed. Reg. 36610).
  • June 28 - IRS, EBSA, OCIIO, interim final rules with request for comments on PPACA preexisting condition exclusions, lifetime and annual limits, rescissions, and patient protections (75 Fed. Reg. 37188).
  • June 25 - OIG policy statement saying waiver of beneficiary cost-sharing amounts attributable to retroactive increases in payment rates resulting from the operation of new federal statutes or regulations will not be subject to administrative sanctions.
  • June 24 - ONC final rule - establishing temporary certification program for HIT (75 Fed. Reg. 36158).
  • June 24 - OIG report, Comparison of Fourth-Quarter 2009 Average Sales prices and Average Manufacturer Prices: Impact on Medicare Reimbursement for Second Quarter 2010 (OEI-03-10-00350).
  • June 22 - OIG report, Review of Medicaid Disproportionate Share Hospital Payment Distribution (A-07-09-04150).
  • June 22 - OIG report, Challenges to FDA’s Ability To Monitor and Inspect Foreign Clinical Trials (OEI-01-08-00510).
  • June 18 - OIG Advisory Opinion No. 10-9, approving health service district’s proposal to transfer funds to county in which it owns hospital for new emergency communications center. 
  • June 17 - IRS, EBSA, OCIIO interim final rules with request for comments relating to grandfathered status under PPACA for group health plans and health insurance coverage (75 Fed. Reg. 34538).
  • June 3 - OIG Advisory Opinion No. 10-07 , saying it would not impose sanctions in connection with charity's proposal to help financially needy afford their medications.  
  • June 1 - GAO report, Medicare Advantage: Relationship between Benefit Package Designs and Plans’ Average Beneficiary Health Status (GAO-10-403).
  • May 28 - CMS final rule allowing states more flexibility to impose premiums and cost sharing on certain Medicaid recipients (75 Fed. Reg. 30244).
  • May 27 - OIG Advisory Opinion No. 10-05, finding proposed rewards program for referrals of prospective residents to CCRCs by current residents and employees would not generate prohibited remuneration under the AKS. 
  • May 26 - GAO report, Nursing Homes: Some Improvement Seen in Understatement of Serious Deficiencies, but Implications for the Longer-Term Trend Are Unclear (GAO-10-434R).
  • May 26 - CMS notice (75 Fed. Reg. 29555) of the draft model agreement that drug manufacturers of applicable Part D drugs will sign to participate in the coverage gap discount program.
  • May 26 - CMS proposed rule (75 Fed. Reg. 29479) revising CoPs for both hospitals and CAHs to allow for a new credentialing and privileging process for physicians and practitioners providing telemedicine services.
  • May 19 - OIG report, Excluded Medicaid Providers: Analysis of Enrollment (OEI-09-08-00330).
  • May 18 - OIG updated guidance on circumstances that might affect the independence or objectivity of an IRO that performs CIA reviews for an individual or an entity. 
  • May 13 - DOJ Health Care Fraud and Abuse Control Program (HCFAC) Annual Report for Fiscal Year 2009.
  • May 13 - HHS, DOL, Department of Treasury interim final rule implementing the requirements for group health plans and health insurance issuers in the group and individual markets under the provisions of the PPACA regarding dependent coverage of children under age 26 (75 Fed. Reg. 27122).
  • May 12 - OIG report, Collection Status of Medicare overpayments Identified by Program Safeguard Contractors (OEI-03-00030).
  • May 12 - OIG report, Medicare Overpayments Identified by Program Safeguard Contractors (OEI-03-08-0031).
  • May 6 - OIG Advisory Opinion No. 10-04,  saying it would not impose administrative sanctions in connection with a proposal by several imaging providers to offer free insurance pre-authorization services to patients and physicians. 
  • May 6 - GAO report, CMS Should Monitor Access to and Quality of Dialysis Care Promptly After Implementation of New Bundled Payment System (GAO-10-225).
  • May 5 - HHS interim final rule with comment period (75 Fed. Reg. 24450) implementing the Early Retiree Reinsurance Program under the PPACA.
  • May 5 - HHS interim final rule with comment period (75 Fed. Reg. 24470) as a first step to implementing a requirement mandated by the PPACA to establish a web portal that allows individuals and small businesses to access information about insurance coverage options.
  • May 5 - CMS interim final rule with comment period implementing PPACA changes in provider and supplier enrollment, ordering, and referring and changes in provider agreements (75 Fed. Reg. 24437).
  • April 30 - CMS final rule (75 Fed. Reg. 23068) giving states more flexibility in designing their Medicaid programs.
  • April 30 - CMS notice (75 Fed. Reg. 23106) updating IPF PPS for rate year 2010 and 2011.  
  • April 26 - GAO report, Medicare Contracting Reform: Agency Has Made Progress with Implementation, but Contractors Have Not Met All Performance Standards (GAO-10-71).
  • April 23 - CMS proposed rule (75 Fed. Reg. 21207) that would allow ASCs to provide patients or the patients’ representative with required patient rights information on the day of the procedure when the procedure must be performed on the same day as the physician’s referral.
  • April 23 - GAO report, Poorly Performing Nursing Homes: Special Focus Facilities Are Often Improving, but CMS’s Program Could be Strengthened (GAO-10-197).
  • April 21 - FDA draft guidance that would expand transparency and disclosure when the agency grants a conflict-of-interest waiver to permit an individual’s participation in an FDA advisory committee meeting. 
  • April 20 - FTC released a proposed revision to the Horizontal Merger Guidelines. 
  • April 15 - CMS final rule (75 Fed. Reg. 19678) establishing a mandatory out-of-pocket limit, or MOOP, on overall cost-sharing for Parts A and B services (i.e., caps the amount MA plan enrollees will pay in deductibles and copayments).  
  • April 14 - OIG report, Analysis of Improper Payments Identified During the Payment Error Rate Measurement Program Reviews in 2006 and 2007 (A-06-09-0070).
  • April 14 - HHS, DOL , IRS - Request for information (75 Fed. Reg. 19297) on medical loss ratios for purposes of PPACA.
  • April 13 - OIG report, Medicare Payments for Medical Equipment and Supply Claims With Identical Referring Physician and Supplier National Provider Identifiers (OEI-04-10-00110).
  • March 31 - DEA interim final rule on electronic prescribing for controlled substances (75 Fed. Reg. 16236).
  • March 30 - GAO report, Medicare Recovery Audit Contracting: Weaknesses Remain in Addressing Vulnerabilities to Improper Payments, Although Improvements Made to Contractor Oversight (GAO-10-143).
  • March 23 - GAO report, Food and Drug Administration: Opportunities Exist to Better Address Management Challenges (GAO-10-279).
  • March 18 - OIG audit report, Review of Additional Rebates for Brand-Name Drugs With Multiple Versions (A-06-09-00033).
  • March 11 - OIG annual compendium of unimplemented recommendations.
  • March 10 - ONC proposed rule establishing certification programs for HIT (75 Fed. Reg. 11328).
  • March 4 - GAO report, Food and Drug Administration: Improved Monitoring and Development of Performance Measures Needed to Strengthen Oversight of Criminal and Misconduct Investigations (GAO-10-221).
  • March 2 - GAO letter report, Group Purchasing Organizations: Research on Their Pricing Impact on Health Care Providers (GAO-10-323R).
  • March 2 - OIG report, Beneficiaries Remain Vulnerable to Sales Agents' Marketing of Medicare Advantage Plans (OEI-05-09-0070).
  • March 1 - GAO report, Medicare Part D: Spending, Beneficiary Cost Sharing, and Cost-Containment Efforts for High-Cost Drugs Eligible for a Specialty Tier (GAO-10-242).
  • February 23 - OIG Advisory Opinions Nos. 10-01, 10-02, 10-03, saying Medigap plans may use preferred hospital networks.
  • February 19 - OIG report, Recovery Audit Contractors’ Fraud Referrals (OEI-03-09-00130).
  • February 17 - GAO report, Electronic Personal Health Information Exchange: Health Care Entities' Reported Disclosure Practices and Effects on Quality of Care (GAO-10-361). 
  • February 12 - OIG report, Average Sales Prices: Manufacturer Reporting and CMS Oversight (OEI-03-08-00480).
  • February 2 - IRS, DOL, HHS interim final rules implementing mental health parity law (75 Fed. Reg. 5410).
  • January 29 - GAO report Patient Safety Act: HHS Is in the Process of Implementing the Act, So Its Effectiveness Cannot Yet Be Evaluated (GAO-10-281).
  • January 26 - CMS notice approving three national accreditation organizations to participate in Advanced Diagnostic Imaging Supplier Accreditation Program (75 Fed. Reg. 4088).
  • January 20 - OIG report, A Comparison Of Medicaid Federal Upper Limit Amounts To Acquisition Costs, Medicare Payment Amounts, And Retail Prices (OEI-03-08-00490).
  • January 20 - OIG report, Outlier Average Manufacturer Prices In The Federal Upper Limit Program (OEI-03-07-00740).
  • January 19 - GAO report, Medicare Advantage: CMS Assists Beneficiaries Affected by Inappropriate Marketing but Has Limited Data on Scope of Issue (GAO-10-36).
  • January 19 - GAO report, Medicaid and CHIP: Enrollment, Benefits, Expenditures, and Other Characteristics of State Premium Assistance Programs (GAO-10-258R).
  • January 13 - CMS proposed rule on HITECH Act incentive payments to eligible providers to adopt EHRs (75 Fed. Reg. 1844).
  • January 13 - HHS interim final rule adopting initial set of standards, implementation specifications, and certification criteria (75 Fed. Reg. 2014).
  • January 13 - OIG fraud alert to DME suppliers about telemarkting prohibition.
  • January 11 - GAO report, Corporate Crime: DOJ Has Taken Steps to Better Track Its Use of Deferred and Non-Prosecution Agreements, But Should Evaluate Effectiveness (GAO-10-110).
  • January 11 - GAO report, Brand-Name Prescription Drug Pricing: Lack of Therapeutically Equivalent Drugs and Limited Competition May Contribute to Extraordinary Price Increases (GAO-10-201).
  • January 5 - OIG report, Adverse Events in Hospitals: Public Disclosure of Information About Events (OEI-06-09-00360).
2009
  • December 30 - OIG report, Medicare Power Wheelchair Claims Frequently Did Not Meet Documentation Requirements (OEI-04-07-00401).
  • December 28 - GAO report, Nursing Homes: Addressing the Factors Underlying Understatement of Serious Care Problems Requires Sustained CMS and State Commitment (GAO-10-70) and questionnaire.
  • December 28 - GAO report, Medicaid Outpatient Prescription Drugs: Second Quarter 2008 Federal Upper Limits for Reimbursement Compared with Average Retail Pharmacy Acquisition Costs (GAO-10-118R).
  • December 28 - GAO report, Medicare Managed Care: Observations about Medicare Cost Plans (GAO-10-185).
  • December 22 - GAO report, Ongoing Federal Oversight of Payments to Offset Uncompensated Hospital Care Costs Is Warranted (GAO-10-69).
  • December 18 - Midyear Formulary Changes in Medicare Prescription Drug Plans (OEI-01-08-00540).
  • December 9 - CMS final rule on Medicare claims appeal procedures  (74 Fed. Reg. 65296).
  • December 9 - GAO report, Drug Safety: FDA Has Begun Efforts to Enhance Postmarket Safety, but Additional Actions Are Needed (GAO-10-68).
  • December 7 - GAO report, CMS Working to Address Problems from Round 1 of the Durable Medical Equipment Competitive Bidding Program (GAO-10-27).
  • December 7 - OIG report, Aberrant Medicare Home Health Outlier Payment Patterns in Miami-Dade County and other Geographic Areas in 2008 (OEI-04-08-00570).
  • November 30 - CMS final rule delaying the effective date of two Medicaid rules that would have given states more flexibility in designing Medicaid benefit packages (74 Fed. Reg. 62501).
  • November 27 - Federal Matching Shares for Medicaid, SCHIP for October 1, 2010 through September 30, 2011 (74 Fed. Reg. 62315).
  • November 25 - Payment Policies Under the Physician Fee Schedule for CY 2010 (74 Fed. Reg. 61738).
  • November 24 - GAO report, Centers for Medicare and Medicaid Services: Deficiencies in Contract Management Internal Control Are Pervasive (GAO-10-60).
  • November 23 - CMS notice withdrawing proposed rule withdrew on definition of Medicaid “rehabilitative services” (74 Fed. Reg. 61096).
  • November 20 - CMS final rule with comment period on the CY 2010 OPPS (74 Fed. Reg. 60316).
  • November 2 - OIG report, Medicare Drug Integrity Contractors’ Identification of Potential Part D Fraud and Abuse (OEI-03-08-00420).
  • November 2 - OIG report, Reassignment of Medicare Benefits (OEI-07-08-00180).
  • October 30 - HHS interim final rule implementing increasing penalty amounts for violating HIPAA in accordance with HITECH Act (74 Fed. Reg. 56123). 
  • October 26 - GAO report, New Drug Approval: FDA Needs to Enhance Its Oversight of Drugs Approved on the Basis of Surrogate Endpoints (GAO-09-866).
  • October 26 - GAO report, Medicare: Per Capita Method Can Be Used to Profile Physicians and Provide Feedback on Resource Use (GAO-09-802).
  • October 23 - OIG Health Care Fraud and Abuse Control annual report (HCFAC report).
  • October 23 - OIG report, Adverse Event Reporting For Medical Devices (OEI-01-08-00110).
  • October 22 - CMS proposed rule revising MA and Part D programs to clarify various participation requirements, specify changes to strengthen beneficiary protections, ensure plan offerings to beneficiaries include meaningful differences, improve plan payment rules and processes, and implement new policies (74 Fed. Reg. 54634).
  • October 22 - GAO report, Oversight of Clinical Investigators: Action Needed to Improve Timeliness and Enhance Scope of FDA’s Debarment and Disqualification Processes for Medical Product Investigators (GAO-09-807).
  • October 20 - OIG report, Medicare Part D Plan Sponsor Electronic Prescribing Initiatives (OEI-05-08-00322).
  • October 14 - OIG report, Medicare Part D E-Prescribing Standards: Early Assessment Shows Partial Connectivity (OEI-05-08-00320).
  • October 7 - OCR proposed rule modifying HIPAA privacy rule to implement Genetic Information Nondiscrimination Act of 2008 (74 Fed. Reg. 51698).
  • October 7 - IRS, DOL, HHS interim final rules with request for comments implementing Genetic Information Nondiscrimination Act of 2008 (74 Fed. Reg. 51644).
  • October 1 - FDA proposed rule on postmarketing safety reporting for combination products (74 Fed. Reg. 50744).
  • September 30 - GAO report, Medicare Physician Services: Utilization Trends Indicate Sustained Beneficiary Access with High and Growing Levels of Service in Some Areas of the Nation (GAO-09-559).
  • September 30 - GAO report, Nursing Homes: CMS’s Special Focus Facility Methodology Should Better Target the Most Poorly Performing Homes, Which Tended to Be Chain Affiliated and For-Profit (GAO-09-689).
  • September 30 - GAO report, Medicaid: Fraud and Abuse Related to Controlled Substances Identified in Selected States (GAO-09-957).
  • September 23 - FDA proposed rule on current good manufacturing practice requirements for combination products (74 Fed. Reg. 48423).
  • September 16 - CMS final rule limiting Medicare recoupments of provider and supplier overpayments (74 Fed. Reg. 47458).
  • September 16 - CMS proposed rule on states' CHIP allotments for FY 2009 through 2013 (74 Fed. Reg. 47517).
  • September 14 - GAO report, Medicaid Preventive Services: Concerted Efforts Needed To Ensure Beneficiaries Receive Services (GAO-09-578).
  • September 8 - OIG report, Medicare Part D Reconciliation Payments for 2006 and 2007 (OEI-02-08-00460).
  • September 8 - OIG reports, Medicare Hospice Care: Services Provided to Beneficiaries Residing in Nursing Facilities (OEI-02-06-00223) and Medicare Hospice Care for Beneficiaries in Nursing Facilities: Compliance With Medicare Coverage Requirements (OEI-02-06-00221).  
  • September 1 - OIG report, MSIS Data Usefulness for Detecting Fraud, Waste, and Abuse (OEI-04-07-00240).
  • August 31 - GAO report, Private Health Insurance: Research on Competition in the Insurance Industry (GAO-09-864R).
  • August 31 - GAO report, Medicare Physician Payments: Fees Could Better Reflect Efficiencies Achieved When Services Are Provided Together (GAO-09-647).
  • August 27 - CMS final rule and interim final rule on hospital IPPS for FY 2010 and changes to LTCH PPS for Rate Years 2010 and 2009 (74 Fed. Reg. 43754).
  • August 21 - GAO report, Health Insurance: Enrollment, Benefits, Funding, and other Characteristics of State High-Risk Health Insurance Pools (GAO-09-730R).
  • August 18 - Advisory Opinion No. 09-13 (Dep’t of Health and Human Servs. Office of Inspector Gen. Aug. 11, 2009) (saying hospital may subsidies affiliated ambulance cooperative).
  • August 14, 2009 - Advisory Opinion No. 09-12, (Dept. of Health and Human Servs. Office of Inspector Gen. Aug. 7, 2009) (allowing copayment subsidies for Medicare Part D enrollees).
  • August 13, 2009 - FDA final rule ammending new drug applicationregulation concerning charging patients for investigational new drugs (74 Fed. Reg. 40872).
  • August 13, 2009 - FDA final rule clarifying the circumstances and the types of costs for which a manufacturer can charge patients for an investigational drug when used as part of a clinical trial or when used outside the scope of a clinical trial (74 Fed. Reg. 40900).
  • August 8, 2009 - Advisory Opinion No. 09-11 (Dep’t of Health and Human Servs. Office of Inspector Gen. Aug. 3, 2009) (approving hospital's provision of free blood pressure screenings).
  • August 7, 2009 - OIG MFCUs report for FY 2008.
  • August 6, 2009 - CMS final rule on FY 2010 Medicare hospice wage index (74 Fed. Reg. 39384).
  • August 6, 2009 - OIG report, Prevalence And Qualifications Of Nonphysicians Who Performed Medicare Physician Services (OIE-09-06-00430).
  • July 29, 2009 -

    Advisory Opinion No. 09-09 (Dep’t of Health and Human Servs. Office of Inspector Gen. July 22, 2009) (approving hospital-physician joint venture).

  • July 28, 2009 - FDA final rule requiring brand-name drug makers to report authorized generics (74 Fed. Reg. 37163)





 
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