drug manufacturers. Sec. 353. Biological product innovation. Sec. 354. Clarifying the meaning of new chemical entity. Sec. 355. Prompt approval of drugs related to safety information. Sec. 356. Conditions of use for biosimilar biological products. Sec. 357. Education on biological products. Sec. 358. Congressional review of the Food and Drug Administration rulemaking. Sec. 359. Government Accountability Office study of rules. Subtitle D—Prescription Drug and Pharmacy Benefit Manager Transparency Sec. 361. Patent disclosure requirements. Sec. 362. Biological product patent transparency. Sec. 363. Orange Book modernization. Sec. 364. Modernizing the labeling of certain generic drugs. Sec. 365. Requirements with respect to prescription drug benefits. Sec. 366. PBM transparency and elimination of DIR fees. Sec. 367. Health plan oversight of pharmacy benefit manager services. Sec. 368. Study by Comptroller General of United States. Subtitle E—Medicare and Medicaid Prescription Drug Reforms Sec. 371. Medicare part B rebate by manufacturers for drugs or biologicals with prices increasing faster than inflation. Sec. 372. Market based part B pricing index. Sec. 373. Innovation model testing of Medicare drug payments. Sec. 374. Modification of maximum rebate amount under Medicaid drug rebate program. Subtitle F—Medical Malpractice Reform Sec. 381. Definitions. Sec. 382. Encouraging speedy resolution of claims. Sec. 383. Compensating patient injury. Sec. 384. Maximizing patient recovery. Sec. 385. Authorization of payment of future damages to claimants in health care lawsuits. Sec. 386. Product liability for health care providers. Sec. 387. Effect on other laws. Sec. 388. Limitation on expert witness testimony. Sec. 389. Expert witness qualifications. Sec. 390. Communications following unanticipated outcome. Sec. 391. Affidavit of merit. Sec. 392. Notice of intent to commence lawsuit. Sec. 393. Limitation on liability for volunteer health care professionals. Sec. 394. Rules of construction. Sec. 395. Effective date. Title